--- title: "CSPC PHARMA: JSKN 003 has been granted breakthrough therapy designation in China for the treatment of patients with HER2-positive advanced colorectal cancer" description: "CSPC PHARMA announced that its subsidiary has received breakthrough therapy designation from the National Medical Products Administration of China for JSKN003, developed in collaboration with Jiangsu " type: "news" locale: "en" url: "https://longbridge.com/en/news/261787921.md" published_at: "2025-10-20T00:43:05.000Z" --- # CSPC PHARMA: JSKN 003 has been granted breakthrough therapy designation in China for the treatment of patients with HER2-positive advanced colorectal cancer > CSPC PHARMA announced that its subsidiary has received breakthrough therapy designation from the National Medical Products Administration of China for JSKN003, developed in collaboration with Jiangsu Hengrui Medicine Co., Ltd., for the treatment of patients with HER2-positive advanced colorectal cancer. The drug has shown good efficacy and safety in preliminary clinical studies, meeting the clinical needs of this patient population According to the announcement from CSPC PHARMA (01093), the company's subsidiary Shanghai Jinmant Biotech Co., Ltd. has collaborated with Jiangsu CanSino Biologics Inc. to develop JSKN003 (an antibody-drug conjugate targeting HER2 dual epitopes), which has once again been granted breakthrough therapy designation by the National Medical Products Administration of the People's Republic of China (NMPA). The proposed indication is for monotherapy in patients with HER2-positive advanced colorectal cancer who have previously failed treatment with oxaliplatin, fluorouracil, and irinotecan. Colorectal cancer is one of the most common malignant tumors worldwide. According to statistics from the International Agency for Research on Cancer (IARC), there were 1.9262 million new cases of colorectal cancer and 903,900 deaths globally in 2022, ranking third in incidence and second in mortality among all malignant tumors. In China, colorectal cancer is particularly prevalent, with an incidence rate second only to lung cancer, ranking second overall, with more than 500,000 new cases each year, and the number is increasing annually. For patients with HER2-positive advanced colorectal cancer who have previously failed treatment with oxaliplatin, fluorouracil, and irinotecan, approved drugs in China include regorafenib, fruquintinib, and trifluridine/tipiracil, but the efficacy of these drugs is very limited, with a median progression-free survival (mPFS) of only 2-3.7 months and a median overall survival (mOS) of about 7-10 months. Therefore, there remains a significant unmet clinical need in this patient population. Preliminary clinical research results for JSKN003 in this indication show outstanding efficacy and good safety, demonstrating significant clinical advantages compared to existing treatment methods. At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, a summary analysis of "JSKN003 monotherapy in patients with advanced HER2 high-expressing (IHC3+) gastrointestinal tumors" was published. This summary analysis included a Phase I clinical study (JSKN003-101) conducted in Australia and a Phase I/II clinical study (JSKN003-102) conducted in China. As of February 28, 2025, a total of 50 patients with advanced gastrointestinal tumors expressing high levels of HER2 (including 23 cases of colorectal cancer) were enrolled in the two studies, with 38% of patients having previously received ≥3 lines of antitumor therapy. Preliminary research results indicated that JSKN003 monotherapy for HER2 high-expressing advanced colorectal cancer patients demonstrated significant efficacy and good safety: among 21 colorectal cancer patients who had undergone at least one tumor efficacy assessment, the objective response rate (ORR) was 61.9%, the disease control rate (DCR) was 95.2%, the mPFS was 13.77 months, and the median duration of response (mDoR) was 12.06 months. Among the 20 patients with BRAF V600E wild-type colorectal cancer, the ORR reached 65.0%. In terms of safety, among 43 patients who received the recommended Phase II dose (RP2D), only 6 patients (14.0%) experienced treatment-related adverse events (TRAEs) of grade ≥3, 3 patients (7.0%) experienced treatment-related serious adverse events (TRSAEs), and 7 patients (16.3%) had dose reductions due to TRAEs No TRAEs leading to treatment discontinuation or death were observed in patients. This indication is the second breakthrough therapy designation granted to JSKN003. In March 2025, JSKN003 was also granted breakthrough therapy designation by the National Medical Products Administration for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Currently, JSKN003 is undergoing multiple Phase II and III clinical studies in China for the treatment of solid tumors such as breast cancer, ovarian cancer, and gastric cancer. The re-granting of breakthrough therapy designation to JSKN003 will further accelerate the development and review process of this product, aiming to benefit more cancer patients as soon as possible ### Related Stocks - [01093.HK - CSPC PHARMA](https://longbridge.com/en/quote/01093.HK.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | 野村将石药集团的目标价从 9.11 港元调整至 12.04 港元，并维持买入评级 | 野村将石药集团的目标价从 9.11 港元上调至 12.04 港元，维持 “买入” 评级 | [Link](https://longbridge.com/en/news/276056763.md) | | 石药集团获得监管机构的批准以启动药物试验 | 石药集团获得监管批准开始药物试验 | [Link](https://longbridge.com/en/news/276035104.md) | | 港股异动：石药集团跌 12.35%，巨额合作协议未能提振市场信心，短期前景存疑 | 石药集团跌 12.35%；恒瑞医药跌 1.50%，成交额达到 3.05 亿港币；中国生物制药跌 2.91%，成交额达到 2.99 亿港币；翰森制药涨 0.73%，成交额达到 1.22 亿港币；复星医药跌 2.67%，市值达到 543 亿港币 | [Link](https://longbridge.com/en/news/274253407.md) | | 早盘趋势｜石药集团（1093.HK）金叉创新药题材发酵强势领涨 | 石药集团（1093.HK）昨日早盘即成为医药资金追逐对象，全天表现强势，创下阶段新高。利好消息传出公司创新药有望纳入医保，直接点燃医药板块做多热情，盘中分时量价协调，主力资金集聚推动个股领涨行业。消息公布后，海外机构快速增配港股医药龙头，石 | [Link](https://longbridge.com/en/news/273959334.md) | | 石药集团宣布，罗哌卡因长效注射剂已获准在中国开展临床试验 | 石药集团表示，罗哌卡因长效注射剂已获得中国临床试验批准 | [Link](https://longbridge.com/en/news/276051793.md) | --- > **Disclaimer**: This article is for reference only and does not constitute any investment advice.