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Shijiazhuang Sihua Pharmaceutical Group Approved to Conduct Clinical Trials of Mannitol-Sorbitol Injection
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发布时间：2024-08-26
【概要描述】
On August 26, Shijiazhuang Sihua Pharmaceutical Group received from the National Medical Products Administration an approval notice for clinical trials of mannitol–sorbitol injection, paving the way for the initiation of clinical trials of this combination formulation.
On August 26, Shijiazhuang Sihua Pharmaceutical Group received from the National Medical Products Administration an approval notice for clinical trials of mannitol–sorbitol injection, paving the way for the initiation of clinical trials of this combination formulation.
According to available information, the indications for mannitol–sorbitol injection include (i) reduction of intracranial pressure and brain volume, (ii) reduction of intraocular pressure, and (iii) prevention and treatment of acute renal failure caused by intraoperative, postoperative, traumatic, or drug-induced factors through osmotic diuresis.
Both mannitol and sorbitol are osmotic diuretics; as single-agent injectable formulations, they have been marketed in China for many years and hold multiple manufacturing registration approval numbers. They are widely used in clinical practice and are classified as commonly prescribed, essential, and emergency medications. Mannitol–sorbitol injection effectively combines the clinical advantages of the two individual formulations, mannitol and sorbitol. To date, no combination formulation of mannitol–sorbitol injection has been approved for production by domestic pharmaceutical companies; Shijiazhuang Sihua Pharmaceutical Group is among the first enterprises to undertake development and testing of this product.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has taken the health needs of the people as its starting point, vigorously implemented an innovation-driven development strategy, focused on advancing complex formulations, improved new drugs, and innovative medicines, actively pursued the development of high-tech, high-barrier drugs, and continuously elevated the level of drug development while enhancing drug safety, efficacy, and accessibility.
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