IMA ART Fertility Celebrates 1-Year Beverly Hills Anniversary

BEVERLY HILLS, CA, May 3, 2023 – (ACN Newswire) – IMA ART Fertility celebrates their one-year anniversary in Beverly Hills – launching a first-of-its-kind luxury fertility and surrogacy concierge service, dedicated to helping high-net-worth individuals realize their dreams of parenthood.

Long before arriving on U.S. soil in the spring of 2022, the CEO & Co-Founder of IMA ART Fertility, Michelle Tang, identified an opportunity in a yet-to-be-defined field – luxury fertility and surrogacy.

The wealthy are not immune from the medical challenges and international legal hurdles associated with creating their families. Moreover, the super-rich often find themselves with little time to spare, as they're busy creating wealth for others. IMA ART Fertility Co-Founders made the decision to create and build a brand in a new rarified fertility space, exclusively targeting the uber-wealthy.

Researching the surrogacy digital landscape in the U.S., Ms. Tang identified a similarity among companies, vying for intended parents looking to create their families. Her objective was to bring something to the market which was appreciably and profoundly unique.

First, and foremost, on the list of marketing priorities, would be the creation of a website exuding luxury. Coming from Hong Kong, with an appreciation for European elegance, Ms. Tang selected a website developer from that part of the world, with a feel for refinement and exquisiteness -imaartfertility.com was born.

Secondly, a highly focused marketing campaign was launched targeting discreet high-net-worth and ultra-high-net-worth individuals valuing privacy.

Ms. Tang and fellow Co-Founder, Ron Sonnenberg, arrived in Beverly Hills on May 2, 2022, marking the one-year anniversary of relocating their operations from Hong Kong. Once on the ground, they embarked on a focused marketing campaign – introducing luxury fertility and surrogacy solutions to the world's well-heeled. Marketing involved a number of exclusive and high-visibility advertorials and memberships:

– SEEDS
– Financial Times
– Beverly Hills Chamber of Commerce
– LUXUO
– Elite Traveler
– Glion Institute of Higher Education
– Salon Prive
– Yahoo News
– AP

In less than one year, management was able to stake out its claim to being the first dedicated luxury fertility & surrogacy concierge in the US, and the entire world. In addition to an abundance of luxury hotels, fine dining and shopping concierge options in Beverly Hills, the Co-Founders engaged and emphasized working relationships with top professionals in the fields of Assisted Reproductive Technology, Egg & Sperm banking, Reproductive Law, Surrogacy Specific Medical Insurance, Escrow Management, a world-renowned OBGYN and a Specialized Labor and Delivery Registered Nurse, Double Certified in Obstetrics.

Ms. Tang emphatically states, "Nobody does what we do, at the high level we do it. Wealthy individuals appreciate the finer things in life – this beautifully extends to creating their heirs. We provide an ultra private atmosphere for our parents and exceptional interpersonal care."

About the Company: IMA ART is a high-value, bespoke professional advisory service providing transformative luxury fertility & surrogacy concierge – Beverly Hills. The company offers an exclusive suite of discreet fertility options to high-net-worth individuals. Learn more about IMA ART Fertility.

Contact Information
Ron Sonnenberg
Co-Founder
ron@imaartfertility.com
(424)-284-1408

SOURCE: IMA ART Fertility

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Moderna Announces Establishment of an Enterprise Solutions Hub and Commercial Operations in The Philippines

Cambridge, MA, May 3, 2023 – (ACN Newswire) – Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced plans to establish an Enterprise Solutions Hub in the Philippines. The Moderna Enterprise Solutions Hub will provide business services across the Asia Pacific region, where Moderna currently has operations in six markets. Moderna also plans to establish commercial operations in the Philippines.

