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本月全球药品研发进展取得成效的药物有56个,较上月大幅增加了15个,除进入Ⅲ期临床研究的药物数量骤增10个以外,其它各研发阶段的药品数量均较上月略有增加。进入注册阶段的有19个,较上月增加2个。其中6个为全球首次注册的新活性物质和新制剂,其余1 3个均为在新市场补充注册。本月全球首次注册6个药品,较上月增加1个。其中5个为新活性物质,分别为神经系统用药(2个)、抗肿瘤药(2个,其中1个同属生物技术药物)和免疫调节剂(同属生物技术药物),其中抗肿瘤药hydralazine(肼屈嗪)和magnesium valproate(丙戊酸镁)belimumab为罕用药,为新的固定剂量复方制剂。另1个新制剂为抗
There were 56 pharmaceuticals that made progress in global pharmaceutical research and development this month, a substantial increase of 15 from the previous month. Except for the number of drugs entering Phase Ⅲ clinical trials surging by 10, the number of other pharmaceuticals in all phases of development was slightly lower than that of the previous month There is increase. 19 have entered the registration phase, an increase of 2 from the previous month. Six of these were the first new active substances and new preparations registered in the world, and the remaining 13 were all newly registered in the new markets. This month the world’s first registration of six drugs, an increase of the previous month. Among them, 5 were new active substances, which were 2 drugs for nervous system, 2 drugs for antineoplastic drugs (including 1 biotech drug), and immunomodulators (all biotech drugs). Among them, the antineoplastic hydralazine ( Hydralazine) and magnesium valproate (valproate) belimumab is a rare drug, a new fixed-dose compound. Another new formulation is anti-inflammatory