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本月全球药品研发进展取得成效的药物有68个,较上月增加了20个,除进入Ⅲ期阶段的药物数量与上月相近外,进入注册和注册前阶段的药品数量均有大幅增加。进入注册阶段的有39个,比上月增加13个。其中6个为全球首次注册的新活性物质和新制剂,其余33个均为在新市场补充注册。本月全球首次注册6个药品,较上月减少1个。其中2个为新活性物质,为内分泌及代谢调节用药和抗肿瘤药。4个新制剂,分别为抗感染药“青蒿琥酯+pyronardine”的固定剂量复方制剂和奈韦拉平的24 h缓释制剂、其他口服制剂,以及感觉器官用药瑞巴派特和呼吸系统药物吡非尼酮的
Sixty-eight drugs were achieved in the global pharmaceutical research and development this month, an increase of 20 from the previous month. The number of drugs entering the pre-registration and pre-registration phase has increased substantially, except for the number of drugs entering the phase III phase which was similar to that of the previous month. There were 39 registrations, an increase of 13 from the previous month. Six of the new active substances and new preparations were first registered in the world and the remaining 33 were newly registered in the new markets. This month the world’s first registered six drugs, a decrease of the previous month. Two of them are new active substances for endocrine and metabolic regulation and anti-tumor drugs. Four new formulations, namely the anti-infectives “fixed dose combination of artesunate + pyronardine” and the 24 h sustained release formulation of nevirapine, other oral formulations, and the sensory organ administration of rebamipide and respiratory system drugs Pirfenidone