智通财经APP讯,百利天恒(688506.SH)发布公告,公司近日收到国家药品监督管理局(NMPA)正式批准签发的4个《药物临床试验批准通知书》,公司自主研发的创新生物药注射用BL-B01D1(EGFR×HER3双抗ADC)的4个联合用药的II期临床试验获得批准。
根据《中华人民共和国药品管理法》及有关规定,经审查,注射用BL-B01D1临床试验符合药品注册的有关要求,同意本品开展联合仑伐替尼用于晚期肝癌、联合阿昔替尼±帕博利珠单抗用于晚期肾癌、联合贝伐珠单抗±化疗用于晚期结直肠癌、联合帕博利珠单抗±化疗用于晚期胆道恶性肿瘤的临床试验。
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