HUTCHMED (00013.HK): ATLED (Fanregratinib) Approved by NMPA for FGFR2 Fusion Cholangiocarcinoma

NewTimeSpace News: On 28 August 2026, HUTCHMED (China) Limited (stock code: 00013) announced that the new drug application for fanregratinib (HMPL-453) has been conditionally approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma harbouring FGFR2 fusions or rearrangements who have received prior systemic therapy. The drug will be marketed in China under the brand name ATLED.

According to the announcement, the approval is based on data from the Phase II registration cohort of a single-arm, multi-centre, open-label Phase II/IIIb pivotal trial conducted in China (NCT04353375), which met its primary endpoint with an objective response rate of 42.5% as assessed by an independent review committee, a median progression-free survival of 6.9 months and a median overall survival of 16.6 months. Intrahepatic cholangiocarcinoma accounts for approximately 8.2%-15.0% of primary liver cancers with a five-year overall survival rate of approximately 9%, and approximately 10%-15% of global patients harbour FGFR2 fusions or rearrangements. Patient enrolment in the confirmatory Phase IIIb cohort commenced in January 2026.

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