Shanghai Henlius Biotech (HKG: 2696) has announced the dosing of the first subject in a Phase I clinical study for its biosimilar candidate HLX15, targeting Johnson & Johnson’s (J&J, NYSE: JNJ) blockbuster drug Darzalex (daratumumab). The study aims to evaluate the pharmacokinetics, safety, and immunogenicity of HLX15 in healthy male patients with multiple myeloma (MM) in China.
HLX15: Biosimilar Development
HLX15 is being developed as a biosimilar version of Darzalex, the world’s first CD38-targeted antibody. Daratumumab binds to the CD38 receptor on MM cells, inducing tumor cell death through various immune-mediated mechanisms. Originally approved by the US FDA in 2015, Darzalex has since received six additional indications as a combination therapy for MM. The drug also secured conditional approval in China in July 2019 for relapsed or refractory MM following first-line therapy.
Clinical Trial and Comparative Data
Henlius’ Phase I study will assess the pharmacokinetics, safety, and immunogenicity of HLX15 compared to daratumumab. Preclinical data from comprehensive head-to-head studies suggest that HLX15 is highly similar to daratumumab in terms of pharmacology and pharmacodynamics, both in vivo and in vitro. The trial aims to further validate these findings in a clinical setting.-Fineline Info & Tech
