Apollomics, Inc. and Edison Oncology Announce Licensing Agreement for Novel Protein Tyrosine Kinase Inhibitor Targeting Solid Tumors

FOSTER CITY, Calif. and HANGZHOU, China and MENLO PARK, CA, Feb 10, 2021 – (ACN Newswire) – Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Edison Oncology Holding Corp., today announced that Apollomics has been granted worldwide rights, excluding China, Hong Kong and Taiwan, for the development and commercialization of EO1001. EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.

"We are excited to add EO1001 to our clinical development portfolio as its pan-erbB inhibition and well-tolerated preclinical safety profile makes it a potential targeted therapy for the treatment of solid tumor malignancies that overexpress EGFR and/or HER2," said, Sanjeev Redkar, PhD, Co-Founder and President of Apollomics. "In preclinical models, EO1001 is potent against mutations in both the intracellular and extracellular domain of EGFR and has demonstrated activity in tumors with the ability to penetrate the central nervous system. As we advance our clinical development pipeline, we continue to seek assets like EO1001 with clearly defined mechanisms of action and differentiating attributes that we believe can make a difference for cancer patients worldwide. Looking ahead, a Clinical Trial Notification (CTN) Application in Australia will be submitted to initiate a clinical trial in the second quarter of this year."

Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan. Edison Oncology will receive an upfront cash payment and will be eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for EO1001 in the territories.

"Our extensive and successful preclinical work with EO1001 has led us to this collaboration with Apollomics who will now advance the asset into clinical trials with their experienced development team. Over 90% of solid tumors overexpress erbB pathways, and with the data we have produced to date, we are confident that EO1001 has the potential to improve treatment outcomes for patients suffering from life-threatening cancers," concluded Jeffrey A. Bacha B. Chief Executive Officer of Edison Oncology.

About EO1001
EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, and against mutations in the extracellular domain of EGFR including the EGFR-variant III (EGFRvIII) mutation that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well tolerated and demonstrated activity against treatment-resistant ErbB-driven tumors, including malignancies in the central nervous system, in vivo.

About Edison Oncology

Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients.

About Apollomics, Inc.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

Edison Oncology Contacts:

Company Contact:
Jeffrey Bacha
Chief Executive Officer
(650) 690-1927
jb@eohc.com

Media and Investor Relations Contact:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com

Apollomics Contacts:

Investor Contact:
Wilson W. Cheung
Chief Financial Officer
(650) 209-4436
wcheung@apollomicsinc.com

U.S. Media Contact:
Remy Bernarda
Corporate Communications
(415) 203-6386
remy.bernarda@apollomicsinc.com

China Media Contact:
Porda Havas International Finance Communications Group
Kelly Fung
General Manager
(852) 3150 6763
kelly.fung@pordahavas.com

Phoenix Fung
Assistant Vice President
(852) 3150 6773
phoenix.fung@pordahavas.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Two Immigrants, One Unique Plan For A Biopharma

HONG KONG, Feb 2, 2021 – (ACN Newswire) – The American Dream is why the United States is considered the "land of opportunity," and why for centuries immigrants have flocked to our shores seeking their fortunes. Guo-Liang Yu, Ph.D., (China), and Sanjeev Redkar, Ph.D., (India), came to the U.S. in the 1980s. By anyone's reasonable measure, both have achieved the American Dream. However, their dream as scientists remained at arm's length. Their desire? Create a pharmaceutical company that leverages the best of what the U.S. and China have to offer toward discovering and developing new oncology therapeutics, while using the smallest drug development program possible to do so. This is the story of how the scientific careers of an intrapreneur (Redkar) and an entrepreneur (Yu) came together to cofound and co-lead Apollomics.

Guo-Liang Yu, Ph.D., (China), and Sanjeev Redkar, Ph.D., (India), came to the U.S. in the 1980s. By anyone's reasonable measure, both have achieved the American Dream. However, their dream as scientists remained at arm's length.

"The American Dream is that dream of a land in which life should be better and richer and fuller for everyone, with opportunity for each according to ability or achievement." — James Truslow Adams

From Immigrant To Biopharma Intrapreneur

After arriving in the U.S. in 1989, Redkar completed his M.S. and Ph.D. degrees in chemical engineering and took a job as a research scientist with Matrix Pharmaceutical in the San Francisco Bay area. While those were formative years, it wasn't until 1998 when he joined SuperGen that the scientist embarked on his intrapreneurial journey. "We had a lab where we were coming up with novel formulations for cancer drugs," he recalls. "We formed an internal group, and I started filing and prosecuting a lot of patents." Prosecuting in the sense that he worked closely with company lawyers to figure out what was needed to get SuperGen's IP protected. Realizing he had much to learn, he took a week-long intensive course on patents. This helped him understand the importance of the Manual of Patent Examining Procedure (MPEP), which is the "Bible" for patent attorneys and agents. Being able to apply this skill is one reason he holds more than 200 patents today.

Redkar's stint at SuperGen (later renamed Astex Pharmaceuticals) lasted almost 18 years. "We had a lot of commercial programs for the oncology drugs we were bringing to market, so I got to work closely with my commercial colleagues, an experience I'd advocate for all scientists." This experience was, in part, why he went back to get an MBA in 2008. "If I wanted to be a leader in biopharma, I knew I needed to become more of a generalist in my knowledge base and experience."

After holding senior level positions in various areas such as preclinical development, operations, and manufacturing, something interesting happened in 2011. "I had built a group in Pleasanton, CA and had begun filing patents to fill the R&D pipeline of Montigen Pharmaceuticals, a company we had acquired within SuperGen." His group also had a lab in Utah, and the two began collaborating on small molecule discovery. But then SuperGen merged with Astex.

Pharmaceuticals leaving the company with four R&D operations. The decision was made to consolidate those four down to two, which meant closing the 20-person lab Redkar had built. "At that point I thought, maybe I should try my stint as an entrepreneur," he states. His idea was to find a compound that would fit into that lab, thereby keeping most of the team intact, while building a company around it.

Working his network, Redkar came across a cytidine deaminase inhibitor (E-7727) owned by Eisai that made it possible to deliver cytosine-based nucleoside drugs in an oral pill. Eisai had decided to cut the program and were not going to make the payment to keep patent protection in place. Redkar saw potential. "We had worked on an oral cytidine hypomethylating agent for a long time, and we could combine it with E-7727 into one pill and form a small company around it." He negotiated the terms with Eisai, and with the Astex CEO's blessing, began creating a pitch deck. There was an understanding that he would found the new company outside of Astex, and Astex could choose whether or not to invest.

Redkar began forming a team, building out a board, keeping his CEO in the loop while also continuing to do his day job and pitching investors. "I thought I could put together a development program for about $500,000." Considering Eisai had done a lot of work already on the asset, Redkar felt he could convince the FDA to utilize that information, along with the data from his company's drug, to prove the drug's safety in a combined form. That way, the company could work toward gaining an approval using a small Phase 3 trial of maybe 100 patients.

About a month into the process, Redkar received a call from Astex' CEO asking, "What if Astex pays the half a million? If the program is as good as you say it is, convince some folks internally, convince the FDA, and then we can help you form the company." His first entrepreneurial journey suddenly shifted back to that of the intrapreneur, having to convince colleagues that this two-drug oral combination was something of value. "People were not easily convinced, because we were working on a lot of new drugs and new pathways." Fast-forward to the summer of 2020 and the drug, INQOVI, finally gained FDA approval for myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Although Redkar had left the company in 2016 to start his entrepreneurial journey in earnest, he takes delight in seeing his former colleagues succeed at bringing a new oral treatment to patients using only a 133-patient registration study.

Guo-Liang Yu – The Making Of An Entrepreneur

Guo-Liang Yu, Ph.D., cofounder, Chairman and CEO of Apollomics, came to the U.S. in 1984 to complete a Ph.D. "I joined Dr. Elizabeth Blackburn's lab, and contributed quite a bit to her and Carol Greider winning the Nobel Prize in physiology or medicine in 2009." Following a post-doc at Harvard, Yu was poised to become an academician, but got recruited to become a gene hunter at Human Genome Sciences (HGS) in 1993.

At HGS, Yu and colleagues sought to find genes with interesting biological function. Those newly identified molecules would then serve as drug targets to treat various diseases. He also continued his education, as HGS, being in Rockville, MD, was not far from Johns Hopkins University. "I took night classes for business law and marketing for a year to gain a better understanding for how businesses work." He became very interested in patents, inventors, and inventions, and his "education" in that respect would continue as he worked at HGS. "When we were sequencing genes at HGS, we were taught to file patents on any molecule that looked interesting, along with how to do additional experiments to have strong claims protection." As a result, today Yu is associated with more than 500 patents and has become an expert at strategizing IP protection. "When younger companies come to me for help, I always encourage them to build a strong patent portfolio."