"We are pleased to expand our footprint into the Philipines by establishing an Enterprise Solutions Hub and commercial operations. The Philippines has a critical mix of talent and global business service expertise, which makes it an excellent location to scale efficiently and provide regional support," said Stephane Bancel, Chief Executive Officer of Moderna."The Asia Pacific region is integral to Moderna's business, with established subsidiaries in Australia, Hong Kong, Japan, Singapore, South Korea, and Taiwan. We look forward to further solidifying our presence. The addition of the Philippines site completes our strategy to provide regional solutions across the business, complementing our existing locations in Atlanta, Georgia, which services the Americas, and Warsaw, Poland, which covers Europe, the Middle East, and Africa."

"We are very pleased that Moderna has selected the Philippines as the location for its third Enterprise Solutions Hub, serving the Asia Pacific market. We are confident that the Philippines has the talent and the capabilities to support Moderna's operations and drive its expansion throughout the region. The Philippines is well-positioned to host global services and facilities that advance health and pharmaceutical technology. Our partnership with Moderna underscores the Philippines' position in promoting healthcare and addressing emerging health threats. It also highlights Moderna's role in delivering life-saving vaccines during the COVID-19 pandemic and the ability and promise of their mRNA platform," said Jose Manuel G. Romualdez, Ambassador of the Republic of the Philippines to the United States.

Moderna will provide enterprise solutions in the Philippines, similar to its counterparts in Warsaw, Poland, and Atlanta, US, which were established in May 2021 and March 2022, respectively. The Hub will initially house finance, pharmacovigilance, medical, and HR personnel, in addition to commercial-focused roles, to support its direct presence in the market. Moderna will continue to identify opportunities to host additional functions and business services as the Company grows and operations mature. The Company expects to employ approximately 40-50 employees in the Philippines in 2023.

The Moderna Enterprise Solutions Hub Philippines will provide new capabilities, service lines, and capacity to help meet the growth of Moderna's commercial and business operations in the Asia Pacific region. Moderna plans to begin operations in the Philippines in the second/third quarter of 2023.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio, and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company's plans to establish an Enterprise Solutions Hub in the Philippines and anticipated hiring and staffing for the Hub; and the plans to establish commercial operations in the Philippines. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Contacts

Media:
Luke Mircea Willats
Senior Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President& Head of Investor Relations
Lavina.Talukdar@modernatx.com
617-209-5834

SOURCE: Moderna, Inc.

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

KYT Launches Designer Bags for Diabetics

WELLINGTON, New Zealand, May 2, 2023 – (ACN Newswire) – Diabetics now have their own designer bags to streamline their daily treatment. KYT, which stands for Keeping You Together, has revealed three new contemporary, premium bags purpose-built for the everyday needs of people with diabetes – a chronic condition that the World Health Organization (WHO) says affects 422 million people worldwide.

Crafted with the insights of hundreds of diabetics from around the world, the bags have innovative features, smart layouts, premium materials like gold-rated Italian leather and solid brass hardware, and ethical craftsmanship. A contemporary exterior discreetly hides diabetes supplies like a testing kit, pump consumables, and insulin pens. The bags now available for global pre-order are:

SideKYT: a contemporary crossbody bag that streamlines users' essential diabetes supplies. The bag splits in two: life essentials up front and diabetes equipment out back. A testing station allows blood glucose levels to be tested straight from the bag.

SideKYT+: a larger crossbody built for pump users or those who want to take more equipment or spares.

StarterKYT: a compact case that lets users take their supplies on the sly. The size of a sunglasses case, it smartly locks together with magnets, unfolds completely flat to create a testing station, and then folds back together in a snap.

KYT is also committed to ethical production and materials, and a donation from every bag sold helps diabetes charities get crucial supplies to those in need.

At age 20, Designer & KYT Founder Bridget Scanlan was diagnosed with Type 1 Diabetes. As her pancreas stopped producing insulin, she had to learn to manage multiple blood glucose tests and insulin injections every day. Along with all the equipment that came with it.

"From talking to diabetics around the world, I got universal insights into the daily diabetes struggle," Scanlan says. "It sparked a thought: could smarter design empower people to feel better about dealing with daily treatment? I wanted to redesign diabetes so we could all redefine it."

