Core Viewpoint - 康哲药业's subsidiary 德镁医药 has received approval from the NMPA for its innovative oral JAK1 inhibitor povorcitinib, which is expected to accelerate the drug's development and review process in China for treating non-segmental vitiligo [1][2] Group 1: Product Development - Povorcitinib is a selective oral small molecule JAK1 inhibitor with substance and use patents in specific countries/regions [1] - The drug is currently undergoing Phase 3 clinical trials for non-segmental vitiligo, moderate to severe hidradenitis suppurativa, and nodular prurigo in several overseas countries, along with a Phase 2 trial for asthma [1] Group 2: Market Potential - The inclusion of povorcitinib in the breakthrough therapy list is expected to expedite its research and review process in mainland China, potentially leading to a faster market launch [2] - If approved, povorcitinib will complement 德镁医药's existing innovative drugs, enhancing clinical and commercial value for skin disease patients [2] - The product will provide differentiated and comprehensive treatment options for vitiligo patients alongside the topical formulation of phosphoric acid lukotinin ointment [2] Group 3: Licensing and Collaboration - On March 31, 2024, 德镁医药 entered into a collaboration and licensing agreement with Incyte for povorcitinib, securing exclusive rights for research, development, registration, and commercialization in mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries [2] - The subsidiary has sublicensed rights for regions outside mainland China, excluding 德镁医药 and its subsidiaries [2]
康哲药业(00867)：创新药口服小分子JAK1抑制剂Povorcitinib 纳入突破性治疗品种名单