【摘要】 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,生物药注册申报数位居全国前列,其中具有知识产权的创新药占1/3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程序性细胞死亡蛋白-1及其配体、肿瘤坏死因子-α、人类表皮生长因子受体2、血管内皮生长因子等靶点。目前,申报的各生物类别品种仍处于临床前研究和临床试验阶段,预计3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。更多还原

【Abstract】 Biological drug is the focus of the development of the world’s pharmaceutical industry. In recent years, the research and development of biopharmaceuticals in Jiangsu province is in the ascendant. The number of registered biopharmaceuticals comes at the top of the rankings in China and more than one third of the drugs are innovative drugs with intellectual property rights. Therapeutic biological products include monoclonal antibodies, macromolecular proteins and cell therapy products. The research and development of antibody drugs mainly focus on targets such as programmed cell death protein 1(PD-1) and its ligand PD-L1, tumor necrosis factor-α(TNF-α), human epidermal growth factor receptor 2(HER2) and vascular endothelial growth factor(VEGF). At present, the biological products with accepted application are still in the stage of pre-clinical research or clinical trial. It is expected that the development stage of biotechnology industrialization will come three years later. It is urged that governments, industry, universities and research institutes should work together to increase the investment in technology and capital, forming the strength to catch up with the international advanced level of biopharmaceutical manufacturing.更多还原