On December 4th, CSPC Innovation Pharmaceutical (300765.SZ) announced that its controlling subsidiary, CSPC Pharma Group's Ju Shi Biopharmaceutical Co., Ltd., has granted Corbus Pharmaceuticals, Inc. (hereinafter referred to as "Corbus" ), the Fast Track Qualification awarded by the U.S. Food and Drug Administration for the development of CRB-701 (SYS6002) for the treatment of recurrent or refractory metastatic cervical cancer.
This product is a new generation antibody-drug conjugate (ADC) targeting Nectin-4, containing a site-specific cleavable linker, using MMAE as the payload, with a precise drug-antibody ratio of 2.
This product has recently completed the dosing escalation portion of a Phase I clinical trial (NCT06265727) conducted in the USA and Europe. This Phase I trial, consisting of three parts, is evaluating the safety, pharmacokinetics, and efficacy of the product in patients with late-stage solid tumors known to have high Nectin-4 expression.
