On the development trend of new drugs in China in recent years

Recently, Wuxi apptec listed in Hong Kong and realized the landing of a + H-share dual capital platform Junshi is also about to have a new three board + H-share dual capital platform Although the 4 + 7 volume purchase caused tears in the secondary market, it brought us many real benefits Although this year is not a capital bull market, it is definitely a year of new drugs As soon as nilapari was listed in Hong Kong, it transferred to the mainland for production reporting and has been accepted, bringing new hope to the platinum sensitive recurrent ovarian cancer patients in China In addition, the import of keytruda and opdivo immunotherapy has been approved, which also benefits the Chinese melanoma and non-small cell lung cancer patients By November 30, the FDA had approved 55 new drugs, a record high, as shown in the table below Driven by capital, technology and policy, global new drugs have stepped into the stage of acceleration However, there are just 55 Chinese class 1 new drugs (10 of which are vaccines) approved for marketing in China, accounting for less than 10% of global new drugs, far less than the proportion of Chinese population in the world (more than 19%) Among them, there are also several fake 1 categories, plus 4 introductions Looking at the structure carefully, me too is the majority, and its innovation is obviously insufficient However, it is gratifying that in recent years, the quality of the approved class 1 new drugs is gradually improving, the clinical efficacy is excellent or not bad, and the safety and tolerance are also improved In addition, the number of class 1 new drugs in clinical stage has increased significantly Recently approved class 1 new drugs have an average of 1-2 per day, which is in positive proportion to the application speed At present, there are nearly 70 class 1 new drugs in three phases that have not been terminated, and about 2 times and 8 times in two phases and one phase respectively If the clinical success rate is calculated by about 10% (ideal point) within 6 years from the clinical launch, the number of approved new drugs of category 1 in the future will keep a steady growth This year, China has approved more than 3500 chemical and biological drugs (including different specifications, dosage forms and the same varieties of different manufacturers) The proportion of biological drugs is only 4%, and the proportion of imported drugs is 19% However, nearly 60% of biological drugs are imported, and about 80% of the new molecular entities approved in China are imported drugs Looking back on the past years, although the number of CFDA approvals is different, the overall trend is different It's the same The following table shows the application and acceptance of class 1 chemical drugs and therapeutic biological products in China in the past five years It can be seen that the research and development of chemical drugs has become stable Although the research and development of therapeutic biological drugs started late, it has developed rapidly in the past two years In 2018, seven varieties have been applied for production So it seems that at present, China's drug research and development is still dominated by chemical generic drugs and improved new drugs Although the domestic innovation strength is growing, especially in the field of bio medicine, it may take more efforts to catch up with the international level For the huge unmet demand for treatment, import and import is still a strategy The following table shows the application and acceptance of imported biological and chemical products for treatment in China in the past five years It can be seen that although there was a significant decline in 2016, the two years have tended to be stable, but the surprise is that the proportion of imported class 1 new drugs has increased significantly in the past two years This is closely related to China's clinical, review and approval policies and international standards In addition, the reduction of tariff gate card and the accelerated approval of urgently needed drugs have greatly accelerated the import of innovative drugs All of these make the patients in China have the hope to use the medicine and life-saving medicine as early as possible With the optimization of domestic policy environment, the increase of capital injected into the pharmaceutical industry and the return of high-tech talents, China's innovative drugs will have a huge potential space and future development impetus In the case of weak innovation foundation, to get rapid development, introduction has become a hot topic Nilapari, a star drug, was also introduced from tesaro to China for research and development In 2017, it applied for a class 1 new drug in China and was approved for clinical application It is also a class 1 new drug in China In the first half of recent years, tengshengbo pharmaceutical, which has just won 260 million US dollars, has also recently reached a number of cooperation to obtain the rights of multiple drugs in Greater China Among the 6 new drugs just approved this year, two are imported from abroad Apatinib, the leading product of Hengrui medicine, was the first product introduced from abroad and successfully listed in China The Morgan conference will come soon, and there will be a boom in M & A transactions It is estimated that there will be a large wave of transactions soon after this year At present, there is another way for the domestic innovative medicine team to grow, that is, foreign companies set up subsidiaries in China, such as losartan, which is used to treat anemia, which is produced by fabergen, which has set up a subsidiary in Beijing In addition, Xi'an Janssen, a subsidiary of Johnson, is the first pharmaceutical company to enter China since the reform and opening up Its famous abitron has just obtained the approval for the expansion of indications in China, providing more treatment options for prostate cancer patients in China Beida pharmaceutical, which is listed by Kemena, is also a joint venture of beta company in the United States In fact, there are many such companies in China China's two major cancer drugs, androtinib and apatinib, are developed in cooperation with advanchen laboratories, and this company has a joint venture in China, Nanjing Echeng pharmaceutical In recent years, such as mushrooming out of less well-known but innovative strength of the company, may be foreign companies to enter and create This shows that the improvement of China's innovation environment has not only attracted the return of high-tech talents, but also attracted foreign enterprises and foreign investment, significantly improving the level of new drug innovation in China With the improvement of living standards, people's demand for new drugs has increased from whether there is medicine to whether there is high-quality medicine available China's new drug research and development has entered a new stage, integrating local independent research and development, import, introduction, foreign investment and other forms The future trend is to work together to improve the level of new drugs, gradually realize the synchronous growth with the world, meet the needs, and pursue better and more accurate In this way, China's overall medical level will be significantly improved With the improvement of the medical insurance system, people can use medicine and medicine This article is a reflection of the author's work I'd like to talk about the R & D of innovative drugs with you I'm sorry for the lack of depth.