A panoramic observation of imported new drugs approved by CFDA in 2017 (1)

Based on the published data of CFDA / CDE, the new chemical drugs (NME / and its compound drugs) and biological drugs (BLA) were combined After searching on CFDA and CDE official websites, the author has determined that the following 40 imported varieties (see the table below) have been newly approved for listing by CFDA in 2017 Six of them are biological products or vaccines, and the rest are small molecule drugs or compound drugs The top multinational enterprises that have obtained CFDA approval are: Novartis, 6 varieties have been approved; Johnson & Johnson, 6 varieties have been approved; bringer Ingelheim, 5 varieties have been approved 40 imported varieties cover the following disease fields: anti-tumor or prevention, 9 items, including solid tumor and haematoma; type 2 diabetes, 6 items; hepatitis C, 6 items; central nervous system disease, 4 items; autoimmune disease, 4 items; anti hypertension or pulmonary hypertension, 3 items, etc After CFDA issued the opinions of the General Administration on solving the backlog of drug registration applications and implementing the priority review and approval in 2016, the speed of the listing of new drugs and generic drugs was significantly accelerated At present, CDE has released 25 batches of 423 varieties to be included in the priority review process (the previous batch 26 was not found) Many of the 40 varieties approved below are subject to priority review According to the priority evaluation of these drugs, the time difference between the time to market of Chinese imported innovative drugs and the time to market abroad was reduced to one year and five months (oxitinib, azd9291), followed by the time to market of Novartis' sakubatravalin sodium two years and one month later than that in the United States In addition, the food and drug administration has increased the number of reviewers, and the current CDE has increased from 150 to more than 800 The next section will comment on some of the 40 blockbuster drugs, especially those in great demand in the Chinese market Attachment: 40 imported new drugs approved by CFDA in 2017