HENLIUS (02696.HK): Biosimilar HLX18 to Nivolumab Doses First Patient in China for Global Multi-centre Phase I Trial

NewTimeSpace · 2026/07/16 16:41 · By Boyuan Chen

NewTimeSpace News: Henlius (02696.HK) announced on 16 July that HLX18, its self-developed biosimilar of nivolumab (recombinant anti-PD-1 humanised monoclonal antibody injection), has administered the first patient in China in its global multi-centre Phase I trial for resected solid tumours. The Company plans to expand the trial to the US and other regions when conditions permit. Targeting PD-1, the reference drug recorded global sales of approximately USD11.785 billion in 2025 per IQVIA data. The Company cautions there is no guarantee of successful development and commercialisation of HLX18.

NewTimeSpace News: On 16 July 2026, Henlius (02696.HK) released a voluntary announcement. HLX18, the Company’s independently developed biosimilar to nivolumab (recombinant anti-PD-1 humanised monoclonal antibody injection), has completed first patient dosing in China for its global multi-centre Phase I clinical study enrolling patients with various resected solid tumours. The Group intends to further carry out this clinical trial in the United States and other regions once conditions are met.

This is a multi-centre, randomised, double-blind, parallel-controlled Phase I clinical trial designed to evaluate the similarity in pharmacokinetic profiles, efficacy, safety and immunogenicity between HLX18 and OPDIVO® in patients with resected solid tumours including oesophageal cancer/gastro-oesophageal junction cancer, melanoma or urothelial carcinoma. The authorisations to conduct Phase I trials for HLX18 were obtained in the US and China in December 2025 and March 2026 respectively.

Per IQVIA statistics, the global sales of nivolumab reached approximately USD11.785 billion in 2025. The Company reminds investors that it cannot guarantee the successful development and commercialisation of HLX18.

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