European and American drug listing report in August 2019

Key information in this report: 84 drugs have been approved for listing by the US FDA this month, 10 of which are declared by Chinese pharmaceutical companies; and 24 human drugs have been approved for listing in the EU this month 1、 Overview of FDA drug listing in the United States 84 kinds of drugs have been approved and listed by FDA this month Due to space limitations, this paper only lists 10 kinds of drugs approved and listed by FDA in August by Chinese pharmaceutical companies See the table below for details Remarks on the ranking of the number of drugs approved by FDA for listing by Chinese pharmaceutical companies this month: Category 1 includes Shanghai xuantai pharmaceutical, Jiangsu Hengrui pharmaceutical, Qingdao Baiyang pharmaceutical and Nantong Lianya pharmaceutical It should be noted that this month, the number of drugs approved for listing by the FDA of China's pharmaceutical companies ranked first is glundpharmatald (there are four kinds) Glandpharmaltd is the first injection drug manufacturer approved by FDA in India, and has obtained GMP certification in major regulatory markets around the world In 2016, the company was acquired by Shanghai Fosun Pharmaceutical 2、 Overview of drug listing in the EU this month, only one of the drugs approved for listing by the EMA, the name of which is azacytidine Azacytidine is a chemical analogue of cytidine, which exists in DNA and RNA It is mainly used in the treatment of myelodysplastic syndrome Azacytidine has antitumor activity mainly through two mechanisms: at low dose, by inhibiting DNA methyltransferase, it leads to DNA hypomethylation; at high dose, it leads to abnormal cell death directly through the cytotoxicity of DNA and RNA to abnormal bone marrow hematopoietic cells There are 23 drugs approved through HMA decentralization and mutual recognition, which are mainly distributed in the fields of antihypertensive, broad-spectrum antibacterial, male erectile dysfunction and hepatitis B antiviral treatment See the following table (list part) for details Compared with the number of drugs on the market in July, the number of drugs on the market in August decreased by 86.9 percentage points, and the number of drugs approved by HMA has always accounted for more than EMA in the overall listing of the EU, which is related to the field of drugs on the market The European Medicines Agency (EMA) is responsible for the approval of centralized procedure (CP) applications; the drug agency headquarters (HMA) is responsible for coordinating the approval of decentralized procedure (DCP) and mutual recognition procedure (MRP) applications Drugs containing new active ingredients for the treatment of the following diseases must be approved through a centralized procedure: AIDS, cancer, neurodegenerative diseases, diabetes, viral diseases, autoimmune diseases and other immunodeficiency diseases, rare diseases The following drugs must be approved through a centralized process: ◇ drugs prepared through biotechnology processes such as genetic engineering; ◇ leading edge therapeutic drugs such as gene therapy, somatic therapy or tissue engineering therapy Data source: drug intelligence EU (US) drug listing database, FDA / EMA / HMA portal website can obtain more details of the report through the following ways: 1 Copy the link to open the website in the browser to consult drug intelligence customer service: https://vip.yaozh.com/service; 2 Call service hotspot 400-678-0778; 3 Drug intelligence EU listed drug database link (enterprise version): Https://vip.yaozh.com/epyp; Yaozhi U.S listed drug database link (enterprise version): https://vip.yaozh.com/fdadrug; statement: this point of view only represents the author, not the position of yaozhi.com, 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.