中国抗体药物产业现状与发展前景

The Status and Development Prospect of Chinese Antibody Drug Industry

我国抗体药物起步晚,研发与生产技术与国际水平相比尚有一定的差距,但我国抗体药物产业发展迅速,国家政策支持以及研发投入力度较大,目前已取得一定的成果,市场潜力巨大。根据近年来国内相关文献报道以及CFDA、CDE网站的数据库,对我国抗体药物的上市、注册、审批情况以及产业化现状、重点研发企业、发展方向等方面进行归纳总结。综述了我国抗体药物的研究进展及发展前景,为生物制药企业及从事生产研发的科研人员提供了参考依据。

The current development of monoclonal antibody drugs industry in China has just entered the initial stage, there is a big gap compared with the United States and theEuropean Union. But the antibody drug industry is developping rapidly in our country, and the policy support was significantly increased and the market average annual compound growth rate increased year by year, antibody drug industry has a huge market potential. According to some reports and domestic literature in recent years, as well as the CFDA, CDE website database, the present situation of domestic therapeeutic mABs through CFDA approval, registration, industrialization status were summarized and the research progress and development prospect of chinese antibody drug industry were reviewed, to provide comprehensive theoretical basis for research and development.