Shanghai-based Henlius Biotech has entered into a significant licensing agreement with biosimilar leader Sandoz, granting exclusive commercialization rights for its ipilimumab biosimilar HLX13 across major global markets. The deal, announced on April 29, 2025, covers the United States, 42 European countries and regions, Japan, Canada, and Australia.
Under the terms of the agreement, Henlius will receive an upfront payment of $31 million and is eligible for additional milestone payments that could bring the total value to $301 million. Henlius will maintain responsibility for development, manufacturing, and commercial supply of HLX13, while Sandoz will leverage its established global network and commercialization expertise to bring the therapy to patients.
Strategic Importance in Immuno-Oncology
HLX13 is a biosimilar version of Bristol-Myers Squibb's Yervoy® (ipilimumab), the world's first CTLA-4 inhibitor. Yervoy® has been approved in various countries for multiple oncology indications, particularly in combination with nivolumab (Opdivo®) for the treatment of melanoma and hepatocellular carcinoma, among others.
The partnership represents a significant step in expanding access to critical immuno-oncology therapies. CTLA-4 inhibitors like ipilimumab work by blocking the CTLA-4 protein, which helps regulate immune system responses, thereby enhancing T-cell activation and immune response against cancer cells.
Expanding Global Biosimilar Footprint
For Sandoz, this agreement aligns with its strategic ambition to strengthen its position in the global biosimilar market. Already the leading biosimilar provider globally, Sandoz has recently moved up to third position in the U.S. market and aims to secure the leading position there as well.
"This collaboration will leverage Sandoz's established global network and commercialization expertise to accelerate the accessibility of HLX13 in mainstream biopharma markets," stated the joint announcement.
Sandoz's marketed biosimilar oncology portfolio currently includes Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®. The company is also planning to launch its biosimilar versions of denosumab (Wyost®/Jubbonti®) in the U.S. in the second quarter and in Europe in the fourth quarter of this year.
Henlius's Growing Global Presence
For Henlius, this partnership further validates its capabilities in developing high-quality biosimilars for the global market. The company has established an integrated global platform for R&D, regulatory registration, and clinical operations, supported by manufacturing and quality management systems that meet global regulatory standards.
Henlius has already successfully launched four products in markets beyond China and continues to expand its international footprint. HLX13 represents a key component of the company's self-developed biosimilar pipeline.
Market Impact and Patient Access
The introduction of biosimilar versions of established therapies like ipilimumab is expected to significantly impact the oncology treatment landscape by potentially reducing costs and expanding patient access. Ipilimumab, particularly when used in combination therapies, has demonstrated significant clinical benefits in treating various cancers.
According to market data, the originator product Yervoy® continues to be a major revenue generator for Bristol-Myers Squibb, with substantial patient populations across G7 markets relying on this therapy.
Looking to the Future
Both companies have expressed commitment to advancing the global development of HLX13 and working together to provide more high-quality, affordable treatment options for patients worldwide. This partnership represents another step in the growing trend of cross-border collaborations aimed at expanding access to critical biologic therapies through biosimilar development.
As biosimilars continue to gain traction globally, partnerships like this between companies with complementary strengths—Henlius in development and manufacturing, and Sandoz in global commercialization—may become increasingly common in the pharmaceutical landscape.