One of the molecules was Benlysta, which eventually was approved by the FDA. "Today, it remains the only drug discovered through the human genome project and is the only treatment for systemic lupus erythematosus (SLE)," he attests. Yu credits HGS as his first exposure to entrepreneurship. "I witnessed how HGS needed a multinational like GSK and support of the chemical market to bring a treatment to market." And being that HGS was still very much a startup when he first joined, he also got to observe how management made decisions.

Preferring the Bay area, Yu moved back West and joined Mendel Biotechnology in 1998, before starting his first company, Epitomics, in 2001. "That was my first actual entrepreneurial experience that involved raising money, building a budget, delivering on what was promised operationally, and figuring out how to grow the company." The company had two primary activities, building research tools and diagnostic reagents and developing therapeutic antibodies. The life science part was sold to Abcam in 2012 for about $170 million, while the therapeutic arm was spun out as Apexigen, an immuno-antibody company that is still in existence.

Having provided a fine return for investors and himself, Yu was recruited to join a CRO, Crown Biosciences in 2013. "At the time, many Chinese scientists who had trained in the U.S. were going back to China and building CROs to provide services to larger companies looking to enter the market," he explains. But according to Yu, being good at science and being good at business are two different things, and as Crown wasn't doing well financially, the board hired him in hopes he could turn it around. The process took about three years. Yu's plan was to do what he had done with Epitomics – spin out a therapeutics company. But that new company would need a CEO.

Biopharma Startup Requires The Connecting Of "Preneurs"

Redkar and Yu met while each was serving on the advisory board of the University of Pacific (UOP) School of Pharmacy. Yu had told the dean of the college he was looking for a CEO for a startup, and asked if there was someone he could recommend. "He said, 'Why don't you see if Sanjeev is willing to jump out of a large pharma to become an entrepreneur," Yu recalls.

At the time, Redkar was looking to pivot from being an intrapreneur to an entrepreneur, and Yu already was the cofounder on more than two dozen companies. The two began discussing entrepreneurship, and the topic of Crown Biosciences eventually came up. Crown had some oncology assets and was interested in seeing how these could be developed outside of China. Having spent his entire career focused on oncology, Redkar's interest was piqued. "I spent the next three months reviewing information, got my China visa, and went over for a visit," he elaborates. Seeing what he thought were gaps, Redkar spent the next four months creating a plan for how these compounds could be developed, along with how he'd pitch investors. He gave a convincing presentation to Crown's board in 2015, and the decision was made to spin out the company. Redkar would be given some seed funding to lead the effort to build a team in the U.S.

But leaving an 18-year career as an intrapreneur was not an easy decision, because by now Astex had been acquired by Otsuka, and he had gained a fondness for how this company valued people. Plus, Otsuka was doing well financially. "I knew that becoming the CEO of a startup was going to involve a huge step down in salary and benefits," he shares. He also understood that taking this position would place him in in a more generalist role, and if things didn't work out, it may have been difficult to go back and apply for jobs as a domain expert. He deliberated for about a month, speaking to mentors, entrepreneurs, board members, and his family as he weighed the decision.

Resigning from Otsuka at the end of 2015, Redkar attended the annual J.P. Morgan healthcare conference (JPM) in January 2016. There, Yu introduced him to some people from OrbiMed, a life science venture capital group. Subsequently, Redkar conducted a formal presentation of the startup to OrbiMed. "I had begun putting together a development plan, but at that point, I was a single-person company." He remembers the presentation involving about 15 to 20 people from OribMeds' India, Asia, and New York offices, and how they deliberated about investing in a one-person company, something they, "normally never do." But given Yu's consistent success, they decided to make an exception, and agreed to provide the company $10 million to fund its series A. At the time, the company was registered in the Cayman Islands as CB Therapeutics (the CB coming from Crown Biosciences), and one of Redkar's first tasks was to register the company in the U.S. Unfortunately, that name was taken. "I quickly had to decide upon a new name, which is how we ended up with CBT Pharmaceuticals."

From One-Person Company To $125 Million Series C

Working as CEO, Redkar grew the company to seven employees and several pipeline assets by the end of 2017. At the same time, Yu was running Crown Biosciences, but near the end of 2017 the company was acquired. Redkar seized on this opportunity to get Yu more actively involved in CBT. "He was chairing our board, but I asked if he'd come on as CEO," Redkar says. In turn, Redkar would take the position of president, and the two would apply a co-leadership approach. "I wasn't really sure how this would work, but we determined that I would focus on all development and operational activities, while Yu would spearhead the funding along with building out an office in Hangzhou China. We'd collaborate on building the company's strategic path."

That plan worked out well, as early 2109 brought an announced $100 million series B – and a new name. "We were trying to come up with a better name for the company, and we recalled that our first combination trial was called APOLLO, derived from the Greek God of healing," explains Redkar. That was written on the whiteboard. "Apollymi means to destroy," he adds. That, along with others, also were added to the whiteboard. "Omics is a term used for large amounts of biological data, a coming together, if you will." The three words were combined to come up with Apollomics, signify a group of people coming together to destroy cancer.

Now, with a new name and $100 million in the bank, the next steps were to hire a CFO and chief medical officer. These positions were filled in 2019, and by Q3 of 2020, the company had grown to approximately 50 employees, with about 30 in the U.S. and 20 in China. It even completed a $125 million series C financing in Nov. 2020, and has plans for building out R&D and manufacturing operations in China.

"Our dream is to build Apollomics into a cross-border innovation engine between China and the U.S., by conducting small clinical trials with equal representation between the two countries so a package can be registerable anywhere in the world," Redkar says. For example, in January 2020, Apollomics announced an exclusive collaboration and license agreement with GlycoMimetics to develop and commercialize Uproleselan and GMI-1687 in greater China. GlycoMimetics already had received an FDA breakthrough therapy designation for uproleselan for relapsed/refractory acute myeloid leukemia (AML) in 2017 and has started a Phase 3 global clinical trial for uproleselan for that breakthrough indication. "We've negotiated with China's National Medical Products Administration [NMPA] to do a Phase 3 bridging study for the same compound [APL-106 in the Apollomics portfolio] in combination with chemotherapy in r/r AML, with plans to borrow data readouts from the GlycoMimetics global trial to bridge our Phase 3, significantly speeding China development."

Sounds like the entrepreneur is borrowing from his intrapreneurial toolbox. One compound at a time, Redkar and Yu move ever closer to achieving what every scientist dreams of – making a positive difference for humankind. And if you think about it, doesn't that seem well aligned with what many Americans dream of?

"So even though we face the difficulties of today and tomorrow, I still have a dream. It is a dream deeply rooted in the American dream." — Martin Luther King, Jr.

Sidebar 1: Leveraging The Best Of The U.S. And China

"We wanted to create a biopharmaceutical company with a slightly different business model," says Guo-Liang Yu, Ph.D., cofounder and CEO of Apollomics. The company wanted to be in the U.S., as that is where the best scientific expertise and thinking still resides. But with China having more than 500 million people residing below poverty, that is where the most significant impact on global health can be had. However, Yu realized that, given the current state of geopolitical affairs, it would be difficult to run a business in China. Besides, Yu hoped that by having operations in both countries, the Chinese team could learn the best practices of their U.S. counterparts, and then apply those in developing products best suited for the Chinese market.

Given the current market, raising money does not seem to be a challenge for Yu. All of the funds Apollomics has raised thus far (i.e., $235 million) is of Chinese origin, although in U.S. dollars. "Sanjeev [Redkar] is handling the clinical operations and U.S. buildout, while I've been taking care of most of the finances and the China buildout," Yu says.

One challenge they are experiencing is the big difference in market perceptions of value between the two countries. In the U.S., very few biotechs are willing or able to move into clinical development with multiple assets. "Most senior leaders and board members will typically agree that we should focus all our resources on the most promising asset." But Yu says that's not the culture of a Chinese biotech. "If you look at all the public Chinese biotechs, they have at least a dozen assets/molecules moving toward clinical development." From his U.S.-trained perspective, having too many assets moving toward the clinic sends the signal that you really don't have a strong lead candidate to begin with. "It is just a show, and something I still struggle with, as I have to think about how I'm being perceived as an entrepreneur to Chinese investors who might not yet see things the same as their U.S. counterparts." So, one of the challenges is that by having operations in both countries, the company will be compared to other Chinese biotechs with lengthy pipelines, many of which Yu says don't even make sense scientifically. "In China, some companies will count their assets as a means of deriving valuation to investors," he explains. Regardless, he says the Apollomics approach is to put most of the company's resources into its lead product, as that is the product that will either make or break the company.

