HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with ...

HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 27, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR…

HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma

Novel, highly potent oral selective FGFR 1/2/3 inhibitor approved for patients with advanced FGFR2-altered intrahepatic

Hutchison China MediTech Announces Approval of Ayvadex® (Fanregratinib) for Treatment of FGFR2 Fusion/Rearranged Intrahepatic Cholangiocarcinoma Patients in China

Hutchison China MediTech, also known as HUTCHMED (NASDAQ/LSE: HCM; HKEX: 13), disclosed that the new drug application for Fanregratinib (HMPL-453) has received conditional approval from the China National Medical Products Administration ('NMPA') for the treatment of advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma ('ICC') adult patients with FGFR2 fusion or rearrangement who have previously received systemic therapy. Fanregr…