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奥赛康(002755.SZ):与上海药明康德合作开发新药并签署合作开发合同书
格隆汇 03-18 17:24

格隆汇 3 月 18日丨奥赛康(002755.SZ)公布,公司的子公司江苏奥赛康药业有限公司(“子公司”)与上海药明康德新药开发有限公司(“上海药明康德”)于近日合作开发新药并签署《合作开发合同书》。

项目名称:用于Exon14突变及第三代EGFR抑制剂耐药性的NSCLC治疗的类新药开发。

项目内容:按照中国国家药品监督管理局(National Medical Products AdministrationNMPA”)的要求及相关法规的要求,完成治疗Exon14突变及第三代EGFR抑制剂耐药性的NSCLC类新药研发项目的临床前候选化合物(PCC)和临床候选化合物(IND)的相关研究工作。

公司按照合同约定方式分阶段向上海药明康德支付临床前研发费用、临床里程碑金以及上市销售提成。合同临床前研发费用总额为人民币4000万元整

合同的履行符合公司战略发展目标的要求,肿瘤领域是本公司主要聚焦领域,尤其针对其中发病率最高的肺癌,已布局系列产品。ASK120067是靶向作用于T790M的三代EGFR抑制剂,用于治疗非小细胞肺癌。目前ASK120067获得了国家药品监督管理局药品审评中心(CDE)许可,完成临床II期研究后可有条件批准,奥赛康目前已完成临床II期入组,预计2021年完成临床研究并向CDE请上市。本次公司与上海药明康德合作开发的创新项目,除用于Exon14突变的非小细胞肺癌,还将与公司三代EGFR抑制剂ASK120067联合,用于一代EGFR抑制剂耐药的T790M阴性患者,以及用于三代EGFR抑制剂耐药的患者,进一步拓展非小细胞肺癌的目标人群,使更多的患者获益。该合作将有利于进一步完善公司抗肿瘤产品线,提高公司的竞争力和持续盈利能力,对公司的战略布局起到积极作用。

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