By Fineline Cube 
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that JSKN003, a HER2‑bi‑epitope targeted antibody‑drug conjugate (ADC) co‑developed by Shanghai JMT Biotechnology Co., Ltd and Alphamab Oncology (HKG: 9966), has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) of China. The designation applies to JSKN003 as a monotherapy for patients with HER2‑positive advanced colorectal cancer who have progressed on oxaliplatin, fluorouracil, and irinotecan.
Key Highlights
| Feature | Details |
|---|---|
| Indication | HER2‑positive advanced colorectal cancer (post‑oxaliplatin/fluorouracil/irinotecan) |
| Therapeutic Class | HER2‑bi‑epitope ADC |
| Mechanism | Glycan‑site‑specific conjugation of a topoisomerase‑I inhibitor to antibody KN026 (anti‑HER2 bispecific) |
| Technology Advantage | Click‑chemistry linker yields superior serum stability versus maleimide‑Michael addition |
| Pre‑clinical Efficacy | Enhanced internalization & bystander killing; potent antitumor activity in HER2‑expressing models |
Strategic Development & Licensing
- July 2024 – Alphamab Oncology and JMT Biotechnology signed a licensing agreement. JMT obtained exclusive rights to develop, commercialize, and market JSKN003 for oncology indications in mainland China.
- Marketing Authorization – JMT is the sole Marketing Authorization Holder (MAH) for JSKN003 in China.
- Manufacturing – Alphamab retains exclusive manufacturing rights.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech