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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
Continuous New Product Launches: Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Four New Products—Formulation (Lincomycin Hydrochloride Injection) and Active Pharmaceutical Ingredients (Fenofibrate, Fenofibric Acid Choline, and Sodium Levofloxacin Phosphate)—on the Same Day
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发布时间：2025-11-04
【概要描述】
On November 3, Shijiazhuang Sihua Pharmaceutical Group received approval on the same day for four new products spanning both active pharmaceutical ingredients and finished dosage forms. Since the beginning of this year, the company has secured approval for a total of 79 new products, surpassing last year’s figure for the same period.
On November 3, Shijiazhuang Sihua Pharmaceutical Group received approval on the same day for four new products spanning both active pharmaceutical ingredients and finished dosage forms, bringing the total number of newly approved products this year to 79—exceeding the figure for the same period last year.
These approved formulations and active pharmaceutical ingredients include: Lincomycin Hydrochloride Injection (2 mL: 0.6 g), which has been approved following the evaluation of generic drug quality and therapeutic equivalence; and three active pharmaceutical ingredients—fenofibrate, fenofibric acid choline, and sodium levoornidazole phosphate dihydrate—developed by the Group’s Hebei Guangxiang Pharmaceutical Co., Ltd., which have been registered as APIs for use in marketed formulations.
According to reports, Lincomycin Hydrochloride Injection (2 mL: 0.6 g) is a lincosamide antibiotic indicated for severe infections caused by susceptible strains such as streptococci, pneumococci, and staphylococci; however, it is reserved for patients who are allergic to penicillin or for whom penicillin is contraindicated as determined by a physician. Fenofibrate is primarily used as a lipid-lowering agent; choline fenofibrate is indicated for the treatment of severe hypertriglyceridemia and primary hypercholesterolemia; and sodium levoornidazole phosphate is indicated for the treatment of severe intestinal and hepatic amebiasis, for the management of postoperative infections caused by anaerobic bacteria susceptible to ornidazole, and for the prevention of infections due to susceptible anaerobic bacteria following surgical procedures.
In recent years, the Group has closely aligned its strategies with industry development and market demand, continuously deepening its integrated innovation framework of “APIs + formulations.” This approach has effectively promoted the specialization of product portfolios, the consolidation of industrial clusters, the greening of manufacturing processes, and the diversification of distribution channels, thereby achieving deep integration and synergistic collaboration between the Group’s formulation and API businesses. As a result, the Group has secured robust dual-engine momentum to accelerate its growth.
To date, the Group has a total of 156 drug varieties and 207 dosage forms that have either passed or are deemed to have passed the Consistency Evaluation for Quality and Therapeutic Equivalence of Generic Drugs. In addition, the Group holds 87 marketing approvals for active pharmaceutical ingredients, and its continuously expanding product portfolio continues to inject new momentum into the Group’s efforts to accelerate industrial transformation and upgrading and pursue development through innovation.
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Non-Commercial (Filing) – 2025-0091