Review of the performance of the US anda approved by Chinese pharmaceutical enterprises in 2018

Although China is a big pharmaceutical country, the API industry has always occupied a large proportion, while the proportion of preparations is relatively insufficient For foreign trade exports, this proportion is even more obvious After years of development, the pharmaceutical industry has entered the stage of industrial integration, and the pharmaceutical manufacturing industry as a whole has shown a steady growth trend In recent years, the pace of internationalization of domestic pharmaceutical enterprises has accelerated, and the export of pharmaceutical products has also increased significantly However, in the overall pharmaceutical foreign trade, the proportion of Chinese pharmaceutical products is still low, and compared with APIs, it still does not have a competitive advantage In addition, due to the difficulty of international certification and registration of drugs in developed countries, the R & D capacity of domestic preparations is relatively weak, and there is a lack of innovative varieties with international competitiveness The export of preparations is still concentrated in the non-standard market dominated by price competition, with artemisinin products, cephalosporin products, vitamin products and hormone and sex promoting hormone products as the leading products However, in recent years, the more More and more innovative pharmaceutical companies have increased investment in R & D and international certification They have set their eyes on the standardized market in Europe and the United States and began to seek international routes According to incomplete statistics, domestic pharmaceutical enterprises have more than 300 anda numbers in the United States, among which Huahai Pharmaceutical Co., Ltd and Nantong Lianya have made remarkable achievements in the number of applications Meanwhile, humanwell Pharmaceutical Co., Ltd and Fosun Pharmaceutical Co., Ltd will obtain multiple anda numbers due to merger and acquisition of overseas enterprises On the other hand, Dongyang, Qilu Pharmaceutical Co., Ltd., Ouyi, Hengrui Pharmaceutical Co., Ltd and Haizheng Pharmaceutical Co., Ltd are making steady progress in the United States Market In 2018, a total of 78 US anda approval numbers were obtained by domestic pharmaceutical enterprises, a record high See Table 1 at the end of the article for details We have carried out a simple analysis and summary of the enterprises with anda number (consolidation statistics of the same enterprise branch) See Figure 1 for details The top 4 enterprises are Renfu pharmaceutical, Dongguang pharmaceutical, Huahai pharmaceutical and Sinopharm Europe The Anda numbers obtained by humanwell include humanwell, a subsidiary of humanwell in the United States, epic and Yichang humanwell Pharmaceutical Co., Ltd acquired by humanwell, which has a strong momentum; dongyangguang, with a strong accumulation and a leading role in scientific research and innovation, has the reputation of "Huawei of pharmaceutical industry"; in addition, Yiling Pharmaceutical Co., Ltd., Hainan Puli Pharmaceutical Co., Ltd., Jingfeng Pharmaceutical Co., Ltd are all new members of domestic anda enterprises, and have obtained the Anda numbers of the United States for the first time, especially It is Hainan Puli, with a high starting point, and has become one of the few domestic companies with FDA injection anda Fig 1 analysis table of enterprises that obtained the US anda number in 2018 - list of Anda approved by domestic pharmaceutical enterprises in the United States in 2018 since Zhejiang Huahai obtained the first anda (nevirapine tablets) in 2007, outstanding members of Chinese pharmaceutical enterprises have been exploring and cultivating in the international pharmaceutical market through various channels and competitive strategies Through these years' efforts, the technical advantages and market share of Chinese preparations in the international market are growing I believe that with more efforts of Chinese enterprises, this trend will continue to improve in the years to come At the same time, it also reminds China's enterprises to develop the international market, to work hard, strengthen the cultivation of technological advantages, strengthen risk prevention and control measures, and strive to be invincible in the treacherous market competition Data source: 1 - US FDA website 2 - other media reports