[drug Kajun] the clinical urgently needed drug is approved for marketing; the world's best-selling vaccine variety is approved soon in China; another rare disease drug is approved for marketing; the world's first atopic dermatitis biological drug is approved in China

Highlights: 1 The clinical urgent need drug gusecchiumab injection was approved for marketing! 2 Domestic first! The world's best-selling vaccine varieties will be approved soon! 3 Patients with acromegaly, a rare disease, welcome new hope! 4 Dupilumab, the world's first bio drug for atopic dermatitis, has been listed in China New trend of nmpa approval: 51 production acceptance numbers (35 varieties) will be submitted this week for review and approval Details are as follows: gusecchiumab injection Guselkumab is the first anti-human interleukin-23 (IL-23) monoclonal antibody approved for the treatment of psoriasis in the world By blocking the binding of IL-23 with IL-23 receptor on the cell surface, it destroys il-23-mediated signal transduction, activation and cytokine cascade reaction, inhibits the biological activity of IL-23, and has therapeutic effect on plaque psoriasis In July 2018, it was approved by FDA for listing, and on December 27, it was approved for listing in China The approved gussechiumab injection was declared by Janssen cilag international NV on behalf of Xi'an Janssen Pharmaceutical Co., Ltd This variety has been listed in the first batch of overseas new drugs urgently needed in clinical practice 13 valent pneumococcal polysaccharide conjugate vaccine 13 valent pneumococcal vaccine was originally developed by Pfizer for the prevention of invasive diseases caused by pneumococcal serotypes 1, 3, 4, 5, 6a, 6b, 7F, 9V, 14, 18C, 19A, 19F, 23F (including bacteremic pneumonia, meningitis, septicemia, bacteremia, etc.) It was first approved by FDA in 2010 and approved to be listed in China in November 2016 It is used for the prevention of 13 kinds of invasive diseases caused by pneumococcal serotypes in infants aged 6-15 months 13 price Peier vaccine has always been the best-selling vaccine product in the world In China, a number of vaccine enterprises have joined the research and development team of 13 valent pneumonia vaccine According to the pharmaceutical intelligence data, in addition to Watson biology, there are also minhai biology, Lanzhou biology, Beijing Kexing Zhongwei, and Wyeth pharmaceutical, etc Among them, minhai biology has been declared for listing on December 13, 2019; Lanzhou biology is in phase III clinical stage; Beijing Kexing Zhongwei is in the approved clinical state; bowo biology and antjin biology are in the clinical application stage On December 25, the processing status of Watson biological class 1 new drug - 13 pneumococcal polysaccharide conjugate vaccine was updated to "under approval" If approved, it will be the first domestic vaccine and the second global vaccine with 13 price Watson bio will become a domestic enterprise with the world's best-selling vaccine varieties LRP acetate sustained release injection (precharge) Yipu Sheng's LRP acetate sustained release injection (precharge) is the first ready-to-use sustained-release preparation based on self-assembled nanotube technology, which has been registered and listed in about 70 countries around the world and widely used in clinical treatment of acromegaly Its listing will accelerate the in-depth development of Epson in China in the field of rare diseases, and bring more patients with innovative treatment methods Yipu Health China has been widely recognized in the field of diarrhea based digestive tract diseases With the investment of Yipu health group in the research and development field, there are other specialized drugs to be listed in China In the future, China will be the strategic growth direction of Yipu health global market This week, 45 new production acceptance numbers (33 varieties) were reported for new acceptance of CDE, including 5 new drugs, 5 imported drugs and 23 generic drugs The details are as follows: Dupilumab injection Dupilumab injection is a kind of human monoclonal antibody, which is used to treat asthma and allergic dermatitis with interleukin-4 (IL-4) receptor blocker Jointly developed by Sanofi and Zaihuan On March 28, 2017, dupixent ® was approved by FDA to be the first biological agent for the treatment of moderate to severe atopic dermatitis At present, dupixent has been approved and listed by regulators in about 40 countries and regions including the United States, Japan and the European Union From the listing in 2017 to the sales growth in 2018 According to the drug intelligence database, dupixent is currently carrying out a number of clinical trials in the world, among which, in China, dupilumab is being used in the three-stage clinical trials of adult patients with moderate and severe atopic dermatitis (clinical registration number: ctr20181386), with a planned enrollment of 160 people The international multicenter phase 3 clinical treatment of COPD is also in progress (clinical registration number: ctr20191944) The planned number of participants: international multicenter trial: 924 in total, 82 in China At present, Sanofi dupilumab injection has applied for listing in China With the continuous increase of its clinical indications and market expansion, the drug will become the world's second-largest selling anti-inflammatory drug in the future after Abel maintenance Merlot Data source: drug intelligence data, enterprise announcement and other network public data information sources: drug intelligence network, enterprise announcement and other network public information With high integration, in-depth analysis and intelligent intelligence of pharmaceutical intelligence data, the intelligent tool platform for pharmaceutical data has been specially built for VIP enterprise customers, covering core data such as drug registration, hospital sales, drug reports, enterprise reports, clinical trials, drug listing, drug bid winning, device listing, drug sales, etc., and providing all-round access to enterprise users from production, research and development, sales, and use And other information channels in various links to help enterprises in R & D and decision-making Welcome to click the link "https://db.yaozh.com/" to enter drug intelligence data ~ Mengmeng's article is the integrated content of drug intelligence website, the copyright belongs to the original author, and the purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.