[yaocajun] during the first outbreak of imitation, a number of heavy-duty products have been accepted; psoriasis will usher in New Star ixekizumab; consistency evaluation on overtaking of Yaoyou and Cr Shunfeng

Highlights: 1 Add the first potential product in China in Qilu cardiovascular field; 2 Chongqing Yaoyou duloxetine hydrochloride enteric coated capsule will be approved, and the consistency evaluation of overtaking; 3 Another potential imitated product from Zhejiang Haizheng will be "under approval"; 4 There are new imported drugs for psoriasis, and Lilly ixekizumab has applied for listing, with the sales volume of 559.2 million US dollars in one year after listing; 5 The first imitation station of memantine hydrochloride sustained-release capsule for the treatment of moderate to severe Alzheimer's disease started; 6 39 enterprises such as Hengrui, hausen, Ouyi, Huahai, etc were nervous, weighing heavily on cardiovascular system drugs, and the first four kinds of imitation declaration enterprises were launched In this week (March 1-March 8), there are 18 drug acceptance numbers reported for production, among which 2 acceptance numbers are new drugs, 5 acceptance numbers are imported drugs and 11 acceptance numbers are generic drugs On March 4, the new drug Changchun Changsheng biotech tetravalent influenza virus split vaccine was approved At present, there are only two domestic enterprises producing the new drug, and the other enterprise is Hualan biotechnology, which was approved and listed in June 2018, with an annual issuance of 512.25 million bottles (pieces) Tetravalent influenza virus split vaccine is used to prevent influenza virus infection in people aged 3 years and over On March 4, Lilly dulaglutide injection, an imported drug, was approved by Lilly As early as February 26, Lilly China announced that the drug had been approved and was applicable to the blood glucose control of adult type 2 diabetes patients, including single drug and patients who still had poor blood glucose control after receiving dimethylbiguanide and / or sulfonylurea drugs Dulaglutide is a glucagon like peptide-1 (GLP-1) receptor agonist It can activate GLP-1 receptor on the cell surface and exert adenosine cyclase activity by activating G protein Trulicity is a subcutaneous injection containing 0.75mg/0.5ml or 1.5mg/0.5mldulaglutide The recommended initial dose is 0.75mg once a week Developed by Lilly, it was approved by the US Food and Drug Administration (FDA) on September 18, 2014, under the trade name of trulicity At present, dulaglutide has been successfully listed in more than 70 countries in the Americas, Europe, Asia, etc., benefiting more than 2.9 million diabetics in the world It has been widely recognized as a market leader of GLP-1 receptor agonists in the United States, Japan, South Korea and Germany due to its strong hypoglycemic effect, simple use and good safety In Japan, dulaglutide has surpassed basic insulin and become the leading drug in the injection Market According to the sales database of smart drugs, the sales volume of the drug reached 14.37 billion yuan in 2017 On March 4, bevaludine for injection declared by Hangzhou Taige Pharmaceutical Co., Ltd showed "issued documents" in the import application of bevaludine for injection Bivalirudin is an anticoagulant developed by the medicines company It was approved by the US Food and Drug Administration (FDA) on December 15, 2000 Its trade names are Angiomax (USA) and angiox (Europe) It is usually used in unstable angina pectoris and heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (hits) in percutaneous coronary angioplasty (PTCA) and percutaneous coronary intervention (PCI) It is also temporarily used to replace glycoprotein I in PCI Ib / IIIa inhibitors At present, there are 3 domestic enterprises in production, including Hainan Shuangcheng Pharmaceutical Co., Ltd., Jiangsu Haosen Pharmaceutical Co., Ltd and Shenzhen xinlitai Pharmaceutical Co., Ltd There is no imported medicine On March 4, tetizolamine phosphate for injection and tetizolamine phosphate tablets for injection declared by Bayer medical health care showed "delivered" Tetizolamine phosphate is a new anti bacterial drug developed by cubistpharms On June 20, 2014, it was approved by FDA of the United States for use in adult acute bacterial skin and skin structural infection (absssi) caused by specific sensitive bacteria, and the trade name is sivextro At present, the preparation has not been listed in China On March 4, trimetazidine hydrochloride sustained-release tablets approved by Qilu Pharmaceutical Co., Ltd showed "developed products", adding another potential product in the field of cardiovascular Trimetazidine is clinically suitable for first-line anti angina therapy to control or intolerable stable angina By regulating myocardial energy metabolism, it can effectively improve the symptoms of myocardial ischemia and prevent the recurrence of angina pectoris It is worth mentioning that Qilu has applied for approval with the new registration classification of 4 categories, which is equivalent to the same efficacy as the original study, and will have an advantage in the consistency evaluation of other trimetazidine hydrochloride preparations At present, among the domestic trimetazidine hydrochloride, 10 enterprises hold the production approval documents, of which 3 enterprises have applied for conformity assessment; 2 enterprises hold the production approval documents for capsule and 15 enterprises hold the production approval documents for API On March 4, the application for listing of four types of generic drugs of Aluminum Magnesium Carbonate Chewable Tablets declared by China Resources Shunfeng Pharmaceutical Co., Ltd showed "issued" Magnesium aluminum carbonate chewable tablets are used for gastric and duodenal ulcer, acute and chronic gastritis, bile reflux gastritis, esophagitis, and non ulcer dyspepsia (heartburn, acid reflux, heartburn, fullness, early satiety, nausea, vomiting, etc.) At present, a total of 29 domestic enterprises hold production approval documents, while at present, only Chongqing Huasen pharmaceutical has applied for conformity assessment, which has not yet been approved On March 4, the olacetam injection declared by the pharmaceutical industry of Tianjin Pharmaceutical Research Institute showed "approval completed - to be certified" The indications of oxiracetam injection are for the treatment of brain injury and the neurological deficit, memory and intelligence disorders caused by