$1.53 billion partnership! China biopharmaceuticals' first-ever global exclusive license for a new drug to Sanofi

In the current landscape where BD transactions among Chinese pharmaceutical companies are becoming more routine, a full equity deal for a mature asset has attracted industry attention. On March 4th, Hong Kong-listed leading pharmaceutical company China Biological Products Holdings (01177.HK) and global pharmaceutical giant Sanofi jointly announced an exclusive global licensing agreement for the first-in-class (FIC) JAK/ROCK dual inhibitor Rovaxtinib. Under the agreement, China Biological and its subsidiary Chia Tai Tianqing Pharmaceutical will grant Sanofi exclusive rights worldwide to develop, manufacture, and commercialize the product, with total payments potentially reaching up to $1.53 billion.

Source of screenshot: Corporate announcement

Notably, this is not only the first innovative drug licensing project between China Biological and multinational corporations (MNCs) in recent years but also one of the few full rights licensing collaborations with global MNCs involving late-stage clinical assets among large Chinese pharmaceutical companies. This transaction signifies that China Biological’s entire R&D chain—from drug initiation, clinical development, registration, to manufacturing quality control—has been recognized by top global pharmaceutical companies through rigorous system certification. It also marks a further enhancement of this leading Chinese pharma’s dual BD capabilities—both “bringing in” and “going out”—creating space for global value realization of its extensive innovative pipeline matrix.

This also reveals a new industry trend—Chinese pharmaceutical companies’ full-chain R&D capabilities are increasingly recognized by MNCs, elevating mutual trust to a new level.

1. Niche Segment, Big Blockbuster: Why Does Rovaxtinib Win Favor?

A BD deal that impresses global MNCs always hinges on the clinical value of the asset itself. Rovaxtinib is precisely a “big fish” in the niche field of rare diseases that China Biological has cultivated with global competitiveness.

Image source: MoEntropy Pharma - Global Drug Development Database

As an independently developed first-in-class drug by Chia Tai Tianqing, Rovaxtinib is the world’s first approved JAK/ROCK dual-target small molecule inhibitor. It exerts dual pharmacological effects—anti-inflammatory and anti-fibrotic—through synergistic pathways, precisely targeting the core pathological mechanisms of diseases such as myeloproliferative neoplasms and transplant rejection. It is a leading product in development progress and clinical data among drugs targeting the same pathways globally.

Image source: MoEntropy Pharma - Global Drug Development Database

Currently, the core indications for this product are myelofibrosis (MF) and chronic graft-versus-host disease (cGVHD). In 2023, MF was included in China’s “Second Batch of Rare Disease List,” with over 60,000 new cases annually and more than 200,000 existing patients domestically. Rovaxtinib has achieved breakthroughs in efficacy and safety through its dual-target mechanism. Phase III clinical data show significant improvements in spleen size reduction and symptom relief, with a substantial decrease in adverse reactions.

According to the NMPA official website and MoEntropy Pharma Database, in February 2026, Rovaxtinib (brand name: Anxu®) was approved by China’s National Medical Products Administration (NMPA) for 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).

Source of screenshot: NMPA official website

What truly elevates this product beyond the domestic market and gains global recognition is its breakthrough potential in the field of chronic graft-versus-host disease (cGVHD).

Known as “chronic rejection,” cGVHD is the most common “secondary disaster” after allogeneic hematopoietic stem cell transplantation. The incidence rate among post-transplant patients worldwide is as high as 30%–70%, with 50% diagnosed at moderate to severe stages. It not only severely impairs patients’ quality of life but is also a leading cause of non-relapse mortality post-transplant, representing a core clinical challenge that has remained unsolved for many years.

The clinical value of Rovaxtinib has been globally recognized by authoritative academic circles: in February 2025, its phase I/IIa results for cGVHD treatment were published in the top hematology journal Blood. Data showed that 59.1% of subjects experienced significant symptom improvement, with an overall best response rate of 86.4%; the 12-month failure-free survival rate was 85.2%, significantly better than approved therapies, with excellent safety and tolerability, and no dose-limiting toxicities or discontinuations due to adverse reactions.

Currently, this indication has been included as a breakthrough therapy by China’s CDE, with phase III clinical trials progressing steadily domestically, and the U.S. FDA has approved phase II clinical development, marking a comprehensive global development process. This breakthrough clinical value in a niche area ultimately led to the global collaboration with Sanofi. According to incomplete statistics, this is also one of the largest BD deals in China’s transplantation field, breaking the industry’s traditional “small pond” mindset that big fish cannot be bred in small pools.

2. A Win-Win Deal

This is undoubtedly a win-win collaboration.

For China Biological, the value of this deal far exceeds short-term financial gains. The upfront payment of $135 million provides immediate profit. As a mature asset, subsequent milestone payments and sales royalties will offer clear, long-term stable revenue streams. Additionally, China Biological will gain international development experience through Sanofi’s involvement in future domestic phase II and III clinical trials.

For Sanofi, as a leading multinational company specializing in vaccines, autoimmune, and rare diseases, it can leverage its global clinical development and commercialization resources to rapidly expand Rovaxtinib’s international market, maximizing its long-term global value.

Especially now, in indications like myelofibrosis and other hematologic malignancies, Sanofi is increasing its presence: with products and pipelines such as CD38 monoclonal antibodies, CD20 bispecific antibodies, GPRC5D monoclonal antibodies, and others, both R&D and commercialization efforts can synergize with Rovaxtinib. The breakthrough clinical value of Rovaxtinib in GVHD aligns highly with Sanofi’s existing pipeline strategy; moreover, as a late-stage mature asset, its development risk is low, enabling rapid expansion of Sanofi’s transplant and hematology product portfolio and strengthening its global market position.

3. China Biological’s Global Expansion Gains Momentum

The significant collaboration with Sanofi not only provides authoritative endorsement of China Biological’s full-chain capabilities—especially in asset acquisition and licensing—but also fully unlocks the global valuation potential of its innovative pipeline.

In China’s innovative drug industry, BD capability is not simply about “buying” and “selling,” but a comprehensive reflection of R&D strength, commercialization ability, and global vision. Previously, China Biological leveraged its strong domestic commercialization and full-chain clinical development capabilities to become a preferred partner for MNCs like Boehringer Ingelheim entering the Chinese market; through multiple high-profile licensing collaborations, it has built a mature “bring-in” BD system.

In recent years, China Biological has driven growth through both in-house R&D and acquisitions, continuously expanding its innovative pipeline matrix and preparing ample “ammunition” for global expansion. In the hematology field alone, more than ten innovative pipelines are steadily advancing, including core products like BCL-2 inhibitor TQB3909 and Syk inhibitor TQB3473, both entering phase III trials, with approval expected in the coming years.

By acquiring biotech companies such as Lixun Medicine and Hegira Biotech, and leveraging over two decades of continuous investment in independent R&D, China Biological has developed a large-scale innovative pipeline covering key areas such as oncology, liver diseases, respiratory, and cardiovascular-metabolic diseases, with numerous assets having global development potential, including FIC and BIC assets.

This year, China Biological will release major clinical data at multiple top international conferences, including TQH3906 (TYK2 inhibitor), LM/302 (CLDN18.2 ADC), LM/108 (CCR8 monoclonal antibody), TQB3019 (BTK OAPD), Kylo-11 (LPA), among others, laying a solid foundation for licensing and collaboration.

With the Rovaxtinib deal finalized, China Biological’s external licensing capability has received a key validation. Its extensive innovative pipeline assets are expected to accelerate onto the global stage through BD models, opening a new chapter for international growth.