JSKN003 received the U.S FDA approval to initiate a Phase 2 clinical study in the treatment of PROC not restricted by HER2 expression

CAR-T Digest - August 2020

Weekly Digest - August 2025

27 July 2025: JSKN003 received the U.S FDA approval to initiate a Phase 2 clinical study in the treatment of PROC not restricted by HER2 expression

Alphamab Oncology received U.S. FDA approval to initiate a Phase 2 clinical trial (JSKN003-202) for JSKN003 in treating platinum-resistant ovarian cancer (PROC), which includes epithelial ovarian, primary peritoneal, and fallopian tube cancers, regardless of HER2 expression
The Phase 2 study is a randomized, open-label, multi-center trial designed to evaluate the safety, efficacy, and determine the recommended Phase 3 dose of JSKN003
JSKN003 is a biparatopic HER2-targeting ADC, composed of a topoisomerase I inhibitor conjugated to the bispecific antibody KN026 using glycosite-specific click chemistry, offering improved serum stability and stronger internalization and bystander killing effects
The FDA approval aligns with Alphamab’s global development strategy and strengthens its position in the oncology therapeutics field