Inventory: in the first half of 2019, 47 more andas approved by FDA were added by Chinese pharmaceutical companies, an increase of 30.56% year on year

In the first half of 2019, China's pharmaceutical companies obtained FDA approved anda to add another 47 application numbers, a year-on-year increase of 30.56% (36 in the first half of 2018), with a total of 40 active ingredients from 16 Chinese pharmaceutical companies Table 1: in the first half of 2019, the products approved by the FDA by Chinese pharmaceutical companies in the first half of 2019 by anda reached nine tentatively approved varieties, accounting for 19.15% FDA's provisional approval means that it cannot be listed in the U.S due to patent rights and / or exclusivity, but it meets FDA quality, safety, and effectiveness standards for listing in the U.S In the first half of 2019, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., another new face in the internationalization path of Chinese pharmaceutical enterprises, obtained a tentative approval of pantoprazole sodium in April Up to now, 37 Chinese pharmaceutical companies (some with multiple subsidiaries) have obtained FDA approved anda In the first half of the year, the most approved Chinese enterprises are Haizheng and dongyangguang, both of which have reached 7 application numbers Different from the official approval of Haizheng, dongyangguang has 3 provisional approvals Next, Nantong Lianya has 6 application numbers Table 2: in the first half of 2019, the total number of Anda approved by the FDA by Chinese pharmaceutical enterprises is generally speaking, the approved anda in the first half of 2019 has reached a new record, and the dividend of the China US dual report is more obvious In the second half of 2019, more enterprises may go to the United States to apply Let's look at the FDA approved anda of Chinese pharmaceutical companies in the past 10 years, including the data of purchases and after the acquisition of companies For example, after Fosun Pharmaceutical acquired gland, the Anda of gland is included in Fosun Pharmaceutical Some people may think it's wrong Didn't the number of approvals reach 100 in 2018? It's because some of the provisional approvals are no longer counted after they become regular, so there are a few less Finally, I would like to give you an idea of the Anda query method approved by the US FDA for Chinese pharmaceutical enterprises Click the link to enter the pharmaceutical intelligence data enterprise version of the US listed drug database (https://vip.yaozh.com/fdadrug), find a search column of Chinese pharmaceutical companies in the condition screening, and all the andas are screened out, isn't it very simple? Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.