On October 27, 2025, Alphamab Oncology, an innovative biopharmaceutical company based in Suzhou, China, announced that its lead investigational asset, the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003, has received formal approval from China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) to commence a pivotal Phase III clinical study for HER2-positive advanced colorectal cancer (CRC).

2025年10月27日，总部位于中国苏州的创新型生物制药公司康宁杰瑞宣布，其主要在研药物——双表位HER2靶向抗体偶联药物（ADC）JSKN003，已正式获得中国国家药品监督管理局（NMPA）下属药品审评中心（CDE）批准，将启动针对HER2阳性晚期结直肠癌（CRC）的关键III期临床研究。

This trial marks a significant advancement for JSKN003, as it becomes the fourth late-stage clinical trial for the compound, underlining the company’s comprehensive clinical development plan in major oncological indications..

这项试验标志着 JSKN003 取得了重要的进展，因为这是该化合物的第四项后期临床试验，突显了公司在主要肿瘤适应症方面的全面临床开发计划。

Colorectal cancer is one of the most prevalent cancers globally, and China accounts for over 500,000 new diagnoses annually. Notably, about 83% of Chinese CRC patients present at an advanced stage at diagnosis, and approximately 44% exhibit metastatic disease to organs such as the liver or lungs. Despite the availability of several systemic therapies, the prognosis for metastatic CRC remains poor, with a 5-year survival rate below 20%.

结直肠癌是全球最常见的癌症之一，中国每年有超过50万的新发病例。值得注意的是，约83%的中国结直肠癌患者在诊断时已处于晚期，约44%的患者出现肝、肺等器官的转移性疾病。尽管已有多种系统性治疗方法，但转移性结直肠癌的预后仍然较差，5年生存率低于20%。

There are currently no approved HER2-targeted therapies for CRC in China. The median progression-free survival (mPFS) for this patient group with standard therapies is only 2.0–3.7 months, underscoring the sizable unmet need for innovative interventions targeting the HER2 pathway..

目前在中国，尚无获批的针对结直肠癌的HER2靶向疗法。该患者群体使用标准治疗的中位无进展生存期（mPFS）仅为2.0至3.7个月，凸显了对针对HER2通路的创新干预措施的巨大未满足需求。

Developed independently by Alphamab Oncology and co-developed with JMT-Bio Technology, a wholly owned subsidiary of CSPC Pharmaceutical Group, JSKN003 is a next-generation biparatopic ADC engineered for enhanced specificity and anti-tumor potency. The compound leverages proprietary site-specific conjugation technologies, binding strongly to two separate HER2 epitopes on tumor cells and internalizing to release a topoisomerase I inhibitor directly within cancerous tissue.

由康宁杰瑞独立研发，并与石药集团全资子公司津曼特生物联合开发，JSKN003 是一款下一代双表位抗体偶联药物 (ADC)，具有更高的特异性和抗肿瘤效力。该化合物利用专有的定点偶联技术，能够强效结合肿瘤细胞上的两个不同 HER2 表位，并内化释放拓扑异构酶 I 抑制剂，直接作用于癌组织内部。

Early clinical studies have demonstrated that JSKN003 offers improved safety, tolerability, and anti-tumor activity—crucially, showing a superior therapeutic window and lower hematological toxicity compared to first-generation ADCs. Importantly, JSKN003 received Breakthrough Therapy Designation from China’s CDE for its application in HER2-positive advanced CRC following failure of conventional chemotherapies with oxaliplatin, fluorouracil, and irinotecan..

早期临床研究显示，JSKN003在安全性、耐受性和抗肿瘤活性方面均有提升——尤为重要的是，与第一代ADC相比，其治疗窗口更优，血液学毒性更低。值得一提的是，JSKN003已获得中国CDE授予的突破性疗法认定，用于治疗经奥沙利铂、氟尿嘧啶和伊立替康等常规化疗失败后的HER2阳性晚期结直肠癌。

The Phase III study (JSKN003-005) is designed as a randomized, open-label, multicenter trial directly comparing the efficacy and safety of JSKN003 against current standard-of-care regimens such as regorafenib, fruquintinib, or trifluridine tipiracil. This trial is expected to provide key confirmatory data that could potentially support regulatory filings and future commercialization in China and other markets..

III 期研究 (JSKN003-005) 设计为一项随机、开放标签、多中心试验，直接比较 JSKN003 与当前标准治疗方案（如瑞戈非尼、呋喹替尼或曲氟尿苷/替吡嘧啶）的疗效和安全性。该试验预计将提供关键的确证性数据，可能有助于在中国及其他市场的监管申报和未来的商业化。

JSKN003 is already under evaluation in other global pivotal studies, including those for HER2-positive and HER2-low expressing breast cancer as well as platinum-resistant ovarian cancer—demonstrating Alphamab Oncology’s ambition to rapidly expand the clinical footprint of this differentiated ADC. Furthermore, JSKN003 has been granted Orphan Drug Designation by the United States Food and Drug Administration for both gastric and gastroesophageal junction cancers, and holds two NMPA Breakthrough Therapy Designations for ovarian and colorectal cancer indications..

JSKN003已在其他全球关键研究中进行评估，包括HER2阳性、HER2低表达乳腺癌以及铂耐药卵巢癌的研究，这显示了康宁杰瑞生物制药快速扩展这一差异化ADC临床应用范围的雄心。此外，JSKN003已获得美国食品药品监督管理局（FDA）授予的胃癌和胃食管结合部癌孤儿药资格，并拥有中国国家药品监督管理局（NMPA）颁发的两项突破性疗法认定，分别针对卵巢癌和结直肠癌适应症。

Alphamab Oncology retains exclusive production rights for JSKN003 in China, while its partner JMT-Bio holds exclusive development and commercialization rights on the mainland. The company’s robust proprietary platform covers single-domain and bispecific antibodies, and advanced conjugation technologies, enabling Alphamab to deliver globally competitive therapies for malignancies with high unmet clinical needs.

康宁杰瑞保留了JSKN003在中国的独家生产权，而其合作伙伴健民生物则拥有该药物在大陆的独家开发和商业化权利。公司强大的自主平台覆盖单域和双特异性抗体以及先进的偶联技术，使康宁杰瑞能够为具有高度未满足临床需求的恶性肿瘤提供全球竞争力的治疗方案。

This milestone highlights continued R&D momentum among domestic biopharma innovators and underscores China’s growing leadership in targeted oncology drug development, with wide-ranging implications for both Asian and international markets facing a rising burden of colorectal and other solid tumors..

这一里程碑突显了国内生物制药创新者持续的研发动力，并强调了中国在靶向肿瘤药物开发方面日益增长的领导地位，对亚洲和国际市场都有广泛的影响，这些市场正面临着结直肠癌和其他实体瘤负担增加的问题。