CDE drug review weekly report (2015.2.9-2.15)

Under the influence of the new year's atmosphere, only four drugs have entered the approval process this week, all of which are chemical drugs, including three drugs in 1.1 category and one drug in 6 categories Three new drugs of class 1.1 are prochlorazine tablets of Suzhou Kaifa Pharmaceutical Co., Ltd., bpi-9016m tablets of Beida Pharmaceutical Co., Ltd and lilotinib mesylate capsules of Guangdong dongyangguang Pharmaceutical Co., Ltd., respectively; and class 6 are cefthiophene sodium raw materials of Shandong Luoxin Pharmaceutical Co., Ltd Prochloraz is an androgen receptor inhibitor used in the treatment of prostate cancer According to its common name, this product should be a substance similar to enzalutamide, which was listed in the United States in 2012 and has not yet been listed in China Incidence rate of incidence rate of prostate cancer is relatively low in China Prochloraz tablet is a major special product in China It has a special review channel and is supplemented once during the period At present, the first application for clinical results is near at hand, hoping to be approved smoothly Bpi-9016m tablet is a kind of c-met (hgfr) inhibitor Like other growth factor receptors, bpi-9016m tablet is also a hot target in the research and development of anticancer drugs There are two kinds of c-met inhibitors on the market, i.e czotinib and cabotinib, but these two molecules inhibit c-met and other targets at the same time Bpi-9016m tablet of Beida Pharmaceutical Co., Ltd is also a major special variety It experienced a supplement in August 2014 and is currently in the critical stage of clinical batch Lelotinib mesylate capsule is a kind of tyrosine kinase inhibitor, which is used to treat tumor and is not a major special product At present, the clinical application has been reviewed and is in the approval stage Of the 44 approved drugs, 36 chemical drugs, 2 traditional Chinese medicine, 4 biological products for treatment, 1 biological product for prevention and 1 pharmaceutical excipient The following details about chemical drugs: shr0302 tablets have been approved in the last period Enoxaparin sodium and its lyophilized preparations of Chengdu Baiyu science and technology Pharmaceutical Co., Ltd have completed the three in one review and will be batch produced without accident At present, enoxaparin for injection is only produced by Suzhou Erye, which has been approved for a while Now it seems that Chengdu Baiyu will also take a share In addition, Sanofi's enoxaparin injection has also been re registered, feeling that a new round of sales war will start again Acarbose chewable tablets in Hangzhou, Central America and East China have also completed the three in one review At present, acarbose only has tablets and capsules in China There are two production of tablets and one production of imported Bayer pharmaceutical Hangzhou, Central America and East China is the only one in China The capsule is produced by only one enterprise, Sichuan LVYE Baoguang Pharmaceutical Co., Ltd However, according to the sales volume in 2013, tablets are the largest in the market, while the sales volume of sample hospitals in China, the United States and East China in 2013 is 160 million This time, the exclusive chewable tablets will be on the market again, and they can take an advantage in the competition Trippidil capsule of Hebei Changtian Pharmaceutical Co., Ltd has also completed the three in one review and will soon be approved for production At present, trippidil is only listed in three domestic enterprises Now, it's better to change the capsule Let's see the follow-up sales After the completion of the preparation of the certificate, there are 9 drugs completed this week, all of which are chemical drugs The specific information is as follows: after the completion of the preparation of the certificate this week, all of them are clinical approval documents Which of the above enterprises has been approved, you can wait for the approval documents.