Jiangsu Kanion Pharmaceutical (600557.SH): Total flavonoids of Epimedium Capsules approved for clinical trials for vascular dementia indications.
Health Edge Pharmaceuticals (600557.SH) announced that its holding subsidiary, Jiangsu Health Edge Sunshine Pharmaceuticals Co., Ltd. ("...
Jiangsu Kanion Pharmaceutical (600557.SH) announced that its controlling subsidiary, Jiangsu Kangyuan Yangguang Pharmaceutical Co., Ltd. ("Kangyuan Yangguang"), recently received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for the indication of vascular dementia for Epimedium Flavonoids Capsules.
It is reported that Epimedium Flavonoids Capsules were approved for marketing in 2014 and are an exclusive variety of Kangyuan Yangguang, a subsidiary of the company, belonging to the category of protected traditional Chinese medicine. The newly added indication for vascular dementia (VaD) refers to a disease characterized by cognitive impairment caused by cerebrovascular diseases (such as ischemic stroke, hemorrhagic stroke). Pharmacological studies have shown that Epimedium Flavonoids Capsules can significantly improve cognitive impairment and depressive symptoms, reduce white matter lesions and demyelination, promote remyelination, reduce neuronal loss in gray matter (cerebral cortex, hippocampus), enhance synaptic plasticity, improve behavioral changes caused by cognitive impairment, and improve the extent of brain tissue lesions. Toxicological studies have shown that the drug has a wide safety dose range and good safety profile. As of now, the company has invested approximately 2.15 million yuan in the cumulative research and development of the newly added indication for Epimedium Flavonoids Capsules.
Upon receiving the clinical trial notice for Epimedium Flavonoids Capsules, the company is required to conduct and complete Phase II and Phase III clinical trials in accordance with the notice and the requirements of new drug development and drug registration regulations, and then submit the integrated application materials to apply for a drug registration certificate.
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