HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma
HUTCHMED (China) Limited - American Depositary Shares (HCM)
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chi-med.com/investors/information-for-shareholders
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Source: GlobeNewswire
— NDA supported by results from a Phase II registration trial in China — — Second most common form of liver cancer after hepatocellular carcinoma, with generally poorer long-term survival in comparison — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM; HKEX:?13) today announces that the New Drug Application (“NDA”) for fanregratinib (HMPL-453) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (“ICC”) with fibroblast growth factor receptor (“FGFR”) 2 fusion/rearrangement who have previously received systemic therapy has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). Fanregratinib (HMPL-453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver
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News
- HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma [Yahoo! Finance]Yahoo! Finance
- HUTCHMED Initiates Global Clinical Development of ATTC Candidate HMPL-A251 in Patients with Solid TumorsGlobeNewswire
- HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in ChinaGlobeNewswire
- HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress and the 2025 ASH Annual MeetingGlobeNewswire
- HUTCHMED (NASDAQ:HCM) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=HCM&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> froMarketBeat
HCM
Sec Filings
- 12/29/25 - Form 6-K
- 12/17/25 - Form 6-K
- 12/8/25 - Form 6-K
- HCM's page on the SEC website