Sidebar 2: Entrepreneurs Need To Be Good Storytellers

Guo-Ling Yu, Ph.D., is a highly successful entrepreneur who has served as co-founder of more than two dozen companies and made successful exits from at least two that provided handsome returns for investors and himself. But a venture never gets off the ground without money. And getting investors to want to give money requires an entrepreneur to be a good storyteller. With complicated science, sometimes this means having to "dumb things down." Yu says when preparing to pitch his approach is to think from a layperson's point of view and use a variety of metaphors. He then tests them to see which resonate best. This requires practice. "Try thinking about how you can ask a question so the other side can answer using the metaphor. That way you are facilitating communication and understanding instead of just forcing people to listen to what you have to say."

Yu adds that leading in an entrepreneurial setting requires a whole different set of skills – and a willingness to change old habits. "You need to find a way to treat employees so that, if there are business challenges, they don't immediately want to jump ship. And you need to make sure they are having fun while still putting in the long hours and workweeks that a startup requires."

One more trait of a good entrepreneur is the ability to teach everyone in the company the importance of being frugal. Yu's approach was to be overly transparent. For example, he remembers raising $1 million dollars for his very first startup, Epitomics. "I called a staff meeting and said, "I have good news and bad news. The good news is we now have $3 million. The bad news is that we as a company now have to generate a certain level of revenue and results if we hope to stay alive." According to Yu, most scientists don't often worry about the revenue component, because that's not their responsibility. But in a startup, you need to train your scientists why they need to care about it, because biotech is a game of survival, and money needs to be stretched as far as possible to get to the next raise.

Finally, Yu says that being a good entrepreneur requires a change in mindset, from inductive thinking to deductive thinking. "Inductive thinking is: We have this technology, now what can we develop to sell to the market," Yu explains. "Deductive thinking is: Here's a market with an unmet need. Now, how can that need be satisfied?" In other words, inductive thinking is a solution in search of a problem, while deductive thinking begins with the end in mind.

BTPP 1: Have You Heard Of The Chinese Biopharmaceutical Association (CBA)?

The Chinese Biopharmaceutical Association (CBA) is one of the largest Chinese American professional associations in the U.S. (www.cba-usa.org). It was founded in 1995 by Guo-Liang Yu, Ph.D., who today is the cofounder and CEO of Apollomics, an oncology therapeutic discovery and development company (to be featured in an upcoming issue of Life Science Leader). But back then, he was still at his first job, working as a "gene hunter" at Human Genome Sciences (HGS) in Rockville, MD. "At the time, HGS had a good group of Chinese scientists who had come from all over the country. Plus, with AstraZeneca, MedImmune, and the FDA and NIH nearby, it was a very nice biopharmaceutical community." As such, Yu began discussing with his friends and colleagues the idea of forming some sort of association. "We could help one another as we became entrepreneurs, along with helping to bridge the gap between the U.S. and China, and academia and industry." Twenty-five years later, CBA remains headquartered in Maryland, but now boasts more than 700 active members, over 8,000 registered individual members, and more than 100 institutional members. While most hail from the nearby geography, the association now has chapters in Canada and China. "When you set up such an organization, it is really important to put some thought around the bylaws." For example, Yu only stayed one term as president, and insisted that each subsequent president do the same. "A CBA president needs to give to the community and grow themselves as leaders, but by limiting that responsibility to just a year, many more will gain the opportunity to learn, grow and lead," he contends. "Every single CBA president has become successful, and many have gone on to found companies, with at least three now having gone public," Yu contends.

BTPP 2: We Need To Expand How We Value Companies

During an interview for an upcoming feature in Life Science Leader, Sanjeev Redkar, Ph.D., cofounder and president of Apollomics (a biopharmaceutical company discovering and developing oncology treatments), discussed the topic of an exit strategy. "Are you looking to exit or leave a legacy?" I queried. "To build something," he replied. But the question must have touched a nerve, as Redkar began to opine about how biopharmaceutical companies are valued. "We always evaluate companies based on their PE ratios, speed to market, return, stock price, and all that, but there is no value assigned to the social impact a company has," he contends. Take J&J for example, which employs about 100,000 people globally. Depending on the size of the families associated with all those employees, that could equate to J&J helping to feed half a million people. "If J&J's stock price goes up by 5%, and another public company employing 50 people goes up by 5%, the market treats them the same. But the social impact had by J&J is much more significant. As a society, this is something we need to figure out." Redkar says that if you go to any financial or investment website, none will have anything recognizing the social impact those companies have on people. "Maybe we need a PE ratio to the number of employees employed," he considers. "Sure, we've talked about being green, and there are metrics to measure a company's sustainability, but that misses much of what I see as 'social impact.'"

By Rob Wright, Chief Editor, Life Science Leader
Follow Him On Twitter @RfwrightLSL

Be sure to not miss the upcoming feature about Apollomics and Sanjeev Redkar by subscribing to Life Science Leader today. For more information, please find the links below:

– This article: https://www.lifescienceleader.com/doc/two-immigrants-one-unique-plan-for-a-biopharma-0001
– The full publication, digital edition: http://digitaledition.qwinc.com/publication/?m=53489&i=690286

Source: Life Science Leader, Magazine Article | February 1, 2021

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Shanghai Longyao Chief Scientist Professor Xuanming Yang published a research article on optimizing CAR-T cells function with independently expressed full-length OX40

HONG KONG, Jan 29, 2021 – (ACN Newswire) – China Biotech Services Holdings Limited ("CH BIOTECH SER" or "Company", stock code: 8037.HK) non-wholly-owned subsidiary Shanghai Longyao Biotechnology Co., Ltd. ( "Shanghai Longyao"), the Chief Scientist Professor Xuanming Yang published a CD20-CART-OX40 related research article on January 27, 2021, EST, on Science Translational Medicine. Professor Yang found that an independently expressed full-length OX40 not only enhanced the cytotoxicity of CAR-T cells, it also reduced the exhaustion markers, thereby maintaining their function in immunosuppressive tumor microenvironment. In mouse tumor models and in patients with metastatic lymphoma, these CAR-T cells exhibited robust amplification and antitumor activities. The findings provide an alternative option for CAR-T optimization with the potential to overcome the challenge of treating solid tumors.

LY007 Cellular Injection is a chimeric antigen receptor T-cell (CAR-T) injection and is mainly used in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and metastatic follicular lymphoma. LY007 Cellular Injection has been developed independently by Shanghai Longyao and incorporates its patented OX40 co-stimulatory signal design. Experiments have proved that the design enhances the efficacy of the Product without compromising safety. According to the clinical trial application of LY007 Cellular Injection, Shanghai Longyao will commence Phase I clinical trial and study of LY007 Cellular Injection based on the submitted proposal. On January 21, 2021, the National Medical Products Administration's approval of Shanghai Longyao's clinical trial application for LY007 Cellular Injection demonstrates Shanghai Longyao's capabilities in the research and development of immunocellular drugs.

For further information about the CD-20-CART-OX40 related research article of Professor Yang Xiaoming, please visit the website of Science Translational Medicine https://stm.sciencemag.org/content/13/578/eaba7308

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

China Biotech Services LY007 Cell Injection Obtained Clinical Trial Approval Letter

HONG KONG, Jan 28, 2021 – (ACN Newswire) – China Biotech Services Holdings Limited ("CH BIOTECH SER" or "Company", stock code: 8037.HK) non-wholly-owned subsidiary Shanghai Longyao Biotechnology Co., Ltd. ( "Shanghai Longyao") received an approval letter from the National Medical Products Administration for a clinical trial of the Company's LY007 Cellular Injection on January 21, 2021, which is registered as a Class I new drug. LY007 Cellular Injection is mainly used for the treatment of non-Hodgkin lymphoma. It is currently the first and only CD20-targeted CAR-T product whose application for a registered clinical trial has been approved in China.

LY007 Cellular Injection is a chimeric antigen receptor T-cell (CAR-T) injection and is mainly used in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and metastatic follicular lymphoma. LY007 Cellular Injection has beenwas developed independently by Shanghai Longyao and incorporates its patented OX40 co-stimulatory signal design. Experiments have proved that the design enhances the efficacy of the Product without compromising safety. According to the clinical trial application of LY007 Cellular Injection, Shanghai Longyao will commence Phase I clinical trial and study of LY007 Cellular Injection based on the submitted proposal.The National Medical Products Administration's approval of Shanghai Longyao's clinical trial application for LY007 Cellular Injection demonstrates Shanghai Longyao's capabilities in the research and development of immunocellular drugs.

