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On September 28, CDE's official website showed that Hengrui had submitted an application for the listing of a new class of drugs, "Reglitin Phosphate Tablets", which had been approved.
is a DEP-4 inhibitor developed by Hengrui for the treatment of type 2 diabetes.
The drug was approved as early as 2009 clinical, in 2015 Hengrui had submitted a listing application, but due to the company in accordance with NMPA requirements for clinical self-examination, found data normative problems, the initiative to withdraw the application;
public figures show that Reglitin is similar to Sigletin in the structure listing, and it is understood that Henri has invested more than 100 million yuan in research and development when it voluntarily withdrew in 2015.
, in 2016, Henri re-launched the Reglitin clinical trial, which has so far registered 23 clinical trials in the CED.
from: Insight Database () DPP-4 inhibitors are heavyweights in the field of sugar-lowering drugs.
, a total of 5 DPP-4 inhibitors have been approved for market, all foreign research and development, and domestic generic drugs have been approved.
Deadline: September 28, 2020 According to public data, in 2019, China's public medical institutions terminal oral sugar sales exceeded 28.5 billion yuan, an increase of 15.01% YoY;
2019, its public health facilities terminal sales exceeded 2.1 billion yuan, of which Sigredin was the largest, with sales of nearly 1 billion yuan.
, although a number of DPP-4 inhibitor-type anti-sugar drugs have been approved in China, including generic drugs, there are still many enterprises layout DPP-4 new drugs.
According to Insight database statistics, the new drugs currently entering Phase II and III also include Xinlitai's compound gretin, Sheng Gretin of Shengshiteko, DBPR108 of Stone Pharmaceutical Group, Yuglitin of Chengdu Yuandong Bio and TQ-F3083 of Zhengda Tianqing.
from: Insight Database ()