[inventory] in the first half of 2018, there were 26 more andas approved by the FDA for Chinese pharmaceutical enterprises, and Yiling, Tianjin TIANYAO, Boya Xinhe and other enterprises were shortlisted for the first time

In the first half of 2018, Chinese pharmaceutical companies obtained FDA approved anda to add another 26 application numbers, a year-on-year increase of 38.5% (16 in the first half of 2017), a total of 25 active ingredients, from 15 Chinese pharmaceutical companies At the same time, statistics show that the total number of Anda approved by the FDA by Chinese enterprises has reached more than 250 application numbers Table 1: in the first half of 2018, China's pharmaceutical enterprises have been approved by the FDA with the red anda icon as the provisional approval In the first half of 2018, there were 8 anda, accounting for 31% FDA's provisional approval means that it cannot be listed in the United States due to patent rights and / or exclusivity, but it meets FDA's quality, safety and effectiveness standards for listing in the United States In 2018, many new faces have been welcomed in the internationalization of Chinese pharmaceutical enterprises, such as Yiling pharmaceutical, Tianjin TIANYAO, Shandong new era, Hainan Shuangcheng, Boya Xinhe Up to now, 35 Chinese pharmaceutical companies have obtained the FDA approved anda Zhejiang Huahai Pharmaceutical Co., Ltd has 5 anda drugs approved by FDA through its US subsidiary Princeton, which is worthy of being a leading international pharmaceutical enterprise in China Recently, valsartan of Huahai Pharmaceutical Co., Ltd was approved The product is an oral solid preparation that completes the curve overtaking with the policy dividend of "listing in the U.S but not listed in China, applying for overseas data, and passing the consistency evaluation according to the approval of new 4 categories of generic drugs" Humanwell also obtained 5 anda numbers, but its applicants are epicpharma (3), humanwell puck (1) and Yichang humanwell (1) Epicpharma is a U.S company wholly acquired by humanwell in 2016 In statistics, the approval after acquisition will be given to humanwell Hengrui Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., dongyangguang Pharmaceutical Co., Ltd., Ouyi Pharmaceutical Co., Ltd and other well-known international pharmaceutical companies are not willing to be outdone They have obtained three, two, two andas respectively In the first half of 2018, the remaining seven pharmaceutical companies all obtained one anda number In general, the approved anda in the first half of 2018 has reached a record high In addition, the dividend of China US dual report is more obvious In the second half of 2018, more enterprises may go to the United States to apply It is hoped that domestic pharmaceutical companies can obtain an NDA drug in the United States as soon as possible Finally, I'd like to give you an idea of the Anda query method approved by Chinese pharmaceutical companies Enter the FDA drug database (https://db.yaozh.com/fdadrug), find the search column of "Chinese drug companies" in the search box, select "yes" from the drop-down option, and all andas are screened out, isn't it very simple? Click here to enter the FDA drug database~