AffaMed Therapeutics Receives NMPA Approval to Initiate Phase III Clinical Trial in China with Herceptin® (Trastuzumab) Biosimilar Candidate AMT901
- Category: Antibodies
- Published on Wednesday, 11 December 2019 10:42
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AMT901/SB3 is an intravenous trastuzumab for the treatment of HER2-positive breast cancer
SHANGHAI, China I December 10, 2019 I AffaMed Therapeutics, a biopharmaceutical company founded and funded by CBC Group, a healthcare private equity firm 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 biosimilar for Herceptin® (trastuzumab). AMT901 is 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) Food and Drug Administration (FDA). Clinical study preparation is on track and first 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 efficacy 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® (aflibercept) 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 Pacific markets and globally. AffaMed was founded and funded by CBC Group in 2019.
About CBC Group
CBC Group is a healthcare dedicated private equity firm, 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 fulfil unmet medical needs, thus continuously improving the standard and quality of care for patients.
SOURCE: AffaMed Therapeutics