The board of directors of CSPC Pharmaceutical Group Limited announced that the antibody-drug conjugate CPO204 developed by the Group has obtained approval of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) to initiate a Phase I, dose escalation and dose expansion study in the U.S. to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the Product in patients with locally advanced or metastatic urothelial cancer. The Product is a monoclonal antibody-drug conjugate which can bind to specific receptors on the tumor surface and achieve tumor cell killing by entering the cells through endocytosis and releasing toxins. The Product has demonstrated good anti-tumor effects on a variety of cancers in the preclinical studies, providing a promising prospect of demonstrating good efficacy in subsequent clinical trials.

The Group will endeavor to push forward the clinical trials in the U.S. and strive to launch the Product as soon as possible.