Combining her background in fashion design and entrepreneurship, Scanlan was inspired to channel her chronic condition to help empower other diabetics by creating designer bags specifically for diabetics.

"Every zip, every angle, every equipment detail has been influenced by the insights gathered from the hundreds of incredible diabetics who have opened up and shared their diabetes stories (and gripes) with me," Scanlan says.

According to WHO, globally 8.5% of adults aged 18 and older have diabetes, making it one of the most prevalent chronic conditions worldwide.

Stanford University research estimates that people managing diabetes make around 180 extra health-related decisions every day to keep themselves safe.

Here is some of the feedback from diabetics using KYT's original Crossbody bag:

"I've been waiting 50 years for a bag like this…. it is so easy to 'keep me together.' Pick it up and off I go, and no one knows what I am having to carry around." – Joy, New Zealand Diabetic

"I am loving my KYT for travel! It's such a great bag, I now take it with me whenever I go away." – Megan, London Diabetic

"Cannot be more excited for this amazing bag designed for diabetics. Fully functional & more importantly so stylish!" – Kyoko, Tokyo Diabetic

For more information, please visit https://kytbags.com/. Photos can be downloaded from KYT's media kit. https://pr.report/d8RmPCyY

About KYT Diabetes Bags

KYT stands for KEEPING YOU TOGETHER. We're redefining diabetes by redesigning it. With look-good, feel-good, do-good bags designed to help you feel great about doing diabetes on the daily.

Contact Information:
Bridget Scanlan
Designer & KYT Founder
bridget@kytbags.com

JP Twaalfhoven
Creative Director
jp@kytbags.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Envision Pharma Group Appoints Mike Glover to Senior Vice President, Payer and HTA Solutions to Drive Acceleration and Expansion in Value & Access and Data Analytics

PHILADELPHIA, PA, May 2, 2023 – (ACN Newswire) – Envision Pharma Group (Envision) has appointed Mike Glover to Senior Vice President, Payer and HTA Solutions. Mike will be responsible for leading and developing Envision's distinctive market access and HTA strategies for early-stage and late-stage businesses, combining customer insights, vision, and creativity. Mike's key focus areas will be transformations in patient access, global pricing strategies, real-world evidence, and improving patient outcomes.

Meg Heim, CEO of Envision Pharma Group, shares, "I am excited to welcome Mike to the team at Envision as Senior Vice President, Payer and HTA solutions. As we continue to accelerate Envision's business expansion, mission, and commitment to our clients' needs. Mike's extensive experience in developing and executing cutting-edge access, policy, and pricing strategies while executing fully integrated market access programs will be critical in partnering with our clients to execute upon their goals, improve performance, and meet their unique business needs with the support of our technology platforms."

Prior to joining Envision, Mike served as Vice President, Head of Global Access and Pricing Strategy for GlaxoSmithKline. Before that, he held various leadership positions of increasing responsibilities at GSK, Sanofi, and Bristol Myers Squibb. He brings with him a diverse background across multiple geographies, functions, and therapeutic areas. His global commercial leadership experiences spanning oncology, cardiovascular, diabetes, and virology from asset development to in-market delivery will be a valuable asset to Envision.

Mike adds, "The energy and passion of the Envision team shines through in every interaction I've had. It was this passion and desire to be the very best at what they do that made this an easy decision for me to join Envision. Our industry is facing a changing and challenging environment and Envision is building an organization that will not just deliver, but will become a true partner for our customers adding real value across the life cycle of a brand. I am delighted to be joining them at this important time in our industry's future."

About Envision Pharma Group

Founded in 2001, Envision Pharma Group is a leading global technology-enabled strategic solutions partner for the life sciences industry, working with over 200 pharma and biotech companies, including 18 of the top 20 pharmaceutical companies. Envision supports clients across the product life cycle through a comprehensive suite of services and industry-leading technology solutions that include artificial intelligence and natural language processing, commercialization and integrated strategic consulting, evidence-based scientific communications and engagement, HEOR/market access and data analytics, medical capabilities, and omnichannel solutions. Learn more at www.envisionpharmagroup.com.

