First Patient Dosed In The U.S. For International Multi-Center Phase 1 Clinical Trial Of Henlius' Subcutaneous Daratumumab Biosimilar HLX15-SC

hanghai Henlius Biotech, Inc. today announced that the first patient in the U.S. has been dosed in the international multi-center Phase 1 clinical trial (HLX15-SC-NDMM-001) of its self-developed subcutaneous formulation of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody), HLX15-SC, for the first-line treatment of newly diagnosed multiple myeloma (NDMM). Previously, the trial also completed first patient dosed in China, and further international multicenter clinical studies are planned to advance across multiple countries, including Australia, Serbia, and Georgia. To date, no daratumumab biosimilar has been approved in major global biologics markets including the United States, Europe and Japan.

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius and is being developed as a biosimilar candidate to both the intravenous formulation Darzalex and the subcutaneous formulation Darzalex Faspro of daratumumab. In February 2025, Henlius entered into a license agreement with Dr. Reddy’s Laboratories, granting Dr. Reddy’s the exclusive commercialization rights to both the SC and IV formulations of HLX15 in the United States and 42 European countries and regions.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more disease areas, commit to bring quality and affordable treatments for patients worldwide.

About HLX15-SC-NDMM-001
This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 trial in transplant-ineligible patients with newly diagnosed multiple myeloma, aiming to compare the pharmacokinetic (PK) characteristics, safety, tolerability, and immunogenicity of HLX15-SC versus the US-licensed DARZALEX FASPRO (US-DARZALEX FASPRO), each in combination with lenalidomide and dexamethasone (Rd). The primary objective of this study is to evaluate the PK similarity of HLX15-SC and US-DARZALEX FASPRO after single and multiple SC injections in the target patient population. The secondary objective is to compare the PK characteristics, safety, tolerability, immunogenicity, and efficacy of HLX15-SC and the reference product following single and multiple SC injections.