Core Viewpoint - The stock of Jiangsu Hengrui Medicine Co., Ltd. (药捷安康-B) has seen a significant increase, attributed to the approval of its drug, Tienogratinib, for priority review by the NMPA for treating advanced cholangiocarcinoma [1] Group 1: Stock Performance - Jiangsu Hengrui Medicine's stock rose over 9% in early trading and is currently up 4.9%, priced at 179.7 HKD, with a trading volume of 77.964 million HKD [1] Group 2: Regulatory Approval - Tienogratinib has been included in the priority review list by the NMPA, aimed at treating adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment [1] - The drug has also been designated as a breakthrough therapy for cholangiocarcinoma by the NMPA [1] Group 3: 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 anti-tumor activity in other FGFR gene-altered cholangiocarcinoma patients [1]

Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., announced the publication of exploratory Phase 2 clinical trial results for its core product, Tiengogatinib, targeting cholangiocarcinoma in the journal "The Lancet Gastroenterology & Hepatology" [1] Group 1: Clinical Trial Details - The Phase 2 study (NCT04919642) is an open-label, multicenter trial involving eligible cholangiocarcinoma patients, including those with FGFR2 fusions and primary or acquired resistance to FGFR inhibitors [1] - Tiengogatinib demonstrates the ability to overcome acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma patients and shows antitumor activity in patients with other FGFR gene alterations [1] Group 2: Disease Background - Cholangiocarcinoma is a highly aggressive cancer of the biliary system, often driven by FGFR2 fusions, which can be targeted by inhibitors such as pemigatinib and futibatinib [1] - The emergence of acquired FGFR2 mutations frequently leads to resistance against these targeted therapies [1]