HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Shots: The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapy NDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, incl….

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Transcenta and EirGenix Collaborate to Advance Integrated Continuous Biomanufacturing Technologies

Shots: EirGenix has entered into a strategic collaboration and non-exclusive licensing agreement with Transcenta for its Highly Intensified Continuous Bioprocessing (HiCB) platform Under the agreement, Transcenta will grant EirGenix a non-exclusive license to its HiCB platform, incl. continuous perfusion & integrated hybrid continuous purification process technologies, as well as documentation, know-how & regulatory support to…

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Innovent receives NMPA approval for Tabosun colon cancer treatment

Innovent receives NMPA approval for Tabosun colon cancer treatment

MSI-H/dMMR colon cancer comprises 15% of resectable cases and responds poorly to chemotherapy. Credit: NMK-Studio/Shutterstock.com. Innovent Biologics has received China’s National Medical Products Administration (NMPA) approval for the New Drug Application (NDA) for Tabosun (ipilimumab N01 injection), a CTLA-4 monoclonal antibody for colon cancer. The approval covers its use in combination with sintilimab as a…

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