Henlius Licenses Ipilimumab Biosimilar HLX13 to Sandoz in $301M Global Deal

30 April 2025 | Wednesday | News


Partnership spans U.S., Europe, Japan, and Australia to accelerate global access to HLX13; Henlius receives $31M upfront with up to $270M in milestones

  • Partnership covers North America, Europe, Japan, and Australia to accelerate global access of HLX13 in immuno-oncology combinations
  • Henlius to receive $31 million upfront, and up to $270 million in milestones

Shanghai Henlius Biotech, Inc. (2696.HK) announced a licensing agreement with Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in generic and biosimilar medicines, granting exclusive commercialization rights for its self-developed ipilimumab biosimilar HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

Under the agreement, Henlius will be responsible for development, manufacturing and commercial supply of HLX13, and is eligible to receive up to a total of $301 million, including a $31 million upfront and additional milestone payments. As the global leader in generic and biosimilar medicines, Sandoz is committed to its purpose of "pioneering access for patients" and has benefited over 900 million patients worldwide with approximately 1,300 products. This collaboration will leverage Sandoz's established global network and commercialization expertise to accelerate the accessibility of HLX13 in mainstream biopharma markets.

"At Henlius, we remain deeply committed to delivering high-quality biologics to patients around the world," said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. "Our collaboration with Sandoz marks another important step toward enhancing the global accessibility of our therapies. We believe that putting patients at the core of our globalization strategy is key to fulfilling our vision of 'Developed in China, Access for the World.'"

"We're excited to join forces with Sandoz," said Ping Cao, Chief Business Officer and Senior Vice President of Henlius. "By combining Henlius' proven strengths in biologics R&D and manufacturing with extensive global reach and commercialization expertise of Sandoz, we aim to accelerate the worldwide expansion of HLX13 and bring advanced treatment options to more patients across key markets."

HLX13 is a key component of Henlius' self-developed biosimilar pipeline. Its reference product, Yervoy®, the world's first CTLA-4 inhibitor, has been approved in various countries and regions in combination with nivolumab for the treatment of melanoma and hepatocellular carcinoma, among other indications. Henlius has established an integrated global platform for R&D, regulatory registration, and clinical operations, backed by a manufacturing and quality management system that meets global regulatory standards. The company has successfully launched four products in markets beyond China. Henlius is committed to advancing the global development of HLX13 and working with partners to provide more high-quality, affordable treatment options for patients worldwide.

* Yervoy® is a registered trademark of Bristol-Myers Squibb (US)

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