CSPC pharmaceutical secures clinical trial approval for Daratumumab biosimilar in China

CSPC Pharmaceutical Group Limited announced today that its Daratumumab Injection, a biosimilar to Darzalex®, has obtained approval from China's National Medical Products Administration to commence clinical trials. This human monoclonal IgG1 antibody binds to ADP-ribosyl cyclase (CD38) and is being developed as a Class 3.3 therapeutic biological product for adult patients with multiple myeloma.

The group developed the product following relevant research guidelines for biosimilars. Pharmaceutical and non-clinical studies have demonstrated its high similarity to the original reference drug in terms of quality, safety, and efficacy, paving the way for further clinical development.

This announcement was made in Hong Kong on December 23, 2025.