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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
Attention! Domestic substitution achieved for infusion tubing; Shijiazhuang Sihua Pharmaceutical Group’s physiological saline solution “revamped” receives approval.
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发布时间：2026-03-14
【概要描述】
On March 13, Shijiazhuang Sihua Pharmaceutical Group’s sodium chloride injection (3000 ml: 27 g) submitted a related application that designated the three-layer co-extruded infusion tubing manufactured by its subsidiary, Jiangsu Bosheng Medical New Materials Co., Ltd., as the pharmaceutical packaging material, and subsequently received formal approval from the National Medical Products Administration in the form of a supplemental drug application. This approval signifies that the critical pharmaceutical packaging material associated with this product—the three-layer co-extruded infusion tubing—has, for the first time, achieved domestic substitution.
On March 13, Shijiazhuang Sihua Pharmaceutical Group’s sodium chloride injection (3000 ml: 27 g) submitted a linked application that designated the three-layer co-extruded infusion tubing manufactured by its subsidiary, Jiangsu Bosheng Medical New Materials Co., Ltd., as the pharmaceutical packaging material, and subsequently received formal approval from the National Medical Products Administration in the form of a supplementary drug application. This approval signifies that the critical pharmaceutical packaging material associated with this product—three-layer co-extruded infusion tubing—has now been successfully localized and substituted with a domestically produced alternative.
Due to the stringent requirements and standards for safety, stability, and clinical application associated with large-volume infusion products such as flush solutions and dialysate, high-performance infusion bag tubing has historically relied heavily on imports, creating a critical bottleneck that has constrained the development of the domestic industry in this field.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has focused on market needs and its own development objectives, vigorously advancing an integrated “API–formulation–pharmaceutical packaging” strategy, continuously accelerating product iteration and upgrading, and promoting synergistic development across the industry chain. Through independent innovation, the Group has adopted a medical-grade material system and a three-layer co-extrusion structure, with functionally tailored formulations developed for the outer, middle, and inner layers. This approach has effectively addressed key technical challenges, including product stability, PC-interface connectivity, and seal integrity after high-temperature sterilization, leading to the successful development of a three-layer co-extruded tubing for infusion bags and achieving domestic substitution for critical pharmaceutical packaging materials. The innovation has significantly enhanced the safety of infusion products while also offering strong potential for industrial expansion.
The approval of this sodium chloride injection–associated infusion tubing underscores the Group’s groundbreaking, independently developed innovations in the pharmaceutical packaging materials sector. Not only does it ensure independent control over high-end infusion soft tubing, thereby significantly enhancing product competitiveness and accessibility, but it also provides robust assurance for supply-chain security in the large-volume parenteral solutions industry.
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Non-Commercial (Filing) – 2025-0091