Successful Completion of Ph 1 Clinical Study of Daratumumab HLX15 Announced
“Shanghai Henlius Biotech, Inc. (2696.HK) announced that a phase 1 clinical trial (NCT05679258) of the company’s daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection, met its primary endpoint. HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM). In accordance with the biosimilar guidelines of NMPA, EMA, and FDA, HLX15 has been developed strictly following the principles of stepwise development, comparability and similarity assessment and has been compared head-to-head with reference daratumumab via analytical studies and preclinical studies. The results of these preclinical studies showed that HLX15 is highly similar to reference daratumumab. And the results of this Phase 1 study suggest that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab (“reference drug”).”
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