China's new drug R & D has entered the fast lane of development, and Xuanning, an innovative high blood pressure drug, has entered the U.S. market

[pharmaceutical network industry trends] on December 20, the innovative antihypertensive drug L-amlodipine maleate (listed in China: Xuanning), independently developed by Shiyao group, was reviewed and approved by the U.S Food and drug administration as a new compound This means that Chinese innovative drugs have entered the US market It is understood that high blood pressure is a major cause of heart disease and stroke Relevant statistics show that there are about 1 billion adults with hypertension in the world, and 245 million in China Over the years, imported antihypertensive drugs have occupied a large market share in China, and the high price of drugs has made patients miserable Xuanning was listed in China in 2003 Its efficacy is better than that of imported drugs The dosage is half of that of imported drugs, and the price of single drug is less than one third of that of imported drugs, which greatly reduces the burden of patients For the significance of Xuanning's approval for listing in the United States, the head of the group said that the sales of Xuanning in the United States will directly promote the market expansion of the drug in other regions of the world However, the market return is only one aspect The person in charge said that for the enterprise itself, from the export of APIs to the export of generic drugs to the approval of innovative drugs in the United States for listing, petrochemicals has realized the transformation from a "follow-up" to an international giant, and will stand on the world pharmaceutical industry stage with a new attitude At the same time, Xuanning's listing in the United States also represents the international recognition of China's new drug R & D level It is understood that with the continuous increase of national R & D efforts for new drugs, China has also made rapid development in innovative drugs, while the country is also constantly accelerating the transformation from a big country of generic drugs to a big country of innovative drugs The industry said that in recent years, China's pharmaceutical innovation capacity has been rapidly improved, the industry scale has been expanding, and the industry environment has been continuously improved In addition, some industry personages said that China's drug regulatory reform has entered a new stage of accelerating the implementation The review center will take the opportunity of implementing the new drug management law, issue and improve relevant implementation rules as soon as possible to help the development of new drugs The late train of new drug research and development in China has entered the fast lane and has a bright future At the same time, the value of an innovative drug should be reflected on the international stage and recognized by the international market Only by going out and learning to swim in the international market can Chinese pharmaceutical enterprises not drown in the face of greater competition This is also a key step for China's pharmaceutical enterprises to achieve high-quality development and a new look on the international stage Xuanning's going abroad is the result of the country's strong support for drug innovation According to reports, Xuanning related research has been listed in the national "12th Five Year" major new drug science and technology project, with a sample size of more than 10000 cases, covering 21 cities across the country Safe and effective clinical data is the key to obtain full approval from the United States Innovation has become the common choice of domestic leading pharmaceutical companies, and we believe that in the future, there will be more Chinese innovative drugs going abroad However, some experts also pointed out that new drug development is an interconnected ecosystem In the process of China's transformation from a big country of generic drugs to a powerful country of innovative drugs, there are still four short boards that need to be supplemented urgently First, basic research Both universities, scientific research institutions and new drug development enterprises should attach great importance to basic research, increase investment and deepen cooperation with greater efforts and an open mind, and strive to make breakthroughs in new discoveries, new targets and new technologies Second, clinical research For a long time, China has been dominated by generic drugs, and the clinical research of new drug development is still relatively weak Although in recent years, relevant departments and major hospitals have accelerated the construction of clinical research centers, but the quantity and quality need to be improved Third, low-level repetitive R & D Although the innovation speed of China's biomedical industry has accelerated significantly in recent years, the quality of innovation is not high, and the low-level duplication of "cluster innovation" is particularly prominent In this regard, no matter the national management department or the investors, the person in charge of the enterprise, all need to attach great importance to it Fourth, regulatory policies In order to make a breakthrough in new drug research and development in the next decade, fair, just, fast and effective administrative supervision is indispensable The continuity, scientificity, compliance and internationalization of policies are crucial.