江苏省生物药研发与注册现状分析

Analysis on the Research and Registration of Biopharmaceuticals in Jiangsu Province

生物药是当今世界医药产业发展的重点。近年来,江苏省生物药研发方兴未艾,注册申报位居全国前列,其中具有知识产权的创新药占三分之一以上。治疗用生物制品涉及单克隆抗体、大分子蛋白、细胞治疗产品,抗体类药物研发主要集中在PD-1/PD-L1、TNF-α、HER2、VEGF等靶点。目前申报的品种尚处在临床前研究和临床试验阶段,预计三年后将进入生物技术产业化发展期,需要政产学研各方协同加大技术和资金投入,形成追赶国际生物药制造先进水平的实力。

Biopharmaceuticals are becoming more and more important in the pharmaceutical industry.In recent years,the development of biopharmaceuticals in Jiangsu Province is booming,and the registration quantity ranks among the top in China,of which more than one-third of the innovative drugs with intellectual property rights.The therapeutic biological products involve monoclonal antibodies,macromolecular proteins,and cell therapy products.The development of antibody drugs mainly focuses on targets such as PD-1/PD-L1,TNF-α,HER2,and VEGF.The candidates currently are mainly in the pre-clinical research and clinical trial stages.They are expected to be in NDA period after three years.