In the first half of the year, drug registration applications increased in general, and there was no domestic approval for 19 varieties of generic applications

Abstract in June, the application for registration of new drugs continued to pick up, and in the first half of the year, the overall trend was on the rise In June, three new drugs of category 1 entered CDE in dongyangguang Pharmaceutical Co., Ltd., and the first innovative narcotic drugs in Kelun Pharmaceutical Co., Ltd applied for clinical application 19 varieties of the imitated drugs did not have domestic approval, and 10 varieties were exclusive varieties There are signs of clustering in the imitated declaration of parecoxib sodium for injection and moxifloxacin hydrochloride Novartis has two new drugs of class 1 applied for clinical application Naprotinib xylenesulphonate of Shenzhen Haiwang pharmaceutical has been approved for clinical application 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 the first half of the year, drug registration applications showed an upward trend According to the statistics of MED drug review database on the intranet, there were 550 new drug registration applications for CDE in June In general, the number of new drug registration applications in the first half of 2017 showed an upward trend From the perspective of application types, new drug applications and generic applications continued to increase in June, among which generic applications increased significantly, while import applications were basically the same as last month     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; "> domestic new drug application: three class 1 new drugs of dongyangguang entered CDE, and the first clinical application of narcotic innovative drugs of Kelun pharmaceutical industry According to the meddrug evaluation database of midnet, 65 new drug applications were added in June 2017, including 38 applications of class 1 new drugs, involving 13 varieties After the completion of the clinical trial phase, furquitinib will be applied for production this month In June, Guangdong dongyangguang Pharmaceutical Co., Ltd had three class 1 new drugs entering CDE, namely, ritapiren API and its tablets, hec74647pa API and its tablets, hec68498 sodium salt and its tablets However, the specific information of these three varieties has not been retrieved at present In addition, kangdariwei sodium and hec30654acoh declared in March before, dongyangguang had five class 1 new drugs entering CDE in the first half of 2017 Here is a brief introduction of some new class 1 new drugs in June, furquitinib: a highly selective VEGFR long-acting inhibitor developed for the treatment of rectal cancer, non-small cell lung cancer and gastric cancer Hutchison Whampoa hospital owns the independent intellectual property rights of the drug At present, the clinical research on the indication of the drug for advanced non-small cell lung cancer is in progress Nb001: a class 1 innovative drug declared by Zhejiang Yongzhan Pharmaceutical Co., Ltd for the treatment of chronic pain Yongzhan Pharmaceutical Co., Ltd has core patents and independent intellectual property rights worldwide Zsp0391: the second class 1 new drug declared by Zhongsheng pharmaceutical in this year According to the announcement of Zhongsheng pharmaceutical, zsp0391 is the fourth small molecule class I innovative drug with independent intellectual property rights that Zhongsheng pharmaceutical has submitted clinical trial registration application since 2016 Zsp0391 API and tablet were jointly developed by Guangdong Zhongsheng Pharmaceutical Co., Ltd and Shanghai yaomingkant Co., Ltd., mainly for the treatment of non-small cell lung cancer patients with EGFR sensitive mutation and T790M resistant mutation Kl100137: independently developed by Kelun Pharmaceutical Co., Ltd., it is the first innovative drug of Kelun Pharmaceutical Co., Ltd in the field of anesthesia, and also the third class 1 new drug of Kelun Pharmaceutical Co., Ltd into CDE in the year after kl070002 and kl-a167 injection The results of non clinical studies show that kl100137 exerts anesthetic effect by activating GABAA receptor, and it has the characteristics of quick onset, rapid induction and stability, no accumulation after continuous infusion, rapid recovery, no obvious respiratory and cardiovascular inhibition, and over anesthesia can be reversed and rescued by flumazenil, which is superior to propofol and rimazazolam in efficacy and safety     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; "> domestic replication application: there are no domestic approvals for 19 varieties at present In June, 50 domestic replication applications were added According to the statistics of mid drug index database of midnet, there are 19 varieties in the copy application of CDE in June, and there is no production approval document of relevant domestic manufacturers at present In addition, 10 varieties, such as apixaban tablets, alisentan tablets, dasatinib APIs, flurbiprofen ester injection, gefitinib APIs, arginine glutamate APIs, moxifloxacin hydrochloride tablets, pramipexole hydrochloride tablets, parecoxib sodium for injection and paclitaxel for injection (albumin binding type), are currently exclusive in China It is worth mentioning that there are 48 on-the-spot acceptance numbers of parecoxib sodium for injection and moxifloxacin hydrochloride APIs, which show 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 side: border box! 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Im portant; "> Import Declaration: Novartis has two class 1 new drugs for clinical application In June, 28 new import applications were applied for CDE, involving 18 varieties, with more applications for class 5 In June, two class 1 new drugs were applied for clinical application by Novartis, namely cnp520 API and lik066 tablets It is reported that cnp520 is jointly developed by Novartis and Amgen for the treatment of Alzheimer's disease At present, it is in the third phase of clinical research abroad Lik066 tablet is a sglt-2 inhibitor, which is used to treat type 2 diabetes mellitus     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: four new drugs of class 1 were approved in June In June, four new drugs of class 1 were approved in clinic, namely, xy0206 APIs and tablets of Yiling Pharmaceutical Co., Ltd in Shijiazhuang, apg-1252 APIs and injections of Yasheng Pharmaceutical Co., Ltd in Suzhou, yy-20394 APIs and tablets of Yingli pharmaceutical Co., Ltd in Shanghai, and naprotini mesylate APIs and tablets of Haiwang Pharmaceutical Co., Ltd in Shenzhen