贝达药业：盐酸恩沙替尼胶囊获澳门批准上市

Core Viewpoint - The approval of Enasidenib capsules (brand name: Beimingna) by the Macao Drug Regulatory Authority marks a significant milestone for the company in treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development and Approvals - Enasidenib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery [1] - The drug received approval for second-line indications from the National Medical Products Administration of China in November 2020 [1] - In March 2022, the first-line indication was approved, followed by the approval for clinical trials of postoperative adjuvant therapy in April 2022, with ongoing Phase III clinical research [1] Group 2: Market Access and Insurance Inclusion - Enasidenib was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2023) with an agreement valid until December 31, 2025 [1] - The first-line indication is expected to receive approval from the U.S. Food and Drug Administration in December 2024 [1] Group 3: Competitive Landscape - As of the announcement date, other ALK inhibitors available in Macao include Crizotinib, Ceritinib, Alectinib, Brigatinib, and Lorlatinib [1]