HUTCHMED (China) Limited said China’s National Medical Products Administration (NMPA), the country’s medicines regulator, granted conditional approval to fanregratinib (HMPL-453), a selective oral inhibitor of FGFR 1, 2 and 3, for adults with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) carrying an FGFR2 fusion or rearrangement after prior systemic therapy. The medicine will be sold in China as ATLED®. The approval was supported by the Phase II registration cohort of a single-arm, multicenter, open-label pivotal Phase II/IIIb trial in China. The cohort met its primary endpoint, with an Independent Review Committee-assessed objective response rate of 42.5% (95% confidence interval: 30.0%–53.6%). Median time to response was 1.4 months, median duration of response was 6.9 months (95% CI: 5.6–8.5), and disease control rate was 83.9% (95% CI: 74.5%–90.9%). Median progression-free survival was 6.9 months (95% CI: 4.1–8.2), while median overall survival was 16.6 months (95% CI: 12.4–16.6). The results were recently presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2026. HUTCHMED Acting Chief Executive Officer and Chief Financial Officer Johnny Cheng said the approval addresses a major treatment gap and that the company is prepared to use its commercial infrastructure to make ATLED® available rapidly. The Phase IIIb portion, whose confirmatory cohort began enrollment in January 2026, will further assess the medicine’s clinical benefits and safety.