Hehuang Pharmaceutical (00013) announced that the marketing application for vanreglatinib (HMPL-453) for second-line treatment of intrahepatic cholangiocarcinoma in China has been accepted and included in priority review

Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced that the new drug marketing application for adult patients with advanced, metastatic, or intrahepatic cholangiocarcinoma (ICC) with advanced, metastatic, or inoperable intrahepatic cholangiocarcinoma (ICC) who have received systematic treatment and have fibroblast growth factor receptor (“FGFR”) 2 fusion or rearrangement has been accepted by the China Drug Administration (“State Drug Administration”) and included in priority review. HMPL-453

Veragratinib is a novel, selective FGFR1, 2, and 3 oral inhibitor. Intrahepatic cholangiocarcinoma is a highly aggressive malignant tumor originating from the epithelium of the bile ducts in the liver. It accounts for about 8.2% to 15.0% of primary liver cancer, and is the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has continued to rise, with an overall 5-year survival rate of about 9%. About 10-15% of patients with intrahepatic cholangiocarcinoma worldwide have FGFR2 fusion or rearrangement.

Data from a single-arm, multi-center, open-label Phase II registration study conducted in China supported the submission of this Chinese new drug marketing application. The study reached the primary endpoint of objective response rate (ORR). Secondary endpoint results, including progression-free survival (PFS), disease control rate (DCR), duration of remission (DoR), and overall survival (OS), also supported the discovery of primary endpoints. The full research data will be presented at an academic conference in the near future.