Jiangsu Kanion Pharmaceutical (600557.SH): Guben Xiaozhen Granules receive approval for clinical drug trials.
Kangyuan Pharmaceutical (600557.SH) announced that the company has recently received the National Medical Products Administration's issuance of the Fixed Assets Destruction Notice.
Jiangsu Kanion Pharmaceutical (600557.SH) announced that the company recently received the Drug Clinical Trial Approval Notice for Guben Xiezhen Granules issued by the National Medical Products Administration.
It is reported that the prescription of Guben Xiezhen Granules is based on clinical experience. Its main function is to tonify Qi and warm Yang, expel wind and solidify the surface. It is used for chronic spontaneous urticaria with the symptom of weakness in the surface. Pre-clinical pharmacological studies have shown that Guben Xiezhen Granules can reduce scratching behavior in sensitized animals, decrease local skin capillary permeability, alleviate ear swelling, inhibit degranulation of mast cells in sensitized mice, and increase the pruritus threshold in guinea pigs. By reducing the levels of inflammatory factors in mouse serum, it effectively relieves symptoms of chronic urticaria. Toxicological studies have shown that this drug has a wide range of safe doses and good safety.
After receiving the clinical trial notification for Guben Xiezhen Granules, the company will conduct and complete Phase II and Phase III clinical trials in accordance with the notification and requirements of the new drug development and drug registration regulations, and then submit the integrated application materials for product approval for market launch.
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