From January to November: CDE accepted 6668 drugs, with an average of 58 new drugs and 45 consistency evaluation drugs

From January to November, a total of 6668 drugs were accepted, up 52.65% year on year; 835 generic drugs, up 97.40% year on year; 58 new drugs, 45 consistency evaluation drugs and 76 generic drugs were declared on average every month; clinical drugs were approved in January to November 2018 to reach a new low in the same period of three years; drugs were approved to be produced in the same period of three years with a straight line rising; On average, 41 drugs are approved to be manufactured, 36 clinical drugs are approved, and 7 are approved for consistency evaluation; patozumab, Roche's "magic drug" for breast cancer, is about to be approved in China; Gilead's three in one new anti AI drug approved by FDA in 2018 is declared to be on the market; Qilu's first breast cancer generic drug is declared to be on the market This week is the last week of November and the beginning of December in 2018 In the whole year, from January 1 to November 30, CDE received 6668 drugs (calculated by acceptance number, the same below), an increase of 52.65% year-on-year Among them, 642 new drug applications increased by 13.22% year-on-year; 351 imported drugs decreased by 12.03% year-on-year; 835 generic drugs increased by 97.40% year-on-year Data source: drug registration and acceptance database has an average of 606 application drug acceptance numbers per month, including 58 new drugs per month, 32 imported drugs per month, 76 generic drugs per month, and 45 consistency evaluation acceptance numbers per month The specific application quantity is as follows: data source: drug registration and acceptance database At the same time, from January to November 2018, up to now in 2018, the review conclusion is that there are 446 acceptance numbers of approved production, 391 clinical approval and 48 import approval From the situation of approval in the same period of three years, the number of drugs approved for production has increased in a straight line, while the number of drugs approved for clinical use has declined significantly Data source: the approval of the registration and acceptance database of smart drugs in 2018 is shown in the figure below The average number of approved clinical drugs is 36, the average number of approved production is 41, the average number of approved imported drugs is 4, and the average number of approved consistency evaluation drugs is 7 Data source: the database of registration and acceptance of intelligent drugs this week's important drugs dynamic report new trends of production drugs this week (November 24-november 30) less updates are reported on the status of production drugs processing, mainly including two new drugs, two imported drugs, and one generic drug showing "under approval" Accession On November 28, olacetam, a new chemical drug of five categories in two injection formulations of olacetam, a new drug of Jilin Sifang pharmaceutical, was "under examination and approval" Oxiracetam was first synthesized by ISF in 1974 Its oral preparation was first listed in Italy in 1987 and its injection was first registered in South Korea and Italy in 1990 Capsule was first listed in China in 2003 and injection was first listed in China in 2005 At present, 8 domestic enterprises hold the approval documents for injection production Accession Luoshipatozumab injection On November 28, the import application of pertuzumab injection of Roche pharmaceutical showed that it was "under examination and approval" The drug was listed in the United States in June 2012, known as the "God drug" of breast cancer It is a choice of medication for breast cancer patients with positive HER2 amplification and the whole course of treatment (new adjuvant before operation can be used, postoperative adjuvant treatment can be used, and late treatment can also be used) Compared with Herceptin combined chemotherapy, patozumab combined with Herceptin can significantly improve the effective rate and prolong the survival period This is another blockbuster targeted drug for HER2 that Roche is about to launch in China (the first is trastuzumab, trade name Herceptin, which has been listed in China for many years and has entered the medical insurance) The industry people call this drug Accession On November 28, the application for import of mosadongposaconazole enteric coated tablets showed that it was "under examination and approval" The drug was developed by mosadong company and first approved by the European Drug Administration (EMA) on October 25, 2005, and then approved by the food and Drug Administration of the United States (FDA) on September 15, 2006, under the trade name of noxafil The drug is suitable for the treatment of refractory fungal infections (such as invasive Aspergillus, Fusarium, yeast, Mycobacterium, coccidiosis) It is the first time for the treatment of thrush and the prevention of serious fungal infections At present, only posaconazole oral suspension is imported in China Accession Hainan Huigu Pharmaceutical Co., Ltd aluminum magnesium carbonate granules on November 28, Hainan Huigu Pharmaceutical Co., Ltd six kinds of generic magnesium carbonate granules showed "under approval" The medicine is suitable for the treatment of acute and chronic gastritis, gastric and duodenal ulcer, reflux esophagitis, bile reflux and high gastric acid diseases At present, 8 domestic enterprises hold the approval documents for the production of magnesium aluminum carbonate granules There are 1 new drug reported for production, 3 imported drugs and 10 generic drugs reported for new acceptance this week The details are as follows: Accession On November 28, the application for class 2.4 new drugs of androtinib hydrochloride capsule was accepted Since May this year, androtinib hydrochloride capsule has been approved for listing In September, it has also applied for three class 2.4 new drugs accepted, which have been included in the priority review and special approval, and another two months later Accession On November 28, CDE accepted the teravir potassium tablet of mosadong, which is suitable for the treatment of human immunodeficiency virus type I (HIV-1) infection in combination with other anti retroviral drugs At present, there are only imported drugs in China Accession On November 28, the application for listing of Gilead ketiravir / enteltabine / propofol tenofovir tablets was accepted The drug was used to treat HIV-1 infection It was a three in one compound formulation developed by Gilead and approved by the US FDA on February 7, 2018 Accession Qilu piperacillin capsule was accepted by CDE on November 28 The drug was used to treat postmenopausal women with first-line combination of aromatase inhibitors The hormone receptor positive (HR +), human epidermal growth factor receptor 2 negative (HER2 -) locally advanced or metastatic breast cancer At present, there is no generic drug listing in China, and Qilu is the first one to apply for listing Accession On November 26, topiramate tablets were accepted in Huahai, Zhejiang Province As a single drug, it can be used to treat epilepsy, as well as auxiliary treatment of epilepsy and migraine It was first listed in the UK in 1995, and was approved by the U.S Food and Drug Administration (FDA) on December 24, 1996 After that, it was approved by the Japanese pharmaceutical and medical device comprehensive agency (PMDA) on July 31, 2007 It is the R & D of Johnson & Johnson's Janssen Pharmaceutical, which launched in the United States under the trade name topamax At present, only one enterprise of Xi'an YANGSEN in China holds the production approval.