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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
The 140th Product Has Passed Evaluation! Shijiazhuang Sihua Pharmaceutical Group’s Rosuvastatin Ezetimibe Tablets (I) Have Been Approved
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发布时间：2025-07-28
【概要描述】
On July 28, the Class 4 chemical drug rosuvastatin–ezetimibe tablets (I), developed and submitted for approval by Shijiazhuang Sihua Pharmaceutical Group, received production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation, making it the third such product approved in China. To date, the Group has a total of 140 drug varieties comprising 186 dosage forms that have either passed or are deemed to have passed the bioequivalence evaluation.
On July 28, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug, rosuvastatin–ezetimibe tablets (I), received production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation, making it the third such product approved in China. To date, the Group has a total of 140 drug varieties comprising 186 dosage forms that have either passed or are deemed to have passed the bioequivalence evaluation.
According to available information, Rosuvastatin Ezetimibe Tablets (I) is a fixed-dose combination formulation comprising rosuvastatin, an HMG-CoA reductase inhibitor, and ezetimibe, a selective cholesterol absorption inhibitor. This medication lowers plasma levels of total cholesterol (T-C), LDL-C, apolipoprotein B (ApoB), triglycerides (TG), and non-HDL cholesterol by inhibiting both cholesterol absorption and synthesis, while simultaneously increasing high-density lipoprotein cholesterol (HDL-C) levels, thereby improving lipid profiles. It is primarily indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH).
Previously, the Group had successively obtained approval for rosuvastatin calcium tablets (10 mg and 5 mg) and their corresponding active pharmaceutical ingredients. The recent approval of this new product further underscores the advantages of its integrated “API–formulation” development model and will help enhance the product’s market accessibility.
“The R&D of combination formulations requires overcoming significant barriers in formulation technology, placing even higher demands on a company’s technical capabilities and innovative capacity,” said the head of the Group’s R&D Center. The center will fully leverage its research strengths, collaborate with renowned universities and research institutes to establish joint innovation platforms, focus on mastering critical core technologies, and break through bottlenecks in key technological areas. At the same time, it will intensify efforts to continuously enhance the industrialization efficiency of high-end, complex formulations, thereby better meeting the health needs of the public.
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Non-Commercial (Filing) – 2025-0091