On August 28, 2026, HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) announced that the New Drug Application (NDA) for fanregratinib (HMPL-453) has been granted conditional approval by China's National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have received prior systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED®.
Intrahepatic cholangiocarcinoma is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2%-15.0% of primary liver cancers and ranking as the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has been continuously rising, with a 5-year overall survival rate of approximately 9%. Approximately 10%-15% of intrahepatic cholangiocarcinoma patients worldwide harbor FGFR2 fusions or rearrangements.
This approval is supported by data from the Phase II registration cohort of a single-arm, multicenter, open-label Phase II/IIIb pivotal clinical trial conducted in China. The study met its primary endpoint, demonstrating strong and clinically meaningful responses in previously treated patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The objective response rate (ORR) assessed by an independent review committee (IRC) was 42.5% (95% CI: 30.0%-53.6%). Key secondary endpoints also showed consistent clinical activity, with a median time to response of 1.4 months, median duration of response (DoR) of 6.9 months, disease control rate (DCR) of 83.9%, median progression-free survival (PFS) of 6.9 months, and median overall survival (OS) of 16.6 months.
ATLED® is a novel, highly selective, and potent inhibitor of FGFR 1, 2, and 3, and is the first domestically developed FGFR1/2/3 inhibitor approved in China, directly filling a major treatment gap in this clinical area. HUTCHMED currently holds all worldwide rights to fanregratinib. The Phase IIIb confirmatory portion of the clinical trial initiated patient enrollment in January 2026 and will further validate its clinical benefit and safety.
Source: HUTCHMED / PR Newswire | http://cnmobile.prnasia.com/story/545580-1.shtml