Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (1093), has received breakthrough therapy designation from CDE for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1: Product Development and Clinical Trials - JSKN003 has previously received breakthrough therapy designation for treating PROC, regardless of HER2 expression levels [1] - CRC is the second most common malignant tumor in China, with over 500,000 new cases annually and a rising trend [1] - There are currently no approved anti-HER2 targeted therapies for CRC in China, and existing therapies for HER2+ advanced CRC patients have a median progression-free survival (mPFS) of only 2.0-3.7 months and a median overall survival (mOS) of approximately 7-10 months, indicating a significant unmet clinical need [1] Group 2: Clinical Research Findings - A summary analysis presented at the 2025 ASCO annual meeting showed that JSKN003 monotherapy for HER2 high-expressing advanced CRC patients demonstrated significant efficacy and good safety [2] - The analysis included 50 HER2 high-expressing advanced gastrointestinal cancer patients, with 23 being CRC patients; 38% had previously received three or more lines of anti-tumor therapy [2] - Among 21 HER2 high-expressing CRC patients who underwent at least one tumor efficacy assessment, the overall response rate (ORR) was 61.9%, disease control rate (DCR) was 95.2%, mPFS was 13.77 months, and median duration of response (mDoR) was 12.06 months [2] - In a subgroup of 20 BRAF V600E wild-type CRC patients, the ORR reached 65.0% [2] - Safety data indicated that out of 43 patients who received the recommended phase II dose, only 14.0% experienced grade 3 or higher treatment-related adverse events (TRAEs) [2] Group 3: Mechanism and Collaboration - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to a recombinant humanized anti-HER2 bispecific antibody using glycosylation point coupling technology, providing better serum stability [3] - The bispecific targeting of HER2 enhances JSKN003's internalization activity and bystander killing effect, resulting in strong anti-tumor activity in HER2-expressing tumors [3] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotech to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications, with three ongoing phase III clinical trials for HER2+ breast cancer, HER2 low-expressing breast cancer, and PROC [3]
康宁杰瑞制药-B：JSKN003再次获得CDE突破性疗法认定