InaVac gets emergency approval from BPOM

Surabaya, East Java, Indonesia, Nov 14, 2022 – (ACN Newswire) – The Food and Drug Supervisory Agency (BPOM) has issued emergency use authorization (EUA) for InaVac, a COVID-19 vaccine developed by researchers from Airlangga University (Unair).


InaVac, COVID-19 vaccine, is developed by the University of Airlangga in Surabaya, East Java Province. (ANTARA/HO-BPBRIN Unair)


"InaVac has obtained emergency use authorization from BPOM and will be mass-produced," the rector of Unair, Prof. Moh. Nasih, said on the sidelines of the campus' dies natalis (anniversary) on Wednesday.

The vaccine, which can be used to prevent a COVID-19 infection, has been made using an inactivated virus, which means, a virus that cannot reproduce and cause disease.

InaVac has been approved for use as a primary vaccine for people aged 18 and above for boosting immunity levels.

According to Nasih, the vaccine was developed as part of an effort by the university to significantly contribute to and impact the health sector.

Following the provision of EUA from BPOM, he expressed his gratitude to various stakeholders that have supported the development of the vaccine.

"Thank you to the Ministry of Health for providing support in the form of large amounts of funding; the provincial government has also provided extraordinary support," he remarked.

"Dr. Soetomo Hospital has also been very supportive. Equally important has been the role of Unair researchers who worked hard for this," he added.

Former state-owned enterprises minister Dahlan Iskan also expressed his pleasure over the completion of the domestically-made COVID-19 vaccine.

"I am happy because Unair has processed this vaccine to completion. How this vaccine was successfully launched, how to find people who want to undergo the vaccine. Finding people who are willing to be clinically tested is extremely difficult but Unair managed to finish it," he said.

It is hoped that after InaVac, more vaccines will be produced through continued research and development so that they can answer future challenges and problems.

Unair is currently developing a booster vaccine and a COVID-19 vaccine for children.

"The news about vaccines has been very encouraging; hopefully, later booster vaccines and children can be produced," he said.

For further information, please visit: https://www.unair.ac.id/

Written by: Abdul Hakim, Yashinta Difa, Editor: Fardah Assegaf (c) ANTARA 2022

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy

SYDNEY, AU, Nov 11, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO, is sponsoring BioCentury-BayHelix East-West Summit 2022, and Novotech's Chief Commercial Officer Barry Murphy is Session Chair for the expert panel on How to Build and Finance an East-West MRCT Strategy Workshop at the Summit (14-16 November 2022).

Novotech is sponsoring the Networking Reception and Dinner.

Workshop details:
Global Development Workshop: How to Build and Finance an East-West MRCT Strategy
November 15, 2022
2:30 PM – (PACIFIC TIME ZONE)
BioCentury-BayHelix East-West Summit 2022
https://conferences.biocentury.com/china-healthcare-summit/schedule

Panelists are:
– PATRICIA KEEGAN, M.D.: Chief Medical Officer, Junshi Biosciences
– KE LIU, M.D., PH.D.: Chief Development Officer, Marengo Therapeutics
– ROGER LUO, PH.D.: Chief Development Officer, Overland Pharmaceuticals
– PEONY YU, M.D.: Chief Medical Officer, Apollomics Inc.

Novotech has significant real-world experience in East-West MRCT strategy after more than 2 decades managing clinical research programs for biotechs across Asia Pacific and the US.

Commenting on Novotech's experience, Chief Commercial Officer Barry Murphy said the right drug development pathway supports investor attraction and a successful clinical program.

"Local regulatory knowledge and expertise will accelerate early clinical programs, while a global perspective with a focus on US FDA and NMPA requirements, will support key market approvals. Strategies for an East-West MRCT include:

– Companies should engage with the US FDA and NMPA early to confirm guidance on their clinical roadmap.

– Biopharma companies should take advantage of China's revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.

– For biopharma companies looking to enter China, China's pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favourable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.

Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China.

The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA and NMPA approval process, avoiding delays and additional costs.

Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research. The company has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.

Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.

About Novotech

Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
communications@novotech-cro.com

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Legend Capital Portfolio Company Giant Biogene Successfully Lists on the HKEX

HONG KONG, Nov 7, 2022 – (ACN Newswire) – On November 4, 2022, Legend Capital portfolio company Giant Biogene (2367.HK) was successfully listed on the main board of the Hong Kong Stock Exchange. The number of Giant Biogene's offer shares under the global offering is 22,608,800 shares at an issue price of HK$24.3 per share, which includes 2,261,200 Hong Kong offering shares, 20,347,600 international offering shares, as well as a 15% over-allotment option.



Giant Biogene is a leader in the bioactive ingredient-based professional skin treatment product industry in China and the first company in the world to successfully develop and industrialize recombinant collagen skin treatment products. Giant Biogene has been the largest collagen-based professional skin treatment product company by retail sales in China for the latest three consecutive years since 2019. According to Frost & Sullivan, Giant Biogene was the second-largest professional skin treatment product company in China in 2021, and its Collgene and Comfy, the flagship brands of recombinant collagen-based products, were the third and the fourth best-selling professional skin treatment brands, respectively. Giant Biogene is the first company to obtain a medical device registration for recombinant collagen-based products in China.

Legend Capital participated in Giant Biogene's only round of financing in 2021. Following the investment, Legend Capital provided Giant Biogene value-added services on core issues such as business strategy discussion, upstream and downstream business resource docking, executive talent introduction, and IPO listing process.

Richard LI, President of Legend Capital, said: "Congratulations to Giant Biogene on its successful listing on the main board of the Hong Kong Stock Exchange. Legend Capital is very honored to be an investor in Giant Biogene and to carry out in-depth investment cooperation with the company. With 22 years of development and unremitting efforts under the leadership of the company's management, Giant Biogene has achieved excellent results and has become a pioneer enterprise in the field of biosynthetic materials and products in China. We hope that Giant Biogene will make steady progress and achieve greater achievements in the future development and continue to brave the wind and the waves in the changing market."

Tony WANG, Managing Director of Legend Capital, said: "Giant Biogene is a pioneer in the synthetic biology industry. It not only builds a leading technology platform for genetic engineering, tissue engineering and material engineering but also applies scientific research results to the field of healthcare. Giant Biogene demonstrated the best practice out of the combination of production, education and research. We look forward to this diligent and pragmatic team continuing to go forward and leading Chinese brands to the international market in the future."

About Legend Capital

Founded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea.

It currently manages USD and RMB funds of over US$10 billion in commitments, and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies by solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors.

Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative.

For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital (https://www.linkedin.com/company/legend-capital).


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SinoMab Announces Appointment of Mr. Shanchun WANG as the President (China) of the Company

HONG KONG, Nov 4, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", 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, Mr. Shanchun WANG has been appointed as the President (China) of the Company. Mr. Wang will mainly be responsible for the China operation.

Mr. Shanchun WANG, served as the executive director of Sino Biopharmaceutical Limited (stock code: 1177) and the president of Chia Tai – Tianqing Pharmaceutical Group Co. Ltd., joined SinoMab lately as the President (China) of the Company. Mr. Shanchun WANG has rich experience and practical achievements in corporate strategic management, organizational management, innovation research and development and product commercialization. He is a specialist that granted the special government allowances of the State Council and awarded as a national model worker, a Jiangsu Province Technology Advanced Worker, a Jiangsu Province Model Labour, a winner of the Shanghai Technology Advancement First Honour Award, a Jiangsu Province Outstanding Entrepreneur, a Jiangsu Province Young and Middle-aged Expert with Outstanding Contribution, a Jiangsu Advanced Individual with Outstanding Contribution in Manufacture etc.

Mr. Shanchun WANG said that: "Under the leadership of Dr. Shui On LEUNG, SinoMab has gathered a very strong R&D force, forged a unique B-cell therapeutic platform, and prospectively launched a pipeline with a series of potential key products, with truly internationally recognized original innovation strength. At the same time, SinoMab's dedication to the field of autoimmune diseases and its vision of growing into a global leader in novel treatments of immunological diseases is highly consistent with the development model of my service enterprises in the past, which is also an important reason why I chose to join SinoMab."