According to a research report issued by China Merchants Bank on CH BIOTECH SER on November 20, 2020, the analyst recommended to watch for the results of the LY007 Cellular Injection clinical trial which could enhance the company's market value. The report also pointed out that the company's current market capitalization is slightly less than US$200 million while market capitalization of CAR-T comparable companies listed on the main board of the Hong Kong Stock Exchange is between US$600 million and US$1.4 billion. The current market value of CAR-T comparable Chinese companies listed on NASDAQ is approximately US$3.5 billion.

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

New benchmark set to deliver optimal osteoporosis care throughout Asia Pacific

The Asia Pacific Consortium on Osteoporosis (APCO) has today (Thursday, January 28, 2021) launched the first pan-Asia Pacific clinical practice standards for the screening, diagnosis, and management of osteoporosis, targeting a broad range of high-risk groups.

Published in Osteoporosis International today, ‘The APCO Framework’ comprises 16 minimum clinical standards set to serve as a benchmark for the provision of optimal osteoporosis care in the region.

Developed by APCO members representing key osteoporosis stakeholders, and multiple medical and surgical specialities, this set of clear, concise, relevant and pragmatic clinical standards aims to support national societies, guidelines development authorities, and health care policy makers with the development of new guidelines, and to encourage the revision of existing guidelines.

According to the Framework lead author, APCO Chairperson, and Director of the Osteoporosis and
Bone Metabolism Unit at Singapore General Hospital, Dr Manju Chandran, Singapore, APCO employed a
5IQ analysis and the well-established Delphi Consensus process to analyse the 18 clinical practice guidelines currently available in the Asia Pacific region, to inform the development of The APCO Framework.

“Utilising a comprehensive, four-round Delphi consensus method enabled our APCO members who work in vastly different health care systems, to reach a remarkable level of consensus on a benchmark set of clinical standards for the provision of quality osteoporosis care for the Asia Pacific region.”

The APCO Framework offers clinicians structured, well-articulated, and readily accessible clinical practice guidelines that define:
o Individuals to be identified for assessment;
o Investigations required;
o Relevant indications for treatment;
o Appropriate selection of interventions to be made;
o The guidance and information patients need for self-care;
o Integration of healthcare systems for optimal provision of care; and
o The need, and methods for monitoring and improving the quality of osteoporosis care.

“Implementation of The APCO Framework, or a similar set of standards of care informed by the Framework, is expected to significantly reduce the burden of osteoporosis not only in the Asia Pacific region, but also worldwide. We hope that the Framework can serve as a stimulus for harmonisation of guidelines in other regions that have similar socio-economic diversity and heterogeneity of health care resources,” Dr Chandran said.

Globally, the population aged 65 years or over increased from six per cent in 1990, to nine per cent in 2019.(1)
This proportion is projected to rise to 16 per cent by 2050,(1) meaning one in six people worldwide will be aged
65 years or over by 2050.(1) The number of people aged 60 years and over in the Asia-Pacific region – home to
more than a third of the world’s population aged 65 years and over, and to more elderly people than any other region(2) – is predicted to triple between 2010 and 2050, reaching a staggering 1.3 billion people.(3)

Osteoporotic fractures among Asia-Pacific populations are expected to increase exponentially, not only because of the region’s rapidly aging population, but also due to mounting urbanisation, and the subsequent increase in sedentary lifestyles.(4)

Despite the presence of generally safe and effective treatments for osteoporosis, as many as five in six patients presenting to their primary care physician (PCP), or to a hospital with a fragility fracture, will not be assessed for osteoporosis, nor appropriately managed to prevent further fracture.(5)

According to Medical Director of Osteoporosis Australia, and APCO Executive Committee member,
Professor Peter Ebeling AO, Australia, as many as half of those who have sustained a hip fracture, have already experienced a previous fracture at other skeletal sites.

“In fact, a prior fracture at any site is associated with a doubling of future fracture and mortality risk. The unfortunate ramifications of the gross under-diagnosis and under-treatment of osteoporosis is that a large number of people sustain further debilitating secondary fractures, which places a substantial, but importantly, preventable burden on already strained healthcare systems,” said Prof Ebeling.

A fragility fracture, which occurs every three seconds worldwide,(6) compromises quality of life and loss of independence.(6),(7) Concerningly, one-in-four patients who sustain a hip fracture die within a year, and less than half of those who survive, regain their previous level of function.(8),(9) In 2010, an estimated 158 million people aged
50 years and above were at high risk for osteoporotic fracture – a figure which is set to double by 2040.(10)

According to International Osteoporosis Foundation (IOF) CEO and APCO Executive Committee member,

Dr Philippe Halbout, Switzerland, these alarming statistics, coupled with the anticipated, exponential rise in osteoporotic fractures among Asia-Pacific populations, warrant a standardised set of minimum clinical standards for the region.

“Anecdotal evidence to date reveals significant inconsistencies in osteoporosis clinical practice guidelines in the Asia Pacific region, which vary widely in scope and recommendations. This was confirmed when we analysed the 18 guidelines.

“Implementation of the minimum clinical standards proposed by The APCO Framework, and reform of existing guidelines, will support clinical improvement initiatives, while also paving the way for a more holistic approach to osteoporosis care, and ultimately, greater consistency across all national and regional clinical practice guidelines in the region,” Dr Halbout said.

To download or access The APCO Framework, head to www.apcobonehealth.org/apco-framework

To learn more, visit www.apcobonehealth.org or follow APCO on LinkedIn: asia-pacific-consortium-on-osteoporosis

About APCO

The Asia Pacific Consortium on Osteoporosis (APCO) comprises osteoporosis experts from several countries and regions in the Asia Pacific, charged with developing tangible solutions to the substantive challenges involving osteoporosis management and fracture prevention in this most populated and fastest growing part of the world. APCO’s mission is to engage with relevant stakeholders, including healthcare providers, policy makers and the public, to help develop and implement country and region-specific programs for the prevention and treatment of osteoporosis, and its complication of fragility fractures, in the Asia Pacific.

About IOF

The International Osteoporosis Foundation (IOF) is the world’s largest non-governmental organisation dedicated to the prevention, diagnosis and treatment of osteoporosis and related musculoskeletal diseases. IOF’s mission is to promote bone and musculoskeletal health as a worldwide priority.

The 5IQ analysis and Delphi consensus process

The 5IQ exercise assessed the extent of disparity when comparing the national guidelines currently available throughout the Asia Pacific region.

The Delphi technique (a structured communication technique using a systematic, interactive forecasting method reliant upon an expert panel) was employed to achieve APCO member consensus for the development of clinical standards of care.(11)

EXPERTS AVAILABLE FOR INTERVIEW

Dr Manju Chandran – APCO Executive Committee Chairperson, Senior Consultant, Department of Endocrinology, Director, Osteoporosis & Bone Metabolism Unit, Singapore General Hospital, SINGAPORE

Dr Philippe Halbout – Chief Executive Officer (CEO), International Osteoporosis Foundation (IOF), APCO Executive Committee member, SWITZERLAND

Prof. Peter Ebeling AO – Medical Director, Osteoporosis Australia & APCO Executive Committee member, AUSTRALIA

Dr Zhao Yanling – Obstetrician & Gynaecologist, Beijing United Family Hospital, & APCO Member, Beijing, CHINA

Prof. Atsushi Suzuki – Professor & Chair, Department of Endocrinology & Metabolism, Fujita Health University & APCO Member, JAPAN

Prof. Yoon-Sok Chung – Professor, Department of Endocrinology & Metabolism, Director, Ajou Institute on Aging, Ajou University Medical Center & APCO Member, SOUTH KOREA

Dr Hew Fen Lee – Consultant Endocrinologist, Puchong Medical Specialist Centre, Subang Jaya Medical Centre & APCO member, MALAYSIA

Dato’ Dr. Lee Joon-Kiong – Consultant Orthopaedic Surgeon, Beacon Hospital & APCO Member, MALAYSIA

Dr Nigel Gilchrist – Specialist Consultant Physician, Canterbury District Health Board & APCO ExecutiveCommittee Member, Christchurch, NEW ZEALAND

Mr Paul Mitchell – Adjunct Senior Lecturer, School of Medicine, University of Notre Dame Australia & APCO Executive Committee Member, Auckland, NEW ZEALAND

MEDIA CONTACTS & INTERVIEWS

Kirsten Bruce & Mel Kheradi, VIVA! Communications, Sydney, Australia
T +61 (0)401 717 566; +61 (0)421 551 257
E: kirstenbruce@vivacommunications.com.au; mel@vivacommunications.com.au

