On September 9, according to the China Drug Evaluation Database by PharmaOcean,Qilu PharmaceuticalGeneric Drug Category 4 Applicationω-3 Fatty Acid Ethyl Esters 90 Soft CapsulesApproved for production and considered to have passed the evaluation, making it the 4th Chinese manufacturer to pass the evaluation for this drug variety. This is an oral lipid-lowering medication, with sales in China's hospital market exceeding 3 million yuan in 2023.

ω-3 Fatty Acid Ethyl Esters 90 Soft CapsulesThe main active ingredients are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) extracted from fish oil.Can reduce the synthesis of triglycerides in the liver, and is suitable for lowering triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500mg/dL) on the basis of dietary control.It has been marketed for many years in numerous countries and regions worldwide, accumulating over a decade of clinical application experience. According to the PharmaOcean database,ω-3 Fatty Acid Ethyl Esters 90 Soft CapsulesSales in the Chinese hospital market exceeded 3 million yuan in 2023, with a year-on-year increase of 539.41%.

According to the PharmaOcean database, the original research manufacturer'sω-3 Fatty Acid Ethyl Esters 90 Soft CapsulesApproved to enter the Chinese market in April 2022. Currently, four pharmaceutical companies have received approval for this product in the Chinese market: Qilu Pharmaceutical, Sichuan Guowei Pharmaceutical, Chengdu Shengdi Pharmaceutical, and Renfu Puke Pharmaceutical (Wuhan). Among them, Sichuan Guowei Pharmaceutical was the first to receive approval for this product, and this time, Qilu Pharmaceutical is the fourth.

Screenshot source:PharmCube Approved Drugs Summary Database

In terms of generic drug布局, currently, five pharmaceutical companies—Beijing SL Pharm, Yangtze River Pharmaceutical, Jiangsu Wango Pharmaceutical, Xinchang Pharmaceutical Factory of Zhejiang Medicine Co., Ltd., and Wenzhou Haihe Pharmaceutical—have submitted Class 4 generic applications, all of which are under review.

From 2024 to present, Qilu Pharmaceutical(Including Subsidiaries)Thirty-five varieties have passed the evaluation, including cardiovascular system drugs.Carvedilol Tablets, ω-3 Fatty Acid Ethyl Ester 90 Soft Capsules, Macitentan TabletsThree varieties.Qilu Pharmaceuticalω-3 Fatty Acid Ethyl Esters 90 Soft CapsulesThe approval and market launch further enriches Qilu Pharmaceutical's cardiovascular product pipeline, providing more treatment options for patients with high triglyceride levels and further improving drug accessibility.

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