Analysis of the R & D and Registration of Biopharmaceuticals in Jiangsu Province

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.