In 2014, Guangdong Province completed 22 class 1 new drug applications

On April 29, Guangdong food and Drug Administration held a regular press conference for the first quarter of 2015 At the meeting, it was revealed that Guangdong province accounted for a quarter of the varieties approved in the annual report of national drug registration review last year, and the innovation driven effect played a positive role "For the first time, Guangdong Province has achieved a higher registration volume of new drugs than that of generic drugs under the condition that the total base of newly registered drugs keeps growing in 2014." Chen Dewei, deputy director of Guangdong food and drug administration, said at the Bureau's regular press conference in the first quarter of 2015 He said that under the strictest food and drug safety supervision measures in Guangdong Province, Guangdong pharmaceutical enterprises have made a breakthrough in the number of new drug registration applications higher than that of generic drug registration applications, thanks to the initiative of Guangdong food and drug regulatory agencies to adapt to the new economic normal, actively serve innovation and lead innovation in recent years He said that Guangdong's achievements in promoting the development of innovation driven pharmaceutical enterprises and institutions are also reflected in the following three aspects: first, in 2014, Guangdong accounted for 1 / 4 of the national research and development of 12 clinical new drugs in 12 important treatment areas approved by the state in 2014, and Guangdong Province developed 3 varieties, accounting for 1 / 4 of the national research and development of 12 clinical new drugs in 9 important treatment areas "They are xidaban tablets developed by Shenzhen micro core Biotechnology Co., Ltd., recombinant human tissue plasminogen activator TNK mutant for injection (rhtnk TPA) developed by Guangzhou Mingkang Bioengineering Co., Ltd and sildenafil tablets developed by Guangzhou Baiyunshan Pharmaceutical General Factory of Guangzhou Pharmaceutical Group." Chen Dewei revealed
The reporter looked up the website of the drug review center of the State Food and drug administration, and found that the 2014 annual drug review report published by the center listed nine fields of drugs that are urgently needed in clinic, such as anti-tumor drugs, vaccine drugs, endocrine drugs, etc., while three kinds of drugs, which are respectively used in the treatment of relapsed and refractory peripheral T-cell lymphoma, myocardial infarction and Ed (penile erectile dysfunction) "These three kinds of new drugs are really of great significance in clinical application They are all drugs that are urgently needed in clinical practice, or in the past period of time, they have been sold solely on the market or monopolized by foreign brands." Chen said II In 2014, Guangdong's class 1 innovative drugs were higher than the national level, nearly five times higher than that in 2011 "Compared with 57 applications in 2011, in recent three years, the growth rate of new drug applications in Guangdong Province is significantly higher than that of the whole country, especially 150 in 2014, which is nearly 15% higher than that of the same period in China Among them, the growth trend of class 1 innovative drugs is significant, which is nearly 5 times higher than the number of applications in 2011 and 2014 " 3、 The number of new drug registration applications in Guangdong Province is increasing year by year "In recent years, the number of new drug registration applications in Guangdong Province has been increasing year by year," Chen said Nevertheless, Chen Weide reminded that the weak foundation of innovation is still a shackle restricting the development of pharmaceutical enterprises in Guangdong Province According to the data provided by Guangdong food and drug administration, Guangdong accounts for less than one eighth of the 212 research institutions in 12 provinces involved in the research work of class 1 innovative drugs declared by Guangdong "Pharmaceutical research outsourcing institutions are mainly distributed in Beijing, Shanghai and Jiangsu, which account for 75% of the total research institutions, while Guangdong Province only accounts for 12%." He reminded that the supporting foundation of drug innovation and R & D in Guangdong Province still needs to be strengthened Chen Weide revealed that in the next step, Guangdong food and Drug Administration will actively do a good job in information exchange and policy guidance, provide service support for the implementation of innovation driven development strategy, promote the integration of innovation resources in Guangdong Province, and guide research and development institutions to actively participate in drug innovation in Guangdong Province.