Dr. Shui On LEUNG said that: "It is a great pleasure to have Mr. Shanchun WANG joining the Company. Our Group has been engaging extensively in the field of autoimmune disease and with the mission of growing into a global leader in the novel treatments of immunological diseases. We have a strong research and development capabilities. Leveraging on our Group's B-cell therapeutic platform, Alarmins-pathway therapeutic platform and selective T-cell therapeutic platform, the Group has a strategic plan in expanding and diversifying our product pipeline. We believe that Mr. Wang's rich experience in the pharmaceutical industry for more than 30 years, and as one of the leaders in the biotech industry in China, will help expediting the Company's development from a global drug research and development enterprise to a biopharmaceutical company bearing commercialization capabilities and international perspective. Mr. Wang's engagement as the President (China) of the Company while also subscribing shares of the Company also reflects the confidence and commitment of Mr. Wang and our senior management towards the long-term and sustainable growth of the Group, and the continuous support of our senior management will be beneficial to the long-term business development of the Group."

The Company entered into a subscription agreement with Mr. Wang earlier. Pursuant to the subscription agreement, Mr. Shanchun WANG conditionally agreed to subscribe for and the Company conditionally agreed to allot and issue 14,340,000 subscription shares. This reflects his confidence and commitment towards the long-term and sustainable growth of the Group.

About SinoMab BioScience Limited
SinoMab BioScience Limited (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 (RA) 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 (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Led by Legend Capital, Easy-Flow Raises Tens of Millions of CNY in Angel Round

HONG KONG, Nov 1, 2022 – (ACN Newswire) – Shanghai Easy-Flow ("Easy-Flow") recently completed its Angel financing round by raising tens of millions of CNY, led by Legend Capital. The fresh capital will be used for the R&D of Easy-Flow's peripheral intervention pipeline.



Data shows that there are a large number of patients with peripheral vascular disease, of which about 40 million patients with lower extremity arteries and about 100 million patients with varicose veins. Given the number of patients is increasing yearly, there is a huge clinical demand foreseeable, indicating that the peripheral vascular interventional device trajectory is likely to be the next market worth CNY10 billion.

Founded in November 2021, Easy-Flow is committed to efficiently creating a complete set of solutions in the field of peripheral interventional devices. The company develops products such as drug balloons, catheters, stents, and thrombus removal equipment for treating peripheral arteriovenous diseases. Since its establishment, Easy-Flow has been committed to creating peripheral interventional product packages, and developing Me-too, Me-better and Me-only products at the same time. It is expected that several products will be submitted for registration or initiated into clinical practice by 2030.

In addition to its independent R&D, Easy-Flow also simultaneously carries out external cooperation to further expand its product pipeline. Easy-Flow recently has reached a cooperation with Control Medical in the United States to introduce the FDA-approved Control(TM) mechanical thrombus removal system, which can be manually controlled by doctors to achieve efficient and controllable thrombus aspiration.

The founder of Easy-Flow, MIAO Zhenghua, who has more than 20 years of experience in the field of vascular intervention, said: "At present, the biggest challenge to many startups is how to rapidly commercialize their certified products. On the one hand, many founders have R&D backgrounds but lack experience in marketing their products quickly, and some companies only focus on one or two items, making them hard to cover marketing expenses with their revenue and profits. On the other hand, there are many product categories in the field of peripheral interventional devices. The treatment of disease often requires multiple products, and it is difficult to support the market with a single product. Therefore, the integrated package of peripheral interventional products is more suitable for commercial promotion."

