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HUTCHMED Announces that it has Completed Enrollment of a Phase II Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China

March 6, 2025 – Clinical Trials, Drug Discovery, Pharmaceutical – HUTCHMED, clinical trial, intrahepatic cholangiocarcinoma, oncology

6 March 2025 — Hong Kong, Shanghai and New Jersey, US — HUTCHMED (China) Limited
today announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptor (“FGFR”)2 fusion/rearrangement.

The study is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced IHCC patients with FGFR2 fusion/rearrangement.

Primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival
(PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS). A total of 87 patients
were enrolled into the registration phase of the study. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.

The first patient received the first dose in March 2023 and HUTCHMED expects to announce topline results
from the study around the end of 2025. If favorable, the results could enable a New Drug Application
submission to China’s National Medical Products Administration (NMPA).

About HUTCHMED
HUTCHMED is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit: www.hutch-med.com.