CDE drug review weekly report (October 18, 2015 to October 24, 2015)

In the review this week (2015.10.18-2015.10.24), 113 drugs (calculated according to the acceptance number, the same below) entered the review status, and the number slightly decreased compared with the previous week Among them, there are 108 chemicals, the most of which are 6 categories, 50 in total, followed by 3.1 categories, 36 in total, and 3.2 categories, 9 in total This week, there are no class 1 chemicals, only two class 2 chemicals In addition, there are 2 therapeutic biological products, 1 class 8 traditional Chinese medicine and 2 imported pharmaceutical excipients The drugs reviewed this week mainly focus on the following treatment areas: digestive tract and metabolism 20; nervous system 17; systemic anti infective drugs 15; cardiovascular system 12; anti-tumor drugs and immunomodulators 9 Key drugs: 1 midazolam nasal spray and rectal gel: all 2 drugs were declared by the Institute of toxicology of Military Medical Science Academy of the PLA, the Chinese people's Liberation Army, and a new dosage form for midazolam For midazolam nasal spray, there are also studies on this dosage form abroad, and 1 phase clinical trials have been carried out The dosage form is mainly for the rescue treatment of patients with acute recurrent epilepsy (ARS) or continuous seizures Midazolam rectal gel is also designed for patients with epilepsy and even convulsions who are unable to take orally or intramuscularly At present, midazolam of these two dosage forms has been queued for review, and we hope to get approval as soon as possible A total of 438 drugs entered the approval process this week, a significant increase from last week There are 434 chemicals and 4 biological products for treatment Among the chemicals, 3.1 is the most, with a total of 169; 6 are the second, with a total of 141; the third is imported, with a total of 53; in addition, there are 32 and 5 categories The key points are as follows: 1 Angiopoietin and its injection: This product is declared by Beijing Institute of cancer prevention and treatment, category 1.1 Angiopoietin (FPAT) is a human endogenous peptide composed of 15 amino acids found in the serum of gastric cancer patients by the biochemical and Molecular Biology Laboratory of Beijing Institute of cancer prevention and treatment, using protein mass spectrometry analysis technology The peptide can specifically enter the vascular endothelial cells, inhibit the proliferation, migration and apoptosis of endothelial cells, and play an anti-tumor role Its molecular mechanism may be related to the inhibition of sphingosine kinase activity This product was undertaken by CDE in August 2014, which is a special approved product At present, it has been reviewed and approved for clinical use 2 Lalotasil and its lipid microsphere injection: This product is declared by Shanxi Zhendong Pharmaceutical Co., Ltd as an anti-tumor drug and a new generation of anti multidrug resistant Taxus derivative, which may act on the mitotic inhibition stage of cells and prevent microtubule separation This product was also undertaken by CDE in August 2014 It is a special approved product and has been approved for clinical use This week, 587 drugs were approved Except for 39 traditional Chinese medicine and 11 biological products for treatment, the remaining 537 were chemical drugs, nearly three times the number last week Among them, there are 6 categories 1.1, 1 category 1.5, 1 category 1.6, 136 categories 3.1, 219 generic drugs (including 6 categories and existing national standards), 76 imports, etc A large number of drugs have been approved for clinical use this week Among the approved clinical 3.1 categories, Chenxin pharmaceutical and Zhejiang Haihua's iparinone and their preparations received 8 acceptance numbers, Jiangsu Xiansheng and other 4 enterprises received 7 acceptance numbers of lulaxione hydrochloride and its tablets, Shandong Xinhua and other 6 enterprises received 9 acceptance numbers of ibuprofen injection
7 drugs were inspected on site, including abidore hydrochloride tablets (Hubei Qianjiang Pharmaceutical Co., Ltd.); rosuvastatin calcium tablets (Suzhou Dongrui Pharmaceutical Co., Ltd.); rosuvastatin calcium tablets (Suzhou Dongrui Pharmaceutical Co., Ltd.); faropenem sodium capsule (Hainan Kangzhi Pharmaceutical Co., Ltd.); migraine (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.) ; ruishuvastatin calcium tablets (Suzhou Dongrui Pharmaceutical Co., Ltd.); Yizhikang capsule (Harbin Tonghua Biotechnology Development Co., Ltd.) This week, 170 drugs, 165 chemicals, 2 biological products for prevention, 2 biological products for treatment and 1 Traditional Chinese medicine have been made Compared with last week, the number is greatly reduced There are 5 1.1, 28 3.1, 9 3.2, 3 3.3, 4 5, 104 6 and 12 imported chemicals It is said that the National Bureau is seriously short of people to make various certificates There are too many medicines involved in this week, so Xiaobian can't list them one by one Interested partners can leave messages at the background, and Xiaobian will present them separately