药捷安康-B早盘涨超9% 此前替恩戈替尼片获国家药监局批准纳入优先审评品种名单

Core Viewpoint - The stock of Jiangsu Hengrui Medicine Co., Ltd. (02617) has seen a significant increase, attributed to the approval of its drug, Tienogratinib, by the NMPA for priority review in treating advanced cholangiocarcinoma patients [1] Group 1: Company Developments - Jiangsu Hengrui Medicine's stock rose over 9% in early trading, currently up 4.9% at HKD 179.7, with a trading volume of HKD 77.964 million [1] - The NMPA has included Tienogratinib in its priority review list for patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] - Tienogratinib has also been recognized as a breakthrough therapy for cholangiocarcinoma by the NMPA [1] Group 2: Clinical Research - Jiangsu Hengrui Medicine announced the publication of exploratory Phase 2 clinical trial results for Tienogratinib in cholangiocarcinoma in The Lancet Gastroenterology & Hepatology [1] - The Phase 2 study (NCT04919642) included eligible cholangiocarcinoma patients with FGFR2 fusions and those with primary or acquired resistance to FGFR inhibitors, as well as patients with other FGFR gene alterations and FGFR wild-type patients [1] - Tienogratinib demonstrated the ability to overcome acquired resistance in FGFR2 fusion-positive cholangiocarcinoma patients and showed antitumor activity in other patients with FGFR gene alterations [1]