JSKN003 was granted Breakthrough Therapy Designation in China

CAR-T Digest - August 2020

18 Mar 2025: JSKN003 was granted Breakthrough Therapy Designation in China

JSKN003, a HER2-targeting ADC, has been granted BTD by China’s National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent ovarian cancer, primary peritoneal carcinoma, and fallopian tube cancer
Ovarian cancer has a high mortality rate in China, with most patients diagnosed at advanced stages and developing resistance to platinum-based chemotherapy, creating a significant unmet medical need
Clinical trials for JSKN003 have shown promising efficacy in treating platinum-resistant ovarian cancer, with an ORR of 56.8% and tumor shrinkage in 88.6% of patients
The safety profile of JSKN003 is favorable, with only 10% of patients experiencing Grade 3 or higher treatment-related adverse events, and no treatment-related deaths reported
The Phase 3 trial for JSKN003 is currently enrolling patients, and it is also being tested in Phase 2 and Phase 3 trials for other cancers, including breast, gastric, colorectal, and cholangiocarcinoma