[Yao Kejun] who is the first to imitate the hottest global antithrombotic drug of 40 billion level? Who is the winner of Zhengda Tianqing, Huahai, Yangzi River and Ouyi? Changsheng was cancelled the vaccine, and then came to the enterprise to make up

New trends of review and approval this week (may 10-may 17), a total of 28 acceptance numbers of drugs reported for production are updated dynamically, including 3 acceptance numbers (3 varieties) for new drugs, 10 acceptance numbers (5 varieties) for imported drugs, and 18 acceptance numbers (13 varieties) for generic drugs Among the processing status of new drugs and imported drugs reported this week, 4 imported drugs were updated again on the basis of last week (check the previous period and click [drug Kajun] 5-pound bomb detonating drug circle, Hengrui, hausen, Bayer, Pfizer, and Alberta ）; the status of lamotrigine dispersible tablets and bicalutamide tablets was updated to "issued" from "approved - to be certified" last week; the status of heavy-duty products of Pfizer and ibuprofen, such as dacomitinib tablets and gekariwepirantavir tablets, was updated to "approved - to be certified" from "approved" last week, and the efficiency of the drug Audit Center was further improved Note: Blue medicine is a new variety Kanghong biokang "bosipu ophthalmic injection" in the last week's handling status On May 15, Kanghong pharmaceutical's new class 1 therapeutic biological product "kangboxipu ophthalmic injection" was approved This approval is a new indication "treating visual impairment caused by diabetic macular edema (DME)", which is the third indication Conbercept ophthalmic injection was approved in 2013 for the treatment of wet age-related macular degeneration (namd) and 2017 for the treatment of visual impairment (pmcnv) secondary to choroidal neovascularization in pathological myopia According to Kanghong pharmaceutical company's announcement, the drug's retinal vein occlusion (RVO) is currently in the phase III clinical stage in China, and industry insiders say it is expected to be approved in 1-2 years Conbercept ophthalmic injection is a kind of innovative biological drug independently developed by Kanghong biology, which has full independent intellectual property rights It is a fusion protein of VEGF receptor and human immunoglobulin fc gene recombination It can effectively combine with VEGF in blood vessels and tissues, and block the signal transmission mediated by VEGF to promote the sprouting and growth of new blood vessels At present, there are five kinds of macromolecular drugs approved for marketing worldwide, including three kinds of monoclonal antibodies: bevacizumab, remulus mAb, Leizhu mAb, and two kinds of fusion proteins: arbacip and conbercept Among them, bevacizumab, rapacizumab and arbacip are the best-selling drugs with an annual sales volume of more than 3 billion US dollars According to industry professionals, by 2020, the global market size of ophthalmic anti VEGF drugs will reach 12 billion US dollars, and Kanghong and conbercept have a promising future On May 14, the "influenza virus split vaccine (tetravalent)" of jindick biology in Jiangsu Province showed "under approval" In June 2018, the first batch of domestic tetravalent influenza virus split vaccine was approved to prevent influenza virus infection among people aged 3 and above The approved enterprises are Hualan biological vaccine Co., Ltd and Changchun Changsheng Biological Technology Co., Ltd However, after the outbreak of Changchun Changsheng vaccine, on April 4, 2019, the State Food and Drug Administration issued a notice to cancel 18 vaccine products of Changchun Changsheng, among which there are four valent influenza vaccines Therefore, Hualan bio is the only one listed on the market According to the sales database of pharmaceutical intelligent biological products, in 2018, Hualan bio has issued 5.2276 million bottles (bottles) Novo Nordisk's "digumendon double insulin injection" on May 13, Denmark Novo Nordisk's "digumendon double insulin injection" showed "under approval" Digumendon double insulin preparation is composed of a new generation of ultra long acting basic insulin analogue (digumendon) combined with a meal insulin analogue (aspart insulin), which aims to improve blood glucose control in adult diabetic patients Compared with the premixed insulin analogues, it can better simulate the physiological insulin secretion mode In the production of generic drugs and generic drugs reported, 6 drugs are the products with the status updated last week It is worth noting that the