AffaMed Therapeutics Secures NMPA Approval for Phase III Trial of Herceptin Biosimilar AMT901 in China
Dec 13, 2019 13:41
CST Updated
13:41
CBC Group
Diversified Alternative Asset Management Institution
AffaMed Therapeutics
Biological Drug Manufacturer
Samsung Bioepis
Biosimilar Developer
December 13, 2019 /BioonBIOON/ -- AffaMed Therapeutics, a biopharmaceutical company founded by CBC Group, recently announced that the National Medical Products Administration (NMPA) of China has approved the Phase III clinical trial of AMT901 (SB3).Clinical TrialsApplication (CTA): The drug is a trastuzumab biosimilar, co-developed with Samsung Bioepis, formulated as an intravenous injection for HER2-positiveBreast Cancertreatment.
AMT901 is intended to be developed as a biosimilar to Roche’s branded drug Herceptin (generic name: trastuzumab). Currently, the clinical study preparations for AMT901 are on track, with Phase III trials expected to commence in the first quarter of 2020.Clinical Trial. This trastuzumab biosimilar has been approved in the United States and the European Union.
Dr. Nathan Pang, CEO of AffaMed Therapeutics, stated, “The approval of the CTA marks a significant milestone for AffaMed as we transition into a clinical-stage biotechnology company. We are fully committed to launching this clinical development program with the goal of making AMT901 available at an affordable price to benefit more patients in China.”
The approval of the CTA was based on a review of a comprehensive data package demonstrating the biosimilarity of AMT901 to Herceptin® (trastuzumab). This included results from a comparative clinical study, which found no clinically meaningful differences between AMT901 and the reference product in terms of efficacy and safety in patients with HER2-positive breast cancer.
In February 2019, CBC Group established AffaMed Therapeutics and announced a collaboration agreement with Samsung Bioepis to jointly develop multiple next-generation products in China.Biosimilarsclinical development, regulatory registration, and commercialization. In addition to AMT901, AffaMed Therapeutics has an expanding product pipeline, including multiple candidates in the field of ophthalmic treatment developed in collaboration with Samsung Bioepis Co., Ltd.Biosimilarsclinical development, such as for Lucentis® (ranibizumab) and Eylea® (aflibercept)
ofBiosimilars. (Bioon.com)