Regarding this financing round, Joe ZHOU, managing director of Legend Capital, said: " Legend Capital has long focused on investment in medical devices. We have invested in a number of companies focusing on the unmet clinical needs of major diseases, especially chronic diseases. Cardiovascular and cerebrovascular-related fields have always been the focus of systematic analysis and research of the Legend Capital team. Easy-Flow has a talent team with extensive experience, led by the founder MIAO Zhenghua. We are very pleased to cooperate with Easy-Flow and participate in the development of the company. In the future, Legend Capital will give full play to the advantages of the healthcare portfolio ecosystem to support Easy-Flow's development and move forward hand in hand."

About Legend Capital

Founded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea.

It currently manages USD and RMB funds of over US$10 billion in commitments, and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies by solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors.

Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative.

For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital (https://www.linkedin.com/company/legend-capital).


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Malaysian Genomics Signs Strategic Collaboration Agreement for Expansion in the UAE

United Arab Emirates (UAE), Oct 26, 2022 – (ACN Newswire) – Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, today announced the signing of a Strategic Collaboration Agreement (SCA) outlining partnerships to market and distribute the Group's Dtect(R) range of genetic screening services in the United Arab Emirates (UAE).


Consul General of Malaysian Consulate in Dubai Mohd Fadly Amri Aliaman; ED of Malaysian Genomics Azri Azerai; Co-Founder/Director of Wellness by Design Dr. Lama Al Naeli; Chairman of ASC, BALSAM and Wellness by Design Dr Hisham Hakim; CEO of Balsam Health Services Abdulkader Awad; CEO of IAC Nurul Faten Jasmee; Director of ASC Kair Hakim and Secretary General of Malaysian Business Council Izwan Adnan [L-R]

Director of ASC Kair Hakim; ED of Malaysian Genomics Azri Azerai; Consul General of Malaysian Consulate in Dubai Mohd Fadly Amri Aliaman; Chairman of ASC, BALSAM and Wellness by Design Dr Hisham Hakim; CEO of Balsam Health Services Abdulkader Awad, and CEO of IAC Nurul Faten Jasmee [L-R]


Other than Malaysian Genomics, the SCA involves American Spine Center (ASC), a Dubai, UAE-based specialist in spinal injury and spine pathology; BALSAM Health Services, a Dubai, UAE-based healthcare service provider; Wellness by Design FZ LLC, a Dubai, UAE-based nutrition, obesity and weight loss specialist, and Sharjah, UAE-based IAC International LLC.

Under the SCA, Malaysian Genomics, ASC, Balsam and Wellness by Design will explore common strategies for joint or allied projects that translate to innovative healthcare tools or solutions, while the role of IAC is to support activities in priority areas, aligning the parties and work with other organisations, where appropriate. IAC will also be the point of contact between Malaysian Genomics and ASC, Balsam and Wellness by Design.

Noor Azri bin Dato' Sri Noor Azerai, Executive Director of Malaysian Genomics, said, "The SCA will allow us to formally explore how the parties can work together, including technical trials and evaluation of our Dtect screening tests for commercialisation in the UAE. Malaysian Genomics' role will be to provide technical and scientific support under the SCA. In addition, we constantly look for opportunities to partner with like-minded businesses and organisations in expanding our market reach for Dtect and our other services."

Dr. Hisham Hakim, Chairman of ASC, BALSAM and Wellness by Design, said, "We welcome this first step in a working relationship with Malaysian Genomics and IAC, and look forward to the inclusion of Dtect to offer more choices to our patients. We are committed to clinical and technological excellence as we bring coordinated patient care with compassion and commitment while ensuring cost efficiency."

Ms. Nurul Faten Jasmee, CEO of IAC, said, "There are lots of opportunities for the expansion of genetic screening services in the UAE and the wider Middle East and North Africa (MENA) region. We will provide the coordination, business delivery and project management between the parties during the technical trials for Dtect in the UAE, followed by the commercial rollout and expansion throughout the MENA region."