status of Zhengda Tianqing gefitinib tablets was updated from "in the approval status" last week to "approved - to be prepared" Note: the blue drugs are the updated varieties of Zhengda Tianqing "apixaban tablets" in the last week's handling status On May 15, the generic drug listing application of Zhengda Tianqing "apixaban tablets" shows "approval completed - to be certified" Apixaban, for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement In May 2011, it was approved by the European drug regulatory agency, and in November, the drug's listing application in the United States was accepted by the U.S FDA On April 12, 2013, it was announced to be officially listed in China Eliquis (apixaban) is a new, oral, reversible, highly selective and direct XA factor inhibitor As a popular anticoagulant FXa inhibitor, eliquis continued to enjoy a good sales situation In 2017, eliquis became the best-selling drug in the cardiovascular field, with annual sales of US $7.4 billion, equivalent to 49.9 billion yuan, a year-on-year increase of 46.24% It was jointly sold by Pfizer and Bristol Myers Squibb, with Bristol Myers Squibb contributing US $4.872 billion and Pfizer contributing US $2.523 billion At present, there are the first imitations of imported drugs and Haosen pharmaceutical industry in China, and they have entered the catalogue of drugs on the market in China However, due to the expiration of the patent of the drug compound in China in 2022, Haosen has not been officially SOLD yet, and Zhengda Tianqing is about to be approved In the subsequent market competition, the winner still depends on the market development ability of the enterprise On May 13, the "rivaroxaban tablets" of Suzhou No.3 pharmaceutical factory showed "under approval" According to the pharmaceutical intelligence data, there are 14 enterprises applying for rivaroxaban tablets in accordance with the new four categories of imitations, which is one of the hottest products to be applied for (see the article: generic drugs in the process of transformation, the hottest application for 16 varieties), including such powerful enterprises as Zhengda Tianqing, Shiyao Ouyi, Yangzi River, Huahai, etc This time, Suzhou No.3 pharmaceutical factory took the lead in entering the approval stage, or became the first one to obtain approval However, the patent of rivaroxaban compound expires in 2020, which is still a certain stage from the official sale Rivaroxaban is a selective clotting factor Xa inhibitor, ranking second only to apixaban in the global cardiovascular system drugs in 2017 In 2017, the sales volume of xarelto reached US $6.59 billion, equivalent to RMB 42.04 billion, up 22.64% year on year Developed jointly by Bayer and Janssen, it was approved by the European Drug Administration (EMA) on September 30, 2008, and approved by the FDA on July 1, 2011 In June 2009, rivaroxaban produced by Bayer entered China (trade name: byritol) for the prevention of venous thrombosis after elective total hip or total knee replacement in adults In May 2015, two new indications of rivaroxaban tablets were approved by CFDA, respectively, for the treatment and prevention of deep vein thrombosis and pulmonary embolism, and stroke prevention in patients with atrial fibrillation This week, 25 acceptance numbers of new acceptance for review and approval have been reported to the production drugs for acceptance, including 1 new drug acceptance number, 1 imported drug acceptance number and 23 generic drug acceptance numbers On May 15, "azilsartan tablet" of Zhaoke Pharmaceutical Co., Ltd., the application for listing the generic drug "azilsartan tablet" declared by Zhaoke Pharmaceutical Co., Ltd was accepted Azilsartan was first developed by Takeda pharmaceutical company of Japan and approved for listing in Japan in January 2012 Its precursor drug azilsartan ester was approved by the US FDA for the treatment of adult hypertension on February 25, 2011 At present, the drug has not been listed in China There are five generic drug reports with production acceptance numbers, all of which are declared according to three types of drugs, involving Jiangsu Hengrui, Beijing Baiao pharmaceutical and Zhaoke pharmaceutical Among them, Hengrui's application was included in the priority review on December 18, 2017 on the basis of "drug production application one year before the patent expires" Part of information sources: enterprise announcement, FDA official website information data source: drug intelligence data statement: this opinion only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.