HUTCHMED wins approval for ATLED cancer treatment

• HUTCHMED received conditional approval in China for ATLED to treat advanced intrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
• The Phase II registration cohort reported an objective response rate of 42.5% and median progression-free survival of 6.9 months.
• HUTCHMED said it plans to commercialize ATLED in China while retaining worldwide rights to fanregratinib.

HUTCHMED (NASDAQ:HCM) received conditional approval from China’s National Medical Products Administration for ATLED® (fanregratinib, HMPL-453), an oral FGFR 1/2/3 inhibitor for certain adults with advanced intrahepatic cholangiocarcinoma.

The approval applies to patients in China with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma carrying FGFR2 fusion or rearrangement after prior systemic therapy, based on results from a Phase II registration cohort.

The Phase II registration cohort reported an investigator review committee-assessed objective response rate of 42.5%, median duration of response of 6.9 months, disease control rate of 83.9%, median progression-free survival of 6.9 months, and median overall survival of 16.6 months.

The company stated that enrollment for a Phase IIIb confirmatory study began in January 2026.

ATLED was evaluated in the Phase II study NCT04353375, which included patients with FGFR2 fusion or rearrangement-positive intrahepatic cholangiocarcinoma who had received previous systemic treatment.

HUTCHMED said it plans to commercialize ATLED in China using its existing infrastructure while retaining worldwide rights to fanregratinib as it continues development of the treatment.