HUTCHMED (00013): Ailinida (Fruquintinib) has been approved by the National Medical Products Administration of China for the treatment of patients with intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements.

HUTCHMED (00013) announced that the new drug application for Fanregratinib (HMPL-453) has been conditionally approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma who have previously received systemic therapy and have fibroblast growth factor receptor (FGFR) 2 fusion or rearrangement. Fanregratinib will be marketed in China under the brand name Ailingda (English trademark: ATLED). Intrahepatic cholangiocarcinoma is a highly aggressive malignancy originating from the epithelial cells of the intrahepatic bile ducts, accounting for approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has shown a continuous upward trend, with a 5-year overall survival rate of about 9%. Among global patients with intrahepatic cholangiocarcinoma, approximately 10-15% have FGFR2 fusion or rearrangement. This approval is based on data from the Phase II registration cohort of the pivotal, single-arm, multicenter, open-label Phase II/IIIb clinical trial of Ailingda conducted in China (NCT04353375). Results were recently presented at the 2026 European Society for Medical Oncology (ESMO) Gastrointestinal Cancer Congress. The study met its primary endpoint, demonstrating robust and clinically meaningful responses in treated patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusion/rearrangement, with an objective response rate (ORR) assessed by the Independent Review Committee (IRC) of 42.5% (95% CI: 30.0%53.6%). Key secondary endpoints also exhibited consistent clinical activity, with rapid effect, as the median time to reach disease response was 1.4 months. The median duration of response (DoR) was 6.9 months (95% CI: 5.68.5) and the disease control rate (DCR) reached 83.9% (95% CI: 74.5%90.9%). In addition, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.18.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.416.6). Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, stated: As a highly prevalent and destructive subtype of primary liver cancer, intrahepatic cholangiocarcinoma presents a heavy disease burden, and previous targeted treatment options have been very limited. We are delighted to see Ailingda approved by the NMPA, filling a significant therapeutic gap in this clinical field in China. This approval provides an important new treatment option for many previously treated patients with advanced intrahepatic cholangiocarcinoma. We are fully prepared to bring this precision therapy to patients at the fastest pace possible, leveraging our mature commercialization team and systems. The Phase IIIb portion of the clinical trial will serve as a confirmatory study to further validate the clinical benefits and safety of Ailingda in this indication. Patient enrollment for this confirmatory cohort has been initiated in January 2026. Ailingda (Fanregratinib, HMPL-453) is a novel, highly selective, and potent inhibitor of FGFR 1, 2, and 3. Abnormal FGFR signaling has been found to be a driver of tumor growth, angiogenesis, and resistance to anti-tumor therapies. Abnormal FGFR genetic alterations are considered key drivers of the proliferation of tumor cells in a variety of solid tumors. HUTCHMED currently holds all global rights for Fanregratinib.