Shots:
- The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma
- In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced daratumumab
- Additionally, in Feb 2025, Henlius signed a licensing & collaboration deal with Dr. Reddy’s Laboratories, granting exclusive rights for the IV & SC formulations of HLX15 in the US & 42 EU countries
Ref: Henlius | Image: Henlius | Press Release
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