超20亿美元!中国创新药“出海”重大突破
Shang Hai Zheng Quan Bao·2025-10-08 14:21

Core Insights - The collaboration between Nocera Biopharma and Zenas BioPharma involves a global licensing agreement worth over $2 billion, focusing on the development of Orelabrutinib for multiple sclerosis and other autoimmune diseases [2][4]. Group 1: Agreement Details - Zenas will receive global exclusive rights for Orelabrutinib in the multiple sclerosis field and rights for non-oncology development and commercialization outside Greater China and Southeast Asia [4][5]. - Nocera Biopharma will receive an upfront payment of $100 million, milestone payments, and 7 million shares of common stock from Zenas, along with royalties of up to a percentage of annual net sales from licensed products [4][6]. Group 2: Product Potential - Orelabrutinib is the first highly permeable BTK inhibitor for the central nervous system to enter Phase III clinical trials, with trials for primary progressive multiple sclerosis (PPMS) starting in Q3 2025 and secondary progressive multiple sclerosis (SPMS) trials expected to begin in Q1 2026 [4][8]. - The drug has shown significant efficacy in reducing brain inflammation and has an excellent safety profile based on Phase II data [4][8]. Group 3: Strategic Focus - Nocera Biopharma retains global rights for Orelabrutinib in oncology and non-oncology rights in Greater China and Southeast Asia, indicating a strategic focus on dual therapeutic areas [6][8]. - The company aims to enhance its drug discovery platform to develop first-in-class and best-in-class therapies for autoimmune diseases, addressing unmet medical needs in China and globally [9].