Sino Biopharmaceutical Enters Exclusive Global Licensing Agreement with Sanofi for First-in-Class JAK/ROCK Inhibitor Rovadicitinib

Sino Biopharmaceutical (1177.HK) announced today that its subsidiary, CTTQ PHARMA Group, has granted Sanofi an exclusive worldwide license to develop, manufacture, and commercialize rovadicitinib (brand name: Anxu® in China), a novel, potent oral small-molecule JAK/ROCK inhibitor that is first-in-class.

Under the agreement, Sino Biopharmaceutical will receive an upfront payment of US$135 million and is eligible for potential development, regulatory, and sales milestone payments of up to US$1.40 billion, bringing the total deal value to as much as US$1.53 billion. The company will also receive tiered royalties on annual net sales reaching up to double digits. The transaction is subject to customary closing conditions, including regulatory approvals.

Strategic Global Partnership to Advance a First-in-Class JAK/ROCK Inhibitor

Commenting on the partnership, Theresa Tse, the Chairman of Sino Biopharmaceutical said: “We are delighted to join forces with Sanofi to bring this first-in-class JAK/ROCK inhibitor to patients around the world. This collaboration represents an important milestone in our international strategy.

Sino Biopharmaceutical has long been committed to becoming the partner of choice for multinational pharmaceutical companies in China. We are confident that Sanofi’s global expertise in research, development, and commercialization will help accelerate the delivery of innovative therapies and offer breakthrough treatment options to patients globally.”

Rovadicitinib is a dual-pathway inhibitor that simultaneously targets inflammation and fibrosis. It blocks the JAK/STAT pathway to interrupt inflammatory signaling at its source, reducing the production of pro-inflammatory cytokines by myeloid cells. At the same time, it modulates the ROCK pathway by regulating STAT3/STAT5 phosphorylation, thereby suppressing overactive Th17 cells and enhancing regulatory T-cell (Treg) function to restore immune balance.

Clinical Progress and Regulatory Milestones in Myelofibrosis and cGVHD

In February 2026, rovadicitinib received approval from China’s National Medical Products Administration (NMPA) for first-line treatment of adults with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).

The drug has also shown promising potential in chronic graft-versus-host disease (cGVHD). In China, it is advancing in Phase III trials and received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) in August 2025. In the United States, a Phase II study has been cleared to proceed. Data from the Phase Ib/IIa trial, published in the journal Blood, demonstrated superior 12-month failure-free survival (FFS) compared with other approved therapies, along with stronger responses in fibrosis-dominant organs and the ability to overcome ruxolitinib resistance.

Author

Steven Chung

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