Qilu Pharmaceutical Launches First Domestic BE Trial for Dolutegravir Sodium Tablets

On December 6, Qilu Pharmaceutical Co., Ltd. initiated the BE trial for its "Dolutegravir Sodium Tablets." This marks the first generic Dolutegravir in China to enter clinical trials.

Source: Insight Database (http://db.dxy.cn/v5/home/)

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

According to the Insight database, currently, there are three combination formulations of Dolutegravir approved for marketing globally, in addition to the single-agent form. The highest-selling formulation is the triple-combination drug Triumeq, which achieved global sales of $2.98 billion in 2020; while the sales of Dolutegravir as a single agent (Tivicay) declined somewhat in 2020, it still reached $1.973 billion. Both ranked among the top 100 drugs globally by sales in 2020.

Global Sales of Dolutegravir-related Drugs

Trend of Dolutegravir Sales Over the Years

Source: Insight Database (http://db.dxy.cn/v5/home/)

Currently, apart from Qilu Pharmaceutical Co., Ltd., no other company has declared the initiation of clinical trials for generic Dolutegravir.

Qilu Pharmaceutical not only intensifies its efforts in biologic innovative drugs recently, but also maintains its leading position in traditional generic drugs with extremely fast progress. Qilu has obtained the first generic version of CDK4/6 inhibitor Palbociclib, and at the end of October, it was also the first to submit the marketing application for Olaparib generic drug, which is currently the only Olaparib generic drug submitted for marketing. Other companies under research only started BE clinical trials in July and September this year.