Henlius and Sandoz Enter Strategic Collaboration to Unlock Global Value of Biosimilars Platform

Rhea-AI Summary

Sandoz (OTCQX: SDZNY) and Shanghai Henlius Biotech entered a strategic collaboration on August 17, 2026, covering up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar products or components developed by Henlius. Henlius will grant Sandoz exclusive registration and commercialization rights outside China under a multi-product portfolio framework.

Initial assets include HLX05-N (cetuximab biosimilar), HLX16 (evolocumab biosimilar) and a proposed belimumab biosimilar, plus an option on HLXTE-HAase1001. According to Henlius, Sandoz will pay up to US$322 million in upfront, milestone and option fees, with total invoiced amount expected for Henlius in 2026 of up to US$100.5 million.

Positive

• Up to US$322 million in upfront, milestone and option payments from Sandoz
• Expected 2026 invoiced amount up to US$100.5 million for Henlius
• Collaboration may cover up to 10 mAb and/or ADC biosimilar assets
• Exclusive ex-China rights for HLX16 and proposed belimumab biosimilar across all markets
• HLX05-N receives broad exclusive territory including US, EU, Japan, Australia

Negative

• None.

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• 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, Aug. 17, 2026 /PRNewswire/ -- On August 17, 2026, 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.

About HLX05-N

HLX05-N is a cetuximab injection biosimilar independently developed by Henlius, intended for the treatment of metastatic colorectal cancer and head and neck squamous cell carcinoma. In July 2026, the first patient has been dosed in a phase 1 clinical study of cetuximab injection biosimilar HLX05-N independently developed by Henlius in patients with metastatic colorectal cancer (mCRC) in China. According to the statistics released by IQVIA MIDAS™ (IQVIA is a global provider of professional information and strategic consulting services in the pharmaceutical and healthcare industry), the sales revenues of cetuximab injection globally amounted to approximately USD1.696 billion in 2025.

About HLX16

HLX16 is an evolocumab biosimilar independently developed by Henlius, intended for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial types). Currently, this product is in the preclinical research stage. According to the statistics released by IQVIA MIDAS™, the sales revenues of evolocumab injection globally amounted to approximately USD6.602 billion in 2025.

About the proposed belimumab biosimilar

Belimumab biosimilar, independently developed by Henlius, is intended for the treatment of systemic lupus erythematosus and lupus nephritis. Currently, this product is in the preclinical research stage. According to the statistics released by IQVIA MIDAS™, the sales revenues of belimumab injection globally amounted to approximately USD2.475 billion in 2025.

About HLXTE-HAase1001

HLXTE-HAase1001 is a recombinant human hyaluronidase independently developed by Henlius, intended to transform time-consuming intravenous infusion into rapid subcutaneous injection, thereby significantly shortening administration time and improving patient experience. Currently, this product is in the process development stage.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its "Globalisation 2.0" phase, building a scalable and sustainable global growth model. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius' core product, serplulimab (trade name: Hetronifly^® in Europe), is the world's first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and for perioperative gastric cancer. Up to date, it has been approved in 50 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb dulpatatug (HLX22) — are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

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SOURCE Henlius

FAQ

What is the Henlius and Sandoz (OTCQX: SDZNY) biosimilars collaboration announced on August 17, 2026?

Henlius and Sandoz entered a strategic collaboration covering up to 10 proposed mAb and ADC biosimilar assets. According to Henlius, Sandoz receives exclusive registration and commercialization rights outside China, while Henlius leads development, manufacturing and supply under a multi-product portfolio framework spanning the product lifecycle.

How much is Sandoz (SDZNY) expected to pay Henlius under the new biosimilars agreement?

Sandoz is expected to pay Henlius up to US$322 million in upfront, milestone and option fees. According to Henlius, the total invoiced amount anticipated for 2026 is up to US$100.5 million, reflecting early financial impact from the initial portfolio of partnered assets.

Which specific biosimilar products are included in the initial Henlius–Sandoz (SDZNY) collaboration?

The initial assets are HLX05-N, a proposed cetuximab biosimilar, HLX16, a proposed evolocumab biosimilar, and a proposed belimumab biosimilar. According to Henlius, Sandoz also holds an option for HLXTE-HAase1001, a recombinant human hyaluronidase asset within the collaboration framework.

What are the territorial rights for Sandoz (SDZNY) in the Henlius biosimilars deal?

For HLX05-N, Sandoz receives exclusive rights in the US, Canada, EU, certain European countries, Japan, Australia and New Zealand, plus semi-exclusive rights in parts of Asia. According to Henlius, HLX16 and the proposed belimumab biosimilar have exclusive rights worldwide outside China.

How does the August 2026 Henlius–Sandoz (SDZNY) agreement relate to their 2025 HLX13 partnership?

The August 2026 agreement expands the companies’ existing oncology biosimilars collaboration established in April 2025 for HLX13. According to Henlius, that earlier deal granted Sandoz exclusive commercialization rights for the proposed ipilimumab biosimilar across 46 countries and regions, including Europe and the United States.

What stage of development are the Henlius biosimilars in the Sandoz (SDZNY) collaboration?

Most of the partnered monoclonal antibody and ADC biosimilar products are at early development stages. According to Henlius, the parties plan to collaborate closely from early project development through regulatory submissions, manufacturing, launch, commercialization and lifecycle management to support global execution.

What strategic benefits does Henlius expect from partnering with Sandoz (SDZNY) on biosimilars?

Henlius expects to leverage Sandoz’s global footprint and commercialization capabilities to unlock ex-China value for its biosimilars. According to Henlius, Sandoz will integrate international market insights into early development and registration strategies, complementing Henlius’ biologics R&D, manufacturing and global supply strengths.