Globalisation 2.0 | First Patient Dosed In China For International Multi-Centre Phase 1 Clinical Trial Of Henlius' Subcutaneous Daratumumab Biosimilar HLX15-SC

Shanghai Henlius Biotech, Inc. today announced that the first patient in China has been dosed in the international multi-centre 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, company reported that the Investigational New Drug (IND) application for the phase 1 clinical trial of HLX15-SC for the treatment of multiple myeloma (MM) was approved by the U.S. Food and Drug Administration (FDA). 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.

Henlius will continue to place a high value on patients’ needs and clinical data and will continue to diversify innovation by strengthening internal innovation capabilities and external collaboration, extending new drug forms, and processing more clinical trials, to benefit patients around the world.

*Darzalex & Darzalex Faspro are registered trademarks of Johnson & Johnson.

About HLX15-SC-NDMM-001
This study is a multicentre, 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.