DOWNLOAD THE APCO FRAMEWORK DIGITAL MEDIA KIT: www.apcoframeworkmediakit.org

References:
(1) United Nations – Department of Economic and Social Affairs, World Population Ageing 2019 Highlights. 2019.
(2) World Bank Group, Live Long and Prosper – Aging in East Asia and Pacific. 2016.
(3) United National Population Fund (UNFPA) Asia & the Pacific. Ageing. [cited Nov, 2020]; Available from: https://asiapacific.unfpa.org/en/node/15208.
(4) International Osteoporosis Foundation, The Asia-Pacific Regional Audit: Epidemiology, costs & burden of osteoporosis in 2013. 2013. p. 1-128.
(5) Royal Australian College of General Practitioners & Osteoporosis Australia, Osteoporosis prevention, diagnosis and management in postmenopausal women and men over 50 years of age. 2017.
(6) International Osteoporosis Foundation (IOF). Capture the fracture. [cited Jan, 2020]; Available from: https://www.capturethefracture.org/about.
(7) Madureira, M.M., R.M. Ciconelli, and R.M.R. Pereira, Quality of life measurements in patients with osteoporosis and fractures. Clinics (Sao Paulo, Brazil), 2012. 67(11): p. 1315-1320.
(8) National Osteoporosis Foundation, NOF’s Clinician’s Guide to Prevention and Treatment of Osteoporosis.
(9) Australian Institute of Health and Welfare. Musculoskeletal fact sheet. Osteoporosis. [cited Jan, 2020]; Available from: https://bit.ly/3qQOqbi
(10) Oden, A., et al., Burden of high fracture probability worldwide: secular increases 2010-2040. Osteoporos Int, 2015. 26(9): p. 2243-8.
(11) Royal College of Obstetricians and Gynaecologists. The Delphi technique. 2005 [cited Jan, 2020]; Available from: https://bit.ly/39hWags

Heathrow Covid Chaos British Tech Co Has Solution

MANCHESTER, UK, Jan 22, 2021 – (ACN Newswire) – British tech company VST Enterprises (VSTE) warned airlines and the travel industry in December of last year of 'Covid related security threats' prior to the chaotic scenes that unfolded at Heathrow airport (Monday 18th Jan).

Tech boss and CEO Louis-James Davis warned of the very real and serious threats facing airlines, airports and passengers from fake Covid 19 test certificates, vaccination record cards, social distancing breaches and the use of health passports with 'un safe' QR and bar code technology. He also warned of the serious implications of potential data breaches using 'unsecure' code scanning technology in health passports.

Passengers arriving into the UK this week (Monday) were faced with unprecedented scenes at Heathrow airport with long delays, social distancing rules breached, altercations between passengers and border officials, GBP500 on the spot fines and passengers being refused entry to flights for holding invalid Covid 19 certificates. The chaos came as the British Government put in place tough new measures for entry into the UK in a bid to get a grip of the pandemic and prevent the further spread of infection. Passengers were required to provide verifiable proof of their Covid 19 negative test result.

VSTE developed and launched the worlds first secure digital health passport called V-Health Passport(TM) in April (2020) both for passengers and airlines which authenticates a persons health status including Covid test status and their vaccination records all within a secure digital passport. The V-Health Passport(TM) 'cross border' technology can be used across all air, land and sea transport infrastructure. The V-Health Passport(TM) has over 200 clinics across the UK where a person can book a Covid test – including a PCR based test – and be recognised as 'FIT TO FLY' by all International airlines. VSTE believes its solution can solve the global airline and travel issue.

V-Health Passport(TM) will shortly start its roll out program of secure health passport across number of airlines and airports globally. In the UK it has already started this programme and is available through its healthcare testing partners Salutaris People www.salutarispeople.com and Akea Life at www.akealife.co.uk both at Newcastle and Liverpool John Lennon airports.

Both healthcare partners also offer full airline travel Covid testing at their own clinics with PCR based testing for airline travel with a V-Health Passport(TM). They also supply 'home test kits' which are supervised over Zoom calls.

It is the first company in the world to have a fully functioning and secure LIVE health passport that carries a persons Covid test status and vaccination record in one secure app. Most importantly the technology is GDPR compliant and was built on a privacy framework of 'Self Sovereign Identity' where the person – or airline passenger – can choose what information they want to share, when they want to share it and with who. Privacy by design is at the forefront of the V-Health Passport(TM) framework unlike other health passport technologies.

V-Health Passport(TM) is a test and vaccine agnostic platform working with all Covid 19 protocols from PCR to rapid antigen and antibody tests which can also authenticate a persons vaccine immunisation record. V-Health Passport(TM) is also the most secure passport technology in the world unlike bar codes and QR codes which are subject to a process called 'Attagging' where a QR code can be cloned and faked. Using the VCode(R) cyber coding, it works on a 'closed loop' system with 'end-to-end' encryption and has over 2.2 Quintillion variations of codes that are subject to many scanning permissions making it impossible to hack the front or back end.

V-Health Passport(TM) is 10 seconds faster than any code scanner and can also be scanned within and outside of the safe social distancing of 2 metres, whereas bar codes and QR codes have to be scanned in close proximity of inches. In other circumstances it can also be scanned upto 100 metres away, allowing for easier crowd and queue ingress and egress.

In addition to the security flaws and close proximity of QR code scanning, another downfall of using QR Code for this type of passport solution is that a user may have to carry hundreds of different QR codes for the same identity use case. Companies who wish to add any form of extra security to the QR code would also have to offer their own app to scan a QR code which may lead to a consumer having to carry 100's of apps or codes due to the QR codes open source nature (not being generated from a central source).

Commenting on the chaos around the events at Heathrow, VSTE CEO Louis-James Davis said;

"The scenes at Heathrow could have been easily avoided by using a secure system such as V-Health Passport(TM). Both airports and the airlines need to move to a secure digital platform technology to ensure the security and faster processing of passengers to verify their Covid status and vaccination records. We have that technology now and it is available for airline passengers and the airlines to download and use today. By using the V-Health Passport(TM) technology a passengers valid Covid 19 test certificate could have been scanned further than the 2 metre safe social distancing protocols and upto 100 metres away. This would have allowed for a smooth ingress of passengers coming through border control into the UK verified against their identity. This would have also helped the passengers to maintain safe social distancing and a much quicker processing through border control thus avoiding the social breaches which occurred.

The V-Health Passport(TM) would not only provide border officials and airports with authentication of an airline passengers Covid 19 test status – with both a digital and printed PCR test certificate – but also their vaccination records. The technology also verifies a persons genuine identity against their existing Government ID adding another layer of security. There has been a phenomenal rise in the sale of 'Fake Covid' certificates, with both Russia and the Middle East seeing the greatest activity and posing a serious threat to global aviation security.

Using any open-source technology such as RFID, bar code or QR code with any form of health passport or vaccine card/certificate leads it wide open to being hacked or cloned with a person effectively making themselves 'permanently Covid negative' and 'permanently vaccinated' and allowing them to travel freely. By moving towards a secure 'one for all' technology based solution that passengers can use with their phones, will not only protect the data of passengers but also the safety of their health. It will ensure that a passenger who is travelling has a valid Covid test result or vaccine immunisation record and ensuring other fellow passengers are safe."

The V-Health Passport(TM) technology has a complete audit trail of a persons Covid testing, their vaccination records and the clinics where those tests or vaccinations have been conducted. This information is also protected under the 'Self Sovereign Identity' data framework allowing only the passenger to view this information, with officials only able to see a current and valid Covid 19 test or vaccine status in the GDPR display of the app.

With the alarming increase and black market trade in fake Covid 19 test certificates and also vaccination cards and certificates this also puts a very real threat and risk to passenger safety. It poses a threat to airlines and international borders with the potential for a passenger carrying a fake Covid test certificate or vaccination card – who may be asymptomatic – to board an aircraft and infect other passengers. This poses a very real threat to the aviation sector and to Governments around the world as they try to arrest the rate of infection.

It is well documented that bar codes and QR codes can be hacked so any airline who considers using a health passport for Covid 19 testing and vaccination using this method of authentication risks a serious potential breach of its passenger data. In 2018 British Airways was fined a record GBP20M for a data breach on 400,000 of its customers which affected their personal and credit card data. It now faces one of the biggest ever group privacy claims in UK legal history as reported in the Financial Times. It comes at a time when security over the use of bar codes and QR codes in airline travel has come under intense scrutiny following the cyber attack last year on the former Australian Prime Minister Tony Abbot. The former PM had his Qantas airline boarding pass hacked. Details including his passport, mobile phone and messages between Qantas staff about him were intercepted.

