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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
Shijiazhuang Sihua Pharmaceutical Group’s Benidipine Hydrochloride Tablets Approved
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发布时间：2025-08-25
【概要描述】
On August 25, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—benidipine hydrochloride tablets (8 mg)—received production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation, adding another new member to the company’s cardiovascular and cerebrovascular product portfolio. This marks the group’s 40th newly approved dosage-form product so far this year. To date, a total of 141 drug varieties comprising 188 specifications have either passed or are deemed to have passed the bioequivalence evaluation.
On August 25, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—benidipine hydrochloride tablets (8 mg)—received production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation, thereby adding another new member to the company’s cardiovascular and cerebrovascular product portfolio. This marks the group’s 40th new dosage-form product launched this year; to date, a total of 141 drug varieties comprising 188 specifications have either passed or are deemed to have passed the bioequivalence evaluation.
According to available information, benidipine hydrochloride tablets are a long-acting, third-generation dihydropyridine calcium antagonist indicated for primary hypertension and angina pectoris.
According to data from MeneNet, sales of benidipine hydrochloride tablets in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 560 million in 2023 and about RMB 670 million in 2024. Currently, in-hospital sales of benidipine hydrochloride tablets are showing a steady growth trend.
Previously, the active pharmaceutical ingredient benidipine hydrochloride developed by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of the Group, was approved by the National Medical Products Administration in January 2025 and is now authorized for use in marketed dosage forms. The recent approval of the Group’s benidipine hydrochloride tablets will further highlight the advantages of its integrated “API–formulation” development model.
In recent years, the Group has continuously deepened its expertise in the treatment of cardiovascular and cerebrovascular diseases, establishing product lines that include valsartan–amlodipine tablets (I), felodipine sustained-release tablets, bisoprolol–amlodipine tablets, and nifedipine sustained-release tablets (II), thereby steadily expanding and refining its portfolio of antihypertensive medications. The approval of benidipine hydrochloride tablets will benefit a greater number of patients with chronic diseases, provide more therapeutic options for those with cardiovascular and cerebrovascular conditions, and further enhance the Company’s market influence in the field of hypertension treatment.
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