Contact Information:
Colleen Carter
Associate Director, Communications, Office of the CEO
colleen.carter@envisionpharma.com
1 (508) 505 8856

SOURCE: Envision Pharma Group

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

BioMed X Launches XSeed Labs in the US with Boehringer Ingelheim – a New Model for Building an External Innovation Ecosystem on an Industry Campus

RIDGEFIELD, CT, Apr 27, 2023 – (ACN Newswire) – BioMed X announced today the expansion of its collaboration with Boehringer Ingelheim with the launch of a new model for biomedical research: XSeed Labs. The first research project of the new lab will focus on fibrotic disease processes, a key focus area of Boehringer Ingelheim. It will aim for a better understanding of wound healing and fibrosis in diseases of high unmet need, such as non-alcoholic steatohepatitis (NASH), scleroderma, progressive fibrosing interstitial lung diseases (PF-ILDs), and Crohn's disease, to pave the way for developing treatments that significantly improve patient outcomes.

XSeed Labs – Powered by BioMed X

Using its global crowdsourcing process, the BioMed X Institute will recruit a team of outstanding early-career life scientists to form a first-of-its-kind research group that will be hosted at Boehringer Ingelheim's US site in Ridgefield, CT. The goal of this new collaboration is to bring BioMed X's successful innovation model to Boehringer Ingelheim's main US research and development campus and serve as a nucleus for a vibrant external innovation ecosystem. This collaborative effort will aim to further fertilize the company's research and development initiatives in an effort to transform the lives of patients with high unmet medical needs.

Dr. Christian Tidona, Founder and Managing Director of BioMed X, explains: "The principle behind BioMed X has always been to combine the best of both worlds – academia and industry. We started by creating an independent research institute located on a traditional university campus in Heidelberg, Germany. Now, backed by 10 years of experience, we were able to translate the BioMed X concept into something that can be implemented on a research and development campus of a pharmaceutical company. We are grateful to Boehringer Ingelheim for embracing this new concept."

The XSeed Labs will be managed by the newly founded BioMed X Institute in New Haven, CT, which is also home to the world-renowned Yale University. "We are excited to establish this new model here in the US, which will allow us to promote scientific exchange between all major players in the field of biomedical research," says Mark Johnston, CEO of BioMed X USA.

Within the XSeed Labs framework, the teams will focus on chronic fibroinflammatory disease hallmarks such as aberrant tissue repair, pathological matrix production, macrophage and fibroblast activation, as well as metabolic reprogramming. To understand the molecular mechanisms underlying fibrosis as compared to normal wound healing, more complex and physiologically relevant disease models are needed. The new research group at XSeed Labs will focus on developing complex ex vivo tissue culture models to study this process to develop innovative therapies that significantly reduce the progression of fibrosis.

Life sciences researchers who are interested in becoming part of this new BioMed X team on the Boehringer Ingelheim Ridgefield campus are invited to respond to this international call for applications by submitting a project proposal via the BioMed X Career Space ( https://career.bio.mx/call/2023-RDG-C01 ) before June 18, 2023.

About BioMed X and XSeed Labs

BioMed X is an independent research institute located on the campus of the University of Heidelberg in Germany, with a worldwide network of partner locations. Together with our partners, we identify big biomedical research challenges and provide creative solutions by combining global crowdsourcing with local incubation of the world's brightest early-career research talents. Each of the highly diverse research teams at BioMed X has access to state-of-the-art research infrastructure and is continuously guided by experienced mentors from academia and industry. At BioMed X, we combine the best of two worlds – academia and industry – and enable breakthrough innovation by making biomedical research more efficient, more agile, and more fun.

BioMed X started working with Boehringer Ingelheim in 2015 with a series of joint research projects hosted by the BioMed X Institute in Heidelberg, Germany. The new collaboration model – called XSeed Labs – entails an open innovation incubator embedded in the Boehringer Ingelheim Ridgefield campus in Connecticut, USA. The topic of the first research project within this new framework is wound healing and fibrosis.

