China Sino Biopharmaceutical Signs Exclusive Licensing Agreement with Sanofi for Rofalcitinib

March 4, 2026  Source: drugdu 30

On March 4, Sino Biopharmaceutical Limited (1177.HK) announced that it has entered into an exclusive licensing agreement with Sanofi for rofalcitinib, a first-in-class, novel and potent oral small-molecule JAK/ROCK inhibitor.
Under the agreement, Chia Tai Tianqing, a subsidiary of Sino Biopharmaceutical, grants Sanofi an exclusive license for the global development, manufacturing and commercialization of rofalcitinib. Sino Biopharmaceutical is eligible to receive up to **US$1.53 billion** in payments, including a US$135 million upfront payment, as well as potential development, regulatory and sales milestone payments. In addition, the company will receive tiered royalties at up to double-digit percentages based on the annual net sales of rofalcitinib. The agreement is subject to customary closing conditions, including approval from relevant regulatory authorities.
Xie Qirun, Chairman of the Board of Directors of Sino Biopharmaceutical, stated: "We are delighted to join hands with Sanofi to bring the first-in-class JAK/ROCK inhibitor to patients worldwide. This collaboration represents an important milestone in the company's international expansion. Sino Biopharmaceutical has always been committed to becoming the preferred Chinese partner for multinational pharmaceutical companies. We firmly believe that by leveraging Sanofi's global advantages in R&D and commercialization, we will further accelerate the rollout of innovative products and deliver more breakthrough therapies to patients across the globe."

About Rofalcitinib
As a dual-target inhibitor, rofalcitinib achieves anti-inflammatory and anti-fibrotic effects through dual-pathway synergy. On one hand, it targets the JAK/STAT pathway to directly block inflammatory signal transduction, reducing inflammatory cytokines produced by myeloid cells at the source. On the other hand, it targets the ROCK pathway to downregulate overactivated T helper 17 (Th17) cells and enhance the function of regulatory T cells (Treg) by modulating the phosphorylation of STAT3/STAT5, thereby re-establishing immune balance.
In February 2026, rofalcitinib (brand name: Anxu®) was approved for marketing by the National Medical Products Administration (NMPA) of China for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).
In addition, rofalcitinib has demonstrated breakthrough potential in the treatment of chronic graft-versus-host disease (cGVHD): it has entered Phase III clinical trials in China and was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) in August 2025; Phase II clinical studies have been approved in the United States. The Ib/IIa clinical data of rofalcitinib for cGVHD treatment have been published in the journal Blood. The study showed that rofalcitinib achieved superior 12-month failure-free survival (FFS) compared with other approved therapies, exhibited stronger therapeutic responses in fibrosis-dominant organs, and holds the potential to overcome ruxolitinib resistance.

About Sino Biopharmaceutical
Sino Biopharmaceutical is a leading innovation-driven pharmaceutical group in China, covering the entire industrial chain of drug R&D, intelligent manufacturing and commercial sales. Its product portfolio includes a variety of biological and chemical drugs, with leading advantages in four core therapeutic areas: oncology, hepatology/metabolism, respiratory/autoimmunity, and surgery/analgesia. The company has been listed among the "Top 50 Global Pharmaceutical Companies" published by the authoritative US magazine Pharmaceutical Executive for seven consecutive years. Upholding the mission of "Healthcare Technology, Warmth for More Lives", Sino Biopharmaceutical continuously provides innovative therapies to patients worldwide and strives to become a leading global competitive pharmaceutical enterprise.

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