On 17 August 2026, Sandoz and Shanghai Henlius Biotech announced that they have entered into a major development, manufacturing and commercialisation collaboration agreement, covering up to 10 biosimilars (including monoclonal antibodies and/or antibody-drug conjugates).
There are three products initially covered by the agreement:
- HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), which is currently in clinical development;
- HLX16, biosimilar to Amgen’s Repatha® (evolocumab), which is in “technical development”; and
- biosimilar belimumab, referencing GSK’s Benlysta®, which is in “early development”.
Sandoz also has an option for HLXTE-HAase1001, a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar.
Under the terms of the agreement, Henlius will be responsible for biosimilar development and manufacturing, while Sandoz will have certain commercialisation rights for the biosimilars outside of China. For HLX05-N, Sandoz will have exclusive commercialisation rights in the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, and semi-exclusive rights in certain Asian and other countries. The exclusive commercialisation territory for HLX16 and the belimumab biosimilar includes all markets worldwide outside China.
Sandoz will pay Henlius an upfront payment, milestone payments and a non-refundable option fee totalling up to US $322 million, with Henlius expected to receive US $100.5 million in 2026.
The companies have previously partnered on HLX13, biosimilar to BMS’ Yervoy® (ipilimumab). Under an agreement announced in April 2025, Henlius is developing and manufacturing HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan, and Australia. HLX13 entered clinical trials in November 2025.
