Five year review of Chinese drug approvals 2010-2014

Title: as you know in fashion, one day you are in, and the next day you are out! "Is often said by the host of American reality show project runway on the program I think that this sentence is also suitable for industries that need constant innovation, such as new drug research and development For example, anti-tumor drugs, domestic enterprises are still struggling to get approval for listing of zadutinib There are many good news in foreign tumor immunotherapy programs to subvert the existing cognition 1 the top 20 enterprises in the overall number of applications since 2010 have said that it is difficult to queue up for application 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 2 from 2010 to now, the number of chemical drugs approved by the top 20 enterprises in the past three years is shown in the table below 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 Note that the number of approved approval documents does not include the data of replacing old approval documents Application types include new drugs, import, import re registration, existing national standards, supplementary application and imitation 3 from 2010 to now, the number of top 20 enterprises applying for new Chinese medicine approved in recent three years is shown in the table below Only Jiangsu Kangyuan, Shandong Xianhe, Chongqing hilan, 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 Note that the number of approved approval documents does not include the data of replacing old approval documents, and the application type is only new drugs Summary: in recent years, the cumulative number of domestic applications has increased significantly It is said that the current approvals can be queued 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 saying: as the saying goes, "no one is good for a thousand days, and no flower is red for 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 " The technology transfer parties, who are waiting to buy approval documents, need to think about the problem of less and less sources.