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Shijiazhuang Sihua Pharmaceutical Group’s Two New Products—Tranexamic Acid Tablets and Acipimox Capsules—Approved on the Same Day

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Honors Announcement

发布时间：2025-02-25

【概要描述】 Innovation Bears Fruit, Spring Breezes Bring Good News. On February 25, two Class 4 chemical drugs developed by Shijiazhuang Sihua Pharmaceutical Group—tranexamic acid tablets (0.5 g) and acipimox capsules (0.25 g)—received simultaneous approval for registration from the National Medical Products Administration and were deemed to have passed the bioequivalence evaluation. Notably, the tranexamic acid tablets represent the third such approval nationwide, while the acipimox capsules mark the fourth. To date, a total of 117 drug varieties comprising 155 dosage forms have either passed or been deemed to have passed the bioequivalence evaluation.
Shijiazhuang Sihua Pharmaceutical Group’s Two New Products—Tranexamic Acid Tablets and Acipimox Capsules—Approved on the Same Day
Shijiazhuang Sihua Pharmaceutical Group’s Two New Products—Tranexamic Acid Tablets and Acipimox Capsules—Approved on the Same Day
Innovation Bears Fruit, and the Spring Breeze Brings Good News. On February 25, two Class 4 chemical drugs developed by Shijiazhuang Sihua Pharmaceutical Group—tranexamic acid tablets (0.5 g) and acipimox capsules (0.25 g)—were simultaneously approved for registration by the National Medical Products Administration and are deemed to have passed the consistency evaluation. Notably, the tranexamic acid tablets represent the third approval nationwide, while the acipimox capsules mark the fourth. To date, a total of 117 drug varieties comprising 155 dosage forms have either passed or are deemed to have passed the consistency evaluation.
According to available information, tranexamic acid tablets (0.5 g) are a potent antifibrinolytic agent that exerts hemostatic effects by inhibiting fibrinolysis. They are primarily indicated for various types of bleeding caused by acute or chronic, localized or systemic primary hyperfibrinolysis. Data from MeneNet show that in 2023, sales of this product across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 160 million, with sales reaching RMB 81.98 million in the first half of 2024.
Acipimox capsules (0.25 g) are a nicotinic acid derivative that significantly reduces triglyceride levels by inhibiting lipolysis and decreasing very-low-density lipoprotein (VLDL) synthesis. They can be used as monotherapy or adjunctive therapy to lower triglyceride levels in patients whose response to other treatments, such as statins or fibrates, is inadequate, primarily for hypertriglyceridemia (Fredrickson type IV hyperlipoproteinemia) and combined hypercholesterolemia and hypertriglyceridemia (Fredrickson type IIb hyperlipoproteinemia). According to data from MeneNet, the product recorded sales of RMB 86.9 million in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—in 2023, with sales reaching RMB 46.76 million in the first half of 2024.

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