Sanofi Licenses Rovadicitinib from Sino Biopharm in $1.53B Global Deal

Share on Social Media

52667884467_15c9fedda8_k
Image Courtesy: Alpha Photo / Flickr

Sanofi signs a global licensing deal worth up to $1.53B with Sino Biopharmaceutical for rovadicitinib, a novel JAK/ROCK inhibitor recently approved in China for myelofibrosis

Written By: Pharmacally Medically News Desk

Sanofi has entered into an exclusive global licensing agreement with Sino Biopharmaceutical’s subsidiary, Chia Tai Tianqing Pharmaceutical Group, for rovadicitinib, a first-in-class oral JAK/ROCK inhibitor being developed for hematologic and immune-mediated diseases. The transaction was disclosed through a voluntary announcement filed by Sino Biopharmaceutical with the Hong Kong Stock Exchange.

Under the terms of the agreement, Chia Tai Tianqing will grant Sanofi exclusive worldwide rights to develop, manufacture, and commercialize rovadicitinib. Sino Biopharmaceutical will receive an upfront payment of $135 million and is eligible to receive up to $1.395 billion in additional development, regulatory, and commercial milestone payments. The company will also receive tiered royalties on annual net sales of the drug. The agreement remains subject to customary closing conditions, including regulatory approvals.

Rovadicitinib is an oral small-molecule inhibitor designed to target both Janus kinase (JAK) and Rho-associated coiled-coil containing protein kinase (ROCK) signaling pathways. Through this dual mechanism, the drug aims to simultaneously regulate inflammatory signaling and fibrosis-related pathways, processes that contribute to disease progression in several hematologic and immune-mediated conditions.

The therapy recently received approval in China for the treatment of myelofibrosis, a rare bone marrow disorder characterized by fibrosis of the bone marrow, abnormal blood cell production, and systemic symptoms that can significantly impact patients’ quality of life.

Beyond myelofibrosis, rovadicitinib is also being developed for chronic graft-versus-host disease (cGVHD), a serious complication that can occur following allogeneic hematopoietic stem cell transplantation.

In China, the drug has advanced to Phase III clinical trials for cGVHD and was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) in August 2025. In the United States, the therapy has been cleared to proceed with Phase II clinical studies.

Quick Results from Early Clinical Study

Early Phase Ib/IIa clinical findings published in the journal Blood reported encouraging activity of rovadicitinib in patients with chronic graft-versus-host disease. The study showed an overall response rate of 86.4% and a 12-month failure-free survival rate of 85.2%. Investigators also observed notable responses in fibrosis-dominant organs and suggested the therapy may offer potential benefit in patients who are resistant to ruxolitinib.

Through this agreement, Sanofi aims to advance the global development of rovadicitinib and expand its potential use in hematologic and immune-mediated diseases. For Sino Biopharmaceutical, the collaboration enables the company to leverage Sanofi’s global development and commercialization capabilities to accelerate international expansion of the therapy.

Reference

Exclusive License Agreement for Rovadicitinib with Sanofi, Sino Biopharmaceuticals Ltd. 04 March 2026, https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0304/2026030400003.pdf

Zhao YM et al, A first-in-class JAK/ROCK inhibitor, rovadicitinib, for glucocorticoid-refractory or -dependent chronic GVHD. Blood. 2025 Jun 12;145(24):2857-2872. PMID: 40009501, https://doi.org/10.1182/blood.2024026581


Share on Social Media
Scroll to Top