CSPC subsidiary gets clinical trial approval for multiple myeloma drug

CSPC Innovation Pharmaceutical announced that its controlled subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd., has received a Drug Clinical Trial Approval Notice from the National Medical Products Administration for its daratumumab injection. The company plans to commence clinical trials for the drug, classified as a therapeutic biological product (Category 3.3), in the near future.

The daratumumab injection is an IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38). It is a biosimilar to the original drug, Darzalex®, and is intended for the treatment of adult patients with multiple myeloma. The approval was based on an application filed by Jushi Bio, which was deemed to comply with the requirements for drug registration.

CSPC Innovation Pharmaceutical highlighted the inherent risks of drug development, including high investment, long cycles, and potential for clinical trial results falling short of expectations. The company stated that the short-term impact on Jushi Bio's and the company's performance would not be significant and committed to timely disclosure of future development progress.