Henlius and Sandoz expand biosimilars partnership with up to 10 global programmes

The collaboration combines Henlius’ biologics development, manufacturing and supply capabilities with Sandoz’s ex-China commercial infrastructure, initially covering three biosimilars and an option on a recombinant human hyaluronidase programme.

Shanghai Henlius Biotech and Sandoz have expanded their existing partnership through a strategic collaboration potentially covering up to 10 monoclonal antibody and/or antibody-drug conjugate biosimilar products or components, with initial arrangements covering three products plus an option on a fourth asset.

Under those initial arrangements, Sandoz will pay Henlius upfront, milestone and option payments totalling up to $322 million, of which Henlius expects up to $100.5 million to be invoiced during 2026.

Field	Content
Alert Type	Deal
Companies	Shanghai Henlius Biotech; Sandoz
Deal Type	Strategic collaboration and licensing agreement
Asset or Company	Up to 10 proposed mAb and/or ADC biosimilar products or components; initial programmes comprise HLX05-N (cetuximab biosimilar), HLX16 (evolocumab biosimilar), a proposed belimumab biosimilar and an option for HLXTE-HAase1001 recombinant human hyaluronidase
Therapy Area(s)	Oncology; Cardiovascular disease; Immunology
Technology or Modality	Biosimilar monoclonal antibodies; potential ADC biosimilar programmes; recombinant human hyaluronidase
Deal Value	For the three initially agreed products and option on HLXTE-HAase1001, Sandoz will pay Henlius upfront and milestone payments plus a non-refundable option fee totalling up to $322 million. Henlius expects up to $100.5 million to be invoiced in 2026 under the initial arrangements. The $322 million includes contingent payments and should not be treated as guaranteed consideration. (Henlius)
Development Stage	Predominantly early stage. HLX05-N entered Phase I in July 2026; HLX16 and the proposed belimumab biosimilar are preclinical; HLXTE-HAase1001 is in process development. (Henlius)
Geography	Primarily global markets outside China. HLX05-N rights include the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, with semi-exclusive rights in certain Asian and other markets; HLX16 and the proposed belimumab biosimilar cover all markets outside China. (Henlius)
What Happened	On 17 August 2026, Henlius and Sandoz announced an expanded strategic collaboration potentially covering up to 10 proposed mAb and/or ADC biosimilar products or components developed by Henlius. Three initial products have been agreed — HLX05-N, HLX16 and a proposed belimumab biosimilar — while Sandoz has an option on HLXTE-HAase1001. Henlius will undertake development, manufacturing and supply, while Sandoz receives specified ex-China registration and commercialisation rights and will contribute market and commercial input during development. The agreement expands a relationship established in April 2025 through Sandoz’s licensing of ex-China rights to Henlius’ proposed ipilimumab biosimilar HLX13. (Henlius)
Why It Matters	The agreement moves the Henlius-Sandoz relationship from a single-product oncology biosimilar partnership towards a broader portfolio model spanning development through commercialisation. Sandoz gains access to multiple early-stage biosimilar programmes without building the underlying biologics development and manufacturing platform, while Henlius gains an established global partner to support registration, market access and commercialisation across major markets outside China. (Henlius)
Supporting Context	The initial portfolio targets reference products with substantial existing global sales: Henlius cites 2025 worldwide sales of approximately $1.70 billion for cetuximab, $6.60 billion for evolocumab and $2.48 billion for belimumab. These figures describe the reference-product markets and do not represent projected sales for the Henlius biosimilars. (Henlius)
Strategic Rationale	Henlius retains responsibility for developing, manufacturing and supplying partnered products while using Sandoz’s presence in around 100 countries for ex-China registration and commercialisation. For Sandoz, the portfolio framework provides access to a pipeline that can potentially be expanded to as many as 10 programmes rather than relying on individual asset-by-asset agreements. (Henlius)
Potential Impact	If additional programmes are selected and successfully developed, the agreement could substantially broaden the companies’ joint biosimilar portfolio across major international markets. The eventual commercial impact will depend on development success, regulatory approvals, selection of further assets and competitive conditions when individual biosimilars reach the market.
Key Takeaway	Henlius and Sandoz are expanding a single-product relationship into a potentially 10-programme global biosimilars partnership, combining Henlius’ development and manufacturing platform with Sandoz’s international commercial reach.
What to Watch	Selection of additional programmes under the 10-product framework, Sandoz’s decision on the HLXTE-HAase1001 option, clinical progress for HLX05-N and advancement of the earlier-stage HLX16 and belimumab biosimilar programmes.
Primary Source	https://www.henlius.com/en/NewsDetails-6075-26.html
Relevant Date	17 August 2026

---

Discover how nuaxia can support your next medical education initiative:

• Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector 

• Contact us on: support@nuaxia.com