August CDE: the new anticancer drug niraparib was applied for clinical application, and ibotinib capsule was approved for import

Abstract: pyrrolidine maleate of abstract Hengrui medicine is declared to be on the market; gb223 injection and gb235 injection of Jiahe bio start technical review of entering CDE; niraparib capsule (nilapanib) clinical application is approved for entering CDE; application for import of ibrotinib capsule: new registration application tends to be stable According to the statistics of MED drug evaluation database of minenet, 484 new drug registration applications of CDE were added in August, up from last month, including 48 acceptance numbers of listing applications and 83 acceptance numbers of clinical applications From January to August, the new drug registration applications of CDE (calculated by acceptance number) in terms of application types, all application types decreased to varying degrees in August, among which the copy application has declined for the second consecutive month From January to August 2017, application for registration of new drugs of all application types (only new drugs, imitation and import applications) domestic new drug application: two new drugs of category 1 are applied for listing according to the midnet Med drug review database In August 2017, 61 new drug applications were applied, 40 of which belong to category 1 new drugs, involving 23 varieties Pyrrolidine maleate of Hengrui medicine and ninofloxacin malate and sodium chloride injection jointly declared by Zhejiang medicine and Taijing medicine were listed Kelun pharmaceutical declared the fourth class 1 new drug a166 for injection this year Fosun Pharmaceutical, Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences and Jiahe bio have two new class 1 drugs entering CDE Here is a brief introduction of some new class 1 drugs in August Pyrrolidine maleate: independently developed by Hengrui medicine, it can be used in breast cancer, gastric cancer and non-small cell lung cancer The drug was submitted for clinical application in 2011 and approved for clinical application in 2015 According to the Chinese drug clinical trial publicity database of minenet, there are still many clinical trials in progress Nanofloxacin malate and sodium chloride injection: the drug is a new fluoroquinolone free drug, which is used in adult community-acquired pneumonia The drug was previously applied by Huayu (Wuxi) Pharmaceutical Co., Ltd and Taijing pharmaceutical R & D (Beijing) Co., Ltd in 2006 and approved in 2008 A166 for injection: it is the first third generation of anti HER2 ADC in the world to be used in the treatment of HER2 positive breast cancer, gastric cancer and other malignant tumors through the site-specific quantitative coupling of lysine, with innovative linker and high activity toxin small molecule, according to the announcement of colan Fn-1501: the drug is applied by Shanghai fuxingtai Pharmaceutical Technology Co., Ltd., a subsidiary of Fosun Pharmaceutical Holding Co., Ltd It is understood that the new drug is an innovative small molecule chemical drug introduced from outside by Fosun Pharmaceutical and independently developed by Fosun Pharmaceutical, which is mainly used for leukemia treatment At present, there is no drug with independent intellectual property rights and the same target of the new drug in China (excluding Hong Kong, Macao and Taiwan) In addition, a new class 1 drug fcn-437c entered CDE in Fosun medicine this month, which is mainly used for anti-tumor treatment Gb223 for injection and gb235 for injection: both of them are declared by Jiahe biology, a subsidiary of Watson biological holding company Jiahe biology owns core independent intellectual property rights In April this year, gb223 injection submitted clinical applications to Shanghai food and Drug Administration for two different indications, the main indications of which include: osteoporosis in postmenopausal women with high risk of fracture; bone related events in patients with solid tumor bone metastasis, giant osteocytoma, high blood calcium in patients with malignant tumor, etc In March, gb235 for injection submitted a clinical application to Shanghai food and drug administration Indications include: treatment of HER2 positive metastatic breast cancer that has not received anti HER2 treatment or chemotherapy before At present, there is no similar drug production of the two drugs in domestic enterprises, and the two drugs also entered CDE in August for technical review Domestic imitation application: in August, 33 new domestic imitation applications involving 25 varieties were added, with 3 and 4 types of applications as the main ones At present, there are no relevant production approval documents in China for seven varieties of compound amino acid (15aa-i) / glucose electrolyte injection, amino acid (16) / glucose (48%) electrolyte injection, azilsartan tablets, L-malic acid, compound electrolyte injection (III), sitagliptin phosphate and levetiracetam injection Cigliptin phosphate tablets (Merck), calcitriol ointment (Goldmine), solinacin Succinate Tablets (Astaire), olanzapine orally disintegrating tablets (Lilly), sunitinib malate capsules (Pfizer), biotin (Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd.), azacytidine for injection (celgene), moxifloxacin hydrochloride sodium chloride injection (Bayer), shag There are 9 kinds of products, such as letin tablets (AstraZeneca), which are exclusive in China At present, there are more than 15 applications for pemetrexed disodium for injection, sodium hyaluronate eye drops and moxifloxacin hydrochloride sodium chloride injection Import declaration of domestic imitation declaration in August 2017: six varieties were declared in China for the first time, and niraparib entered CDE in August to apply for 37 new imports, involving 24 varieties, of which six varieties were declared for the first time Nirapanib capsule (nirapanib): developed jointly by zaidin and tesaro, nirapanib is an oral PARP inhibitor, which is mainly aimed at cancer with BRCA1 / 2 gene mutation and is developed for ovarian cancer and breast cancer It is understood that niraparib (trade name zejula) was approved by FDA in March this year Isatuximab injection (R & D Code: sar650984) is a human anti-CD38 monoclonal antibody, which can kill tumor cells through tumor targeting and immune system intervention, and is developed for the treatment of refractory multiple myeloma Previously, Yang Sen of Xi'an also declared a human anti-CD38 monoclonal antibody (daratumumab) for the treatment of multiple myeloma At present, the drug is in phase I clinical trials In August 2017, the first imported varieties were approved: Four Class 1 new drugs were approved for clinical use, and four class 1 new drugs were approved for import according to the statistics of midnet Med drug review database In August, four class 1 new drugs were approved for clinical use, and ibutini capsule (Yike ®) of Xi'an Janssen Pharmaceutical was approved for import Approved in August 2017