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Jiudian Hongyang's API Fenofibrate Choline Approved for Marketing
Release time:
2024-10-09 00:00
Source:
On September 30th, Jiudian Hongyang's API fenofibrate choline (Y20230000419) successfully obtained the marketing approval from CDE, and its registration status was officially changed to "A".
As a lipid-regulating drug of clofibric acid derivatives, fenofibrate choline can effectively reduce lipoprotein levels, thereby reducing the risk of cardiovascular events. It can not only be used alone, but also in combination with statins to further reduce the residual cardiovascular risk, and has good safety. In addition to its excellent performance in regulating blood lipids, fenofibrate choline also has many other functions, such as effectively delaying the progression of diabetic retinopathy, improving diabetic nephropathy, reducing insulin resistance in patients with diabetes and gout, and reducing uric acid levels while lowering blood lipids. It is particularly worth mentioning that due to its unique anti-inflammatory effect, fenofibrate choline is not easy to induce acute gout attacks when lowering uric acid.
Fenofibrate choline inhibits the production of very low-density lipoprotein and triglycerides and promotes their catabolism, thereby reducing blood low-density lipoprotein, cholesterol and triglycerides; at the same time, it can also increase the production of apolipoprotein A1 and A11, thereby increasing high-density lipoprotein. Experiments have shown that the hydrophobicity of fenofibrate causes its bioavailability to be low and is greatly affected by food; on the contrary, fenofibric acid choline has a high solubility in the small intestine, which greatly increases the bioavailability of fenofibric acid, and its bioavailability is not affected by food.
With the improvement of people's living standards, changes in dietary structure, accelerates pace of life and increased pressure, the "three highs" problem is becoming increasingly serious. According to the data in the "Report on the Nutrition and Chronic Disease Status of Chinese Residents 2020", there are about 400 million people with dyslipidemia and about 100 million people with hyperlipidemia in my country, and they are showing a continuous upward trend. According to the data from Minnet, the annual sales of fenofibric acid choline preparations in public medical institutions in 2023 will reach about 500 million yuan.
The successful approval of fenofibrate choline for marketing has greatly enriched the product line of our cardiovascular system drug series, which will further enhance our core competitiveness, help build the company's advantageous position, and continuously promote performance growth. Jiudian Hongyang will also usher in a broader space for cooperation.
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