美股IPO·2025-10-08 09:31Core Insights - Orelabrutinib is a potential best-in-class oral small molecule BTK inhibitor with strong CNS penetration, currently in global Phase III clinical development for progressive forms of multiple sclerosis (MS) [1][2][3] - A Phase III trial for primary progressive MS (PPMS) has been initiated, while a trial for secondary progressive MS (SPMS) is expected to start in Q1 2026 [1][2][6] - Zenas BioPharma has entered a significant licensing agreement with InnoCare Pharma, acquiring global rights for Orelabrutinib in MS and other non-oncological indications outside Greater China and Southeast Asia [1][11] Clinical Development - The Phase III trial for PPMS is a global, multicenter, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Orelabrutinib at a daily dose of 80 mg [2][6] - The SPMS Phase III trial is also designed as a global, multicenter, randomized, double-blind, placebo-controlled study, expected to start in Q1 2026 [6][14] - Previous Phase II trials demonstrated significant reductions in Gd+ T1 MRI brain lesions at 12 and 24 weeks, with sustained effects up to 96 weeks [2][4] Strategic Collaboration - The collaboration between InnoCare and Zenas is seen as a milestone in global development, enhancing the clinical and commercial value of Orelabrutinib [3][4] - Zenas aims to leverage this partnership to advance its pipeline, including two additional preclinical molecules: a novel oral IL-17AA/AF inhibitor and a CNS-penetrant oral TYK2 inhibitor, both expected to enter clinical trials in 2026 [3][7][8] Financial Terms - Under the licensing agreement, Zenas will pay InnoCare up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion [11] - Zenas will also issue 7 million shares of common stock to InnoCare, along with tiered royalties based on annual net sales of the licensed products [11] Company Profiles - InnoCare Pharma is a biopharmaceutical company focused on innovative drug development for oncology and autoimmune diseases, with a strong pipeline of products at various stages [16] - Zenas BioPharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for autoimmune diseases, with a focus on Orelabrutinib and Obexelimab [17][18]