Malaysian Genomics Resource Centre Berhad: 0155 [BURSA: MGRC] [RIC: MGRC:KL] [BBG: MGRC:MK], http://www.mgrc.com.my/

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Giant Biogene has Entered Offering Stage: China’s Leading Skin Treatment Company with Annual Profits of More Than RMB800 Million

HONG KONG, Oct 26, 2022 – (ACN Newswire) – With the improvement of people's consumption level and the change in consumption concept, beauty and skincare have become a daily necessity, and the beauty and health industry has ushered in a stage of rapid development. Especially in recent years, many local Chinese brands have rapidly emerged as popular brands among young consumers.

Among them, Giant Biogene is a leader in the bioactive ingredient-based professional skin treatment product industry in China and is the second-largest professional skin treatment product company in China in terms of retail sales in 2021. The Company has officially entered the offering stage in the Hong Kong stock market, adding another high-quality investment target in the biotechnology field, and being the first listed company in collagen.

Proprietary recombinant collagen technology builds core strengths with strong performance growth

In the field of skincare, collagen has been expanding its market share due to its favourable skin regeneration and anti-aging properties. Due to the obvious advantages of recombinant collagen over animal-derived collagen, the market size of functional skincare products based on recombinant collagen is expected to reach RMB64.5 billion (in RMB, the same below) by 2027, surpassing hyaluronic acid to become the top functional skincare product.

In 2000, Giant Biogene developed its proprietary recombinant collagen technology, the first one in the field to be awarded a patent in China. Subsequently, the Company successfully industrialized the technology and became the first company to achieve mass production of recombinant collagen-based skincare products globally. The proprietary recombinant collagen technology has enabled the Company to build a solid barrier in the collagen skincare market and stand out in the fierce market competition. Giant Biogene has been the largest collagen-based professional skin treatment product company by retail sales in China for the latest three consecutive years since 2019.

According to the prospectus, from 2019 to 2021, Giant Biogene achieved revenue of RMB957 million, RMB1.191 billion and RMB1.552 billion respectively, with a compound annual growth rate of 27.39%; in the first five months of 2022, the Company achieved revenue of RMB723 million, representing a year-on-year increase of 38.9%, and continued to maintain an accelerated growth trend. In terms of profitability, Giant Biogene also performed well. In 2019, 2020, 2021 and the first five months of 2022, the net profits of the Company amounted to RMB575 million, RMB826 million, RMB828 million and RMB314 million respectively, representing solid growth.

Keeping recombinant collagen technology as the thread and expanding product portfolio on an ongoing basis

With proprietary recombinant collagen as the common thread of its product branding, Giant Biogene has built up a vast portfolio of professional skin treatment products, which generates spill over effects to the branding of other non-collagen-based products. The Company currently owns eight main brands, including Comfy, Collgene, Keyu, Kehen, Kefuping, Leeyen, SKIGIN and Shengan, covering functional skincare, medical dressings, and functional foods.

"Collgene" and "Comfy", the flagship brands of Giant Biogene's recombinant collagen products, were ranked as the third and fourth best-selling professional skin treatment brands in China in 2021, respectively. As of 31 May 2022, the sales of Comfy reached RMB428 million and the sales of Collgene reached RMB238 million, representing an increase of 62.9% and 18% over the same period in 2021, respectively, and accounting for 59.2% and 33.0% of total revenues, respectively.

In addition to the recombinant collagen technology, Giant Biogene has developed and produced several types of rare ginsenosides using its proprietary biomanufacturing technologies and is currently one of the largest recombinant collagen and rare ginsenosides companies globally in terms of manufacturing capacities. The Company's "SKIGIN" is a high-end skin repair brand based on rare ginsenoside technology.

Furthermore, by expanding product types, Giant Biogene is able to advance its technologies to enter into new product categories to expand its customer reach. Among its self-developed product pipeline, the Company has three Class III medical device products in clinical trials and expects to obtain Class III medical device registration certificates in the first quarter of 2024. From the current clinical trial results, these products are more effective than the control group products, which is expected to drive the injectable products to become one of the main growth areas of the company in the future.

From the medium to long-term perspective, China's skincare market will grow rapidly and consumers will pay more attention to functional products. Giant Biogene has taken the lead in the market with its unique technological advantage. With the continued expansion of its product portfolio, the Company will capture the growth opportunities in the functional skincare market, strive to increase its market share to support the long-term rapid growth of its business, and fully release its long-term value.