Contact Information
Flavia-Bianca Cristian
Recruiting & Communications Manager
fbc@bio.mx
+49 6221 426 11 706

SOURCE: The BioMed X Institute

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical CEO Joins Global BioPharma Panel for Evolution Europe Summit 2023

ADELAIDE, AUS & SAN DIEGO, Apr 18, 2023 – (ACN Newswire) – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers a GlobalReady program to early phase biotech companies to speed up the path to regulatory approval, has been invited to join the Evolution Europe Summit 2023 (Montreux, Switzerland 20 April – 21 April 2023). The panel discussion is focused on the evolution of clinical trials including technology, DCTs, reducing time and cost, drug development planning for approvals, and scaling globally in later phases.

Avance Clinical CEO, Yvonne Lungershausen has been invited to share the Australian and US CRO experience and future projections with a focus on patient centricity and Decentralized Clinical Trials (DCTs) at the Evolution Europe Summit 2023.

Avance Clinical was recently identified by GlobalData as a global leader in DCT technology.

The Evolution Summit is an invitation-only, premium forum bringing leading clinical research executives and innovative solution providers. The summit's content is aligned with key clinical R&D challenges and interests, relevant market developments, and practical and progressive ideas and strategies adopted by successful pioneers. See full details here. https://www.april23.evolution-summit.com/

Avance Clinical has recently been ranked as the world leader in DCT technology adoption by GlobalData and Clinical Trial Arena in the CRO sector. The report found 46% of Avance Clinical's trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical's staff training in the latest technologies was a key factor in the ranking. See the full report here. https://www.clinicaltrialsarena.com/features/year-in-review-dct-2022/

Avance Clinical's unique clinical offering GlobalReady enables biotechs that have completed early to mid-phases in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

There are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

More than 40 biotech clients are now taking advantage of Avance Clinical's GlobalReady program.

This seamless GlobalReady journey is designed so biotechs can:

– Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)
– Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
– Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
– Harness significant speed and cost advantages
– Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

Find out more:
– Learn about the Australian Advantage here. https://www.avancecro.com/the-australian-advantage/
– Learn about the GlobalReady model here. https://www.avancecro.com/avance-clinical-north-america-operations/
– For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. www.avancecro.com

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Endurance RP: Excellent Positive Results from Phase 3 Randomised Clinical Trial of Fortacin(TM)/Senstend(TM) in China

HONG KONG, Apr 17, 2023 – (ACN Newswire) – Endurance RP Limited ("Endurance" or the "Company" and collectively with its subsidiaries, the "Group"; stock code: 0575.HK) is pleased to announce its commercial strategic partner Wanbang Biopharmaceutical Co., Ltd. ("Wanbang Biopharmaceutical") has successfully completed the Phase 3 double-blind placebo-controlled study of Senstend(TM) in China for the treatment of premature ejaculation ("PE").

The study recorded excellent positive results which met all four co-primary endpoints of Intra-vaginal Ejaculation Latency Time ("IELT"), Index of Premature Ejaculation ("IPE") Ejaculatory Control and IPE Sexual Satisfaction domains and IPE Distress. Compared to both baseline and placebo, Senstend(TM) produced clinically and statistically significant increases in IELT, ejaculatory control and satisfaction and reduction in distress. Consistent with our previous studies undertaken in Europe and the United States ("US"), Senstend(TM) was well-tolerated by both Chinese patients and partners and no new side effects were reported.

In this study, there was a study population of 295 male patients aged 20 years or above who were diagnosed with PE, with 197 patients in the Senstend(TM) group and 98 in the placebo group. Patients were treated for three months at multiple sites in China.

Jamie Gibson, CEO of the Group, said, "We are delighted with the highly significant and positive results from the Phase 3 clinical study in China, which reinforces the results from the European and US Phase 3 clinical studies. This represents an important milestone in the regulatory submission process in China. We now look forward to our commercial partner in China submitting the New Drug Application ("NDA") to National Medical Products Administration ("NMPA") by the end of Q3 2023 with approval expected 12 months later."

