智通财经APP讯，首药控股(688197.SH)发布公告，公司于近日收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，作为第四代ALK抑制剂候选药物，SY-12321胶囊单药在间变性淋巴瘤激酶(ALK)阳性晚期实体瘤的临床试验申请获得批准。
SY-12321是公司完全自主研发的化学药品1类创新药，属于第四代小分子ALK抑制剂，是公司完善ALK阳性肿瘤全生命周期治疗布局的重要候选产品，拟重点解决第三代ALK抑制剂治疗后的耐药问题，特别是ALK复合突变介导的耐药。临床前研究显示，SY-12321对ALK野生型以及经第一代、第二代和第三代ALK抑制剂治疗后产生的广泛关键耐药突变均展现出较强的抑制活性，覆盖主要单点耐药突变及多种关键复合突变，并在颅内肿瘤模型中表现出良好的肿瘤抑制作用，提示其拥有克服不同代际ALK抑制剂相关耐药机制及控制中枢神经系统病灶的潜力。
基于上述临床前研究结果，SY-12321除重点面向经第三代ALK抑制剂治疗后进展的患者外，未来亦具备向更前线治疗拓展的潜力。公司将结合后续临床研究结果，审慎评估其在不同治疗线次中的开发价值。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.