Qilu Pharmaceutical's Empagliflozin Tablets Approved for Market Launch in China

Recently, Qilu Pharmaceutical's Empagliflozin Tablets have been approved for marketing by the National Medical Products Administration and are considered to have passed the consistency evaluation. So far, Qilu Pharmaceutical has a total of 151 products that have passed or are considered to have passed the consistency evaluation, of which 54 are the first in China.

China is one of the countries with the fastest-growing prevalence of diabetes. According to data from the 2020 edition of the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes," the prevalence of diabetes in China is as high as 11.2%, making it one of the chronic diseases that severely affect people's health.

Sodium-glucose cotransporter 2 (SGLT-2) is the primary transporter responsible for reabsorbing glucose from the glomerular filtrate into the bloodstream. Empagliflozin, a new-generation SGLT-2 inhibitor, reduces glucose reabsorption in the kidneys, lowers the renal glucose threshold, and promotes glucose excretion through urine. It is used for the treatment of type 2 diabetes and can be combined with other hypoglycemic agents to achieve a synergistic effect. Extensive clinical studies have confirmed that empagliflozin tablets provide dual cardiovascular and renal benefits for patients with diabetes, making it one of the preferred treatments for type 2 diabetes patients with comorbid cardiovascular disease.

As a drug that many diabetes patients in China need to use for life, the price of the original research product is relatively high, which brings a certain economic burden to patients while treating their condition. In order to reduce the medication costs for patients, improve their quality of life, and provide them with equally effective and safe but more affordable treatment options, Qilu Pharmaceutical Co., Ltd. decided to initiate the development of this product.

The R&D team, with the ultimate goal of developing high-quality drugs, followed the regulatory requirements and relevant guidelines for generic drug development both in China and internationally. They scientifically designed research protocols, overcame technical challenges at every stage, and pursued perfection. They successfully developed an easily industrialized Empagliflozin API and formulation process. A systematic pharmaceutical comparative study was conducted between the self-produced product and the originator drug, and it passed the human bioequivalence test, ensuring that the quality and efficacy of the self-produced product are consistent with those of the originator drug.

Over the years, Qilu Pharmaceutical has actively laid out its strategy in the hypoglycemic drug field. Currently, it has several hypoglycemic drugs on the market, such as Metformin Hydrochloride Tablets, Saxagliptin Tablets, Linagliptin Tablets, and Linagliptin Metformin Tablets. In the future, more hypoglycemic drugs will be launched successively, continuously enriching the product pipeline to meet the clinical treatment needs of different diabetic patients.

Editor: Mu Mian

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