VSTE CEO Louis-James Davis added;

"We are the first technology company in the world to have developed a secure, multipurpose, cross corporate & cross government digital health passport that does not rely on using bar codes or QR codes as its authentication technology. Both bar codes and QR codes have huge potential security implications as they can be cloned and hacked with the latter being subject to a process called 'Attagging'. Therefore any suggestion of using this type of technology in a health passport for air travel has very real security risks. Not only is a citizen's personal information at risk, but their Covid test status, vaccination records and also their credit card information. All of this can lead to the very real potential of a massive data breach and a persons personal information and data hacked and stolen. This is of particular concern when using a bar code or QR code technology designed for use to authenticate a persons Covid 19 testing and/or vaccinations records."

Unlike other health passports, V-Health Passport(TM) has been designed with a citizens privacy front and centre. The technology does not track your live location and provides all data in a secure GDPR compliant framework giving citizens a unique 'self sovereign identity' style technology putting them in control of who, when and how they share their data.

Louis-James Davis went on to state that both bar codes and QR codes – which represent first and second generation technology – are unsecure and vulnerable to hacking.

"QR codes were originally developed as a scanning technology for close proximity car parts tracking, a world away from identity and banking use cases and now digital health passports. It was then used to skip the input of websites in marketing and promotional purposes. They were never designed with security or privacy in mind… they are simply not fit for purpose and should not be used at all in any form for delivery of sensitive information, travel or event tickets or health passport."

QR codes can be subject to a process called 'Attagging' or 'cloning.' The process of 'Attagging' is where a 'genuine QR code' is replaced by a 'cloned QR code' which then redirects the person scanning that code to a similar website where personal data can be intercepted and breached. The problem is that serious that in India alone there are over 1BILLION fraudulent financial transactions each day using QR codes. As the scanning user journey is the same, it is only tech savvy individuals that may notice the domain name has changed.

QR codes can be cloned and redirected to other information points or websites. Often criminals and hackers will exploit this by putting a fake QR code over a genuine QR code. So a QR code for example on scanning would link to the genuine website www.similardomain.com but a fake QR code can be made up printed off and placed over the genuine code to redirect to www.similar-domain.com at this point the member of the public is tricked into entering their personal information, private data and financial information. The rogue website looks and feels exactly like the genuine one and is made to mirror it precisely.

VCode(R) which is the ultra secure digital code which powers the V-Health Passport(TM) cannot be cloned. Even if it was printed off, or a photograph was taken and placed over a VCode(R) or V-Health Passport(TM) it simply won't scan as it works on a call and response system of information between the code and web platform to verify location of the code, user ID and time and date and much more.

V-Health Passport(TM) is making a significant contribution to the safety, mobility and return to work of the UK economy, helping businesses and employers return their staff to offices, factories and warehouses.

VSTE is working with the UK Government and a number of other Foreign Governments around the world to use its technology. The company is active in multiple industries and sectors including the maritime and aviation industries, construction and major infrastructure projects, as well as major national and international sporting events. V-Health Passport(TM) is also being used by a number of private Covid testing clinics, manufacturers and healthcare practices.

V-Health Passport(TM) is available on the Apple App Store and Google Play by searching for 'VPassport' and downloading to your device.

For more information on VCode(R) and VPlatform(R) technology please visit
https://www.vstenterprises.com

For more information on V-HEALTH PASSPORT(TM).
https://v-healthpassport.co.uk

For all media enquiries
Please contact Gerard Franklin – Head Of Communications & External Relations
M: 07885 388398 e: gerard@vstenterprises.com
VST Enterprises Ltd | The Lexicon | Mount Street | Manchester | M2 5NT

NOTES TO EDITORS

About the V-Health Passport(TM)
Search 'VPassport'
Apple App Store & Google Play
www.v-healthpassport.co.uk

Available on the Apple App Store and Goole Play by searching for 'VPassport' and downloading to your device.

– V-Health Passport(TM) can be scanned at a safe social distance of 1-2 metres and upto 100 metres away. QR code and Barcode technology has to be scanned inches away and as such breaches social distancing protocols.
– The V-Health Passport(TM) can authenticate a persons genuine Covid 19 test certificate – held in the secure health passport app and a printable version. The ultra-secure platform can now also hold vaccination records of all the major vaccination manufacturers which will be crucial in a person validating they have been vaccinated, the vaccine type, batch, dosage and date.
– V-Health Passport(TM) uses a persons official Government ID such as drivers licence, passport and cross matches against databases. It is then paired against a facial recognition 'Live Likeness' test to verify the persons genuine status.
– V-Health Passport(TM) is a test agnostic platform meaning it works with all Covid testing protocols from PCR based tests to rapid antigen and antibody. It has over 200 clinics across the UK on its app for passengers to book a Covid 19 test including a PCR based test approved for International airline travel.
– V-Health Passport(TM) can be scanned in a 170 degree arc, whilst a person is moving and thus ensures smooth ingress and egress,
– V-Health Passport(TM) It uses the worlds most secure cyber coding technology which works from a close loop system with end to end encryption and has over 2.2 Quintillion combination codes making it impossible to hack the front of back end of its system.
– V-Health Passport(TM) is a GDPR compliant technology built around self sovereign identity, allowing the airline passenger or member of the public to choose what data they want to share, with whom and when.
– V-Health Passport(TM) is available now and can be downloaded from the Apple App Store or Google Play by searching for 'VPassport' or by visiting www.v-healthpassport.co.uk.
– V-Health Passport(TM) also has its own unique contact tracing capability 'True Contact(TM)' built within the technology designed for travel, sports stadiums, venues, factories, offices and construction sites.
– V-Health Passport(TM) is the only health wallet and cross border platform in the world that is multi-functional and GDPR compliant. It allows acts like 'self sovereign identity', meaning a citizens personal data is protected and they choose what they want to share and with whom they want to interact or authorise.

SOURCE: VST Enterprises Ltd

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SN1011 in China

HONG KONG, Jan 18, 2021 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that the first healthy subject was successfully dosed in the Phase I clinical trial of SN1011, an innovative third-generation covalent reversible Bruton's tyrosine kinase ("BTK") inhibitor drug candidate, today in Shuguan Hospital in Shanghai, China. The subject is currently in a normal condition.

Medical staff from Shuguan Hospital in Shanghai conducted the Phase I clinical trial of SN1011.

SN1011 is the third generation, covalent reversible Bruton's tyrosine kinase ("BTK") inhibitor designed for higher selectivity and superior efficacy for the long-term treatment of systemic lupus erythematosus, rheumatoid arthritis, pemphigus, multiple sclerosis and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of selectivity and affinity. The Phase I clinical trial was conducted in Shuguan Hospital in Shanghai, aiming to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in treatment for autoimmune diseases. SinoMab received the approval of SN1011's Investigational New Drug application ("IND") from the National Medical Products Administration of China on 27 August 2020, taking less than 5 months to progress into the current dosing stage, which utterly proves the Company's efficient implementation of new drug R&D programs.

Dr. Weian YUAN, Principal Investigator from Shuguan Hospital in Shanghai for this Phase I Study, said, "So far, there are a number of BTK inhibitors that have been approved, but there is no third-generation BTK inhibitor that is yet approved. Since the third generation BTK inhibitor has much lower effective dose and a better safety profile, it makes SN1011 a promising product to bring patients a much better treatment."

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab, said, "SN1011 successfully completed its first dose, representing another key R&D asset entering the stage of clinical trial following our flagship product, SM03. This is a prominent milestone along SinoMab's progress in the R&D of various products for autoimmune diseases. Last year we launched the multiple ascending dose cohorts for SN1011 in Australia. SN1011, which shows great safety in clinical trials, possesses advantages of working just in a small dose and continuously benefitting patients, outperforming other BTK inhibitors in the market. We are absolutely confident in the enormous prospects of SN1011's clinical development. We will accelerate the program in the future, hoping to provide safe, effective and affordable drugs for patients suffering from autoimmune diseases around the world."

About SN1011
Bruton tyrosine kinase is a key kinase in the BCR signaling pathway in the B cell. Owing to the fact that loss of BTK exerts great impact on B cell development, targeting BTK becomes an attractive therapeutic means for autoimmune disease. SN1011 is a third generation BTK inhibitor which is covalent reversible in binding nature. It has unique chemical structure which renders it high binding affinity and selectivity towards BTK and excellent bioavailability in animal model. SN1011 has better efficacy and safety than other BTK inhibitors in pre-clinical studies. These data support the long-term usage for the treatment of autoimmune diseases in human.

About SinoMab BioScience Limited
SinoMab BioScience Limited ("SinoMab" or the "Company", stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis, systemic lupus erythematosus, non-Hodgkin's lymphoma, asthma, and other diseases with major unmet clinical needs.