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Clinical Research Opportunities in China and the Path to USFDA Approval – Whitepaper

SYDNEY, AU, Oct 25, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO, and GlobalData have published the latest China biotech landscape analysis with expert guidance on pathways to USFDA approval for biotechs conducting research in China.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

The report was prepared for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for USFDA approvals.

Novotech's Vice President, Global Head of Clinical Services Dr. Yooni Kim said: "China presents exceptional clinical opportunities with vast populations and word-class research facilities and KOLs. This concise analysis of the pathway to USFDA approval expertly informs clinical stage biotechs about the China research benefits and how to manage any challenges. The report details the regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful USFDA approval pathway. Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the USFDA approval process, avoiding delays and additional costs."

The key learnings from the report are:

– Companies should engage with the USFDA early and formally to confirm guidance on their clinical roadmap.

– China's clinical development regulations are aligned with the USFDA regulations and present significant benefits for biopharma companies.

– Biopharma companies should take advantage of China's revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.

– For biopharma companies looking to enter China, China's pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favorable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.

– Chinese biotech companies can enter developed markets in the US and Europe through strategic partnerships or by setting-up their own operations in these markets.

Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research. The company has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.

Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.

About Novotech

Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Co-Led by Legend Capital, Top Gene Delivery Enterprise VectorBuilder Secures CNY410mn in Series C Round

HONG KONG, Oct 20, 2022 – (ACN Newswire) – VectorBuilder Biotechnology (Guangzhou) Co., Ltd. (hereinafter referred to as "VectorBuilder"), a top gene delivery enterprise, recently announced the completion of its Series C round with CNY410 million, co-led by Legend Capital. The proceeds will facilitate VectorBuilder in continuously promoting the upgrading and capacity expansion of the gene delivery R&D and production technology platform, further accelerate the global business presence, and boost the R&D of life sciences and genetic medicines.



VectorBuilder was founded by Dr. Bruce Lahn, a world-renowned molecular biologist who was a tenured professor at the University of Chicago and a researcher at Howard Hughes Medical Institute (HHMI). The company provides services such as scientific research and clinical carrier CRO, gene-drug CDMO and gene delivery IP out-licensing, covering the entire field of life science and gene medicine. VectorBuilder has provided more than 1.2 million gene delivery solutions to more than 4,000 scientific research institutes and pharmaceutical companies worldwide, and its gene-drug CRO and CDMO projects are spread all over North America, Europe, Japan and South Korea.

Dr. Bruce Lahn, Founder and Chief Scientist of VectorBuilder, said: "I'd like to take this opportunity to extend my sincere gratitude to investors for the support and trust. Due to a robust technical accumulation and an excellent business model in the gene delivery industry, VectorBuilder enjoys the highest market share in the global gene carrier scientific research market, and we jointly launched the construction of a 45,000-square-meter gene delivery R&D and production base with Guangzhou Development District Investment Group in April 2022. We hope to take this financing round as an opportunity to further accelerate the comprehensive upgrade and optimization of the technology platform and promote the expansion of production capacity and global presence. VectorBuilder has become a pioneer in the entire gene delivery industry chain by empowering basic scientific research and accelerating the clinical application of gene drugs. We believe VectorBuilder will enter thousands of life science laboratories worldwide and become a well-known brand in the field of life science. We will empower the gene-drug industry through core technologies and help China to "overtake" on the genetic drug track. At the same time, we hope to overcome genetic diseases, improve human health, and provide irreplaceable value to the industry and the world."

Jeff Wang, Managing Director of Legend Capital, said: "VectorBuilder is the world's leading gene delivery company, providing full-chain solutions from basic scientific research to clinical application of gene delivery. It is an honor to participate in the future development of VectorBuilder. Dr. Bruce Lahn is an expert in the field of biotechnology innovation, and we are optimistic about VectorBuilder's comprehensive ecological service platform for gene delivery in life science and biomedicine. VectorBuilder has developed the world's first system providing online design, offline production carrier construction and downstream application service, serving thousands of top biopharmaceutical companies and research institutes. We believe VectorBuilder has a promising future as the genetic medicine industry develops."

