CDE Drug Evaluation Weekly Report (2015.7.5-2015.7.11)

In the review this week (2015.7.5-2015.7.11), 123 drugs (calculated by acceptance number) entered the review status, including 115 chemicals, 4 traditional Chinese medicines, 3 biological products for treatment and 1 biological product for prevention The key points are as follows: 1 Sodium D (-) sulbacillin for injection: sulbacillin is a broad-spectrum semi synthetic penicillin antibiotic, which has antibacterial effect on many Gram-negative bacteria, some gram-positive bacteria and anaerobic bacteria D (-) sulbenicillin sodium is an isomer of sulbenicillin sodium, which was declared by Hunan Sanqing Pharmaceutical Co., Ltd in category 1.3, and now it is in the status of queuing for review 2 Memantine hydrochloride oral dissolving membrane: memantine hydrochloride is a non competitive NMDA (N-methyl-D-aspartic acid) receptor antagonist with voltage dependence and moderate affinity It can block the neuronal damage caused by the pathological increase of glutamate concentration and is used to treat moderate to severe Alzheimer's dementia At present, only memantine hydrochloride tablets and oral liquid are listed in China, while capsules, orally disintegrating tablets, dispersing tablets, injections, etc are included in the application This time Qilu Pharmaceutical Co., Ltd exclusively applied for another new dosage form, orally dissolving film Because there are few listed manufacturers and the market of this product is huge, which dosage form will take the advantage in the future is still unknown 3 Pt010: This product was developed by Pearl (later acquired by AstraZeneca), which is a drug for COPD treatment and has not been listed yet Pt010 is a tripartite preparation, which is composed of a long-acting β 2-receptor agonist formoterol fumarate, a M-receptor antagonist, and a inhaled glucocorticoid The first two drugs are a compound preparation pt003 of the company At present, this product is imported by pearl for the first time in China for clinical application 4 Recombinant humanized anti HER2 monoclonal antibody meddensin conjugate for injection: This product is a drug antibody conjugate (ADC), which is declared by baiaotai Biotechnology (Guangzhou) Co., Ltd class 1 At present, there are 1 kinds of ADC composed of recombinant human anti-HER2 monoclonal antibody in China, and there are also recombinant human anti-HER2 monoclonal antibody for injection MMAE coupling agent A similar drug has been launched in the United States, i.e a trastuzumab emtansine injection developed by Roche with the trade name of kadcyla, which is used to treat breast cancer In this week, 42 drugs were approved, including 35 chemicals, 3 traditional Chinese medicines, 3 biological products for treatment and 1 biological product for prevention The key points are as follows: 1 L-ornidazole: the raw materials, tablets and capsules of l-ornidazole declared by Hunan Warner Pharmaceutical Co., Ltd in category 1.3 have completed the three in one review, and are undergoing the three in one review, which will be batch produced in a few days At present, there is more than one application for levononidazole in China The dosage form includes oral and injection The injection has been first listed by Nanjing Shenghe in 2009 In addition, the oral tablets of Nanjing Shenghe are also in the on-site verification stage However, Warner Pharmaceutical Co., Ltd is expected to be the first enterprise to list this oral preparation 2 Migrainet calcium: This product is an insulin secretion promoting agent for the treatment of type 2 diabetes mellitus At present, there are 5 migrainet calcium tablets listed in China, one of which is imported This time, Beijing Sihuan Kebao Pharmaceutical Co., Ltd and Dezhou Bosheng Pharmaceutical Co., Ltd applied for this product in class 3.1 The three in one review has been completed, and the three in one review is in progress It is speculated that it will be listed soon 3 Low molecular weight heparin calcium: This product is a degradation product of heparin, which is used in the surgical operation for the moderate or high risk of venous thrombosis, to prevent venous thromboembolism disease At present, there are many low-molecular-weight heparin on the market in China, including its sodium salt and calcium salt, while only one has the same general name as low-molecular-weight heparin calcium for injection The raw materials and preparations jointly declared by Yantai North Pharmaceutical Co., Ltd and Yantai Dongcheng Biochemical Co., Ltd have completed the three in one review, and will be added to the "chaotic" market of low molecular weight heparin In addition, nivolumab injection, a PD-L1 inhibitor of Bristol Myers Squibb, was approved for the first time in China Shanghai Xinxing Pharmaceutical Co., Ltd accelerating the production of human coagulation factor Ⅷ is undergoing a three in one audit and will soon be mass produced See attached table 1 for drug information under approval Approval completed: 9 drugs have been approved this week, including 3 chemicals, 2 traditional Chinese medicines and 4 biological products for treatment Among them, Tianjin MEITONG Pharmaceutical Co., Ltd approved the production of Diyushengbai capsule The recombinant anti HER2 humanized monoclonal antibody for injection of class 2 biological products of Shanghai Fuhong Hanlin Biotechnology Co., Ltd was approved for clinical use See attached table 2 for the approved drug information There are 47 drugs completed this week, including 25 drugs, 17 traditional Chinese medicine, 4 biological products for treatment and 1 biological product for prevention This week, more than one traditional Chinese medicine was approved for production The National Bureau somehow made nine production approvals of traditional Chinese medicine in one breath In addition, Beijing Representative Office of Schering plough (China) Co., Ltd of Bermuda imported and declared the therapeutic biological product follicle stimulating factor α injection, which was approved for clinical use See attached tables 3 and 4 for the drugs that have been prepared Attached: