Shanghai Henlius Biotech, Inc. (Henlius, 02696) has initiated patient dosing in an international, multicentre Phase 1 clinical study evaluating its independently developed nivolumab biosimilar HLX18 in mainland China. Future expansion of the trial to the United States and additional regions is planned once requisite conditions are met.
The randomised, double-blind, parallel-controlled study will compare pharmacokinetics, efficacy, safety and immunogenicity of HLX18 with Bristol-Myers Squibb’s reference drug OPDIVO®. Eligible patients with resected oesophageal or gastro-oesophageal junction cancer, melanoma or urothelial carcinoma are randomised 1:1 to receive either: • Group A: HLX18 monotherapy; • Group B: OPDIVO® for the first four treatment cycles, followed by HLX18.
Dosing occurs every four weeks for up to 13 cycles (≈12 months) or until disease progression or other discontinuation criteria are met. Primary endpoints are AUC0-28d after the first dose and AUCss after the fourth dose; secondary endpoints encompass additional PK metrics, efficacy, safety and immunogenicity.
HLX18 targets the PD-1 receptor, aiming to replicate OPDIVO®’s approved indications, which include melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma and several other tumour types. Regulatory clearance to start Phase 1 trials was obtained in December 2025 in the United States and March 2026 in mainland China.
According to IQVIA MIDAS, global sales of nivolumab reached USD11.79 billion in 2025, underscoring the commercial potential of successful biosimilar development.
Henlius cautions that successful development and commercialisation of HLX18 are not guaranteed, in line with Hong Kong Listing Rule 18A.05.
Comments