Frequent Breakthroughs in R&D and Innovation | Shijiazhuang Sihua Pharmaceutical Group’s High-End, Complex Injectable, Alprostadil Injection, Approved for Clinical Trials
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发布时间:2023-10-21
Recently, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 new chemical drug—Alprostadil Injection—received a Clinical Trial Approval Notice issued by the National Medical Products Administration, marking a more solid step forward in the group’s research and development in the field of high-end, complex formulations.
According to reports, alprostadil injection is a high-end, complex injectable formulation for which the group has obtained approval for confirmatory clinical trials. In accordance with the requirements of the National Medical Products Administration’s notice on clinical trial approval, Shijiazhuang Sihua Pharmaceutical will conduct clinical trials to evaluate the product’s efficacy in improving limb ulcers and rest pain caused by chronic arterial occlusive disease; ameliorating skin ulcers associated with diabetes, progressive systemic sclerosis, and systemic lupus erythematosus; alleviating subjective symptoms resulting from peripheral circulatory impairment due to vibration-induced vascular disorders and promoting recovery of peripheral circulatory and neuro-motor dysfunction; maintaining patency of the ductus arteriosus in ductus-dependent congenital heart disease; and enhancing the contrast-enhancing performance of specific contrast agents.
In recent years, Shijiazhuang Sihua Pharmaceutical has been driven by innovation, aligning its innovation strategy with the industrial value chain. The company has coordinated and advanced the research and development of high-end, complex generic drugs, innovative medicines, specialty APIs, pharmaceutical packaging materials, and products undergoing bioequivalence evaluation. It has also accelerated its strategic positioning in key therapeutic areas such as antivirals, antibacterials, cough and expectorant treatments, oncology, the nervous system, cardiovascular health, gastroenterology, and anesthesia, gradually establishing a systematic R&D and innovation framework for its product portfolio. Currently, the group has nearly 200 projects in development and more than 100 new products awaiting approval, with an ever-expanding pipeline of innovative achievements that provide a solid foundation and a powerful growth engine for the company’s high-quality development.
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