Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Shots:

• Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma
• The company has compared HLX15 in a head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar to reference daratumumab
• The company has developed the HLX15 in accordance with the Technical Guidelines of Development and Evaluation of Biosimilar Drugs & EMA Guideline on Similar Biological Medicinal Products

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