Monoclonal antibody (mAb) medicines are becoming increasingly significant in the global pharmaceutical business. mAb drug development in China has several obstacles. Several measures have lately been adopted to strengthen support in several sectors. The purpose of this research is to look into the current environment of mAb medicines in China from a policy standpoint, including R&D, clinical trials, marketing approval, and talent pools. For descriptive, statistical, and comparative analysis, data on mAb medicines licensed in the United States, the European Union, Japan, and China by 2017 and mAb-related policies in China were obtained from official websites and third-party statistics sources. When compared to the United States, the European Union, and Japan, the median drug lag in marketing clearance for the 11 imported mAb medicines in China was projected to be 87.1 months. However, with China’s rapidly changing innovation support structure, the creation of new biopharmaceutical firms, the transformation of existing drug companies and their move to antibody treatment, and the pooling of high-level personnel all contribute to mAb development. The number of mAb medication clinical studies, marketing applications, and approvals is likewise increasing.
The study found that reforming numerous rules and incentives for attracting/retaining high-level personnel was clearly beneficial in resolving China’s mAb drug lag. In the future, China should carefully monitor worldwide R&D outcomes and industrial development patterns of mAb medications, and make the legislative environment more appealing in order to allow additional mAb drugs to be sold in China as soon as feasible.
Reference: https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1605809
