On 12 February 2026, Zhitong Finance reported that Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration (NMPA) for a Phase 1 trial of its subcutaneous daratumumab biosimilar, HLX15-SC.
This follows Henlius’ completion of a Phase 1 clinical trial for the IV formulation of HLX15 in June 2024. That trial demonstrated similar pharmacokinetic characteristics and comparable safety and immunogenicity profiles of HLX15 to the US, EU and CN-sourced reference product, J&J’s Darzalex® (daratumumab).
In February 2025, Henlius announced that it had entered into a licence agreement with Dr Reddy’s for commercialisation of HLX15, covering both subcutaneous and intravenous formulations, across 42 European countries and the United States.
The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025, with approval by the Russian Ministry of Health of Daratumia®. There are also other daratumumab biosimilars under development. In December 2025, CSPC Pharmaceutical Group obtained approval from the NMPA to conduct clinical trials in China of its Daratumumab Injection. In September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44.