[chemical medicine list] top 100 of 2019 China chemical medicine R & D strength list was announced!

In recent years, the chemical drug market has been surging From the first round of medical insurance control in 2011, the growth rate of the pharmaceutical industry has been decreasing year by year; from the implementation of the 12th Five Year Plan, the market has been growing vigorously, to the gradual saturation of the coverage ratio of medical insurance; from the implementation of the encouragement documents of generic drugs, the market has recovered, to the introduction of the consistency evaluation policy, the drug quality war has been launched, and the market has fallen back again With the continuous promotion of reform, the malpractice of the pharmaceutical industry is gradually highlighted, focusing on sales rather than research and development China's market is occupied by a large number of APIs, generic drugs and generic drugs The lack of innovative drugs has attracted the attention of the industry From 2007 to 2017, less than 10 independently developed chemical and biological drugs were approved in China, and 46 new drugs were listed in the United States in 2017 alone However, after a series of national policies encouraged the development of new drugs in recent years, in 2018, China's pharmaceutical industry ushered in its first major harvest, with the approval of class 1 Chemical and biological drugs developed by seven local companies, which is a record year for the approval of nmpa new drugs According to the results of review and approval, the drug review and approval reform in 2015 was put on the agenda, and the comprehensive reform of follow-up drug review and approval was launched and entered into full promotion From the overview of chemical drug declaration since the reform, it can be seen that the number of declaration production and clinical acceptance number has declined rapidly in 2016 After that, the number of reported production has increased Especially in 2018, the number of chemical drug declaration production acceptance number has reached 1004, which is two times more than that in 2017 Looking at the acceptance of new drugs, the proportion of reported clinical cases is declining, while the reported productivity is rising slightly In 2018, there are 323 clinical new drugs, accounting for 62.7%; 49 new drug acceptance numbers, accounting for 4.9% In terms of approval, in recent years, the number of approved production acceptance numbers of chemical drugs is also increasing In 2018, the number of approved production acceptance numbers reached 584, an increase of 50.9% year on year Among them, the number of new drug approved production is in a temporary stable stage, and 31 new drug acceptance numbers were approved in 2018, a slight increase compared with 28 acceptance numbers in 2017 However, it is worth noting that there is a great breakthrough in the number of class 1 new drugs (excluding class 1.3 and 1.5) approved 11 acceptance numbers involve 6 class 1 chemicals approved for listing The speed of review and approval of innovative drugs has been accelerated, and the follow-up new drug market will continue to break out National policies help enterprises innovate Now, the drug administration has issued a series of documents to strengthen the communication between drug audit departments and enterprises, strengthen the protection of intellectual property rights, improve the R & D efficiency of innovative pharmaceutical enterprises, and better protect intellectual property rights; at the same time, reasonably optimize clinical examination and approval, accelerate the clinical progress of innovative drugs; accelerate the examination and approval of rare diseases, and successively define the protection period of rare disease medication data, the first batch of rare diseases catalogue, and accelerate the environment Supporting policies and documents for the listing of foreign drugs for rare diseases in China; supporting payment documents for innovative drugs were accelerated from the perspectives of zero tariff for anti-cancer drugs and medical insurance access negotiation; overseas data and drugs were accelerated to be accepted and listed in China, forcing domestic enterprises to compete internationally The R & D strength of enterprises has become an important factor to consider the ability of enterprises The chemical drug market with the most market share is the main battlefield of major pharmaceutical enterprises On June 21, "2019 China Pharmaceutical Health Industry Development Conference and the fourth China Pharmaceutical R & D Innovation Summit" (PDI Conference) opened in Chongqing International Convention and Exhibition Center (Nanping) At the conference, a series of lists of 2019 China's pharmaceutical R & D strength list were announced, including top 100 of 2019 China's pharmaceutical R & D strength list (hereinafter referred to as "chemical medicine list", attached at the end of the article) Chemical strength enterprises such as Zhengda Tianqing Pharmaceutical Group Co., Ltd., Jiangsu Hengrui Pharmaceutical Co., Ltd and Qilu Pharmaceutical Co., Ltd were honored on the list Top 10 enterprises in 2019 top 100 list of China's chemical R & D strength lead the frontier in terms of innovative drugs The battle of "King's glory" broke out in 2018 A total of 6 enterprises were approved to produce new chemical drugs of category 1, which is an industry innovation benchmark Three of them entered the list of chemical drugs by virtue of their innovative drugs and considerable R & D strength As the first class 1 new drug of the whole year, the "androtinib hydrochloride capsule" of Zhengda Tianqing is listed on the market, and it is included in the medical insurance as a domestic innovative drug, which marks that Zhengda Tianqing has made a significant breakthrough in the field of anti-tumor while retaining its leading position in the original liver disease; in 2019 chemical list, Zhengda Tianqing ranks first Jiangsu Hengrui's "pyrrolidine maleate tablet" was approved to be on the market in August 2018 through priority review and approval, providing a new treatment for patients with recurrent or metastatic breast cancer Up to now, Hengrui has invested about 556 million