China's top 20 pharmaceutical companies in the total number of applications since 2010

I since 2010, the top 20 enterprises in the overall number of applications have said that it is difficult to apply for queuing Which enterprises provide more workload to CDE? As shown in Table 1, Changchun Overseas Pharmaceutical Group Co., Ltd has submitted more than 1000 approvals, of which 851 are traditional Chinese medicine Hunan Kelun Pharmaceutical Co., Ltd and Sichuan Kelun Pharmaceutical Co., Ltd of Kelun Pharmaceutical Co., Ltd ranked second and eleventh respectively The top 20 foreign companies are Pfizer and Novartis Table 1 data sources of the top 20 enterprises in the overall application quantity since 2010: XD database, the overall application drug types include chemical drugs, traditional Chinese medicine, biological products and in vitro reagents; the application types include new drugs, import, import re registration, existing national standards, supplementary application and imitation 2、 From 2010 to now, the number of chemical products approved by the top 20 enterprises in the past three years is shown in Table 2 The top 20 enterprises have received more than 10 approvals since 2012, including Pfizer, Shandong Luoxin, Sinopharm and Jiangsu Haosen It is worth noting that although Zhejiang Huahai and Hainan Jinrui have not applied for the top 20, they have received 12 approvals since 2012 Table 2 the number of chemical products approved by the top 20 enterprises from 2010 to now Note that the number of approved approval documents does not include the data of replacing old approval documents The application types include new drugs, import, import re registration, existing national standards, supplementary application and imitation Data source: XD database, China drug registration database 3 The number of top 20 enterprises applying for new drugs of traditional Chinese medicine in recent three years is shown in Table 3 Only Jiangsu Kangyuan, Shandong Xianhe, Chongqing Xi'an, Jiangsu wangao, Shaanxi momeide and Hunan Dekang have been approved by top 20 enterprises since 2012 The latest Chinese medicine injection approval document is ginkgolide and meglumine injection in 2012 In the past two years, no traditional Chinese medicine injection has been approved In recent three years, 99% of the approved Chinese medicine approvals are oral dosage forms Table 3 the number of Chinese medicine new drugs declared by the top 20 enterprises since 2010 Note that the number of Chinese medicine products approved in recent three years does not include the data of replacing old approval documents The application type is only new drugs Data source: XD database, summary of China drug registration database in recent years, the cumulative number of domestic applications has increased significantly, the current approval is said to be able to queue up to 10 years later Registered overheated products are under control It's said that more than 8 generic name applicants can choose their own pass There are also rumors that CFDA intends to speed up the approval of good products The balance of fairness and efficiency of management organization will affect the pattern of product approval and the sustainable development of enterprises How to innovate traditional Chinese medicine and whether so many manufacturers of traditional Chinese medicine will rely on the acquisition of one or two previous exclusive approval documents to develop remains to be seen Finally, I would like to send you a message: no one is good without a thousand days, and no flower is red without a hundred days If there is any disease, it shall be treated in time, and if there is no disease, it shall be prevented as soon as possible.