CDE drug review weekly report (January 26, 2015 to February 1, 2015)

There are 34 drugs that enter the approval process in this week, including 24 chemicals, 3 traditional Chinese medicines, 3 biological products for treatment and 4 biological products for prevention The specific chemicals are as follows: For 24 chemicals, import re registration occupies 7 places, which is one product, enoxaparin sodium injection of Sanofi (China) Investment Co., Ltd., which is a kind of low molecular weight heparin There are four domestic enterprises that have approval documents for this product, but from the sales volume in 2013, only Sanofi and Zhejiang Hangzhou Jiuyuan Genetic Engineering Co., Ltd are selling The sales volume of Sanofi in China takes an absolute leading position Enoxaparin is also a major source of revenue for Sanofi in China We hope that the re registration will be successful this time The rest of the approved drugs are as follows: cefret for injection is the second generation cephalosporin, which was developed and marketed by Squibb in 1984 and then successively marketed in Belgium, Greece and South Korea of Squibb in Europe The product has a wide antibacterial spectrum, strong activity for most of Staphylococcus aureus, pneumococcus, Streptococcus viridis, and strong activity for Klebsiella pneumoniae and Salmonella It is mainly used for gram negative bacteria infection in clinic The treatment of venereal disease caused by Neisseria gonorrhoeae and Neisseria gonorrhoeae infection with cefrett is effective At present, there are three enterprises that have not been listed in China and applied for clinical application, among which Sichuan Antibiotic Industry Research Institute of China Pharmaceutical Group Corporation, which has entered the examination and approval stage in this period, has the fastest speed and is expected to become the first enterprise in China to obtain the clinical approval of this product In addition, the other two declaration enterprises are Henan Zhongshuai Pharmaceutical Technology Development Co., Ltd and Jinan Kanghe Pharmaceutical Technology Co., Ltd Prosaff injection is a CXCR4 chemokine receptor antagonist developed by jianzan company It was listed in the United States in 2008 This product, combined with granulocyte colony stimulating factor (G-CSF), mobilizes hematopoietic stem cells from bone marrow to peripheral blood circulation for collection and autotransplantation in patients with non Hodgkin lymphoma and multiple myeloma In July 2010, prosaff injection imported and declared by jianzan company obtained clinical approval in China In addition, there are four domestic enterprises applying for the clinical application of this product, among which all things (Beijing) Pharmaceutical Technology Co., Ltd obtained the written supplement in June 2014, and it is still in line for review, while Hunan wuzhoutong Pharmaceutical Co., Ltd is the third enterprise entering the stage of clinical application and approval Tameprotin tablets were first marketed in Japan by tokuang Co., Ltd in June 2005 and distributed by Nippon Pharmaceutical Co., Ltd for the treatment of relapsed refractory acute promyelocytic leukemia At present, the product has not been listed in the market There are 9 clinical applications in China, 6 of which have obtained clinical approval, and the first one is Jiangsu Hengrui Pharmaceutical Co., Ltd (October 2008) In addition, there are two not approved, and Chongqing Laimei Pharmaceutical Co., Ltd was informed of the supplement in 2012, and the supplement materials entered the approval stage Entrepidenol tablet is a tripartite preparation containing the nucleoside reverse transcriptase inhibitors entrepidine and tenofovir, as well as the non nucleoside reverse transcriptase inhibitors ribavirin This product is developed by Gillette and is used to treat HIV infected patients At present, there is only one application in China Brinzolam timolol eye drops is a compound preparation developed by Alcon to reduce intraocular pressure It was listed in the European Union in 2008 under the trade name of azarga At present, this product is not listed in China, only one import enterprise applies for it Silibiril tartrate is a benzamide derivative developed by almirall pharmaceutical factory in Spain It was approved to be marketed in Spain in April 1990 It is suitable for gastrointestinal discomfort caused by slow gastric motility Kunshan Longdeng Pharmaceutical Co., Ltd applied for this product in 2000, but it has not been listed At present, only one import has applied for production in China For GlaxoSmithKline's dotiravir sodium tablets, no specific information has been found It is speculated that it is an antiviral drug If anyone in the industry knows it, you can tell Xiaobian backstage Thank you very much! 2 the number of drugs approved this week is less, only 22, including 8 chemicals, 2 traditional Chinese medicine, 3 biological products for prevention, and 9 in vitro diagnostic reagents OK, let's look at these 8 approved chemicals: According to the acceptance number of simvastatin tablets of Shandong Disha Pharmaceutical Co., Ltd of Disha Pharmaceutical Group, it is judged that the drug declaration has completed the bioequivalence test, and the conclusion of this approval is not approved At present, there are more than 70 domestic enterprises with single specification listing simvastatin tablets There are too many listed companies The cefprozil dry suspension of Heilongjiang Zhaodong Huafu Pharmaceutical Co., Ltd is also the drug declaration that has completed the bioequivalence test For the dry suspension dosage form of cefprozil, there are three domestic enterprises listed, and Zhaodong Huafu Pharmaceutical Co., Ltd is expected to become the fourth Istaroxime has been introduced before, but it's not much here 3 There are so many drugs after the completion of the preparation of the certificate this week that the editor has to wonder whether the people of the National Bureau are busy with the preparation of the certificate this week and forget to approve it Most of the 82 drugs that have been certified this week are chemical drugs, 62 in total, while there are 7 traditional Chinese medicine, 6 biological products for treatment and 6 biological products for prevention, and 1 pharmaceutical excipient The specific information of chemical drugs is as follows: among the 62 chemical drugs, one of the imported re registered varieties has been certified, namely maruishi Sevoflurane of pharmaceutical) and six imported drugs have also been certified, involving four varieties, namely sofosbuvir tablets of JINGDING pharmaceutical research and development (Shanghai) Co., Ltd., paritide for injection of Novartis, compound safannamin syrup of Lexin Pharmaceutical Co., Ltd and budesonide enteric coated capsules of Shenzhen kangzhe Pharmaceutical Co., Ltd Azithromycin for injection has been listed with the same product name in China, but Changchun Haiyue Pharmaceutical Co., Ltd has declared a class 2 product, which was also declared in 2014, so it is speculated that it should not be used with the already listed injection, maybe for a long time In addition, the enterprise also declared azithromycin for injection 1.6 and azithromycin for injection 6, which feels that azithromycin has been listed by other companies The game is broken Chongqing shenghuaxi Pharmaceutical Co., Ltd has applied for class 3 + 6 of iprisartan mesylate raw material + preparation, and the bioequivalence test has been approved after this certification The raw materials and preparations of Sichuan HISCO Pharmaceutical Co., Ltd are also declared as 3 + 6 categories After various checks before the batch production, they are now under preparation Sichuan hisic's flupentixomil tablets are the third approved to be listed in China The first one is imported from Lingbei, and the second one is copied from Hainan Yier Pharmaceutical Co., Ltd for listing At the end of December last year, hisic issued the approval document, which was only more than one month late According to the CFDA data, Hainan Yier's tablet production line has expired and has not yet passed the new version, while hisic's tablet production line has passed the new version of GMP, so it is uncertain who will become the first domestic imitation enterprise to sell the drug Let's guess boldly, hisic is very good at it May become the first imitation The raw materials and tablets of lafutidine of Yichang Changjiang Pharmaceutical Co., Ltd have been applied for production in category 3.1, and are almost approved at present However, this product has already been listed in 6 domestic markets, and capsule has also been listed In addition, the application for 6 categories of xanthone piperate hydrochloride tablets of Disha Pharmaceutical Group Co., Ltd has been completed clinically At present, the preparation of the certificate has been completed, and the tablets have also been produced in batches.