Jamie Gibson further added, "Senstend(TM) has the potential to help about 9 million patients in China during its first year of launch, growing to over 170 million by the tenth year. Our strong partner Wanbang Biopharmaceutical, who benefits from being part of the Fosun network. This company has the marketing expertise established e-commerce platforms and an unrivalled nationwide logic and distribution through Sinopharm, China's number one pharmaceutical and healthcare distributor, through its network of hospitals, clinics and pharmacies to ensure the commercial success of Senstend(TM) in China."

Commercial Milestone Payments from Wanbang Biopharmaceutical

All costs of the clinical trials, including any other associated regulatory and submission costs for Senstend(TM) are covered by Wanbang Biopharmaceutical. The group will receive US$5 million (or approximately HK$39 million) (before deduction of PRC withholding tax) assuming NMPA approval for importing Senstend(TM) is granted and US$2 million (or approximately HK$15.60 million) (before deduction of PRC withholding tax) upon first commercial sale of Senstend(TM) in China, from Wanbang Biopharmaceutical.

Additionally, as disclosed on 3 December 2018, there are other significant payments payable to the Group from Wanbang Biopharmaceutical. A payment, which could total up to US$25 million (or approximately HK$195 million) will be made upon the achievement of certain annual net sales milestones by Wanbang Biopharmaceutical and the Group will receive 25 percent of net receipts and tiered percentage royalties on net sales, ranging from the low to high teens, except for circumstances in which a generic product has successfully entered and impacted the market in China, where lower payment structures will apply.

European Market Update

The Company reports positive results in certain countries in the European Union, where Fortacin(TM) has returned to the market. Patients have responded positively, with the first batch of units in Germany experiencing strong demand. The manufacturer has released 30,000 units in February 2023, and the next 30,000 units are scheduled for delivery in July 2023.

About Senstend(TM)
Senstend(TM) (the brand name for Fortacin(TM) in China) is a metered dose aerosol from a proprietary formulation of two marketed drugs, lidocaine and prilocaine, developed for treating premature ejaculation. The disorder affects approximately 20% to 30% of men in China, which translates to a significant initial target male population of approximately 55 million men aged between 20-59 years old, based on World Bank 2022 estimates rising to over 170 million men. In December 2018, Plethora signed an exclusive license agreement with Wanbang Biopharmaceutical Co., Ltd, a wholly controlled company of Shanghai Fosun Pharma, to market Senstend(TM) for premature ejaculation in China.

About Endurance RP Limited (Stock code: 0575.HK)

Endurance is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders since its initial public offering in May 1997.
www.endurancerp.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HanchorBio Announces US IND Clearance for the Multi-Regional Clinical Trial of HCB101 to Treat Solid and Hematological Malignancies

TAIPEI, TAIWAN and SAN FRANCISCO, CA, Apr 17, 2023 – (ACN Newswire) – HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the US. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio, commented, "Although there is demonstrated history of PD-1/PD-L1 immune checkpoint inhibitors showcasing strong efficacy in a variety of cancers and significantly improved the prognosis of certain cancer patients, there is a large percentage of cancer patients who are either refractory to these immunotherapies or develop resistance. HCB101 is our independently-developed leading candidate to block the "do not eat" signal from the SIRPa-CD47 pathway, sufficiently eliminating tumor cells by macrophage while exhibiting excellent safety profile in our preclinical studies. The FDA clearance of our first IND marks a significant milestone for HanchorBio and demonstrates our team's continuous focus and commitment to bringing novel immunotherapies to patients with significant unmet need."

