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Zenas BioPharma Secures Global Rights To InnoCare's Orelabrutinib, Aiming To Advance Multiple Sclerosis Treatments Beyond Oncology

Author: Benzinga Newsdesk | October 08, 2025 05:05am

Zenas BioPharma, Inc. ("Zenas," "Zenas BioPharma" or the "Company") (NASDAQ:ZBIO) and InnoCare Pharma Limited ("InnoCare" or "InnoCare Pharma") (HKEX: 09969; SSE: 688428) today announced a transformational license agreement granting Zenas global development and commercialization rights to orelabrutinib for Multiple Sclerosis (MS) and across all therapeutic areas other than oncology. Zenas also secured rights to a novel, oral, IL-17AA/AF inhibitor, and an oral, brain-penetrant, TYK2 inhibitor.

Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor with the potential to address compartmentalized inflammation and disease progression in MS. A global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of orelabrutinib dosed 80 mg once daily (QD) in patients with Primary Progressive MS (PPMS) has been initiated. Zenas plans to initiate a second global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating orelabrutinib in patients with Secondary Progressive MS (SPMS) in the first quarter of 2026.

In a previously completed global Phase 2 clinical trial in patients with Relapsing-Remitting MS (RRMS), orelabrutinib demonstrated significant reductions in new Gd+ T1 lesions versus placebo at weeks 12 and 24, with sustained reductions in inflammatory activity through week 96 as demonstrated by meaningful impact on endpoints indicative of disease progression. The safety and tolerability profile of orelabrutinib is consistent with other BTK inhibitors in development for MS and is well characterized across multiple prior autoimmune disease and hematologic cancer trials.

Posted In: ZBIO

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