InnoCare Pharma and Zenas BioPharma announce over $2 billion license agreement for three autoimmune product candidates

Orelabrutinib is a potentially best-in-class, highly CNS-penetrant and selective, 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.

"We are delighted to partner with Zenas BioPharma. The partnership with Zenas BioPharma represents a significant milestone in our journey, and we will continue to enhance and advance our globalization efforts in the future," said Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare Pharma. "Orelabrutinib has a differentiated mechanism of action and strong clinical data underscoring its promising potential as a treatment for patients with progressive forms of MS. We are confident in Zenas' management team given their exceptional track record of successful drug development, global regulatory approvals and commercial launches, and their commitment to driving innovation for autoimmune diseases."

"InnoCare is a globally recognized company with a successful track record of drug discovery, development and commercialization. This transformative collaboration with InnoCare further positions Zenas to execute on its vision to become a global, fully integrated development and commercial-stage autoimmune-focused biopharmaceutical company. With global rights to orelabrutinib, we are advancing a potential blockbuster franchise for progressive MS. Orelabrutinib, with its best-in-class potential, is strongly positioned to address disease progression independent of relapse activity, the highest unmet medical need in MS, and to improve the lives of patients living with progressive MS. We are also excited to add two potentially best-in-class molecules, a novel oral, IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor, to our pipeline. We plan to advance each of these programs to human clinical trials in 2026 and expect to have initial patient data from the oral IL-17AA/AF clinical program in 2027," said Lonnie Moulder, Founder and Chief Executive Officer (CEO) of Zenas.  

"This strategic collaboration will leverage our shared focus to accelerate the development of orelabrutinib and help maximize its clinical and commercial potential on a global scale, particularly in MS,"  added Dr. Cui, "Given the statistically significant and clinically meaningful data from the Phase 2 trial, and promising blood-brain barrier penetration capability, orelabrutinib has the potential to transform the treatment paradigm for this devastating disease. In addition to orelabrutinib, we have fortified our powerful discovery engine to focus on cutting-edge targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet medical needs and strong market potential in China and worldwide."

Mr. Moulder continued, "With this transaction we have established a balanced portfolio of complementary mechanisms and modalities with best-in-class blockbuster potential across multiple therapeutic areas. With our two franchise programs, obexelimab concluding Phase 3 development for IgG4-RD, and now orelabrutinib for progressive forms of MS, Zenas is well positioned to meaningfully impact the lives of patients living with autoimmune diseases. We are prioritizing the tremendous opportunity ahead with orelabrutinib in PPMS and SPMS. We expect to report obexelimab topline 12-week primary endpoint results from the Phase 2 MoonStone trial in patients with RMS early in the fourth quarter of 2025 and 24-week data in the first quarter of 2026. We anticipate making a program decision based on these data and the evolving landscape for the development of new therapies for RMS in early 2026."

"BTK inhibition is a validated mechanism for the treatment of progressive forms of MS, and there is immense scientific interest in its potential to impact inflammation compartmentalized in the CNS and thereby potentially impact disability progression independent of relapse activity. We believe the differentiated, potentially best-in-class profile of orelabrutinib could make a meaningful difference for patients with PPMS and SPMS, which have few treatment options. With our late-stage development capabilities and expertise in MS, we are well positioned to execute on the pivotal, global, Phase 3 development of orelabrutinib, as well as advance two early candidates into clinical development," said Lisa von Moltke, M.D., Head of Research and Development and Chief Medical Officer of Zenas.

Pipeline Overview

Orelabrutinib, a highly selective CNS-penetrant, oral, small molecule BTK inhibitor

Oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer and IL-17AF heterodimer signaling

Oral, brain-penetrant, TYK2 inhibitor

Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function

License Agreement

Under the license agreement, Zenas will pay InnoCare upfront and near-term milestone payments of up to $100 million in cash, including milestone achievements expected in 2026, and up to 7,000,000 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 $2 billion.

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.

Source: InnoCare Pharma Limited