[exclusive] 100 andas, 24 pharmaceutical companies, and another success in 2018 on the way of internationalization of China's pharmaceutical industry

In 2018, China's pharmaceutical companies achieved another success with FDA approved anda, reaching 100 application numbers, an increase of 122.22% year on year There are 78 active ingredients from 24 Chinese pharmaceutical companies (see the chart at the end of the article for details of 100 application numbers) In 2018, the FDA approved 817 original approved new drug approvals (andas) and 184 tentative approvals The number of generic drugs and provisional approvals granted to Chinese pharmaceutical companies is 80 and 20 respectively, accounting for about 10%, which is also a happy thing But if we look at new drugs, there will be no shadow of Chinese pharmaceutical companies The market status of 100 application numbers approved in 2018 is as follows: 77 prescription drugs, 20 tentatively approved, 2 over-the-counter drugs and 1 withdrawn from the market FDA's provisional approval means that it cannot be listed in the U.S due to patent rights and / or exclusivity, but it meets FDA's quality, safety, and effectiveness standards for listing in the U.S In particular, some varieties were initially approved temporarily by FDA, and then formally approved due to patent and / or exclusive rights For example, palonosetron hydrochloride of Qilu pharmaceutical was tentatively approved on April 26, 2018, and then officially approved as a prescription drug on September 19 Therefore, this part of data keeps its approval process in statistics In terms of enterprises, the approval of Anda in 2018 was optimistic, and 24 Chinese pharmaceutical enterprises were shortlisted Some international leading enterprises are still on the list, such as Huahai, Renfu, Qilu and other enterprises; fortunately, in 2018, there are also some new faces, such as Yiling, Tianjin TIANYAO, Boya Xinhe and other enterprises In 2018, dongyangguang achieved outstanding performance In the first half of the year, it was approved 4, and in the second half of the year, it was approved as many as 11, with a total of 15, ranking the first in terms of the number approved by anda, of which 3 are provisional approvals With its US subsidiary and domestic Yichang humanwell, humanwell has also obtained 13 acceptance numbers Although Huahai pharmaceutical has received 11 application numbers this year, its internationalization path in 2018 has experienced many setbacks, and it has received a warning letter from FDA However, on May 23, 2018, valsartan of Zhejiang Huahai Pharmaceutical Co., Ltd was approved to be listed in China The product is an oral solid preparation which completes the detour overtaking by virtue of the policy dividend of "listing in the United States but not in China, using overseas data declaration, and passing the consistency evaluation according to the approval of new 4 categories of generic drugs" Fosun Pharmaceutical acquired 9 application numbers through the acquisition of Indian pharmaceutical company gland Earlier, Fosun also spent $18 million to acquire 123 application numbers from Novartis Sandoz Nowadays, there are many gold rich pharmaceutical enterprises like Fosun in China It is also a good choice to broaden their internationalization path by means of capital In general, the approved anda in 2018 has reached a record high In addition, the dividend of China US double newspaper is more and more obvious The enthusiasm of Chinese pharmaceutical companies to the United States may continue In this paper, the analysis is relatively shallow, mainly to provide you with a data, more information can be accessed to the drug intelligence FDA database Data source: Yao Zhi data statement: This article only represents the author, not the position of Yao Zhi 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.