Hengrui 4 class 1 new drugs apply for clinical 10 exclusive varieties to apply for CDE

Abstract in May, the application for new drug registration picked up Hengrui pharmaceutical had 4 new drugs of class 1 applied for clinical application 10 of the generic drug applications are currently the exclusive varieties Qilu pharmaceutical and tenofovir dipivoxil fumarate of Fujian guangshengtang were approved for listing The application for new drug registration picked up in May According to the statistics of MED drug evaluation database of midnet, 419 new drug registration applications of CDE were applied in May, up from last month From January to may 2017, CDE applications for new drug registration (calculated by acceptance number) (data source: meddrug Review Database of minenet, if there is no explanation, the same below) from the perspective of application type, in May, the number of new drug applications and generic applications returned to the average level of the year, while import applications fell for the second consecutive month From January to may 2017, application for registration of new drugs of various application types (only for new drugs, imitation and import) and application for new drugs in China: Hengrui pharmaceutical is the first in China to enter the CDE for four class 1 new drugs According to the meddrug evaluation database of midnet, 57 new drug applications were applied in May 2017, including 39 applications for class 1 new drugs, involving 19 varieties After the clinical trial of recombinant Ebola virus vaccine is completed, it will be applied for production this month In this month, Hengrui medicine has four new drugs of class 1 entering CDE, namely shr-a1403 for injection, shr7280 and its tablets, shr9146 and its tablets, and shr0532 and its tablets Here is a brief introduction of some new class 1 new drugs added in May: shr-a1403 for injection is a humanized monoclonal antibody against c-met Hengrui medicine announced in January that the product has passed the approval of FDA and entered the clinical practice It is understood that there are no similar products with the same target on the market at home and abroad Shr7280 is a gonadotropin releasing hormone (GnRH) antagonist for the treatment of endometriosis Shr9146 is a kind of IDO inhibitor It is known that Ido is highly expressed in many tumor cells and antigen presenting cells It is an important small molecule regulatory target in tumor immunotherapy to play the role of immune regulation by regulating the level of tryptophan and metabolites Hengrui also announced in early May that shr9146 has been approved by the US FDA for clinical use Ro7049389 is a class 1 new drug declared by Roche R & D (China) Co., Ltd., which is an inhibitor of HBV capsid protein assembly, used for the treatment of hepatitis B Application of class 1 new drugs in China in May 2017 domestic replication application: 10 varieties are currently exclusive varieties; 28 domestic replication applications in May, up from last month According to the statistics of midnet mid drug index database, in the copy application of CDE in May, there is no relevant production approval document for viagliptin API in China In addition, montelukast sodium granules, viagliptin tablets, saggliptin API, cefazolin sodium pentahydrate API and its injection, butylphthalide sodium chloride injection, azacytidine for injection, linezolid tablets, moxifloxacin hydrochloride tablets At present, 10 varieties, such as tegrilol tablets and gefitinib APIs, are exclusive in China Domestic imitation declaration in May 2017 (approval statistics to May 31, 2017) import declaration: three new drugs of class 1 are applied for clinical application, 29 new CDE import applications in may involve 26 varieties, with more applications of class 5, among which three new drugs of class 1 are applied for clinical application, namely btki (gdc-0853) tablets (Roche), inc280 tablets (Novartis) and neladenson hydrochloride Biallanate film (Bayer) Data show that gdc-0853 is a new Btk inhibitor discovered by Genentech company, which is used for anti-tumor treatment Novartis declared that inc280 is a highly selective oral small molecule met inhibitor for anti-tumor treatment Neladenson bialanate hydrochloride tablet is a highly selective partial agonist of adenosine A1 receptor, which is developed for the treatment of chronic heart failure Approval of import declaration in May 2017: approved production of tenofovir dipivoxil Fumarate from two manufacturers According to the statistics of minenet, in May, two manufacturers of tenofovir fumarate dipivoxil were approved for production, namely, the raw material and tablets of tenofovir fumarate dipivoxil from Qilu pharmaceutical, and the capsule of tenofovir fumarate dipivoxil Fumarate from guangshengtang, Fujian Tenofovir is the latest generation of anti hepatitis B drugs in the world It has been recommended as the first-line drug for the treatment of chronic hepatitis B by the world's guidelines for the prevention and treatment of chronic hepatitis B Before that, tenofovir dipivoxil fumarate only had the approval of API and tablet in China, and there was no relevant approval for capsule, and the indication approved by Chengdu Beite, a domestic manufacturer, was anti HIV treatment The indication of tenofovir fumarate dipivoxil capsule approved by Fujian guangshengtang is hepatitis B infection, and Qilu pharmaceutical has become the third manufacturer in China to have the approval of raw material medicine and tablet after Chengdu Beite pharmaceutical and geelide, and the approved tenofovir fumarate dipivoxil tablet of Qilu pharmaceutical has no exact indication information It is worth noting that Chengdu Beite Pharmaceutical Co., Ltd also obtained the supplementary application approval document of tenofovir fumarate dipivoxil tablets this month Combined with the relevant application and clinical trial registration information before the application of tenofovir fumarate dipivoxil tablets of Chengdu Beite Pharmaceutical Co., Ltd., the supplementary application approval document may be to increase the indications of hepatitis B infection.