Shanghai Henlius Biotech and Swiss generic drugmaker Sandoz have entered into a strategic collaboration covering up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilars developed by Henlius.
The agreement includes three initial products and an option for one additional asset. Under the deal, Henlius will grant Sandoz exclusive rights to register and commercialize up to 10 partnered products outside China.
The initial assets include HLX05-N, a proposed cetuximab biosimilar; HLX16, a proposed evolocumab biosimilar; and a proposed belimumab biosimilar. Sandoz also has an option for HLXTE-HAase1001, a recombinant human hyaluronidase.
The new agreement builds on the companies’ existing oncology biosimilars partnership. In April 2025, Henlius and Sandoz entered into an exclusive commercialization agreement for HLX13, Henlius’ proposed ipilimumab biosimilar, across 46 countries and regions, including the US and Europe.
Most of the newly partnered products are in the early stages of development. The companies will collaborate across the product lifecycle, covering development, regulatory submissions, manufacturing, launch, commercialization and lifecycle management.
Henlius will leverage its integrated biologics platform to develop, manufacture and supply the partnered products, while Sandoz will contribute its global market expertise to support development and registration strategies outside China.
Under the agreement, Sandoz will pay Henlius upfront and milestone payments, along with a non-refundable option fee, totaling up to $322 million. Henlius expects total invoiced amounts of up to $100.5 million in 2026.
For HLX05-N, the exclusive territory covers the US, Canada, the European Union, the UK, Switzerland, Japan, Australia and New Zealand, among other markets. Semi-exclusive rights apply in certain Asian and other markets. For HLX16 and the proposed belimumab biosimilar, Sandoz will hold exclusive rights in all markets worldwide outside China.
