AffaMed Therapeutics’ AMT901 (biosimilar, trastuzumab) Receives NMPA’s Approval to Initiate P-III Clinical Study in China

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

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