Core Viewpoint - The stock of Zai Lab Limited (药捷安康-B) has seen a significant increase, attributed to the approval of its drug, Tazemetostat, for priority review by the NMPA for treating advanced cholangiocarcinoma in adult patients [1] Group 1: Regulatory Approval - Tazemetostat has been included in the priority review list by the NMPA for the treatment of 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 previously been recognized as a breakthrough therapy for cholangiocarcinoma by the NMPA [1] Group 2: Clinical Trial Results - Zai Lab announced that the exploratory Phase 2 clinical trial results for Tazemetostat in cholangiocarcinoma were published in The Lancet Gastroenterology & Hepatology, which has an impact factor of 38.6 [1] - The Phase 2 study (NCT04919642) included eligible cholangiocarcinoma patients with FGFR2 fusions who had primary or acquired resistance to FGFR inhibitors, as well as patients with other FGFR gene alterations and FGFR wild-type patients [1] - Tazemetostat demonstrated the ability to overcome acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma patients and showed antitumor activity in other cholangiocarcinoma patients with FGFR gene alterations [1]
港股异动 | 药捷安康-B(02617)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