On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.
Shanghai Henlius’ Investigational New Drug (IND) application for the phase 1 clinical trial of HLX15-SC was approved by the FDA in February 2026, shortly after the trial was approved in China.
Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.
Both SC and IV forms of HLX15 will be commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.
The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Daratumia®. Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval from the NMPA in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.