Waltham’s Zenas BioPharma strikes $2 billion deal for multiple sclerosis drug

Waltham-based Zenas BioPharma has signed a major licensing deal with InnoCare Pharma, a Chinese company, to develop and market the experimental drug orelabrutinib for multiple sclerosis and other autoimmune diseases worldwide. The agreement gives Zenas global rights to orelabrutinib, an oral medication designed to target inflammation and slow MS progression, especially in forms of the disease with few existing treatments.

The deal could be worth up to $2 billion for a drug with potential annual sales as high as $12 billion in the United States alone, an estimate based on the size of the market.

A large international study testing orelabrutinib for primary progressive MS is already underway, with another for secondary progressive MS set to begin in early 2026. In earlier trials for relapsing MS, orelabrutinib showed notable reductions in brain lesions and inflammation over almost two years, with safety similar to other drugs in its class.

Zenas is also adding two other drugs, both oral, to its pipeline: an IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both of which could help manage autoimmune conditions and are scheduled for human trials next year, with initial patient data expected in 2027.

In announcing the news, company officials said the partnership strengthens the company’s  efforts to deliver new therapies for MS and other autoimmune diseases worldwide, aiming to improve lives where treatment options are still limited.