On December 10, 2019 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, reported 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) (Press release, AffaMed Therapeutics, DEC 10, 2019, View Source [SID1234553305]). Clinical study preparation is on track and first patient visit is scheduled in Q1 2020.
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"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.