oxiracetam injection At present, the domestic listing is all domestic, and 8 enterprises hold production approval documents Duloxetine hydrochloride enteric coated capsules of Chongqing Yaoyou Pharmaceutical Co., Ltd showed "in approval" on March 1 Duloxetine hydrochloride, developed by Lilly, was approved by the U.S Food and Drug Administration (FDA) on August 3, 2004, under the trade name of Cymbalta The drug is used to treat major depression, generalized anxiety disorder, diabetic peripheral neuralgia, fibromyalgia and chronic muscle and bone pain At present, domestic duloxetine hydrochloride preparation only has enteric coated tablets and enteric coated capsules There are two tablet manufacturers, which are Jiangsu Enhua Pharmaceutical Co., Ltd and Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd at present, only one enterprise of Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd has applied for consistency evaluation This time, Yaoyou pharmaceutical declared according to the new registration classification If it is approved, the conformity evaluation of overtaking will get the market opportunity Zhejiang Haizheng linezolid tablets March 1, Zhejiang Haizheng declaration linezolid tablets show "in the approval." Linezolid, developed by Pfizer, was approved by the US Food and Drug Administration (FDA) on April 18, 2000, under the trade name of zyvox It is applicable to the following infections caused by susceptible Gram-positive bacteria in adults and children: nosocomial pneumonia, community-acquired pneumonia, complex skin or skin soft tissue infection, including diabetic foot infection without osteomyelitis, non complex skin or skin soft tissue infection and vancomycin resistant enterococci infection At present, linezolid only has linezolid glucose injection in China, and there is no tablet on the market At present, 23 acceptance numbers have been applied for production, 19 of which are applied according to the old 6 categories At present, 18 acceptance numbers have been approved One acceptance number of Chongqing Huabang pharmaceutical application is under review and approval, and it is included in the priority review for the reason of "drug production application one year before the patent expires" In addition, there are four applications in accordance with the new four categories, among which Jiangsu Haosen Pharmaceutical Group is also included in the priority review for the reason that "the applicant voluntarily withdraws and changes to the generic registration application which is improved according to the standard consistent with the quality and efficacy of the original research drug" At present, Haihai is entering the stage of examination and approval, and is expected to be the first one to be approved This week, 22 new acceptance numbers of production drugs have been submitted for review and approval, of which 2 are import applications and the rest are generic applications On March 1, ixekizumab injection declared by Shanghai Representative Office of Eli Lilly Asia was accepted Ixekizumab was approved by FDA on March 22, 2016 under the trade name of taltz It is used to treat moderate to severe plaque psoriasis (commonly known as psoriasis) in adults who are suitable for systematic therapy or light therapy One year after going public, we have obtained a lot of sales revenue, and the sales in 2017 reached US $559.2 million In November 2018, Lilly also announced the main results of a uncover study on moderate to severe plaque psoriasis The results showed that ixekizumab of Lilly was superior to etanercept and placebo in all the indexes of skin loss regression in phase III clinical trial Etanercept is one of the most commonly used drugs in the treatment of psoriasis Its efficacy has been fully confirmed After 4 weeks of treatment, the improvement of skin symptoms can be observed The improvement of psoriasis severity index (PASI) can still be maintained after the dose of etanercept is reduced from 50mgbiw to 25mgbiw, and the incidence of rebound is low (0.24%) Etanercept is also the first approved biological agent for the treatment of children's psoriasis It has good long-term treatment tolerance in children with moderate and severe plaque psoriasis On March 4, the generic application for listing of metoprolol succinate sustained-release tablets was accepted Metoprolol succinate sustained-release tablets for hypertension, angina Chronic heart failure with stable symptoms of left ventricular systolic dysfunction At present, there are only imported astrazenecaab drugs in China, but no domestic generic drugs have been listed; 19 generic drug application acceptance numbers have been reported, 10 of which have been approved for clinical application according to the old 6 categories; 9 are under review according to the new 4 categories, involving Nantong Lianya Pharmaceutical (4 acceptance numbers, included in the priority review), Hefei Heyuan Pharmaceutical (2 acceptance numbers), Foshan derico Pharmaceutical Co., Ltd (4 acceptance No.) 3 enterprise Sichuan Pratt medicine Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation, ipratropium bromide inhalation aerosol, Budesonide Nasal Spray In March 4th, Sichuan's Pratt pharmaceuticals reported that the 3 generic drug application was accepted for Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation, ipratropium bromide inhalation aerosol and Budesonide Nasal Spray It is worth mentioning that 3 of the drugs are currently imported only, and no generic drugs have been approved for sale Salmeterol ticasone powder inhaler in combination (bronchodilator and inhaled corticosteroids) for the regular treatment of reversible obstructive airway disease, including asthma in adults and children At present, there are only LaboratoireGlaxoSmithKline imported drugs in China, and the number of generic drugs listed on the market has reached 19 Among them, 12 accepted numbers have been approved for clinical application Currently, the application of Zhengda Tian Qing, Jiangsu Heng Rui and Sichuan pat medicine has been included in the priority review Ipratropium bromide inhalation aerosol is suitable for the prevention and treatment of dyspnea related to chronic obstructive airway disease; chronic obstructive bronchitis or without emphysema; mild to moderate bronchial asthma At present, only boehringeringelheim Pharma GmbH & Co.KG are imported drugs in China There are 7 acceptance numbers of generic drugs declared for listing, among which 5 acceptance numbers have been approved, which are Yamato Tokyo