AffaMed Therapeutics' AMT901 (biosimilar- trastuzumab) Receives NMPA's Approval to Initiate P-III Clinical Study in China
Shots:
- The NMPA has granted CTA approval to AffaMed to conduct a clinical study evaluating AMT901/ SB3- a biosimilar referencing Roche’s Herceptin. The company is preparing for clinical study with its anticipated first patients visit in Q1’20
- The CTA approval is based on the results of the study demonstrating bio-similarity of AMT901 to Herceptin with no clinical differences in efficacy & safety in patients with HER2 + BC
- AMT901/SB3 is an IV trastuzumab being developed in collaboration with Samsung Bioepis for the treatment of HER2+ BC and is an approved therapy in the US and EU. In Feb’2019- AffaMed and Samsung Bioepis collaborated to develop & commercialize multiple biosimilars in China
Click here to read full press release/ article | Ref: GlobeNewswire | Image: GlobeNewswire
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