CDE Drug Evaluation Weekly Report (2015.11.1-2015.11.7)

In the review this week (2015.11.1-2015.11.7), 76 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, 72 chemicals, the most are 3.1, 23; the second is 6, 22; the third is 1.1, 9 In addition, there are 3 therapeutic biological products and 1 class 6.1 traditional Chinese medicine This week's drug reviews focused on the following areas of treatment: 16 antineoplastics and immunomodulators, 11 in musculoskeletal system, 11 in nervous system, 10 in digestive tract and metabolism, 8 in cardiovascular system, 8 in blood and hematopoietic organ, etc Key drugs: 1 Hc-1119 soft capsule: This product is declared by Chengdu Haichuang Pharmaceutical Co., Ltd as a new drug of class 1.1 This product is a brand-new small molecular structure chemical drug, which is the first in the world and has obtained the national invention patent authorization The preliminary experimental results show that its efficacy is significantly better than the same type of products that have been listed abroad The specific targets and indications have not been found yet Some friends can tell Xiaobian 2 Bgb-290 and its capsules: This product is declared by Baiji Shenzhou (Beijing) Biotechnology Co., Ltd in category 1.1 Bgb-290 is a new polyadenyldiphosphate ribotransferase (PARP) inhibitor The members of this PARP family are involved in regulating many cell physiological functions, including DNA repair and programmed cell death Bgb-290 is an innovative targeted anticancer agent The drug is independently developed by Baiji, and signed a joint development cooperation agreement with Merck's schlandau company in Germany 3 Fcn-411 and its capsules: This product is a new drug of class 1.1, which is applied by Chongqing fuchuang Pharmaceutical Research Co., Ltd., a subsidiary of Fosun Pharmaceutical Fcn-411 can inhibit the growth and survival of tumor cells by inhibiting the activity of receptor tyrosine kinase on the surface of tumor cells, blocking the downstream signal pathway, so as to achieve the effect of tumor treatment The new drug showed strong in vitro and in vivo activity, good pharmacokinetic characteristics and safety in preclinical research On October 13, 2015, Chongqing fuchuang submitted the clinical trial application to Chongqing food and Drug Administration for the first time, and passed the on-site verification on October 28, 2015, and now it is in the status of queuing for review There were 509 drugs approved this week, more than five times as many as last week There are 502 chemical drugs, the most of which are 6 categories, 271 in total; the second category is 3.1, 155 in total; the third category is imported, 39 in total In addition, there are 29 categories 5, 4 categories 3.3, 2 categories 3.2 and 2 categories 3.4 In addition, there are 6 imported biological products for treatment and 1 imported pharmaceutical excipients After a week's rest, the National Bureau's centralized review is gaining momentum again This week, about 1 / 81 of the approved drugs in this batch have been approved for clinical use, and there are some 6 types of drugs Recently, the National Bureau issued a draft of "Regulations on the record management of bioequivalence test of chemical generic drugs", which was almost settled In this way, the process of generic drugs entering be will be faster and the clinical pressure will be greater Among the approved drugs this week, the drug with the most acceptance number is dasatinib, with a total of 16 drugs, followed by imatinib mesylate, with a total of 9 drugs, followed by atorvastatin calcium tablets, erlotinib hydrochloride tablets and moxifloxacin hydrochloride tablets It can be predicted that there will be more and more TiNi drugs in the future, and the price will drop again and again This week, 237 drugs, 235 chemicals and 2 traditional Chinese medicines were approved The number of chemicals is more than 1.5 times that of last week Among them, 2 are 1.1, 1 is 1.5, 52 are 3.1, 95 are 6, 51 are imported, etc Two class 1.1 chemicals were bresaphor hydrobromide for injection (Taijing medicine) and adefovir dipivoxil tablets (Zhejiang Beide) Bleshaff hydrobromide for injection has previously been said to be clinically approved Adefovir dipivoxil tablet of Zhejiang Beide is a production application and has been approved for production However, the approval number has not yet been seen and it needs to wait In addition, 103 out of 235 approved drugs were approved for clinical use this week, including 4 cabalatine bitartrate capsules, 3 Acarbose Tablets and 3 rofluorostat tablets This week, 47 drugs, 26 chemicals, 18 traditional Chinese medicines and 4 biological products for treatment were completed Compared with last week, the number has been greatly reduced to nearly one tenth of that of last week Of the 26 chemicals, 10 belong to 6 categories, 6 are imported, 4 belong to 3.1, 3 belong to 3.3 and 2 belong to 5 categories Among them, the electrolyte balance flushing fluid of Zhejiang Wanbang Pharmaceutical Co., Ltd is the listing application of 3.3 drugs, which has completed the three in one review before, so it is presumed that it should be approved for production Looking at this week's data, there are a large number of drugs that are under examination and approval and need to be certified The State Bureau is going to be busy preparing certificates again I wish all of you who have obtained the clinical approval can make a smooth progress in clinical practice and apply for listing as soon as possible, so that the National Bureau will be busy again