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Mabpharm's Biobetter (CMAB008) for Infliximab Receives NMPA's Approval in China

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Mabpharm's Biobetter (CMAB008) for Infliximab Receives NMPA's Approval in China

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  • NMPA has granted approval to market infliximab biobetter in China. Sorrento holds exclusive commercial rights to Infliximab biobetter Ab outside of China and plans to file a BLA for the product in the US and EU in 2021
  • Biobetters are drugs that have similar structure and properties to an innovator product but are enhanced to produce better outcomes. The biobetter Ab produced in CHO cells has demonstrated a better safety profile than the parent mouse cell produced product- while maintaining its efficacy profile
  • The approval covers 6 autoimmune and inflammation indications. Sorrento plans to meet with regulatory agencies to determine the best path towards registration for the US and EU

  | Ref: Sorrento | Image: Analyze Markets

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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