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Foster City, CA, Hangzhou, China, Gaithersburg, MD, Jan 7, 2021 – (ACN Newswire) – Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and GlycoMimetics (Nasdaq: GLYC), today announced APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).

"This Breakthrough Therapy Designation for APL-106 reinforces its potential and is an important regulatory milestone for Apollomics as we prepare to initiate our clinical development work in China for patients suffering from AML," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is an aggressive disease and relapsed/refractory patients have an extremely poor prognosis. We look forward to initiating our Phase 3 bridging study this year and working with the CDE on a potentially accelerated clinical development program to address this important patient need."

In September 2020, the NMPA CDE granted Investigational New Drug (IND) approval for APL-106 enabling the initiation of a Phase 1 pharmacokinetics (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory AML.

The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China. The BTD is designed to expedite the development and review of therapies that are being developed for treatment of serious diseases for which there is no existing treatment or where preliminary evidence indicates significant advantages of the therapy over available treatment options.1

About Uproleselan (APL-106)
Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo' pro le' sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML. Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemic white blood cells called myeloblasts. In the U.S., there are approximately 20,000 new cases of AML each year and a 5-year survival rate of 28.7%.2 The annual incidence of new cases of AML in China is 21,600, and relapsed/refractory AML has an extremely poor prognosis.3

About Apollomics, Inc.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

About GlycoMimetics, Inc.

GlycoMimetics is a biotechnology company with two late-stage clinical development programs and a pipeline of novel glycomimetic drugs, all designed to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML under Breakthrough Therapy designation. Rivipansel, a pan-selectin antagonist, is being explored for use in treatment of acute VOC in sickle cell disease. GlycoMimetics has also completed a Phase 1 clinical trial with another wholly-owned drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

Forward-Looking Statements

This press release contains forward-looking statements, including those relating to the planned or potential clinical development of uproleselan and engagement with regulatory authorities, as well as the potential benefits and impact of the product candidate. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements as they relate to GlycoMimetics, as well as other risks facing GlycoMimetics, please see the risk factors described in the GlycoMimetics annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2020, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

1China Drug Registration Regulation: http://www.gov.cn/gongbao/content/2020/content_5512563.htm
2National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program
3Yang Xiaofeng, Zhang Sufen, Zhang Qingyuan. Practical Therapeutics of Hematological Diseases[M]. Military Medical Science Press, 2008.

Apollomics Contact Information:

Investor Contact:
Wilson W. Cheung
Chief Financial Officer
(650) 209-4436
wcheung@apollomicsinc.com

China Media Contact:
Porda Havas International Finance Communications Group
Kelly Fung
General Manager
(852) 3150 6763
kelly.fung@pordahavas.com

Phoenix Fung
Assistant Vice President
(852) 3150 6773
phoenix.fung@pordahavas.com

U.S. Media Contact:
Remy Bernarda
Corporate Communications
(415) 203-6386
remy.bernarda@apollomicsinc.com

GlycoMimetics Contact Information:

Investor Contact:
Shari Annes
650-888-0902
sannes@annesassociates.com

Media Contact:
Jamie Lacey-Moreira
410-299-3310
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China Medical System (00867.HK) MSCI-ESG Rating Upgraded to AA, Reaching Global Level

HONG KONG, Dec 21, 2020 – (ACN Newswire) – Morgan Stanley Capital International (MSCI) issued a report on December 17 upgrading the ESG (Environmental, Social and Governance) Rating for China Medical System Holdings Limited ("China Medical System"), a well-established, innovation-driven specialty pharma with a focus on sales & marketing in China. China Medical System's ESG Rating has been upgraded from "BBB" to "AA", surpassing 88% of companies in the global pharmaceutical industry, symbolizing that the Company has attained a level among its global peers in ESG management.

MSCI recognized China Medical System's outstanding performance in Corporate Governance, Corporate Behavior, Product Safety and Quality, Human Capital Development, and Access to Health Care, noting that the Company "Leads peers in business ethics and talent management practices". MSCI also gave a positive assessment of the Company's Corporate Behavior, "China Medical System has evidence of detailed policies on business ethics and corruption".

There are seven levels of the MSCI-ESG Rating, from the highest to the lowest are AAA, AA, A, BBB, BB, B, and CCC. Among them, companies with AA or AAA ratings are considered to be industry leaders in managing the most significant ESG risks and opportunities. This year, China Medical System's MSCI-ESG Rating has been upgraded by three levels, from BB to AA.

According to the Company, "Receiving the AA ESG Rating from MSCI reflected China Medical System's long-term focus and resource investment on ESG management and information disclosure, and affirmed the Company's compliance focus and solid business practices. In recent years, with leadership from the Board of Directors, the Company's ESG-related policies have increasingly improved, ESG practices are more standardized, and ESG management is constantly refined.

"In the future, through self-challenge and transcendence, China Medical System will continuously pursue higher corporate governance goals. The Company will continuously regard innovation as its driving force, to fulfill the unmet medical needs, and contribute to the integrated development of society, the environment, and civilization."

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Hua Medicine Successfully Completes Its Registration Phase III Trials; Announces 52-Week Results for DAWN (HMM0302), Dorzagliatin’s Phase III Combination with Metformin Trial

SHANGHAI, CHINA, Dec 18, 2020 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), a leading innovative drug development company focused on developing novel therapies for the treatment of diabetes, today announced:

– Successfully completes two Phase III 53-week registration trials in over 1,200+ Chinese patients in the midst of the COVID-19 global pandemic on time and with high quality data and results

– Dorzagliatin is safe and well tolerated in both the 24-week and 52-week periods of the DAWN Trial in Chinese T2D patients who have failed glycemic control with maximum daily dose of metformin (1500mg/day)

– Unlike many other oral antidiabetic drugs, dorzagliatin does not increase hypoglycemia incidence rate when used in combination with metformin: overall hypoglycemia incidence (blood glucose level ❤ mmol/L) rate during the 52-week period for the DAWN Trial was less than 1%

– At the end of the 24-week period, the primary efficacy endpoint was 1.02% HbA1c reduction for the dorzagliatin-treated group, together with excellent 5.45 mmol/L reduction of post-meal glucose (2h-PPG) from baseline, and are statistically significant over placebo with p-value less than 0.0001

– HbA1c reduction is potent, fast acting and sustained through the 24-week and 52-week trial periods for patients treated with dorzagliatin

– Similar to observations made in the SEED Trial, conducted with drug-naive T2D patients with average disease history of one year, a significant increase in HOMA2-beta and reduction in HOMA2-IR over placebo were observed in the DAWN Trial, suggesting a consistent improvement of beta-cell function and reduction in insulin resistance in diabetes patients with average disease history of almost six years and who had failed glycemic control on maximum daily dose of metformin (1500mg/day)

– First incidence of a China-based biotechnology company introducing a global first-in-class oral therapeutic – a glucose sensitizer, with a novel mechanism of action that targets the underlying cause of Type 2 diabetes, e.g., insulin resistance and beta-cell function

Type 2 diabetes is a worldwide epidemic fueled by the increasing prevalence of obesity, sedentary lifestyles and poor nutrition. Diabetes is characterized by hyperglycemia, which chronic sustained exposure to is associated with long-term damage, dysfunction, and failure of various organs leading to microvascular complications (e.g., retinopathy, nephropathy and neuropathy), as well as macrovascular complications (e.g., stroke, myocardial infarction and peripheral arterial disease). As a result, diabetes is an expensive disease leading to progressively higher medical costs. In a Consensus Report, Diabetes Self-management Education and Support in Adults with Type 2 Diabetes, published in Diabetes Care in July 2020, the American Diabetes Association, et. al., concludes, "Confounding the diabetes epidemic and high costs, therapeutic targets are not being met. There is a lack of improvement in reaching clinical targets since 2005 despite advancements in medication and technology treatment modalities. Indeed, between 2010 and 2016 improved outcomes stalled or reversed." The fundamental defect in current diabetes pharmacologic treatment is the failure of current therapeutics to target repair of the underlying cause of Type 2 diabetes ("T2D") – insulin resistance and beta cell function degeneration. Targeting the repair of the body's glucose sensor, glucokinase, offers the potential to restore the body's natural ability to maintain glucose homeostasis. As a first-in-class oral glucokinase activator, dorzagliatin's mechanism of action is specifically targeting the repair of glucokinase, and extensive clinical data has demonstrated dorzagliatin's ability to maintain glycemic control, as evidenced by significantly reduced HbA1c levels and post-meal glucose levels (2h-PPG), while exhibiting less than one percent incidence of hypoglycemia (blood glucose level ❤ mmol/L) in its two 1,200+ patient Phase III trials in China.

