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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
“Innovative ‘API + Formulation’ Approach Yields Substantial Results: Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Two APIs—Dihydroxypropylxanthine and Acipimox”
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发布时间：2025-04-23
【概要描述】
Continuous innovation and steady accumulation ultimately lead to breakthroughs. On April 22, following the approval of three new products—dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g)—Shijiazhuang Sihua Pharmaceutical Group saw its subsidiary, Hebei Guangxiang Pharmaceutical Co., Ltd., successfully take over and secure approval on the same day for two active pharmaceutical ingredients it had developed and submitted: theophylline dihydrate and acipimox. This marks another significant achievement in the company’s pursuit of integrated development across both API and formulation segments.
Continuous innovation and steady accumulation ultimately lead to breakthroughs. On April 22, following the approval of three new products—dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g)—Shijiazhuang Sihua Pharmaceutical Group saw its subsidiary, Hebei Guangxiang Pharmaceutical Co., Ltd., successfully take up the mantle: two active pharmaceutical ingredients—dihydroxypropylxanthine and acipimox—developed and submitted for approval were also approved on the same day, marking another significant achievement in the company’s pursuit of integrated “API-plus-formulation” development.
According to available information, theophylline dihydrate is indicated for relieving wheezing symptoms in bronchial asthma, asthmatic bronchitis, and obstructive emphysema, and may also be used for wheezing caused by cardiogenic pulmonary edema. Acipimox can be employed as either monotherapy or adjunctive therapy to reduce triglyceride levels in patients whose response to other treatments, such as statins or fibrates, is inadequate; it is indicated for the following conditions: hypertriglyceridemia (Fredrickson type IV hyperlipoproteinemia) and combined hypercholesterolemia and hypertriglyceridemia (Fredrickson type IIb hyperlipoproteinemia).
To date, the Group has received approval for a total of 74 bulk and specialty APIs, with Guangxiang Pharmaceutical accounting for 43 of these approvals. Previously, Acipimox Capsules were approved for registration in February 2025. The recent approval of the Acipimox API will further enhance the Group’s integrated “API-plus-formulation” product portfolio, providing robust assurance for subsequent market commercialization.
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Non-Commercial (Filing) – 2025-0091