"Based on our studies in 15 murine xenograft tumor models of solid and hematological malignancies, HCB101 has demonstrated superior anti-tumor efficacy, both as monotherapy and in combination with other agents. The advantage is even more apparent when comparing HCB101 with other agents targeting the same pathway currently being investigated in clinical trials," said Sean Juo, Ph.D., President and Chief Scientific Officer of HanchorBio. "Unlike other CD47-blocking agents, HCB101 exhibits excellent safety profiles in the repeat-dose cynomolgus monkey toxicology studies, as no abnormality of RBC or platelet levels were observed. It is an important safety factor for differentiation. I look forward to advancing the clinical development of HCB101 and continuing the focus on patient-centric research and development to hopefully bring novel treatments with clinically meaningful benefits to patients as early as possible."

About HCB101

Using structure-guided protein design and engineering supplemented with relevant screening technologies, HCB101 is an engineered extracellular domain of SIRPa fused to the Fc region of IgG4. HCB101 triggers phagocytic activity of the macrophages by blocking the "do not eat" signal between macrophages and tumor cells. Based on the extensive in-vitro and in-vivo preclinical data, HCB101 is potentially a safer and more potent biologic than the anti-CD47 monoclonal antibodies and SIRPa fusion proteins currently being investigated in clinical trials. Furthermore, quantitative RNA transcriptional analysis indicated that HCB101 triggered distinct gene expression profiles inside the tumor and in the tumor microenvironment comparing to other relevant clinical candidates, suggesting that HCB101 might exhibit unique mechanisms of action.

About Multi-Regional Clinical Trial of HCB101

HCB101-101 is a multi-regional, multi-center, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma in the United States and Taiwan. The purposes of the study are to evaluate the safety, tolerability, pharmacokinetics, and clinical anti-tumor activity of weekly HCB101 intravenous injections. The HCB101 IND is on track being reviewed by the Taiwan FDA.

About HanchorBio

Based in Taipei, Shanghai, and San Francisco Bay Area, HanchorBio is a global clinical-stage biotechnology company focusing on immuno-oncology. The Company is led by an experienced team of pharmaceutical industry veterans with proven track-record of success in biologics discovery and global development to transcend current cancer therapies. Committed to reactivating the immune system to fight against diseases, the proprietary Fc-based designer biologics (FBDB(TM)) platform enables unique biologics with diverse multi-targeting modalities to unleash both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB(TM) platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com or follow us on LinkedIn at www.linkedin.com/company/hanchorbio-inc

Contact Information
Scott Liu
Founder, Chairman and CEO
scott_liu@hanchorbio.com

Yi Du
Sr. Director of Business Development
yi_du@hanchorbio.com

SOURCE: HanchorBio Inc

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Essex and Osteopore Entered into Exclusive Distribution Agreement for Oral Maxillofacial products in Singapore

HONG KONG, Apr 14, 2023 – (ACN Newswire) – Essex Bio-Technology Ltd. ("Essex" or the "Group", Stock Code: 1061.HK) is pleased to announce that its wholly-owned subsidiary, Majeton Pte. Ltd. ("Majeton"), has entered into an exclusive Distribution Agreement with Osteopore Limited ("Osteopore") to promote and sell Osteopore's dental and oral maxillofacial products ("Products") in Singapore.

Pursuant to the Distribution Agreement, Majeton will be the exclusive distributor of the Products for an initial period of 3 years, starting from 2023 to 2026.

Osteopore's innovative oral maxilla facial products are used in guided bone regeneration, immediate implant loading, and socket preservation. In unique situations, Osteopore may also make available customised regenerative implants for various oral maxillofacial reconstruction.

The Group believes that Majeton's strong commercial presence in Singapore, will synergistically bring to market Osteopore's innovative products supported by advanced 3D printing technology for improved clinical outcome in dental patients throughout Singapore's dental clinics, private and public hospitals.

About Osteopore
Osteopore is an Australian and Singapore based medical technology company commercialising a range of bespoke products specifically engineered to facilitate bone healing across multiple therapeutic areas. Osteopore's patented technology fabricates specific micro-structured scaffolds for bone regeneration through 3D printing and bioresorbable material. Osteopore's patent-protected scaffolds are made from proprietary polymer formulations, that naturally dissolve over time to leave only natural, healthy bone tissue, significantly reducing postsurgery complications commonly associated with permanent bone implants.

