[exclusive] in 2019, 23 Chinese pharmaceutical enterprises have been added to anda, and the former overlord Huahai has not achieved anything. The enthusiasm of enterprises to the United States has decreased?

As of April 18, 2019, 23 application numbers have been added to the Anda approved by the FDA by Chinese pharmaceutical companies, with a year-on-year increase of 53.3% (15 in the same period of 2018) The overall number has increased compared with the same period of 2018, but the enterprise's popularity has decreased In the past, the former overlord Huahai did not achieve anything Haizheng, dongyangguang and Nantong Lianya performed well Hangzhou, China, the United States and East China were approved by anda for the first time Table 1: five application numbers of Anda approved by the FDA by Chinese pharmaceutical companies in 2019 are currently in provisional approval, and the dosage form is unknown; in addition, tadalafei of Qilu pharmaceutical and tegrilol of Haizheng pharmaceutical both obtained provisional approval in 2018 and formal approval in 2019 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 Figure 1: in terms of market state enterprises of Anda approved by FDA in 2019, from January 1, 2019 to now, only one new face -- Hangzhou, China, the United States and East China -- has been welcomed in the internationalization path of Chinese pharmaceutical enterprises Up to now, 39 Chinese pharmaceutical companies (based on their parent companies) have obtained FDA approved anda However, it is a pity that Zhejiang Huahai Pharmaceutical Co., Ltd has not obtained an application number since January 2019 due to the influence of the previous API impurity storm However, Haizheng, dongyangguang and Nantong Lianya performed well, and obtained 5, 5 and 4 application numbers respectively Table 2: in general, the FDA approved anda of Chinese pharmaceutical enterprises in 2019 increased slightly compared with the same period in 2018, but the heat decreased compared with the momentum in the fourth quarter of 2018 However, the dividend of China and the United States is still obvious In the second half of the year, more enterprises may go to the United States to declare Looking at the approval of Anda over the years, it shows a trend of increasing year by year, reaching a peak in 2018, less than half in 2019, and there is still a chance to surpass 2018 Here is a brief explanation of the statistical rules: 1 The statistical enterprises include local enterprises and acquired enterprises, such as gland and epic acquired by Fosun Pharmaceutical; 2 The approval documents of acquisition are not included, such as 123 approval documents of Shandeshi acquired by Fosun Pharmaceutical, which belong to Fosun Pharmaceutical and Chongqing Yaoyou; 3 After the provisional approval is formally approved, the statistics will not be made, such as those obtained in 2018 The number of andas is 99, but two of them have been officially approved in 2019, so they will not be counted, and will be reduced to 97 Figure 2: FDA approved anda of Chinese pharmaceutical enterprises in recent 10 years Moreover, let's take a look at the overall situation of the approved andas of various pharmaceutical enterprises over the years The largest number is humanwell pharmaceutical, which has reached 75, with its epic (55), humanwell puck (15), and Yichang humanwell (5) Of course, before humanwell pharmaceutical acquired epic in 2016, it had some andas; the second is Huahai pharmaceutical, which has reached 63, mainly approved by Princeton; the third is humanwell pharmaceutical Star Pharma has 52 application numbers, mainly obtained 51 application numbers through the acquisition of gland, and the other one is venlafaxine hydrochloride approved by Chongqing Yaoyou earlier In addition, in recent years, dongyangguang, Shiyao, Qilu and Haizheng have made more international efforts and are catching up with each other Figure 3: at the end of the Anda approved by the FDA by Chinese pharmaceutical companies over the years, let us know the Anda query method approved by Chinese pharmaceutical companies Enter the drug intelligence data - FDA drug database of the United States (click "read the original" at the end of the article), find a search column of Chinese drug companies in the search box, and select "yes" from the drop-down option to query all andas However, due to some tentative approvals not included in the library, the quantity is slightly less 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.