The priority is to review 56 "new drug listing" applications, 15 of which have been approved. Which one do you like best?

Highlights recently, the drug review center of the State Food and Drug Administration (CDE) released the announcement of drug registration applications to be included in the priority review process (the 26th batch) Up to now, a total of 411 acceptance numbers are to be included in the priority review process, of which 361 have been officially included Among the acceptance numbers that have been included in the priority review, 97 acceptance numbers (involving 56 products) apply for "new drug listing", including Hengrui, Novartis, Bayer, Xi'an Janssen, etc., and 26 acceptance numbers (involving 15 products) have been approved for listing Which one do you like best?   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> which kind of CDE" prefer "to apply for" new drug market "products? Since January 29, 2016, CDE has released a list of 26 batches of products to be included in the priority review process, involving 411 acceptance numbers According to the statistics of MEE Review Database, up to now, 361 acceptance numbers out of 411 acceptance numbers have been officially included in the priority review process through publicity, and obtained the qualification of accelerated review, with a pass rate of 88% Among 361 acceptance numbers that have passed the priority review, 97 (involving 56 products) apply for "new drug listing", including Hengrui, Novartis, Bayer, Xi'an YANGSEN, Zhengda Tianqing, etc Table 1: sources of products included in the priority review procedure as "new drug listing": meddrug review databases on CDE website and minenet Figure 1: treatment categories of 56 products applying for "new drug listing" From the perspective of treatment category, the products selected cover multiple categories, among which anti-tumor and immunomodulator occupy the first place with a proportion of 31%, blood and hematopoietic system drugs with a proportion of 15%, followed by systemic anti infective drugs, digestive system and metabolic drugs with a proportion of 11% These four types of drugs account for nearly 60% of all treatment categories At the 14th National Radiation Oncology academic conference of the Chinese Medical Association held in November 2017, Hao Jie, director of the National Cancer Center, pointed out that tumor is the main cause of death for Chinese residents, whether in urban or rural areas, and with the growth of people's age, the cancer incidence and mortality will gradually increase The current situation of cancer treatment in China is poor therapeutic effect, high recurrence rate, poor accuracy and large side effects Strengthening the research and development of new anti-tumor drugs has been included in the 13th five year development plan It is believed that under the priority review procedure, in the near future, there will be many new anti-tumor drugs coming into the market for the benefit of patients Figure 2: reasons why 56 products applying for "new drug listing" are selected for priority review On February 26, 2016, the State Food and Drug Administration (CFDA) issued the opinions on solving the backlog of drug registration applications and implementing the priority review and approval (sfjhg [2016] No 19) (hereinafter referred to as the opinions) The opinions are applicable to the application of drugs in three categories and 17 situations, including drugs with obvious clinical value, prevention and control of major diseases and obvious clinical advantages Enter the priority review and approval procedure According to the reasons why 56 products applying for "new drugs on the market" are selected for priority review, the main reasons are "obvious treatment advantages compared with existing treatment methods", accounting for 64% of the total, "children's drugs" with 16% of the total, followed by "hepatitis C treatment drugs", "rare diseases" with 5% of the total It can be seen that CDE has obvious clinical advantages in selecting priority evaluation products, as well as hepatitis C, children's drugs, rare diseases and other products that are relatively lacking in clinical practice, which also provides a certain direction for drug companies to develop new drugs none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> 56 products applying for" new drug marketing ", 15 products approved for marketing Table 2: 15 product data sources approved for marketing: meddrug Review Database of minenet Alprazole sodium for injection is an exclusive product independently developed by Lizhu group, which is the only innovative drug in the field of digestion in China The indication is peptic ulcer bleeding It has the advantages of long time of acid inhibition, small individual difference and less drug interaction According to the data of MI nei.com, in 2016, the sales volume of terminal peptic ulcer drugs in public medical institutions in China was 37.75 billion yuan, an increase of 8.44% over the previous year It is expected that Yilian ® will become a billion pound product of Lizhu group after being listed Etrapa tablet is the only approved small molecule, non peptide tpo-r agonist for the treatment of primary immune thrombocytopenia (ITP), which is helpful to improve the platelet count level, reduce bleeding events, reduce concomitant medication, and improve the compliance of patients with medication Voltacetin hydrobromide tablet is a new multi-mode antidepressant It acts on six pharmacological targets through two different modes of action, so as to play an antidepressant effect According to the data of minenet, in 2016, the sales volume of terminal antidepressants of public medical institutions in China was 5.77 billion yuan, an increase of 4.7% over the previous year It is believed that the listing of xindayue ® will quickly carve up the more than 5 billion antidepressant markets Recombinant Ebola virus vaccine (adenovirus vector) is an innovative recombinant vaccine product independently researched and developed in China with full independent intellectual property rights, which can be used to prevent Ebola disease Dexamethasone intravitreal implant is the first treatment drug for retinal vein occlusion (RVO) in China It is used to treat macular edema caused by branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO) in adult patients Sakubatrevalsartan sodium tablet is the first drug of renin receptor enkephalinase inhibitor (Arni) in China It plays a role in the treatment of heart failure by inhibiting renin-angiotensin-aldosterone system and enhancing natriuretic peptide system According to the data of minenet, in 2016, the sales volume of drugs used by public medical institutions to act on Angiotension in China was 19.2 billion yuan, an increase of 11.4% over the previous year Ibotinib capsule is the first Btk inhibitor (a relatively safe B-cell-related tumor treatment target) on the market in the world It belongs to the first generation of BTK inhibitors and is mainly used in the treatment of blood tumors According to the data of minenet, in 2016, the sales volume of terminal anti-tumor drugs in public medical institutions in China was 57.3 billion, an increase of 11.5% over the previous year The IPO of Yike ® may bring the performance of Xi'an Janssen to a higher level Duotiabalami tablet is a new generation of integrase inhibitor for HIV It is the first single and compound preparation with complete treatment scheme in the field of HIV treatment in China According to the data of minenet, in 2016, the sales volume of terminal antiviral drugs in public medical institutions in China was 16 billion yuan, an increase of 8.45% over the previous year There are not many drugs for treating HIV in antiviral drugs, and the listing of suimeikai ® will bring good news to HIV patients none="shifuMouseDown('shifu_t_002')" style="margin: 1em auto; padding: 0.5em 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border: none; text-align: center; width: 670px; box-sizing: border-box !im portant; word-wrap: break-word Im portant; "> conclusion New drug research and development is a long-lasting battle, with high investment and high return In order to encourage pharmaceutical enterprises to increase new drug research and development efforts and provide more choices for patients, the state has issued various favorable policies In 2017, a large number of imported and domestic new drugs were approved and listed quickly with priority review, benefiting patients; in 2018, there may be more innovative drugs to be listed, which one do you most expect? Welcome to add "2018 innovative medicine list in your mind" in the message area!