About Essex (Stock Code: 1061.HK)
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun (Iodized Lecithin Capsules) etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,900 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.

About Majeton
Majeton, a wholly owned subsidiary of Essex Bio-Technology, is a sales, marketing and distribution company of therapeutics, medical devices and nutraceuticals for the region of South East Asia. The company embraces innovation to provide a portfolio of first-in-class and best-in-class products with the aim to deliver solutions to commercial and clinical unmet needs, covering a wide range of therapeutic areas.

Media Enquiry:
Strategic Financial Relations Limited (Website: http://www.sprg.com.hk)
Shelly Cheng +852 2864 4857 shelly.cheng@sprg.com.hk
Yan Li +852 2114 4320 yan.li@sprg.com.hk
June Tuo +852 2864 4848 june.tuo@sprg.com.hk
Angela Shen +852 2864 4870 angela.shen@sprg.com.hk
Media: media@essex.com.cn

Investor Enquiry:
Investor Relations: investors@essex.com.cn

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Responding to the Need for Accelerated Nursing Credentials Verification, CGFNS and NCSBN Step Up Collaboration to Address Gaps and Improve Efficiencies

Philadelphia, PA, Apr 12, 2023 – (ACN Newswire) – As U.S. health systems continue to struggle with a chronic nursing shortage, the National Council of State Boards of Nursing and CGFNS International, a global leader in international credentials evaluation to support health professional mobility, are expanding their collaboration to help expedite credentials verification while boosting fraud detection and ensuring patient safety.

The cooperative effort will focus on information-sharing between the two organizations and technology improvements aimed at creating efficiencies that will streamline credentials verification for nurses applying to work in a new jurisdiction. This comes as state nursing boards across the U.S. face growing pressure to accelerate verification processes and enable nursing staff vacancies to be filled more quickly.

Meanwhile, with growing numbers of foreign-trained nurses applying to work in the United States, the collaboration will also aim to improve efficiencies in verifying their qualifications and shorten approval times, while also improving the capabilities of verification systems to detect fraudulent activities. To further strengthen fraud protection and ensure patient safety, the two organizations will work to facilitate data-sharing between CGFNS' worldwide credentials verification systems and NCSBN's online tools that member boards use to share information about imposter and/or fraudulent nurses.

"Together, we want to vastly reduce the time-consuming manual processes that nursing schools, licensing authorities and nurses themselves must go through to gather and verify transcripts, examination scores, licenses and other information that is essential to ensuring that nurses are qualified to practice," said Peter Preziosi, President and CEO of CGFNS International.

"At a time when health systems are struggling to fill nursing staff vacancies, this collaboration will help expand the flow of qualified nurses to where they are needed by making verification systems more efficient, while hardening them against fraud," he added.

"Our members, the state nursing boards, face the enormous challenge of shortening the time it takes to access the necessary information needed to gain licensure, while also ensuring the integrity of the health workforce and patient safety. The steps we are taking to interface our systems with CGFNS will help us achieve both of those goals," said David Benton, Chief Executive Officer of the NCBSN.

About CGFNS International, Inc.

Founded in 1977 and based in Philadelphia, CGFNS International is an immigration-neutral not-for-profit organization proudly serving as the world's largest credentials evaluation organization for the nursing and allied health professions. For more information, visit www.cgfns.org.

About NCSBN

Empowering and supporting nursing regulators across the world in their mandate to protect the public, NCSBN is an independent, not-for-profit organization. As a global leader in regulatory excellence, NCSBN champions regulatory solutions to borderless health care delivery, agile regulatory systems and nurses practicing to the full scope of their education, experience and expertise. A world leader in test development and administration, NCSBN's NCLEX(R) Exams are internationally recognized as the preeminent nursing examinations.

Contact Information:
Mukul Bakhshi, Esq.
Chief of Strategy and Government Affairs
mbakhshi@cgfns.org
(215) 243-5825

SOURCE: CGFNS International

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com