Sino Biopharm and Sanofi reach exclusive global licensing agreement for rovadicitinib, with total transaction value up to $1.53 billion

On March 4, Sino Biopharm (01177.HK), a leading Hong Kong-listed pharmaceutical company, and Sanofi, a global multinational pharmaceutical giant, jointly announced an exclusive global licensing agreement for Rovadicitinib, a first-in-class dual JAK/ROCK inhibitor.

Under the agreement, Sino Biopharm and its subsidiary CTTQ Pharma will grant Sanofi exclusive rights to develop, manufacture, and commercialize this asset worldwide. In return, Sino Biopharm will receive an upfront payment of $135 million, potential development, regulatory, and sales milestone payments of up to $1.395 billion, and tiered royalties up to double digits. This marks the largest out-licensing deal ever signed by a Chinese pharmaceutical company in the transplantation field.

This transaction is not only the first innovative drug out-licensing project between a Chinese biopharmaceutical company and a multinational corporation (MNC) in recent years, but it also represents a rare full-rights licensing collaboration between a Chinese Big Pharma and a global MNC for a late-stage mature asset.

Ms. Theresa Tse, Chairwoman of the Board of Sino Biopharm, stated, "We are very pleased to join hands with Sanofi to bring Sino Biopharm's first-in-class JAK/ROCK inhibitor to patients worldwide. This collaboration is a significant milestone in Sino Biopharm's globalization strategy. Sino Biopharm is always committed to becoming the preferred Chinese partner for multinational pharmaceutical companies. We firmly believe that by leveraging Sanofi's global R&D and commercialization strengths, Sino Biopharm will further accelerate the global launch of innovative products and bring more breakthrough therapies to patients around the world."

The breakthrough clinical value of Rovadicitinib is considered a key factor driving this global collaboration.

As a first-in-class drug independently developed by CTTQ Pharma, Rovadicitinib is the world's first dual JAK/ROCK inhibitor. Through synergistic action on two pathways, it achieves dual pharmacological effects of anti-inflammation and anti-fibrosis, precisely targeting the core pathological mechanisms of diseases such as myeloproliferative neoplasms and transplant rejection. It is a leading product in terms of research and development progress and boasts impressive clinical data among global candidates targeting the same pathway.

The product is currently focused on two major indications: myelofibrosis and graft-versus-host disease. For myelofibrosis, it was included in China's Second Catalog of Rare Diseases in 2023. There are over 60,000 new patients annually in China, with a prevalent patient population exceeding 200,000. Leveraging its dual-target mechanism, Rovadicitinib has achieved a breakthrough in both efficacy and safety. Phase III clinical data show a significant improvement in spleen volume reduction and symptom relief rates, along with a substantial reduction in adverse event incidence. In February 2026, Rovadicitinib (trade name: Anxu®) received marketing approval from China's National Medical Products Administration for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.

Furthermore, its breakthrough potential in graft-versus-host disease has garnered global recognition for Rovadicitinib. In February 2025, results from the Phase Ib/IIa study of Rovadicitinib in chronic graft-versus-host disease were published in the leading hematology journal Blood. Data showed that 59.1 percent of subjects experienced significant improvement in rejection symptoms, with a best overall response rate of 86.4 percent. The 12-month failure-free survival rate was 85.2 percent, significantly superior to approved therapies, coupled with an excellent safety and tolerability profile. Currently, this indication has been granted Breakthrough Therapy designation by the Center for Drug Evaluation of China's National Medical Products Administration, with domestic Phase III clinical trials progressing steadily. Simultaneously, the U.S. Food and Drug Administration has approved the initiation of Phase II clinical trials, marking the full commencement of its global development pathway.

Since last year, there has been a surge in out-licensing deals involving Chinese innovative drugs, but most have involved early-stage assets. The transaction between Sino Biopharm and Sanofi is not only one of the most significant innovative drug licensing deals since the beginning of 2026, but also a rare out-licensing deal in the industry involving a late-stage asset.

Industry insiders believe this signifies that leading domestic Chinese pharmaceutical companies, represented by Sino Biopharm, have obtained certification from top-tier global pharmaceutical companies through their rigorous systems across the entire research and development chain, from drug discovery and target selection, clinical development, and regulatory filing, to manufacturing and quality control. It further implies that this leading Chinese pharmaceutical company has perfected its two-way licensing capability, evolving from in-licensing to out-licensing, thereby unlocking the potential for global value realization across its extensive innovative pipeline matrix.

For Sanofi, a leading multinational corporation with deep roots in vaccines, immunology, and rare diseases, the transplantation field is a core strategic focus. The breakthrough clinical value of Rovadicitinib in chronic graft-versus-host disease aligns highly with Sanofi's pipeline layout. Moreover, as a late-stage mature asset, it carries lower development risk and can rapidly supplement Sanofi's product portfolio in the transplantation and hematology fields, thereby consolidating its global market position.

In China's innovative drug industry, licensing capabilities serve as a comprehensive reflection of a company's research and development strength, commercialization ability, and global vision. Previously, Sino Biopharm had become one of the core strategic partners in China for top-tier multinational corporations such as Boehringer Ingelheim, leveraging its robust local commercialization capabilities and end-to-end clinical development expertise. The landmark transaction with Sanofi now serves as authoritative validation that Sino Biopharm's entire in-house research and production chain meets international standards, fully unlocking the global valuation potential of its subsequent innovative pipeline.

In recent years, Sino Biopharm has continuously expanded its innovative pipeline matrix through a dual-engine approach of internal research and development and external mergers and acquisitions, thereby amassing substantial ammunition for out-licensing. Particularly through the acquisitions of innovative biotech firms such as LaNova Medicines and Hygieia, combined with its own in-house research system built over two decades of sustained investment, Sino Biopharm has accumulated a vast innovative pipeline matrix spanning multiple core therapeutic areas including oncology, liver disease, respiratory diseases, and cardiovascular metabolism. This has generated a substantial reserve of first-in-class and best-in-class assets with global development potential.

This year, Sino Biopharm will unveil pivotal clinical data at several top-tier global academic conferences, including data on TQH3906 (a TYK2 inhibitor), LM/302 (a CLDN18.2 antibody-drug conjugate), LM/108 (a CCR8 monoclonal antibody), TQB3019 (a BTK OAPD), and Kylo-11 (an LPA candidate), laying a solid foundation for future out-licensing and collaborations.

With the conclusion of the Rovadicitinib transaction, Sino Biopharm's out-licensing capabilities have undergone a critical validation. Its vast portfolio of innovative drug assets is now poised to accelerate its journey onto the global stage through licensing deals, charting a second growth curve for the company through internationalization.