First Generic Drug! Qilu Pharmaceuticals’ 'Dolutegravir' Submission Approved

On April 24, the CDE official website showed that Qilu Pharmaceutical's "dotegravir sodium tablet" application for listing was accepted. Dolutegravir is an anti-AIDS drug, and Qilu is the first in China to declare it this time.

Dolutegravir (DTG) is an anti-AIDS drug developed by GlaxoSmithKline/ViiV, which is an integrase inhibitor. In 2015, dolutegravir tablets were approved for marketing in China, and in 2020, GSK submitted an application for the marketing of dispersible tablets, which is currently under review and approval.

According to the Insight database, there are currently 3 combination preparations of Dolutegravir that have been approved for the market in addition to single drugs worldwide. The highest sales are the triple preparation Triumeq, with global sales reaching US$2.980 billion in 2020; while the sales of Dolutegravir single drug Tivicay in 2020 have declined, reaching US$1.973 billion, both ranking in 2020. Ranked among the top 100 pharmaceuticals by annual global sales.

Currently, apart from Qilu, no other company has declared to initiate clinical trials of generic drugs of dolutegravir.

Qilu Pharmaceutical has not only stepped up efforts to develop innovative biological drugs recently, but also has maintained its status as the king of traditional generic drugs, and the speed of advancement is extremely fast. The first copy of the CDK4/6 inhibitor palbociclib was extracted by Qilu. In October last year, it was also the first to submit a generic drug application for olaparib. This year, riociguat and roprostim were all domestically produced. The first, and few other enterprise layouts.