FDA agrees to PharmaMar to file claim for new drug by Zepsyre ®

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　　PharmaMar expects to make an NDA declaration for Theubinectin (Zepsyre ®) in the fourth quarter of 2019 　　About The Sourcebinectin (Zepsyre ®) Lurbinectin (Zepsyre ®) is a spin-off derivative developed by PharmaMar as an innovative drug for tumors 　　Green leaf pharmaceuticals have exclusive rights to the development and commercialization of Zepsyre ® in China, including all indications of small cell lung cancer, and can require Pharmamar to carry out a technology transfer of the drug (http:// , which is produced in China by Greenleaf Pharmaceuticals 　　In August 2018, the FDA granted the orphan drug for the treatment of small cell lung cancer, The Zepsyre ® 　　Under the FDA's expedited approval rules, Lurbinectedin will submit the results of the Phase II drug study as a declaration for those in the study of serious diseases that lack satisfactory therapy 　　The declaration will be based on data from the (http:// of small cell lung cancer queues in the Zepsyedin (Zepsyre ®) Phase II single-drug treatment basket
　　The trial enrolled 105 patients from 39 centers in more than nine countries in the United States and Western Europe 　　The main endpoints of the trial were Total Efficiency (ORR), which was evaluated simultaneously by researchers and an independent review committee, and the secondary endpoints were mitigation duration (DOR), non-progression lifetime (PFS), median total lifetime (OS), and safety