智通财经APP讯，石药集团(01093)发布公告，集团开发的SYS 6041( 抗体偶联药物 )的试验性新药(IND)申请已获得美国食品药品监督管理局(FDA)批准，可以在美国开展临床研究。该产品已于2025年1月获得中华人民共和国国家药品监督管理局批准在中国开展临床试验。
该产品为一款单克隆抗体偶联药物，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。本次获批的适应症为晚期实体瘤。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件专利申请。
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