智通财经APP讯，石药集团(01093)发布公告，集团开发的SYS 6043( 抗体偶联药物 )的试验性新药(IND)申请已获美国食品药品监督管理局(FDA)批准，可以在美国开展临床试验。此前，该产品已经于2024年12月获得中华人民共和国国家药品监督管理局批准，可以在中国开展临床试验。
该产品为一款单克隆抗体偶联药物，可与肿瘤表面的特异性受体结合，通过内吞作用进入细胞并释放毒素，达到杀伤肿瘤细胞的作用。本次获批临床的适应症为晚期╱转移性实体瘤，该产品预计适用于治疗小细胞肺癌、食管鳞癌、头颈鳞癌、前列腺癌、肝细胞癌等。临床前研究显示该产品对多种癌症均有较好的抗肿瘤作用，具有较高的临床开发价值。该产品已在国内外提交多项专利申请。
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