• Collaboration may cover up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar assets, with the majority of programs at early development stages
• Based on the initial arrangements, the total invoiced amount expected to be achieved by Henlius in 2026 is up to US$100.5 million
• The collaboration further expands the parties' 2025 oncology biosimilars partnership

Shanghai Henlius Biotech, Inc. (2696.HK) announced that it has entered into a strategic collaboration with Sandoz (SIX: SDZ; OTCQX: SDZNY), a global leader in generics and biosimilars, covering up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar products or components developed by Henlius. The parties have also signed collaboration terms for an initial three agreed products and an option for one additional asset.

In April 2025, the two companies entered into an exclusive commercialization partnership for HLX13, Henlius' proposed ipilimumab biosimilar, across 46 countries and regions including Europe and the United States. This new agreement further deepens the existing oncology biosimilars collaboration between the two parties.

Under the strategic collaboration agreement, Henlius will grant Sandoz exclusive rights for registration and commercialization outside China for up to 10 partnered products worldwide. Most of the partnered products are currently at early stages of development, and the two parties will collaborate closely from the early stages of project development. Based on a multi-product portfolio framework, the collaboration will cover key stages across the product lifecycle, including product development, regulatory submissions, manufacturing, launch, commercialization and lifecycle management.

Henlius will leverage its integrated biologics platform to undertake the development, manufacturing and supply of the partnered products, thereby accelerating the development and translation of early-stage molecules. Sandoz has a diversified portfolio of approximately 1,300 medicines, a business presence in around 100 countries and reaches over 1 billion patients worldwide. It has established a strong track record in product registration, market access, launch and commercialization. Leveraging its extensive global footprint, deep localized operating capabilities and market-validated commercialization system, Sandoz will incorporate ex-China market insights and commercial perspectives into product development and registration strategies at an early stage, driving the efficient execution of the partnered products in global markets. Through deep synergies across the entire product lifecycle, the two parties will continue to unlock the global commercial value of the partnered products.

The initial assets covered under the agreement include HLX05-N, a proposed cetuximab biosimilar; HLX16, a proposed evolocumab biosimilar; and a proposed belimumab biosimilar. In addition, Sandoz has obtained an option for HLXTE-HAase1001, a recombinant human hyaluronidase. Based on these arrangements, Sandoz will pay Henlius an upfront payment, relevant milestone payments and a non-refundable option fee totaling up to US$322 million. In 2026, the total invoiced amount expected for Henlius is up to US$100.5 million.

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, Japan, Australia and New Zealand, while semi-exclusive rights apply in certain countries and regions in Asia, as well as other markets. For HLX16 and the proposed belimumab biosimilar, the exclusive collaboration territory covers all markets worldwide outside China.

This collaboration represents an important part of Henlius' globalization strategy. It not only demonstrates the company's comprehensive strengths in biologics R&D, quality systems, international registration, large-scale manufacturing and global supply, but also further validates the global value of its biosimilars platform. Henlius has established a diversified pipeline spanning biosimilars and innovative biologics, with multiple self-developed biologic products approved in China, the EU, the United States and other global markets.

By partnering with leading global pharmaceutical companies, Henlius continues to expand product access to more countries and regions and accelerate the global commercialization of more biologics. At the same time, the company is continuing to build its own ex-China commercialization capabilities and, based on the market potential, competitive landscape and commercialization needs of different products, is flexibly adopting a combination of independent advancement and strategic partnerships to bring products to global markets through diversified pathways and further unlock the value of its R&D, manufacturing and global supply platforms.