Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the successful completion of a Phase I clinical study for HLX15, its biosimilar candidate for Johnson & Johnson’s Darzalex (daratumumab). The trial involved healthy Chinese male subjects and met all pre-set endpoints. Daratumumab is a monoclonal antibody therapy indicated for the treatment of multiple myeloma (MM). The study results demonstrate that HLX15’s pharmacokinetic characteristics are comparable to those of different manufacturing batches of daratumumab, with similar safety and immunogenicity profiles.
Daratumumab, the world’s first CD38-targeting antibody, binds to the CD38 surface receptor expressed on multiple myeloma cells, triggering tumor cell death through multiple immune-mediated mechanisms. Johnson & Johnson received initial approval for Darzalex in the US in 2015 for MM, with six additional approvals for combination therapies in MM patients. Darzalex gained conditional approval in China in July 2019 for the treatment of relapsed or refractory MM after first-line therapy, including patients who have previously received a proteasome inhibitor and an immunomodulator and have shown disease progression during their most recent therapy. An extensive comparative study on HLX15’s pharmacology, both in vivo and in vitro, indicates a high degree of similarity to daratumumab.- Flcube.com
