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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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