DAWN (also known as HMM0302), the second Phase III trial with dorzagliatin ("The DAWN Trial") is a 53-week trial (52-week on treatment, plus one-week follow-up), designed to investigate the efficacy and safety of 75mg BID dorzagliatin in 767 T2D patients treated with metformin, with an initial 24-week double blinded, placebo-controlled treatment, followed by an open-label 28-week treatment. The primary efficacy and safety endpoints were evaluated at 24 weeks. The primary objective of the subsequent 28-week trial period was to evaluate and observe the safety profile of dorzagliatin. In both the 24-week double blinded period and the 28-week open-label treatment period, dorzagliatin exhibited a safe and well-tolerated clinical profile. The incidence of adverse events was similar between the dorzagliatin-treated and placebo groups. There was less than 1% hypoglycemia (blood glucose < 3 mmol/L) during the 52-week treatment period. During both the 24-week double blinded period and the 28-week open-label treatment, patients also saw a continued reduction in insulin resistance, as measured by HOMA2-IR (insulin resistance is the hallmark of Type 2 diabetes).

In July 2020, Hua Medicine announced the DAWN Trial had achieved its primary efficacy and safety endpoints over the initial 24-week double blinded period. For the 52-week treatment period, the efficacy and safety profiles were sustained based on the topline data analysis. During the 28-week open-label period, patients initially receiving placebo + metformin (i.e., the placebo group) switched to receive dorzagliatin + metformin. The graph below illustrates the fast onset and sustained efficacy (as measured by HbA1clevels) for the two-cohort groups for the entire 52-week period.

The efficacy and safety results of dorzagliatin in the DAWN Trial mirrored the previously published results from the similarly designed 52-week results of SEED (also known as HMM0301), the first Phase III trial with dorzagliatin (the "SEED Trial"), despite the fact that the SEED Trial enrolled drug-naive T2D patients, with average disease history of one year, whereas the DAWN Trial enrolled T2D patients with average disease history of almost six years and that could not maintain glucose control while on the maximum daily dose of metformin (1500mg/day). Both of the DAWN Trial and SEED Trial have demonstrated that T2D patients administered with dorzagliatin experienced improved beta-cell function, reduced insulin resistance, and substantial post-meal glucose reduction as measured by 2h-PPG levels.

"The results of DAWN have been incredibly positive and recapitulate in patients on baseline metformin therapy the results of the prior large Phase III SEED Trial, in which dorzagliatin monotherapy resulted in a significant decrease in HbA1c that was sustained throughout the 52-week study. DAWN was completed during the COVID-19 pandemic with high quality data and results," said Dr. Wenying Yang of the China-Japan Friendship Hospital and lead principal investigator of DAWN. "The results indicate very good and fast onset HbA1c reduction with sustained efficacy, improved beta-cell function, and reduced insulin resistance. The study shows that dorzagliatin is safe and well-tolerated over the entire 52-week treatment period with low incidence of hypoglycemia, offering a new solution to T2D patients for whom metformin is no longer sufficient to control blood glucose. Additional Phase I studies conducted with dorzagliatin in combination with DPP-4 inhibitors or SGLT-2 inhibitors in the United States have demonstrated synergies in blood glucose control, suggesting dorzagliatin has a broader potential use in T2D patients with different needs in glycemic control and at different stages of the disease progression."

"On behalf of the Chinese Diabetes Society, and the Dorzagliatin SEED clinical trial team, we express our heart-felt congratulations to Dr. Yang for leading the DAWN trial and to the Hua Medicine team, especially in successfully completing the trial on time and in high quality during the COVID-19 global outbreak," said Dr. Zhu Dalong, President of the Chinese Diabetes Society. "We are excited that China has the first opportunity to showcase to the world the benefits of a new first-in-class discovery for Type 2 diabetes, dorzagliatin. In particular, we are excited that dorzagliatin, as a monotherapy, has also demonstrated its potential in a Phase I study with end stage renal disease patients, and therefore, could provide a unique opportunity for diabetes kidney disease patients, who make up 20%-40% of Type 2 diabetes patients globally."

"On behalf of the Scientific Advisory Board of Hua Medicine, I would like to convey our congratulations to Hua Medicine on successfully bringing this global breakthrough innovation for the advancement of Type 2 diabetes treatment to the world," said Dr. Bennett M. Shapiro, member of the Hua Medicine Portfolio Advisory Board since September 2010. "Over the last 10 years, we have advised Hua Medicine on its clinical programs for dorzagliatin, and we are excited to see that dorzagliatin has now successfully completed its two Phase III registration trials in over 1,200 patients in China – demonstrating its safety and efficacy in patients with Type 2 diabetes. We now look forward to working with Hua Medicine to provide our guidance and advice on bringing this drug to Type 2 diabetes patients globally, and on further exploring dorzagliatin's unique mechanism of action for the treatment of diabetes specifically, and on human metabolism in general." (For more information on the composition of the Hua Medicine Portfolio Advisory Board, and the biography of each member, please refer to https://www.huamedicine.com/En/portfolioadvisoryboard.)

"This has been an incredible 10-year journey for the Hua Medicine team, Chinese investigators, Hua's partners and supporters. With the successful completion of dorzagliatin's two registration trials, we have validated Dr. Franz Matschinsky's half century of work on glucokinase's central role in glucose homeostasis, bringing to life a new hope of a treatment that addresses the root cause of Type 2 diabetes to the millions of diabetes patients worldwide. We are incredibly proud that Hua Medicine is at the forefront of this global breakthrough by introducing a new therapeutic class of Type 2 diabetes medication – the glucose sensitizer class – that should be able to dramatically advance Type 2 diabetes standard of care to a new level," said Dr. Li Chen, CEO and founder of Hua Medicine. "In exploring the unique advantages of this new therapeutic class for Type 2 diabetes, we are excited about two investigator initiated trials currently ongoing to support dorzagliatin's role as a glucose sensitizer. One of the trials studies the effects of dorzagliatin on 1st phase insulin secretion, and another is conducted by select principal investigators from the SEED trial, to study the lasting effects of dorzagliatin, including the clinical remission rate, among other relevant biomarkers, of patients after completion of SEED. We look forward to sharing the results of these landmark studies later in 2021, when our respective investigators are expected to make the results available to us. Hua Medicine is now working as expeditiously as practicable to make our NDA submission, and continue to collaborate with our partner in mainland China, Bayer AG, to prepare for the commercialization of dorzagliatin."

DAWN Trial study design
DAWN is a randomized, double-blind, placebo-controlled Phase III study in 767 Type 2 diabetes patients whose blood glucose cannot be controlled with the maximum tolerated dose of equal or greater than 1500 mg/day of metformin. Subjects were treated with metformin (Glucophage) at 1500mg/day as basic therapy throughout the whole 52-week treatment period. Patients were given twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period receiving dorzagliatin 75mg twice daily. The primary efficacy endpoint was evaluated at the conclusion of the first 24 weeks. The trial was conducted in 72 clinical sites across China led by Professor Wenying Yang at China-Japan Friendship Hospital. (NCT03141073).

SEED Trial study design
SEED is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naive T2D patients. Patients were treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks plus one-week follow-up. During the 28-week open-label period, both patient groups were treated with twice-daily doses of dorzagliatin (75 mg). The trial was conducted in compliance with the guidelines of the Chinese Society of Endocrinology, which require physicians to educate patients and strictly enforce improved exercise and dietary control, as well as continuous self-monitoring, in treating Type 2 diabetes. The trial was conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society. (NCT03173391).

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug manufacturing permit" of dorzagliatin issued by the Shanghai Drug Administration, and plans to submit its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

About Hua Medicine Portfolio Advisory Board
The Hua Medicine Portfolio Advisory Board ("PAB") is comprised of distinguished scientists and corporate management with extensive experience in the biopharmaceutical sector. First established in 2010, the current PAB membership has been comprised of the following scientists since 2012: John J. Baldwin, Ph.D, James S. MacDonald, Ph.D, Bennett M. Shapiro, M.D., Catherine D. Strader, Ph.D, and Chris T. Walsh, Ph.D. Additional information on each of the Hua Medicine PAB members can be found at https://www.huamedicine.com/En/portfolioadvisoryboard.

For more information
Hua Medicine Website: www.huamedicine.com
Investors Email: ir@huamedicine.com
Media Email: pr@huamedicine.com

Issued by Porda Havas International Finance Communications Group for and on behalf of Hua Medicine. For further information, please contact:

Mr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.com
Ms. Louisa Chen +86 75523807432 louisa.chen@pordahavas.com
Ms. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.com
Ms. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com

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