Weekly Digest - October 2025
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - October 2025
20 October 2025: JSKN003 granted another breakthrough therapy designation in China for the treatment of patients with HER2-positive advanced colorectal cancer
- JSKN003, a biparatopic HER2-targeting antibody-drug conjugate co-developed by CSPC’s subsidiary Shanghai JMTBIO and Jiangsu Alphamab, received a second breakthrough therapy designation from China’s NMPA for HER2-positive advanced colorectal cancer in patients who failed standard chemotherapy
- Preliminary clinical data from Phase 1/2 trials in Australia and China showed JSKN003 monotherapy had strong efficacy in HER2-overexpressing advanced colorectal cancer, with an objective response rate (ORR) of 61.9%, disease control rate (DCR) of 95.2%, median progression-free survival (mPFS) of 13.77 months, and median duration of response (mDoR) of 12.06 months
- The treatment demonstrated a favorable safety profile at the recommended Phase 2 dose, with only 14% of patients experiencing Grade ≥3 treatment-related adverse events, 7% experiencing serious events, and no discontinuations or deaths due to adverse events
- JSKN003 is also being tested in multiple Phase 2/3 trials for other solid tumors, and the new breakthrough therapy designation will accelerate its development and regulatory review to bring potential benefits to more cancer patients sooner
