On 16 February 2026, Shanghai Henlius Biotech announced it has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its subcutaneous daratumumab biosimilar, HLX15-SC. This will allow Henlius to undertake a phase I clinical study of HLX15-SC, biosimilar to J&J’s Darzalex Faspro® (daratumumab and hyaluronidase-fihj), for the first-line treatment of multiple myeloma.
The FDA clearance follows Henlius’ announcement on 12 February 2026 that China’s National Medical Products Administration (NMPA) approved a Phase 1 trial of HLX15-SC.
Henlius is also developing an IV form of HLX15, having completed a Phase 1 clinical trial of HLX15-IV in June 2024. The trial demonstrated similar pharmacokinetic characteristics, comparable safety and immunogenicity profiles of HLX15-IV to the US, EU and CN-sourced Darzalex® (daratumumab).
In February 2025, Henlius announced it had entered into a licence agreement with Dr Reddy’s for commercialisation of both SC and IV formulations of HLX15, across 42 European countries and the United States.
Henlius’ development appears to be trailing that of Celltrion. In September 2025, the European Medicines Agency approved Celltrion’s IND application for its global Phase 3 clinical trial of CT-P44 (daratumumab), following approval of its US IND submission in December 2024. In December 2025, CSPC Pharmaceutical Group obtained approval from the NMPA to conduct clinical trials in China of its Daratumumab Injection.
In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®. This was the first reported regulatory approval for a daratumumab biosimilar worldwide.