CDE drug review weekly report (April 7, 2015 to April 12, 2015)

The two drugs that entered the approval process this week are Hebei aierhaitai Pharmaceutical Co., Ltd.'s alprinone hydrochloride injection (cxhs1100154) and Hebei jiupai Pharmaceutical Co., Ltd.'s alprinone hydrochloride (cxhs1100153) The two companies should be joint filers, both of which are classified as 3.1 Alprinone hydrochloride is used to treat acute heart failure At present, it is not listed in China The three in one evaluation of alprinone hydrochloride injection declared by Hebei aierhaitai pharmaceutical company has been completed, and it is expected to become the first enterprise to list this product in China Among the 8 approved drugs, 4 chemicals, 3 biological products for treatment and 1 in vitro diagnostic reagent Among them, the four chemicals are civirin hydrochloride tablets of Zhuhai Yibang Pharmaceutical Co., Ltd (cxhl1100188, cxhl1100186), roxithromycin ambroxol tablets of Shandong Luoxin Pharmaceutical Co., Ltd (cxhs1000296), and letrozole (cyhs1100758) of Lianyungang Runzhong Pharmaceutical Co., Ltd Zhuhai Yibang's exclusive application for SIV Merrill Lynch was announced not to be approved Therefore, for patients with Sjogren's syndrome, the probability of using this product in China has lost another way Roxithromycin and ambroxol tablets are used to treat bacterial acute bronchitis, chronic bronchitis and elderly chronic bronchitis caused by sensitive bacteria At present, there is only one enterprise listed in this product, while Shandong Luoxin's tablet has completed the three in one review, and it is believed that the market of this product will be divided in the near future Of the 35 drugs that have been completed this week, 32 are chemicals, 1 is traditional Chinese medicine, and 2 are biological products for treatment The main information of chemical medicine is as follows (except for deoxygenation): for the drugs that have been certified, Xiaobian wants to mention guipaizite maleate At present, this product is monopolized by Beijing 4th Ring Road in China The sales volume of sample hospitals that can be counted in 2014 is more than 460 million, which is quite high At present, Fujian Jinshan biopharmaceutical Co., Ltd has obtained the product approval, and another market of hundreds of millions will be shared.