Shanghai Henlius Biotech (HKEX: 2696) and Sandoz (SIX: SDZ; OTCQX: SDZNY) expanded their biosimilars collaboration into a platform-level agreement covering up to 10 monoclonal antibody (mAb) and antibody-drug conjugate (ADC) biosimilar assets, with payments for the initial tranche potentially reaching USD 322 million and up to USD 100.5 million expected to be invoiced in 2026.
The agreement names three confirmed licensed assets — HLX05-N, a proposed cetuximab biosimilar currently in Phase I; HLX16, a proposed evolocumab biosimilar in preclinical research; and an unnamed belimumab biosimilar also at preclinical stage — plus a non-refundable option on HLXTE-HAase1001, a recombinant human hyaluronidase described by Henlius as intended to enable subcutaneous co-formulation of biologics. Henlius said the total invoiced amount expected in 2026 is up to USD 100.5 million.
The deal expands a relationship that began in April 2025 when the two companies entered an exclusive commercialization agreement for HLX13, Henlius' proposed ipilimumab biosimilar, covering 46 countries including the US and Europe for USD 31 million upfront and up to USD 270 million in milestones. That deal has since advanced to patient dosing in the US in an international multicenter Phase I study. The platform agreement follows within 16 months, potentially indicating growing confidence in Henlius as a development and manufacturing partner, while Henlius' pertuzumab injection passed GMP compliance inspection in June 2026.
Under the structure, Henlius retains responsibility for development, manufacturing, and supply of all partnered products, as well as all China rights. Sandoz receives exclusive ex-China commercialization rights, with geographic scope varying by asset: HLX05-N carries exclusive rights in the US, Canada, EU, UK, Switzerland, Japan, Australia, and New Zealand, with semi-exclusive rights in certain Asian markets; HLX16 and the belimumab biosimilar carry worldwide ex-China exclusivity. The parties describe the arrangement as a co-development-informed model, with Sandoz contributing ex-China market and regulatory input from early development stages.
The option on HLXTE-HAase1001 is structurally distinct from the three licensed assets. Recombinant hyaluronidase functions as an enabling technology for subcutaneous drug delivery rather than a standalone therapeutic — an approach analogous to Halozyme's ENHANZE platform. Henlius received National Medical Products Administration (NMPA) investigational new drug (IND) approval for a related hyaluronidase program in March 2026. An option for this class of asset embedded within a biosimilar supply deal is atypical and would give Sandoz a potential subcutaneous formulation capability applicable beyond Henlius-sourced products.