君实生物(01877.HK)单抗注射液临床试验申请获FDA批准
君实生物(01877.HK)公布,子公司拓普艾莱(TopAlliance Biosciences, Inc.)近日正式获得FDA(美国食品药品监督管理局)关於特异性抗TIGIT单克隆抗体注射液(项目代号TAB006/JS006)用於治疗晚期恶性肿瘤的临床试验批准。
TAB006/JS006是公司自主研发的特异性抗TIGIT单克隆抗体注射液,其临床试验申请已於今年1月获得国家药监局批准,公司将按照相关规定在国内开展临床试验。
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