Henlius and Sandoz Team Up for Global Biosimilars Value Expansion
On August 17, 2026, Shanghai Henlius Biotech, Inc. announced a significant strategic collaboration with Sandoz, the global leader in generics and biosimilars, marking a substantial step forward in unlocking the global potential of biosimilars. This partnership may encompass up to ten proposed monoclonal antibody (mAb) and antibody-drug conjugate (ADC) biosimilar products developed by Henlius, with most of these products currently in the early stages of development. The agreement further strengthens the existing oncology biosimilars partnership initiated in April 2025 when the two companies first joined forces for the commercialization of HLX13, Henlius' proposed ipilimumab biosimilar across several regions, including Europe and the United States.
Under the new collaboration, Sandoz has been granted exclusive rights for registration and commercialization of Henlius’ partnered products outside China, highlighting its extensive operational expertise as the partnership covers essential stages of the product lifecycle, including development, regulatory submissions, manufacturing, and market launch. Henlius aims to utilize its integrated biologics platform for the development and supply of these products, thus streamlining the processes that transform early-stage molecules into market-ready therapies. The projected invoiced amount for Henlius in 2026 is expected to reach $100.5 million, underscoring the economic potential of this collaboration.
One of the initial products under this strategic agreement is HLX05-N, a proposed cetuximab biosimilar intended for treating metastatic colorectal cancer and head and neck squamous cell carcinoma. This product has already begun early-stage clinical trials in China. Also in focus is HLX16, an evolocumab biosimilar intended for primary hypercholesterolemia treatment, currently in preclinical research. A proposed belimumab biosimilar is in the works as well, pointing to Henlius’ diverse product pipeline aimed at addressing significant healthcare needs.
Sandoz, with a robust portfolio of over 1,300 medications and operations spanning around 100 countries, plays a crucial role in this collaboration by bringing invaluable market insights and commercialization strategies to enhance the efficacy of the combined objectives. The integration of Sandoz's market knowledge with Henlius' R&D capabilities aims to lead to a streamlined approach in navigating the international regulatory landscape, launching products, and maximizing their impact across global markets.
This collaboration reflects Henlius' globalization strategy, emphasizing its commitment to provide accessible biologic therapies worldwide and enhance its commercialization capabilities outside of China. By engaging with top global pharmaceutical firms, Henlius is not only expanding the availability of its products but also preparing for a comprehensive and strategic approach in addressing various competitive landscapes across different regions.
The long-term vision of Henlius involves leveraging market potential while maintaining flexibility in advancing its drug development and commercialization endeavors via both independent initiatives and strategic partnerships. This aim is synonymous with the overarching goal of optimizing access to healthcare solutions and maximizing the potential of Henlius’ research, development, and manufacturing capabilities.
Overall, the partnership between Henlius and Sandoz marks a pivotal moment in the growth trajectory of both companies as they look to navigate the rapidly evolving biosimilars landscape and reinforce their respective positions within the global healthcare ecosystem. As both companies embark on this collaborative venture, the prospects for introducing innovative biotherapeutics are promising, signaling a bright future for both players in the biopharmaceutical industry.