Shots:
- Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)
- The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)
- HLX15 is an anti-CD38 daratumumab biosimilar candidate for both IV and SC formulations. In Feb 2025, Henlius licensed exclusive commercialization rights for both formulations to Dr. Reddy’s across the U.S. and 42 European countries & regions
Ref: Henlius | Image: Henlius | Press Release
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