CDE Drug Evaluation Weekly Report (2015.8.16-2015.8.23)

I in the review of this week (August 16, 2015 to August 23, 2015), 41 drugs (calculated by acceptance number) entered the review status, and 35 chemicals, far less than last week, it seems that the policy impact is quite large Among the chemicals, 11 were classified as 3.1, 2 as 3.2, 21 as 6, and 1 as imported In addition, there are 1 Traditional Chinese medicine, 2 biological products for treatment and 3 biological products for prevention This week's 3.1 drugs are far less than last week's 3.1 drugs, which are not the first ones to be declared It seems that everyone's declaration heat of 3.1 drugs has slightly decreased, as for whether it is a short-term fluctuation or a long-term decrease, and wait for next week's data This week's six categories of drugs are almost the same as last week's, so it seems that generic drug applications are still the same as before 2 In this week's approval, three drugs are in the approval status, namely, the raw materials and injection of abecasin sulfate (cxhl1000204 and cxhl1000205) from Hainan general Sanyo Pharmaceutical Co., Ltd., and the ginkgolide B for injection (cxhl0800128) from Hainan Sihuan cardiovascular and cerebrovascular Drug Research Institute Co., Ltd Hainan general Sanyo's abecasin sulfate is a class 3.1 drug It entered CED in September 2011, and was supplemented once in July 2013 There is no review record after that At present, the serial number is 1362, which is directly approved It is speculated that it has not obtained clinical approval At present, this product is not listed in China III there are 59 drugs approved this week, all of which are chemical drugs, including 20 drugs in 3.1, 14 drugs in 6 and 18 imported drugs Key drugs: for class 3.1 drugs, the most approved clinical treatment area this week is nervous system drugs, which are respectively lapamide tablets of Shaanxi step Pharmaceutical Co., Ltd., lapamide injection of Chongqing Libang Pharmaceutical Development Co., Ltd., and lufamide tablets of Beijing SECCO Pharmaceutical Co., Ltd The above two drugs are used to treat epilepsy, among them, laconamide is a new NMDA receptor glycine binding antagonist, which was approved by FDA for the first time in 2008 As an auxiliary treatment drug for this group of patients, there are two dosage forms on the market: film tablet and injection When patients are not suitable for oral administration, push injection can be used In 2014, the indications of single drug for epilepsy were increased In 2010, Hangzhou Rongli pharmaceutical science and Technology Co., Ltd obtained the clinical approval document at the earliest Chongqing Libang Pharmaceutical Development Co., Ltd is the second enterprise to obtain the lapamide tablet This week, it also obtained the lapamide injection At present, only Hangzhou Rongli and Chongqing Libang have been approved in the injection country This product is a derivative of three triazoles, which has been approved by FDA for marketing at the same time It plays a role by regulating the activity of brain sodium channel, and is used to treat epilepsy of Lennox-Gastaut syndrome of over 4 years old and adults Beijing Furui Kangzheng Pharmaceutical Technology Research Institute is the first enterprise in China to obtain the clinical approval of this product, which was approved in 2011 The second is Nanjing Changao Pharmaceutical Technology Co., Ltd., which was approved in 2014, and Beijing SECCO Pharmaceutical Co., Ltd., which was approved for clinical application this week, is the third enterprise In addition, Pfizer's pregabalin capsule (6 acceptance numbers) and pregabalin oral liquid (2 acceptance numbers) have been approved for clinical use It is speculated that the capsule is a new indication or specification, and the oral liquid is a new dosage form At present, there are only 5 kinds of declaration for Hengrui in China Dulacetone hydrochloride tablets of Tianjin hankang Pharmaceutical Biotechnology Co., Ltd and Shandong innovative drug R & D Co., Ltd were also approved for clinical use The import of lulasidone tablets was approved in July 2013 in China From the current execution of Article 72, we still need to consider the import of approved clinical conditions when declaring drugs In March 2015, Jiangsu Haosen Pharmaceutical Co., Ltd was the first in China to obtain the clinical approval of this product Tianjin hankang and Shandong innovation approved this week are tied for the second place See attached table 1 for approved drugs IV there are 32 drugs approved this week after the completion of certificate preparation, all of which are chemical drugs, including 21 drugs of category 3.1, 5 drugs of category 6, and 1 drug imported Key drugs: the three in one review of rabeprazole sodium enteric coated tablets, a class 3.1 drug of the revised Pharmaceutical Group, has been completed and will be mass produced soon In addition, Sichuan Otsuka Pharmaceutical Co., Ltd is carrying out a three in one review of procaterol hydrochloride powder spray, which is also about to be approved This product is a kind of accelerated product decided by the joint meeting It entered CDE in December 2011, and has been issued and supplemented once, and is about to be approved so far Tianjin Pharmaceutical Research Institute was the second in China to obtain the clinical approval of clovidipine butyrate injection, the first one was Wuhan Yuanda, which was approved three months ago The lapamide tablets of Beijing Sihuan Pharmaceutical Co., Ltd and Jinan Bainuo Pharmaceutical Technology Development Co., Ltd were also approved for clinical use Alectinib capsule of Roche pharmaceutical has been approved for clinical application for the first time in China It is a highly selective ALK inhibitor In September 2013, it was awarded a breakthrough treatment drug qualification by FDA with lung cancer indications In July 2014, this product was first marketed in Japan for the treatment of ALK positive non-small cell lung cancer See attached table 2 for the drugs that have been prepared Attachment: