CSPC innovation pharmaceutical gets nod for sacituzumab govitecan clinical trials

CSPC Innovation Pharmaceutical Co., Ltd. announced that its controlled subsidiary, CSPC Group Jushi Biopharmaceutical Co., Ltd., has received a "Notice of Approval for Drug Clinical Trial" from the National Medical Products Administration for its sacituzumab govitecan injection. The product is a recombinant anti-human B-cell lymphoma 2 (BCL-2) monoclonal antibody drug, classified as a therapeutic biological product (Class 3.3).

The clinical trial application, filed on July 7, 2025, has been approved for the indication of "treatment for mild cognitive impairment and mild dementia caused by Alzheimer's disease." This makes it the first sacituzumab govitecan injection in China to receive clinical trial approval. The company will commence clinical trials in the near future.

The company highlights the high investment, high risk, and long development cycle associated with drug research and development, including potential risks such as unexpected clinical trial results or delays in approval and market launch.