About Legend Capital

Founded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea.

It currently manages USD and RMB funds of over US$10 billion in commitments, and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies by solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors.

Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative.

For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital (https://www.linkedin.com/company/legend-capital).


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AcuraBio Appoints Talented Senior Executives to Drive Global Growth Program

BRISBANE, AUS, Oct 18, 2022 – (ACN Newswire) – AcuraBio (formerly Luina Bio), a leading Australian biopharmaceutical CDMO, recently acquired by biotech investor Dr. Glenn Haifer and Ampersand Capital Partners, announced today new senior executive hires to support global growth plans. International biopharma executive Guillaume Herry has been appointed as CEO, while HR executive Joanne Reichardt has been appointed Head of People & Culture.


AcuraBio CEO Guillaume Herry


AcuraBio brings two decades of experience in innovative therapeutics for customers in the biotech, pharmaceutical, and animal health industries. The CDMO provides recombinant proteins, vaccines, and complex live biotherapeutic products to customers on the leading edge in emerging therapeutics.

Dr. Haifer stated "These senior executive appointments are key to shaping the company as we move forward with our growth plans. AcuraBio will immediately benefit from Guillaume Herry's experience with companies in the US, Europe and Australia designing and implementing growth strategies. He brings over 15 years of international operational and strategic consulting experience across the biopharmaceutical and medical device industries."

Mr. Herry said: "I'm excited to be part of this new phase of growth and to be working with Glenn and the Ampersand team. I look forward to leveraging the business' deep technical experience to grow the company and expand the service offering."

Mr. Herry holds an MBA from the Australian Graduate School of Management at University of New South Wales Business School (Australia), a Master's Degree in Engineering for Health and Drugs (Biotechnology, Health and Management) from the University Joseph Fourier in Grenoble (France) and a Master's Degree in Entrepreneurship in Life Sciences & Technologies from the University Paris-Sud X (France).

Regarding the appointment of Joanne Reichardt as Head of People & Culture, Dr. Haifer added "Ms. Reichardt's appointment reflects a significant step in supporting our growth mission as we aim to create a robust culture. Ms. Reichardt brings over 20 years of HR experience and proven leadership expertise in successfully delivering critical people and culture strategies to support changing and growing businesses."

Ms. Reichardt holds a Bachelor of Business (Strategic HR & Marketing) from the University of Southern Queensland and is a CAHRI member of the Australian Human Resources Institute.

Ms. Reichardt she was excited to be joining AcuraBio. "I look forward to working closely with the team to advance people processes and systems, with a focus on attracting and retaining the industry's top talent to strengthen AcuraBio's position as the most experienced biopharmaceutical CDMO. My goal is to enhance our people & culture offering, with a view to becoming industry Employer of Choice."

About AcuraBio

AcuraBio Pty Ltd is one of Australia's most experienced biopharmaceutical CDMOs, offering trusted, client-focused services to both domestic and international clients for the past 20 years. AcuraBio offers significant quality, cost, and IP assurances for biopharma companies around the world. World-class researchers and proven facilities, a streamlined regulatory framework, generous tax incentives, and government funding make Australia a prime location for biotech research. AcuraBio has the following operating licenses: TGA (Australian FDA equivalent) license for the manufacture of human therapeutic APIs from biological and synthetic sources, APVMA (veterinary equivalent of the TGA) license for manufacture of sterile immunobiological products, OGTR license to produce products from genetically modified organisms, and a DAF facility license for import and use of biologic materials. Additional information about AcuraBio is available at www.acurabio.com.

About Ampersand Capital Partners

Founded in 1988, Ampersand is a middle market private equity firm with more than $3 billion of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience in seeking to build value and drive strong long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. Additional information about Ampersand is available at www.ampersandcapital.com

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