In July, the application for drug registration dropped, and there were signs of Clustering Application for three varieties of imitated application

Abstract in July, the application for registration of new registered drugs dropped Chenxin pharmaceutical industry's first new type 1 diabetes drug entered CDE for technical review In July, five new class 1 drugs were approved for clinical use, and Novartis' sacubatrovalsartan sodium tablets were approved for import   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; 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; "> in July, the number of new drug registration applications dropped compared with that of last month According to the statistics of meddrug Review Database on the intranet, 434 new drug registration applications of CDE in July, down compared with that of last month, including 49 acceptance numbers of applications in the previous market and 99 acceptance numbers of clinical applications In terms of application types, both new drug application and import application increased in July, among which import application increased greatly, while copy application decreased     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; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box sizing: border box! Im assistant; word wrap: break word! Im assistant; "> application for new drugs in China: Chenxin pharmaceutical industry's first new type 1 diabetes drug entered the CDE drug review database of midnet Med In July 2017, there were 67 new drug applications, all of which were clinical applications, including 53 applications for new type 1 drugs, involving 25 varieties Nanjing Shenghe Pharmaceutical Co., Ltd and Zhengda Tianqing both applied for the second class 1 new drug of this year, namely, sh-1028 API and its tablet, and tq05510 capsule However, no specific information of these two varieties has been retrieved at present The following is a brief introduction of some new class 1 new drugs in July - syngliptin: syngliptin (R & D Code: dc291407), which was discovered by Shanghai Institute of medicine, Chinese Academy of Sciences, was researched and developed by Chenxin pharmaceutical industry for diabetes treatment It is understood that the drug is the first new type 1 drug of Chenxin pharmaceutical in the field of diabetes, and also the third new type 1 drug declared this year (the previous two new type 1 drugs are wx-081 raw materials and tablets, wxfl10030390 raw materials and tablets) Gb251 for injection: it is independently developed by Jiahe biology, a subsidiary of Watson biological holding company Jiahe biology has core independent intellectual property rights The drug is developed for HER2-positive metastatic breast cancer patients who have previously received trastuzumab single drug treatment or / or combined treatment with Taxus Clonidine: this drug is the first class 1 new drug independently declared and owned independent intellectual property rights by Jiangsu Mindu drug research and Development Co., Ltd clonidine has the same target as that of oxitinib approved by CFDA within the year It is developed for the treatment of brain metastatic non-small cell lung cancer Previously, sutitinib maleate, a class 1 new drug jointly developed by Jiangsu Mindu and Jiangsu Suzhong Pharmaceutical Group, is currently undergoing clinical trials     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; border-style: none none solid; text-align: center; border-bottom-width: 1px; Border bottom color: rgb (0, 0, 0); box side: border box! 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Im portant; "> domestic imitation declaration: there are three varieties with cluster declaration signs In July, 42 domestic imitation applications were added, involving 30 varieties, all of which are chemical drugs, mainly including 3 and 4 types of applications 9 varieties of ceftriaxone sodium for injection / sodium chloride injection, donepezil hydrochloride monohydrate API, parecoxib sodium API, procapride succinate API, alisentan API, amino acid (15) peritoneal dialysate, tadalafil API, therapeutic iodine [131I] sodium capsule have no relevant production approval in China Trimetazidine Dihydrochloride Modified Release Tablets, Vildagliptin Tablets, Saxagliptin Tablets, gefitinib raw material, compound polymyxin B ointment, Oxaliplatin Injection, Prucalopride Succinate Tablets, Moxifloxacin Hydrochloride Tablets, aspirin, reritrexed, and its raw materials for injection, inhalation 17 varieties, such as acyl cysteine solution, L-carnitine drug substance, iodine [131I] sodium capsule for treatment and sodium acetate ringer injection, are exclusive in China It is worth noting that among the varieties that were declared to be imitated in July, there are more than 20 applications for the review of raw materials of parecoxib sodium, ornithine Aspartate Injection and Lansoprazole for injection, and there are also signs of declaration 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; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); Box sizing: border box! 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Im portant; "> Import Declaration: 8 varieties are declared in China for the first time In July, CDE added 39 new import applications, involving 27 varieties, of which 8 varieties are declared for the first time Ro7034067 powder for oral solution (formerly R & D Code: rg7916) was applied by Roche for the treatment of spinal muscular atrophy At present, the product is in phase II clinical trials in the United States Temozomab for injection was developed by Idec company of the United States It was first marketed in the United States in 2002 Its trade name is Ze Valin ® It is used to treat recurrent or refractory low-grade, follicular and metastatic B-cell non-Hodgkin's lymphoma, including the follicular non-Hodgkin's lymphoma with poor efficacy treated by rituximab       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; 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; "> approval status: 5 new drugs of class 1 were approved for clinical use, and Novartis sarkuba and valsartan sodium were approved for import According to the meddrug review database of the intranet, 5 new drugs of class 1 were approved for clinical use in July, and Novartis sarkuba and valsartan sodium tablets were approved for import