Henlius and Sandoz Expand Biosimilars Collaboration to Cover Up to 10 mAb and ADC Assets

Shanghai Henlius Biotech has entered into a strategic collaboration with Sandoz covering up to 10 proposed monoclonal antibody and/or antibody-drug conjugate biosimilar products or components developed by Henlius.¹ The parties have signed collaboration terms for an initial three agreed products, with an option for one additional asset; most of the partnered products remain in early stages of development.¹ Under the agreement, Henlius grants Sandoz exclusive rights for registration and commercialization outside China for the covered products, while Henlius will lead development, manufacturing, and supply through its integrated biologics platform.¹

What assets are included, and what is this deal worth?

The initial assets covered under the agreement include HLX05-N, a proposed cetuximab biosimilar; HLX16, a proposed evolocumab biosimilar; and a proposed belimumab biosimilar, with Sandoz also holding an option for HLXTE-HAase1001, a recombinant human hyaluronidase.¹ Sandoz will pay Henlius an upfront payment, milestone payments, and a non-refundable option fee totaling up to $322 million, with up to $100.5 million in total invoiced amount expected for Henlius in 2026 based on the initial arrangements.¹ For HLX05-N, exclusive collaboration territory covers the US, Canada, the EU and additional European countries including the UK and Switzerland, Japan, Australia, and New Zealand, with semi-exclusive rights in parts of Asia and other markets; HLX16 and the belimumab biosimilar carry exclusive rights across all markets worldwide outside China.¹

How does this build on the companies' existing partnership?

This agreement deepens an oncology biosimilars collaboration the two companies established in April 2025, when they entered an exclusive commercialization partnership for HLX13, Henlius' proposed ipilimumab biosimilar, across 46 countries and regions including Europe and the US.¹ The expanded scope reflects a broader industry trend: high-value monoclonal antibody biosimilars are entering a period of intensified competition as blockbuster reference products near the end of their exclusivity periods, with pembrolizumab's exclusivity anticipated to lapse around 2028, nivolumab expected to lose US exclusivity in 2028, and pertuzumab facing potential biosimilar competition as early as 2026-2027.²

What is the strategic significance for each company?

Sandoz brings a diversified portfolio of approximately 1,300 medicines, a presence in around 100 countries, and reach to more than 1 billion patients worldwide, along with an established track record in product registration, market access, and commercialization that the companies said will help incorporate ex-China market insights into product development and registration strategies from an early stage.¹ For Henlius, the collaboration is described as an important part of the company's globalization strategy, demonstrating its capabilities in biologics research and development, quality systems, international registration, large-scale manufacturing, and global supply.¹ Henlius has said it will continue combining independent advancement with strategic partnerships, based on the market potential and competitive landscape of individual products, to expand global commercialization of its biologics pipeline.¹

What is Henlius' broader position in oncology biosimilars?

Henlius has established regulatory approvals for 10 products across more than 60 countries and regions, including four products approved by the FDA and five approved by the European Commission.¹ The company has separately partnered with Organon on HLX11, a pertuzumab biosimilar that received both FDA approval and European Commission marketing authorization earlier in 2026.³ In an earlier statement about that partnership, Ping Cao, chief business development officer and senior vice president at Henlius, said, "This EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon."³

References

1. Henlius and Sandoz enter strategic collaboration to unlock global value of biosimilars platform. News release. Henlius; August 17, 2026. Accessed August 17, 2026.
2. Soaring off the patent cliff: preparing for the next wave of oncology biosimilars. Pharmacy Times. December 2025. Accessed August 17, 2026.
3. Henlius and Organon gain EC approval for pertuzumab biosimilar. BioPharm International. May 16, 2026. Accessed August 17, 2026.