{"id":43898,"date":"2025-10-20T19:55:53","date_gmt":"2025-10-20T11:55:53","guid":{"rendered":"https:\/\/flcube.com\/?p=43898"},"modified":"2025-10-20T19:55:54","modified_gmt":"2025-10-20T11:55:54","slug":"cspc-pharmaceutical-secures-breakthrough-therapy-designation-for-jskn003-in-her2%e2%80%91positive-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43898","title":{"rendered":"CSPC Pharmaceutical Secures Breakthrough Therapy Designation for JSKN003 in HER2\u2011Positive Colorectal Cancer"},"content":{"rendered":"\n

CSPC Pharmaceutical Group Limited (HKG: 1093<\/a>)<\/strong> announced that JSKN003<\/strong>, a HER2\u2011bi\u2011epitope targeted antibody\u2011drug conjugate (ADC) co\u2011developed by Shanghai JMT Biotechnology Co., Ltd<\/strong> and Alphamab Oncology (HKG: 9966<\/a>)<\/strong>, has been granted Breakthrough Therapy Designation<\/strong> by the National Medical Products Administration (NMPA)<\/strong> of China. The designation applies to JSKN003 as a monotherapy<\/strong> for patients with HER2\u2011positive advanced colorectal cancer<\/strong> who have progressed on oxaliplatin, fluorouracil, and irinotecan.<\/p>\n\n\n\n

Key Highlights<\/h3>\n\n\n\n
Feature<\/th>Details<\/th><\/tr><\/thead>
Indication<\/strong><\/td>HER2\u2011positive advanced colorectal cancer (post\u2011oxaliplatin\/fluorouracil\/irinotecan)<\/td><\/tr>
Therapeutic Class<\/strong><\/td>HER2\u2011bi\u2011epitope ADC<\/td><\/tr>
Mechanism<\/strong><\/td>Glycan\u2011site\u2011specific conjugation of a topoisomerase\u2011I inhibitor to antibody KN026 (anti\u2011HER2 bispecific)<\/td><\/tr>
Technology Advantage<\/strong><\/td>Click\u2011chemistry linker yields superior serum stability versus maleimide\u2011Michael addition<\/td><\/tr>
Pre\u2011clinical Efficacy<\/strong><\/td>Enhanced internalization & bystander killing; potent antitumor activity in HER2\u2011expressing models<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Development & Licensing<\/h3>\n\n\n\n