Zenas and InnoCare Sign $2B+ Global License Deal for Orelabrutinib

Zenas BioPharma (Nasdaq: ZBIO) has entered a broad collaboration with InnoCare Pharma (HKEX: 09969; SSE: 688428) valued at more than US $2 billion, securing rights to three autoimmune programs led by orelabrutinib, a CNS-penetrant BTK inhibitor now in Phase 3 development for multiple sclerosis (MS).

The agreement expands Zenas’s autoimmune and neuroimmunology pipeline beyond its lead anti-CD19 antibody obexelimab, while enabling InnoCare to extend the reach of its small-molecule portfolio beyond China.

Deal Terms and Scope

Under the deal, Zenas gains:

• Global rights (excluding oncology) to orelabrutinib for the treatment of multiple sclerosis and other autoimmune disorders.
• Ex-Greater China and Southeast Asia rights to an oral IL-17AA/AF inhibitor.
• Worldwide rights to a brain-penetrant TYK2 inhibitor.

In return, InnoCare will receive up to US $100 million in upfront and near-term milestone payments, up to 7 million shares of Zenas common stock, and potential development, regulatory, and commercial milestones that could bring the total value above US $2 billion. Tiered royalties reaching the high-teens percentage will apply to future product sales.

Pipeline Focus: BTK in Progressive MS

Orelabrutinib is a highly selective, oral BTK inhibitor designed to cross the blood–brain barrier, allowing it to target resident immune cells such as B cells and microglia implicated in chronic inflammation and neurodegeneration in MS.

Zenas has already begun a Phase 3 study in Primary Progressive MS (PPMS) and plans to start a Phase 3 program in Secondary Progressive MS (SPMS) in early 2026.

Earlier studies in relapsing MS demonstrated sustained reductions in new MRI lesions and favorable safety over nearly two years, suggesting potential differentiation among next-generation BTK inhibitors currently in development for neuroinflammatory disease.

Complementary Assets: IL-17 and TYK2 Programs

Alongside orelabrutinib, the two additional assets strengthen Zenas’s autoimmune portfolio across complementary pathways:

• The IL-17AA/AF inhibitor targets both the A and F isoforms of interleukin-17, aiming to enhance efficacy versus current IL-17A-specific antibodies in diseases such as psoriasis and ankylosing spondylitis.
• The brain-penetrant TYK2 inhibitor offers potential utility in systemic and neurological autoimmune conditions where JAK–STAT signaling is implicated.

Together, these programs position Zenas as a diversified player across humoral, T-cell, and cytokine signaling axes in autoimmunity.

Strategic Context

For Zenas, the deal complements its existing biologics pipeline and provides an entry into neuroimmunology, a field with limited therapeutic innovation beyond anti-CD20 antibodies. The company also announced a US $120 million private placement to fund upcoming clinical trials and regulatory submissions.

For InnoCare, the transaction monetizes its non-oncology assets while retaining oncology rights to orelabrutinib, which is already approved in China for B-cell malignancies. The collaboration also enhances InnoCare’s visibility in global partnering for its early-stage discovery programs.

Outlook

The agreement reflects growing cross-border integration between Chinese discovery platforms and U.S. clinical developers.
Zenas now joins a select group of companies advancing BTK inhibitors for progressive MS, alongside Sanofi (tolebrutinib) and Roche (fenebrutinib) — an area with significant unmet need and regulatory momentum.

If successful, orelabrutinib could become one of the first BTK inhibitors to show disease-modifying benefit in progressive MS, potentially reshaping the therapeutic landscape for neuroinflammatory disorders.

Sources

Zenas BioPharma Press Release, October 8 2025
InnoCare Pharma Company Announcement, October 8 2025

Disclaimer

This article is based on publicly available company announcements and information believed to be accurate as of publication. It is intended for informational purposes only and does not constitute investment, medical, or legal advice.