CDE drug review weekly report (August 29, 2015 to September 5, 2015)

In the review this week (2015.8.29-2015.9.5), 42 drugs (calculated according to the acceptance number, the same below) entered the review status, 36 chemicals, 1 / 3 less than last week Among the chemicals, there are 8 categories 3.1, 1 category 3.2, 3 categories 5, 24 Categories 6 and 6 imported In addition, there are six therapeutic biological products This week, the number of class 3.1 chemicals continued to decline, while the application heat of biological products for treatment increased compared with last week Xiaobian really thinks that biological products may prevail in the world in the future The key drugs are as follows: 1 Abt-414 for injection: This product is developed by abbvie company It is a kind of monoclonal antibody of experimental epidermal growth factor receptor antibody (anti EGFR) It is suitable for the treatment of glioblastoma multiforme On August 6, 2014, both EMA and FDA granted abt-414 orphan status In the United States, it has entered the stage of phase 2 clinical recruitment for the treatment of glioblastoma multiforme, and now it is the first time to declare clinical application in China 2 Mpdl3280a injection: This product is developed by Roche company It is an antibody targeting PD-L1, and is currently a popular anti-tumor target This product has entered the phase 3 clinical recruitment stage in the United States, and is used for the treatment of non squamous non-small cell lung cancer, renal cell cancer, three negative breast cancer, etc In December 2013, we applied for clinical application for the first time in China Now we are still queuing up We will continue to apply for several clinical applications in the future 3 Dulaglutide injection: developed by Lilly company, this product is a glucagon like peptide (GLP-1) receptor agonist, which is suitable for auxiliary diet and exercise to improve blood glucose control in adults with type 2 diabetes It was approved by FDA on September 18, 2014 At present, it is the first clinical application in China A total of 163 drugs are under approval this week It seems that the centralized review has begun A large number of generic drugs and new drugs are concentrated in the examination and approval This week, 163 drugs (according to the acceptance number) are in the approval status 161 chemicals, compared with 5 chemicals last week, increased dramatically in number, including 70 chemicals in 3.1 categories, 87 chemicals in 6 categories and 4 chemicals imported In addition, there are two traditional Chinese medicines: one is of 5 categories and one is of 6.2 categories From the treatment field of approved drugs, we can see that the four fields of systemic anti infective drugs (42 acceptance numbers), antineoplastic drugs and immunomodulatory drugs (36 acceptance numbers), musculoskeletal system (29 acceptance numbers) and cardiovascular system (28 acceptance numbers) account for 83% of the total approval acceptance numbers From the perspective of the manufacturers that enter the approval status, Chenxin Pharmaceutical Co., Ltd., Hainan Meida Pharmaceutical Co., Ltd., Nanjing Haina Pharmaceutical Technology Co., Ltd and Qilu Pharmaceutical Co., Ltd all enter the approval status from five acceptance numbers Guoyao Yixin Pharmaceutical Co., Ltd., Hefei Tuorui Biotechnology Co., Ltd and Hefei Xinfeng science and Technology Development Co., Ltd followed with 4 acceptance numbers There are 8 manufacturers with 3 acceptance numbers in the process of approval, and the remaining 81 manufacturers have 1-2 acceptance numbers The key drugs are as follows: 1 Acarbose Tablets: imitated chemicals A new oral hypoglycemic drug Competitively inhibit glucoside hydrolase in intestine Commonly used alone, or with other oral hypoglycemic drugs, or insulin combined At one time, 5 manufacturers of Acarbose Tablets entered the examination and approval 2 Abitrone acetate: a new chemical Antitumor drugs and immunomodulators, oral drugs for the treatment of metastatic prostate cancer At one time, 33 acceptance numbers are in the process of examination and approval, respectively from 18 manufacturers of APIs or tablets 3 Agliptin benzoate: a new drug, it is a DPP-4 inhibitor It is used in the field of digestive tract and metabolism to treat type II diabetes 18 acceptance numbers from 7 manufacturers were approved this week 4 Sinacase hydrochloride: a new chemical Non sex hormone and insulin hormone system medication This product is used to treat secondary hyperparathyroidism in patients with chronic kidney disease (CKD) undergoing dialysis, hypercalcemia in patients with parathyroid cancer, and HPT in patients with severe hypercalcemia who are unable to receive parathyroidectomy Jiangsu Hengrui Pharmaceutical Co., Ltd and Nanjing Haina pharmaceutical science and Technology Co., Ltd have 6 acceptance numbers of APIs and tablets in the approval status It is expected to break the monopoly position of sinakase hydrochloride tablets of Ohara pharmaceutical in the domestic market as soon as possible There are too many drugs to be approved this week, so we won't list them one by one Interested friends can check them in our database by themselves There are 44 drugs approved this week, with chemical drugs and biological products accounting for half of the total, including 23 chemical drugs, 11 biological products for prevention and 10 biological products for treatment Among 22 new drugs, chemical drugs: 1.1 class 2, 1.2 class 2, 3.1 class 9, 6 class 1 Biological products for prevention: 2 in class 1, 1 in class 6, 2 in class 7 and 1 in class 15 Biological products for treatment: 1 in 10 categories, 2 in 15 categories The drugs approved this week are mainly systemic anti infective drugs (14 acceptance numbers), cardiovascular system drugs (5 acceptance numbers), blood and hematopoietic organ drugs (6 acceptance numbers) and musculoskeletal system drugs (5 acceptance numbers) The key drugs are as follows: 1 Split vaccine of influenza A (h7n9): a systemic anti infective drug developed by Shanghai Institute of Biological Products Co., Ltd for the prevention of influenza A (h7n9) Shanghai Institute of Biological Products Co., Ltd is the second manufacturer to apply for the variety after Beijing Kexing Biological Products Co., Ltd 2 Trastuzumab-mcc-dm1 for injection: antineoplastic and immunomodulatory agents for the treatment of metastatic breast cancer This product has been approved for clinical use See attached Tables 1 and 2 for approved drugs There are 2 drugs approved this week after the completion of certificate preparation, all of which are imported and re registered They are Gliquidone of Shanghai bolingyingehan Pharmaceutical Co., Ltd and indapamide of Servier (Tianjin) Pharmaceutical Co., Ltd Attachment: