CSPC's JSKN003 receives breakthrough therapy designation in China
CSPC Pharmaceutical Group Limited (HKEX: 1093) announced that JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA). The designation is for the intended use of JSKN003 as a monotherapy for all-comer patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer. Clinical data presented at the ESMO Congress 2024 showed an objective response rate (ORR) of 56.8% and a disease control rate (DCR) of 95.5% among efficacy evaluable subjects. In subjects with HER2 expression (IHC 1+, 2+, and 3+) the ORR was 52.8%, while the ORR in subjects with HER2 IHC 0 was 75.0%. A Phase III clinical trial for the Indication is currently enrolling. CSPC believes this designation will expedite development and review of JSKN003.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
News Alerts
Get instant email alerts when CSPC Pharmaceutical Group publishes news
Free account required • Unsubscribe anytime