艾德生物(300685.SZ)与礼来制药子公司LOXOONCOLOGY达成靶向药物临床研究合作协议
格隆汇6月23日丨艾德生物(300685.SZ)公布,近日,公司与LOXO ONCOLOGY, INC. (礼来制药子公司)、PREMIA HOLDINGS(HONG KONG)LIMITED签署了合作协议。
公司自主研发的“艾惠健TM”(基于PCR平台的多基因联合检测产品,2018年8月24日获国家药品监督管理局批准上市,详见公司2018年8月24日披露的《关于公司获得医疗器械注册证的提示性公告》【公告编号:2018-064】)和“维惠健TM”(基于NGS平台的10基因检测产品,2018年11月20日获国家药品监督管理局批准上市,详见公司2018年11月20日披露的《关于公司获得医疗器械注册证的提示性公告》【公告编号:2018-081】)将成为LOXO ONCOLOGY跨癌种RET抑制剂LOXO-292亚洲(包括中国大陆、日本、中国台湾在内)药物临床实验的伴随诊断试剂,并将按日本LC-SCRUM(日本国家癌症中心肺癌项目)的高标准构建服务亚洲患者的临床基因检测平台。
公告显示,LOXO ONCOLOGY, INC.是靶向药物领域的明星企业,旗下拥有RET、NTRK等多款跨癌种靶向药物,于2019年1月被美国制药公司礼来(Eli Lilly)以80亿美元的价格收购。
PREMIA HOLDINGS(HONG KONG)LIMITED成立于2018年,主营业务是通过在亚洲提供高效的临床开发平台来加速新型癌症治疗。
在肿瘤伴随诊断领域,公司严守国家法律和行业规范,构建了完善的、基于多技术平台的基因检测整体解决方案。此前,公司ROS1基因融合检测试剂盒助力辉瑞公司靶向药物克唑替尼(Xalkori)用于一线治疗ROS1融合基因阳性患者的亚太临床研究取得成功,获得日本、韩国、中国台湾医疗器械注册证,并进入日本、韩国医保。此次LOXO ONCOLOGY选择公司作为其在研靶向药物LOXO-292亚洲临床研究的伴随诊断合作伙伴,是对艾德品牌和产品的信任和肯定,有利于进一步增强公司在亚洲市场的竞争力,对公司未来的发展将产生积极影响。
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