Henlius Biotech has entered a strategic collaboration with Sandoz covering up to 10 proposed monoclonal antibody and/or antibody-drug conjugate biosimilar products or components developed by Henlius, along with collaboration terms for an initial three agreed products, and an option for one additional asset.

The agreement builds on an existing relationship between the two companies. In April 2025, Henlius and Sandoz entered an exclusive commercialization partnership for HLX13, Henlius' proposed ipilimumab biosimilar, across 46 countries and regions including Europe and the United States.¹ The new deal deepens the previous oncology biosimilars collaboration and extends it well beyond a single asset, establishing a broader, multi-product framework between the two companies.

What are the details of the deal?

Under the strategic collaboration, Henlius grants Sandoz exclusive rights for registration and commercialization outside China for up to 10 partnered products worldwide.¹ Most products are currently in early-stage development, making the two companies plan to work together from the outset of each project. The collaboration spans the full product lifecycle, including development, regulatory submissions, manufacturing, launch, commercialization and lifecycle management.

Sandoz will pay Henlius an upfront payment, milestone payments and a non-refundable option fee totaling up to $322 million.¹ In 2026, the total invoiced amount expected for Henlius under the agreement is up to $100.5 million.

Henlius is set to handle development, manufacturing and supply of the partnered products through its integrated biologics platform, which the company says will accelerate the translation of early-stage molecules. Sandoz, which markets roughly 1,300 medicines across around 100 countries and reaches more than 1 billion patients worldwide, brings a track record in registration, market access, launch and commercialization. According to the release, Sandoz will incorporate ex-China market insights and commercial perspectives into product development and registration strategies at an early stage to help drive efficient execution in global markets.¹

Which assets are included in the initial deal?

The three initial assets are HLX05-N, a proposed cetuximab biosimilar; HLX16, a proposed evolocumab biosimilar; and a proposed belimumab biosimilar.¹ Sandoz has also obtained an option for HLXTE-HAase1001, a recombinant human hyaluronidase.

For HLX05-N, the exclusive collaboration territory covers the United States, Canada, the European Union and certain other European countries including the United Kingdom and Switzerland, along with Japan, Australia and New Zealand, with semi-exclusive rights in certain Asian countries and regions and other markets.¹ For HLX16 and the proposed belimumab biosimilar, the exclusive territory covers all markets worldwide outside China.

What is the status of the pipeline assets?

HLX05-N is being developed for metastatic colorectal cancer and head and neck squamous cell carcinoma. In July 2026, the first patient was dosed in a Phase I clinical study of HLX05-N in patients with metastatic colorectal cancer in China.² HLX16 is intended for primary hypercholesterolemia, including heterozygous familial and non-familial types, and is currently in preclinical research.¹

The belimumab biosimilar is intended for systemic lupus erythematosus and lupus nephritis and is also in preclinical research. Finally, HLXTE-HAase1001 is designed to convert time-consuming intravenous infusion into rapid subcutaneous injection, shortening administration time and improving patient experience. It is currently in process development.

Why does this matter?

The collaboration represents a key part of Henlius' globalization strategy, according to the company, underscoring its capabilities in biologics research and development, quality systems, international registration, large-scale manufacturing and global supply while further validating the global value of its biosimilars platform.

Sources

1. Henlius and Sandoz Enter Strategic Collaboration to Unlock Global Value of Biosimilars Platform Henlius August 17, 2026, https://www.prnewswire.com/news-releases/henlius-and-sandoz-enter-strategic-collaboration-to-unlock-global-value-of-biosimilars-platform-302852556.html
2. A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer (PK similarity) National Library of Medicine April 24, 2026, https://clinicaltrials.gov/study/NCT07543471