中国给予新的HER2定向癌症药物以突破性地位,以治疗先进的直肠癌。 China grants breakthrough status to new HER2-targeted cancer drug for advanced colorectal cancer.

中国的CDE已经批准了JSKN003,这是针对抗体药物共合体的两面性HER2-目标性抗体-药物双端疗法,这是对以前未接受过治疗的病人的HS2-阳性高血红外切癌的另一个突破性治疗名称。 China’s CDE has granted JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, another breakthrough therapy designation for HER2-positive advanced colorectal cancer in patients who have failed prior treatments. 它由阿尔法玛布肿瘤学和CSPC制药公司开发,在早期试验中表现出很强的功效,在转移性直肠癌患者中,反应率达到68.8%,疾病控制率达到96.9%,安全性也可控。 Developed by Alphamab Oncology and CSPC Pharmaceutical, it showed strong efficacy in early trials, with a 68.8% response rate and 96.9% disease control rate in metastatic colorectal cancer patients, along with manageable safety. 该药物还获得林业发展局对临床试验和胃癌孤儿药物状况的批准。 The drug has also received FDA approval for clinical trials and orphan drug status for gastric cancer. 目前正在对若干固态肿瘤进行多个阶段的第二和第三阶段试验。 It is now in multiple Phase II and III trials across several solid tumors.