Blog Big Molecule Watch July 09, 2021

Innovent Announces the Approval of a First-Line Therapy for People with Hepatocellular Carcinoma in China

Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a bevacizumab biosimilar injection, as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (“HCC”).  According to the press release, this is the first regulatory approval of a PD-1 inhibitor-based combination therapy for the first-line treatment of HCC.  The announcement indicated that this approval was based on the results of a randomized, open-label Phase 3 clinical trial (ORIENT-32).

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