Core Insights - The company, Shiyao Group, announced that its subsidiary, Shanghai Jinmant Biotech Co., Ltd., has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for the treatment of HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1][4] Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2] - In China, colorectal cancer has a high incidence rate, second only to lung cancer, with over 500,000 new cases annually, and the number is rising [2] - Current approved treatments for HER2-positive advanced colorectal cancer patients who have failed previous therapies include regorafenib, fruquintinib, and trifluridine/tipiracil, but these have limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2] Clinical Research Findings - Preliminary clinical research results for JSKN003 show significant efficacy and good safety in the target patient population, with an objective response rate (ORR) of 61.9% and a disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3] - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3] - Safety data indicated that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), and no TRAEs led to treatment discontinuation or death [3] Regulatory Developments - JSKN003 has received its second breakthrough therapy designation, previously granted for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4] - The ongoing clinical studies for JSKN003 in China include multiple Phase II and III trials for various solid tumors, including breast cancer, ovarian cancer, and gastric cancer, which will expedite the product's development and review process [4]
石药集团(01093)：JSKN 003于中国再次获授予突破性治疗认定用于治疗HER2阳性晚期结直肠癌患者