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On September 28, the official website of the State Drug Administration showed that Zhengda Tianqing Pharmaceutical Co., D.C., was approved for production and regarded as the second domestic product by copying 4 categories of declared Kaglie net tablets (acceptance number CYHS1800534).
the world market for SGLT-2 inhibitors (Gree Net) has expanded rapidly as an oral antisaccharide. according to
meter net data, there are currently eight kinds of SGLT-2 inhibitors approved for listing in the world, namely, Kagle Net, Dagle Net, Engli Net, Iglinet, Rugle Net, Togli Net, Etogre Net and Aglei Net, of which Engele Net Market Share is the highest, with global sales of more than US$3 billion in 2019.
Table 1: Domestic listed SGLT-2 inhibitors Note: Approval date by status start date Source: Minet China's public medical institutions terminal competition pattern 4 SGLT-2 inhibitors have been approved for import, of which 3 new drugs approved in 2017 have been negotiated into the 2019 version of the National Health Insurance Category B catalog, the market size is expected to expand.
the largest sales of Dagled net tablets among the four SGLT-2 inhibitors, with total sales of more than 400 million yuan in 2019 at public medical institutions in China and retail pharmacy terminals in Chinese cities, no generic drugs have been approved.
table 2: SGLT-2 inhibitors in review of domestic generic drugs Source: Minet MED2.0 China Drug Review Database Minet data show that 11 SGLT-2 inhibitors domestic generic drugs (in the name of the drug and enterprise name) in a new classification, of which 4 have been approved for production and treated as the same.
of the 7 varieties reviewed, Dagli net tablets have not yet been approved for listing of generic drugs, Shandong Lu Anti-Pharmaceutical, Beijing Fuyuan Pharmaceuticals to copy 4 categories of reported production;
5 domestic new drugs in research, the first class 1 new drugs will be born on September 30, CDE official website shows that Jiangsu Hengrui Pharmaceutical 1 class of new drug proline Hengle net tablets listed application for CDE contractor acceptance, this is the first domestic declaration and listing of domestic SGLT-2 inhibitors.
table 3: SGLT-2 inhibitors domestic 1 new drug research and development progress Source: Minet China drug clinical trial publicity library According to incomplete statistics, in the field of SGLT-2 inhibitor domestic new drug research and development, there are currently 5 domestic 1 class of new drugs in research, Hengrui medicine first Declared listed, is expected to win the first domestic SGLT-2 inhibitor Class 1 new drugs, Dongsian pharmaceutical coke glutamate Ronggli net capsule, Shandong Xuanzhu Medicine's Gagle net tablets are carrying out Phase III clinical, Dongsian pharmaceutical products are expected to be declared on the market in April 2021.
original title: East Sunshine Medicine, Koren... 5 1 class of new drugs, 7 new products hit, East China sprint first imitation.