Insight: CDE drug review report in October 2015

Source: Ding Xiangyuan's focus from November to March, 2015 In October, the number of drug applications dropped to the lowest level in 2015 Sihuan medicine again applied for class 1.1 new drugs Ruiyang and Sichuan Baili simultaneously rushed to imitate the orphan drug nafularphine Sanofi to submit the application for listing of osteoarthritis and stem cell zoology drugs 9 Three new drugs of class 1.1 have been approved clinically, most of which are antineoplastic drugs Class 3.1 new drugs approved clinically account for 67.96% According to the latest statistics of Insight China Pharma data database of DXY, in October 2015, CDE undertook 548 new drug registration applications Number (calculated by acceptance number, the same below) The number of applications in October was 14.9% lower than that in September, the lowest peak in 2015 Although the number of applications in October fell to the lowest in the whole year, due to the centralized review, the highest number of completed reviews in the whole year was ushered in, as shown in the figure below: the following is to analyze the application acceptance and review and approval of chemical drugs, traditional Chinese medicine and biological products in October 1、 The number of new chemical registration applications undertaken by CDE in October was 475, down 15% from September The specific data of each application type are as follows: 1 New drug 1.1 new drug 4 ring medicine re application 1.1 new drug according to insight database statistics, in October, CDE undertook 17 chemical drug 1.1 new drug applications with acceptance number, involving 8 varieties, all of which are clinical applications The specific data are as follows: the indications and targets of eoc315 and its tablets declared by Yiteng pharmaceutical are temporarily unknown Yiteng focuses on new drug research and development with external cooperation There are seven drugs on its R & D line, but eoc315 is not listed So far, Yiteng has applied for 2 new drugs of class 1.1 Guangxi huibaoyuan medicine has declared its first new drug, troxacitabine, which has antitumor activity and can be used in hematological malignancies and solid tumors Trasatabine was first developed by shire pharmaceutical and exclusively licensed to SGX pharmaceutical, but clinical trials for acute myeloid leukemia (AML) were terminated due to insufficient evidence of treatment Shandong xuanzhu under Sihuan Pharmaceutical Group has applied for the 9th new drug of category 1.1, sirotinib maleate, a new generation irreversible pan her receptor inhibitor, which is used to treat esophageal cancer, gastric cancer, lung cancer and other advanced cancers Taijing pharmaceutical R & D (Beijing) Co., Ltd., which is controlled by Taijing pharmaceutical R & D Co., Ltd., has applied for the second new drug of category 1.1, vorarevir, which is used to treat chronic hepatitis C and has activity for six hepatitis C genotypes Xiajiang Hemei Pharmaceutical Co., Ltd is a pharmaceutical industrialization company initiated by Tianjin Hemei Biotechnology Co., Ltd and focuses on the industrialization demand of class 1 new drugs of Tianjin Hemei Hemay007 declared this time is its second class 1.1 new drug, which is TNF - α inhibitor, used to treat inflammatory bowel disease, rheumatoid arthritis and other autoimmune diseases At present, there are 21 candidate R & D drugs in Tianjin Hemei biology, including anti-tumor, anti-inflammatory, cardio cerebral vascular, central and other fields, which are well-established There are seven class 1 new drugs on the R & D line of Beijing keleb, but the indications of the class 1.1 new drug sar107375e applied for this time are unknown temporarily Beijing Kelaibo, formerly known as the National Research Center for new drug development and engineering technology, was transformed into a joint-stock enterprise in 2002 Tq-b3101 and capsule declared by Zhengda Tianqing have been the fourth new drug of category 1.1 declared by Zhengda Tianqing in 2015, and the indications are unknown temporarily In addition, lanthanum polystyrene sulfonate, a new drug of class 1.1 declared by penglainuokang Pharmaceutical Co., Ltd., was used for hyperphosphatemia of chronic renal failure It was first applied for clinical application in 2010 and was specially reviewed, but it was not approved In October 2015, the drug was applied for clinical application for the second time, but the label of special review was missing 3.1 new drugs Ruiyang and Sichuan Baili simultaneously rushed to imitate the orphan drug nafularfine In October, CDE undertook 121 applications for new chemicals 3.1 new drugs with the acceptance number, which was slightly lower than that in September Among them, there are 117 clinical applications, involving 51 varieties; 4 listing applications, involving 3 varieties According to the potential variety screening system of insight database, four new drugs of category 3.1 are screened, which may become the first imitations in China in the future The specific data are as follows: nalfurafine is used for the treatment of pruritus The original research enterprise is Toray Co., Ltd., which has been listed in Japan and is recognized as orphan drug in Europe The original research drug has not been declared in China Ruiyang Pharmaceutical Co., Ltd and Sichuan Baili Pharmaceutical Co., Ltd scrambled to imitate naforapine in October, among which Sichuan Baili only applied for API Jiangsu aosaikang first imitated two drugs in October, one was the injection of severe fungal infection drug savuconazole developed by anstelai and Basilea Pharmaceutical Co., Ltd., the other was the raw material drug r-alpha-lipoic acid trimethyline salt and its two kinds of injection Ceftaroline was developed by Takeda Pharmaceutical Co., Ltd AstraZeneca obtained the license except for the United States, Canada and Japan It was declared in China in August 2010 and has not yet applied for listing Shandong chengchuang Pharmaceutical Co., Ltd is the first one to rush to copy the drug and declare the name of the drug as cefuroxime dipivoxil 2 In October, CDE undertook 150 new applications for chemical and generic drugs with acceptance number, involving 86 varieties, and the number of applications was stable 3 In October, CDE undertook 37 new applications for drug import registration, including 27 clinical applications and 10 listing applications, involving 23 varieties Among them, the data of imported chemical drugs declared for the first time in China are as follows: chemical approval: 9 new drugs of category 1.1 have been approved clinically, and most of them are anti-tumor drugs According to the statistics of insight database, 9 new drugs of category 1.1 have been approved clinically, involving 21 treatment numbers According to the time limit for clinical review approved in October, furetinib succinate, which belongs to a major special project, only took 7 months to obtain the clinical approval document, while other acceptances were reviewed for at least 1 year The specific data are as follows: 67.96% of class 3.1 new drugs are approved clinically According to insight database statistics, in October, there were 552 class 3.1 new drugs approved by CDE with acceptance number, including 487 clinical applications Class 3.1 new drugs that have completed the review are not "shot" as most of them are supposed to be in the industry According to insight statistics, of the 3.1 new drug clinical applications reviewed, 331 are approved clinical acceptance numbers, accounting for 67.96%, 11 are not approved acceptance numbers, accounting for only 2.25%, and the remaining 29.97% are acceptance numbers The approval conclusion is temporarily unknown, but they are in the approval or completion status 2、 In October, CDE undertook 24 new applications for traditional Chinese medicine with acceptance number, including 5 new drug applications, 17 supplementary applications, 1 re registration for import and 1 re examination 3、 In October, CDE applied for 36 new applications of biological products with acceptance number The specific application is as follows: in the import application, only ADO trastuzumab emtansine (kadcyla) of Roche Applied for clinical application in China for the first time with acceptance number of JXSL1500059 、 JXSL1500060 。
ADO trastuzumab emtansine is a new generation of antibody drug conjugate (ADC) It was approved by FDA in February 2013 for HER2 positive advanced (metastatic) breast cancer.