yuan in the R & D project of the product, which only takes 10 months from the submission of the listing application to the formal approval; Hengrui ranks second in the list of chemical drugs in 2019 The "danorevir sodium tablet" of Geli Pharmaceutical Co., Ltd was submitted for listing in January 2017, and was included in the priority review and approval list in February It was approved for listing in June 2018 It is the first domestic direct antiviral drug (DAA) for the treatment of hepatitis C, effectively reducing the strong side effects brought by previous interferon anti-virus treatment, especially bone marrow suppression, and aiming at the hidden nature of hepatitis C As a result, the cure rate was greatly improved Geli pharmaceutical ranked 52nd in the chemical medicine list Among the new generic big market competition and the "hundred schools of thought" generic drugs, the enterprises with outstanding performance in 2018 are Zhengda Tianqing, Yichang humanwell, Harbin Sanlian, Yangzijiang pharmaceutical, Shiyao Ouyi, Qilu pharmaceutical, Jiangsu Enhua, etc Among them, Harbin Sanlian has been approved three kinds of 3 generic drugs in the year, with the largest number; Yichang humanwell has 32 acceptance numbers of 3 kinds of chemical drugs, with the largest number In 2018, Harbin Sanlian approved the production of three types of drugs, namely, balanced salt rinse solution, olacetam sodium chloride injection and olacetam glucose injection In 2018, mirtazapine (15mg), the key product, was the first to pass the consistency evaluation in China In addition, it successfully obtained the supplementary application approval for olacetam injection packaged in polypropylene ampoules, which is the exclusive form of packaging materials in China At the same time, it was also approved by Identified as a national key new product Harbin Sanlian product line is gradually enriched, forming the advantage of product cluster Humanwell pharmaceutical adheres to R & D innovation and international expansion On the one hand, it accelerates the R & D projects of innovative drugs in the core areas, on the other hand, it promotes the development and listing of characteristic generic drugs around the product line, and constantly enriches the product pipeline Fentanyl series is the main leading product of Yichang humanwell According to relevant data statistics, in 2017, the fentanyl preparation of humanwell pharmaceutical was the largest drug in the market, with a market share of more than 95% in the public hospital terminal fentanyl in the city and an absolute advantage In 2018, the total sales volume of fentanyl series products was 85.83 million; in addition, in 2018, the application for production of alfentanil hydrochloride API and its injection was accepted in January, and the product family gained again The "consistency evaluation" knockout competition is booming Since the opinions of the general office of the State Council on the consistency evaluation of quality and efficacy of generic drugs issued by the general office of the State Council, the consistency evaluation "knockout competition" has started In April 2018, the State Council issued the opinions on reforming and improving the supply guarantee and use policy of generic drugs, which clearly proposed to promote the alternative use of generic drugs The generic drugs that are consistent with the quality and efficacy of the original research drugs shall be included in the list of substitutable drugs with the original research drugs Local governments are also supporting drugs that promote research and development of generic drugs and pass the consistency evaluation of generic drugs According to the statistics of drug registration and acceptance database, in the whole year of 2018, there were 604 acceptances of conformity assessment (calculated by supplementary application and acceptance number, the same below), with an increase rate of 738.89% compared with 72 in 2017; there were 85 approved supplements and approved production (excluding deemed), 17.4 times of the number of conformity assessment in 2017; in addition, there were 21 approved clinical trials in 2018 。 It is worth mentioning that in 2018, the consistency evaluation of Qilu and Fosun Pharmaceutical enterprises, which are at the forefront of the list of chemical drugs in terms of R & D strength, is remarkable In 2018, Qilu submitted a total of 49 consistency evaluations (including subsidiaries), and the number of applications for acceptance ranked first among all enterprises In addition, in 2018, Qilu pharmaceutical passed 2 varieties and 1 variety was approved for clinical use Among them, "terbinafine hydrochloride tablet", as the first oral antifungal drug that passed the consistency evaluation in China, is widely recognized in the world, because of its significant bactericidal and bacteriostatic effect, it is internationally recognized Known as the "gold standard" of antifungal, it is the first choice drug for the treatment of skin diseases caused by various fungi In 2018, Fosun (including its subsidiaries) received a considerable number of annual approvals, with a total of 6 evaluated varieties Among them, the "azithromycin capsule" of Suzhou Erye, a holding subsidiary, passed the consistency evaluation on September 25, 2018 The variety is a macrolide antibiotic, widely used as a first-line anti infection drug In 2017, the domestic sales volume of azithromycin capsule was about RMB The sales volume of Suzhou second leaf is about 1.64 million yuan, accounting for about 10% Throughout history, to achieve outstanding achievements, those who dare to innovate, those who dare to innovate, and those who are willing to innovate are the spiritual elements The R & D ability of enterprises is the source power of innovation, and also the guarantee of the healthy development of the pharmaceutical industry In the coming period, under the continuous promotion of top-level design and the driving force of the benchmarking effect of innovative enterprises, the domestic pharmaceutical industry will get considerable development Attachment: Top 100 of 2019 Sinochem R & D strength list statement: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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