Annual inventory: 2019 Chinese pharmaceutical companies approved in the United States anda ranking!

Release date: 2019-12-27 Views: 0

Source: Yaozhi

In 2019, Chinese pharmaceutical companies achieved FDA-approved ANDA and achieved another success, reaching 92 application numbers with a total of 76 active ingredients from 28 Chinese pharmaceutical companies.

Table 1: Chinese pharmaceutical companies receive ANDA approval in 2019


In 2019, the FDA approved a total of 808 Original Abbreviated New Drug Approvals (ANDAs) and 149 Tentative Approvals. The number of generic drugs and tentative approvals approved by Chinese pharmaceutical companies are 76 and 14, respectively, accounting for about 10%. The number of ANDA approved each month has no obvious pattern, and the number of approvals in the first half and the second half is equivalent, 45 and 47 respectively.


Figure 1: Number of ANDA approved by Chinese pharmaceutical companies in each month of 2019

The market status of the 92 application numbers approved in 2019 is as follows: 76 prescription drugs, 14 tentative approvals, 1 over-the-counter drug, and 1 withdrawn from the market. FDA's provisional approval means that it cannot be listed in the United States due to patent rights and / or exclusivity, but it meets the FDA quality, safety, and effectiveness standards for listing in the United States. In particular, some varieties were initially approved by the FDA for tentative approval. Later, they were formally approved due to patent and / or exclusivity requirements. Therefore, only one piece of data is retained in this part of the statistics.


Figure 2: The state of Chinese pharmaceutical companies' ANDA market in 2019

The Chinese company that received the most ANDA approvals in 2019 was Fosun Pharma, with its Gland and Chongqing Yaoyou, reaching 16 application numbers; followed by Nantong United Asia, with 12 application numbers. In terms of quantity, Fosun Pharma, Nantong Lianya, Hisun Pharmaceutical, and Jingfeng Pharmaceutical all experienced significant growth compared to 2018.

In terms of the total number of approvals, 2019 decreased slightly compared to 2018, mainly due to the decrease in the supply of the main force. For example, the top three rankings of Dongyang Sunshine, Renfu Medicine, and Huahai Pharmaceutical have all declined significantly. Dongguang dropped from 15 to 7; Renfu Medicine dropped from 13 to 4; Huahai Pharmaceutical also dropped from 11 to 4.

In 2019, several new faces were added to the internationalization of Chinese pharmaceutical companies: Hangzhou Zhongmei East China Pharmaceutical, Beijing Tide, Zhejiang Jutai Pharmaceutical (a wholly-owned subsidiary of Puluo Pharmaceutical), Borui Pharmaceutical, Zhejiang Yong Too Pharmaceutical.

On April 1, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. obtained tentative approval from the FDA. The main indications are duodenal ulcer, gastric ulcer, acute gastric mucosal lesion, and complex upper gastric ulcer. According to statistics, the total global market sales of pantoprazole sodium products (including injections, tablets, capsules, etc.) in 2018 were approximately US $ 3.069 billion (among which injection sales were approximately US $ 1.054 billion); US total sales were approximately US $ 269 million China's total sales are about $ 1 billion.

On July 29, Beijing Tide's ticagrelor tablet obtained tentative approval from the FDA, which is mainly applicable to the treatment of acute coronary syndrome. According to statistics, the global sales of Tigrelor films in 2017 were about 1.25 billion US dollars, of which the US market sales were about 690 million US dollars; from January to September 2018, the global sales were about 1.18 billion US dollars, of which the US market sales were about 670 million US dollars. At the same time, tigrelor films from Hisun, Huahai and Dongyangguang have also received FDA approval.

On September 5, Zhejiang Jutai Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Puluo Pharmaceutical, was approved by the FDA for the treatment of moderate to severe depression and seasonal affective disorders. The drug was developed by VALEANT and was launched in the United States on August 28, 2003. Jutai Pharmaceutical has invested about US $ 1.5 million in research and development on the bupropion hydrochloride sustained-release tablets project.

On September 25, Bortec's Entecavir tablets received tentative approval from the FDA. This drug is the first-line anti-HBV drug recommended by the United States, Europe, Asia-Pacific, and WHO, all of the guidelines for the prevention and treatment of chronic hepatitis B. According to NEWPORT data, from March 2018 to March 2019, global sales of oral entecavir preparations were $ 1.433 billion, of which US sales were $ 62 million.

On November 4, the rosuvastatin calcium tablets of Zhejiang Yongtai were approved by the FDA, which is suitable for the treatment of high primary blood lipid abnormalities that have not been properly controlled by diet control and other non-drug treatments (such as exercise therapy and weight loss). Cholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb). According to statistics, from July 2018 to June 2019, global sales were about 3.461 billion US dollars, of which the US market sales were about 295 million US dollars.

Table 2: Number of ANDA approved by Chinese pharmaceutical companies in 2019


Let's look at the ANDA that has been approved by the FDA in the past 10 years for Chinese pharmaceutical companies, including data on purchases and acquisitions. The overall trend shows an upward trend, reaching the highest value in 2018 and a slight decline in 2019.

Some readers may think that it is wrong. Isn't the number approved in 2018 reaching 100? It is because some tentative approvals will no longer be included in the statistical scope of the year after being approved.


Figure 3: Number of ANDA approved by Chinese pharmaceutical companies in the past 10 years

Finally, let's talk briefly about the two NDAs approved by Chinese pharmaceutical companies in 2019, which are from Beiji Shenzhou and Shi Yao Ou Yi.

Table 3: NDAs approved by Chinese pharmaceutical companies in 2019


On November 15, 2019, BeiGene announced that its self-developed BTK inhibitor Zebutinib (English name: BRUKINSA ™, English common name zanubrutinib) has been approved by the FDA for accelerated Treat patients with mantle cell lymphoma (MCL) who have previously received at least one therapy. This signifies that Zebutinib has become the first anti-cancer new drug that has been independently developed by Chinese enterprises and approved by the FDA, achieving a "zero breakthrough" for Chinese original new drugs to go to sea.

On December 20, the US Food and Drug Administration (FDA) approved CSJ's CONJUPRI (Levamlodipine Maleate) tablets for the marketing of new drugs (NDA) for the treatment of hypertension. It is reported that this is the first Chinese drug company to submit a new drug listing application to the US FDA and has passed the FDA's normal review and approval process, becoming the first Chinese domestic innovative drug to receive FDA full approval.

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