On 13 July 2026, Shanghai Henlius Biotech announced that the first patient in the US has been dosed in its international multicentre Phase 1 clinical trial of HLX-15-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 trial was approved by the FDA in February 2026, shortly after approval by China’s National Medical Products Administration. The first patient in China was dosed in May 2026.
The Phase 1 study, initiated in May 2026, is designed to evaluate the pharmacokinetic similarity, safety, tolerability, immunogenicity and efficacy of HLX15-SC compared to US-Darzalex Faspro® following single and multiple subcutaneous injections in newly diagnosed multiple myeloma patients ineligible for transplant. Primary completion of the study is expected in May 2027.
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 exclusively 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 Russian approval of Daratumia®. Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval 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.