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News  ›  GlobeNewswire Inc.

HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma

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HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma

HUTCHMED announced that its New Drug Application (NDA) for fanregratinib (HMPL-453) has been accepted with priority review status by China's NMPA for treating advanced intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement. The NDA is supported by a Phase II registration trial in China that met its primary endpoint of objective response rate, with positive secondary endpoints including progression-free survival, disease control rate, duration of response, and overall survival.

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HCM   positive

The company achieved NDA acceptance with priority review status from China's NMPA for fanregratinib, a significant regulatory milestone. The Phase II trial met its primary endpoint and showed positive secondary endpoints, indicating strong clinical efficacy data. Priority review status accelerates the approval timeline, which is favorable for commercialization prospects and shareholder value.