Zenas BioPharma, InnoCare Pharma announce orelabrutinib license agreement

Zenas BioPharma (ZBIO) and InnoCare Pharma (INCPF) announced a license agreement granting Zenas global development and commercialization rights to orelabrutinib for Multiple Sclerosis 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 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 in patients with Primary Progressive MS 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 in the first quarter of 2026. Under the license agreement, Zenas will pay InnoCare upfront and near-term milestone payments of up to $100M in cash, including milestone achievements expected in 2026, and up to 7M shares of Zenas common stock, including shares issuable upon a milestone expected to be achieved in early 2026. The total of the upfront payment, near term milestone and potential development and regulatory milestone payments, along with potential commercial sales achievement milestone payments for all three programs, exceeds $2B. In addition, InnoCare is entitled to receive tiered royalties of up to high teens percentages on annual net sales of the licensed products. Zenas will have the exclusive right to develop, manufacture and commercialize orelabrutinib in the field of MS globally, and non-oncology fields in all territories outside Greater China and Southeast Asia, while InnoCare retains full global rights in the field of oncology. Zenas will also have the exclusive right to develop, manufacture and commercialize the oral, IL-17AA/AF inhibitor in all territories outside Greater China and Southeast Asia, and the oral, brain-penetrant, TYK2 inhibitor globally.