AffaMed Therapeutics Receives NMPA Approval to Initiate Phase III Clinical Trial in China with Herceptin® (Trastuzumab) Biosimilar Candidate AMT901

Dec  2019

AMT901/SB3 is an intravenous trastuzumab for the treatment of HER2-positive breast cancer

SHANGHAI, China, Dec. 10, 2019 (GLOBE NEWSWIRE)  -- AffaMed Therapeutics, a biopharmaceutical company founded and funded by CBC Group, a healthcare private equity rm focused on the development and late-stage investment opportunities, today announced it has  received Clinical Trial Application  (CTA) approval from the China National  Medical Products Administration (NMPA) to conduct clinical trials for AMT901, or SB3, a proposed biosimilar  for Herceptin® (trastuzumab) being developed in collaboration with Samsung Bioepis as an intravenous trastuzumab for the treatment of HER2-positive breast cancer and it has  been  approved by the European Medicines Agency (EMA) and United States (US) Federal  Drug Agency (FDA). Clinical study preparation is on track and rst patient visit is scheduled in Q1 2020.


“This CTA approval is an important milestone for AffaMed as we transition to a clinical- stage biotechnological company,” said Dr. Nathan Pang,  CEO of AffaMed. “We are fully geared up  to  initiate  this  clinical  development  program, with  the  goal  of  providing AMT901 to help more Chinese patients at an affordable price.”


The CTA approval was  based on review  of a comprehensive data  package that demonstrated  biosimilarity   of  AMT901  to  Herceptin®  (trastuzumab).  This  includes results from a clinical comparative study  that found no clinically meaningful differences in terms of ecacy  and safety between AMT901 and the reference product for patients with HER2-positive breast cancer.


In  February   2019,   CBC  Group   formed  AffaMed   Therapeutics  and   announced a partnership agreement with Samsung Bioepis  to  collaborate on  clinical  development, regulatory registration, and commercialization of multiple next-generation biosimilars in China. In addition to the AMT901, AffaMed has  a growing  portfolio  of product pipelines including  in the ophthalmology therapeutic area,  with biosimilars referencing Lucentis® (ranibizumab) and Eylea® (aibercept) also  in clinical development in collaboration with Samsung Bioepis.


About AffaMed Therapeutics


AffaMed  Therapeutics is  a  biopharmaceutical company focused  on  identifying  and licensing late-stage candidates for commercialization in emerging Asia Pacic  markets and globally. AffaMed was founded and funded by CBC Group in 2019.


About CBC Group


CBC Group is a healthcare dedicated private  equity  rm, focused on growth  and  late- stage   investment  opportunities  across   the   healthcare  industry.    CBC  Group   is committed  to  supporting  the commercialization  of  cutting-edge technologies and companies that  full unmet medical needs, thus  continuously improving  the  standard and quality of care  for patients.


Contacts:


Media in US: Mark Corbae

Senior Vice President

Westwicke PR

+1 (203) 682-8288

mark.corbae@icrinc.com



Media in China: Edmond  Lococo Senior Vice President ICR Asia

+86 (10) 6583-7510

edmond.lococo@icrinc.com


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