Shanghai Henlius Biotech (Henlius) and Sandoz have announced they will enter a strategic collaboration covering up to ten proposed monoclonal antibody (mAb) and ADC biosimilars, extending the companies’ existing oncology partnership and strengthening Sandoz’s global biosimilars pipeline.
Under the latest agreement, Sandoz will receive exclusive rights to register and commercialise the partnered products outside China, while Henlius will be responsible for development, manufacturing and supply.
The companies said the partnership will span from early development through regulatory submissions, manufacturing, launch and lifecycle management.
The initial portfolio comprises HLX05-N, a proposed cetuximab biosimilar; HLX16, a proposed evolocumab biosimilar; and a proposed belimumab biosimilar.
Sandoz also has an option to add HLXTE-HAase1001, a recombinant human hyaluronidase designed to enable the subcutaneous administration of biologic medicines.
The initial arrangements include an upfront payment, milestone payments and a non-refundable option fee totalling up to $322m.
Henlius said in its statement that it expects to record up to $100.5m in invoiced amounts during 2026.
Building a global biosimilars pipeline
The deal comes as Sandoz continues to expand its presence in biosimilars, with the company reporting an 18% constant-currency increase in biosimilar sales during the first quarter of 2026.
Biosimilars accounted for 31% of Sandoz’s first-quarter sales, compared with 27% a year earlier.
The firm has also been increasing its development and manufacturing infrastructure. In June, it opened a new $99m biosimilar development centre in Ljubljana, Slovenia, as part of its strategy to capture an expected wave of biologic patent expiries.
The company estimates that more than $300bn worth of branded biologics could lose exclusivity during the coming decade.
The Henlius collaboration therefore adds development-stage assets to a portfolio that Sandoz is positioning to address this huge market opportunity.
Sandoz had also previously announced in March of this year a partnership with Samsung Bioepis covering up to five additional biosimilar candidates.
Expanding beyond oncology
The partnership builds on a 2025 agreement under which Sandoz secured commercialisation rights for Henlius’ proposed ipilimumab biosimilar, HLX13, across 46 countries and regions, including the US and Europe.
That deal was worth up to $301m.
The latest collaboration, however, broadens the relationship beyond oncology.
According to the duo, HLX05-N will remain an oncology-focused asset, targeting metastatic colorectal cancer and head and neck squamous cell carcinoma, while HLX16 and the proposed belimumab biosimilar address cardiovascular and autoimmune indications, respectively.
