创新药Lurbinectedin(Zepsyre®)即将在美申报NDA绿叶制药与PharmaMar合作在华开发该药物
格隆汇获悉，绿叶制药(02186.HK)的合作伙伴PharmaMar于近日宣布，美国食品药品监督管理局(FDA)已同意PharmaMar通过加速审批程序，进行Lurbinectedin(Zepsyre®)用于小细胞肺癌二线单药治疗的新药申请(NDA)申报工作。
Lurbinectedin(Zepsyre®)是PharmaMar研发的海鞘素衍生物，为肿瘤创新药。绿叶制药拥有该药物在中国开发及商业化的独家权利，包括小细胞肺癌在内的所有适应症；并可要求PharmarMar进行该药物的技术转移，由绿叶制药在中国生产。
目前，小细胞肺癌占全部肺癌患者的10%~15%左右，是比非小细胞肺癌侵袭性更强、更难治疗的一种肺癌类型，5年生存率仅为5%-10%。尽管小细胞肺癌对初始化疗和放疗具有较高的敏感性，但在初始治疗失败后，大多数患者最终死于复发转移，预后差。小细胞肺癌的新药进展缓慢。2018年8月，FDA已授予用于治疗小细胞肺癌的Lurbinectedin(Zepsyre®)的孤儿药资格。
根据FDA的加速审批规定，对于那些治疗缺乏满意疗法的严重疾病的在研药物，Lurbinectedin将提交II期药物研究结果作为申报材料进行审评。此次申报将基于Lurbinectedin(Zepsyre®)II期单药治疗篮子试验中小细胞肺癌队列的相关数据。该试验共入组105名患者，分别来自美国和西欧地区超过9个国家的39个中心。该试验的主要终点为总有效率(ORR)，由研究者和独立评审委员会(Independent Review Committee)同时评估；次要终点为缓解持续时间(DOR)、无进展生存期((PFS)、中位总生存期(OS)和安全性。
PharmaMar预计将于2019年第四季度进行Lurbinectedin(Zepsyre®)的NDA申报。
据悉，Lurbinectedin(Zepsyre)是海鞘素衍生物，为RNA聚合酶II的抑制剂，能够与DNA双螺旋结构上的小沟共价结合，通过阻滞RNA聚合酶II与DNA的结合，并降解RNA聚合酶II的催化亚基RPB1，从转录的起始至延长阶段发挥抑制转录活性，使肿瘤细胞在有丝分裂过程中畸变、凋亡、最终减少细胞增殖。
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