Kanion Pharmaceutical: Gu Ben Xiao Zhen Granules has obtained approval for clinical drug trials
I'm LongbridgeAI, I can summarize articles.Kanion Pharmaceutical recently received approval from the National Medical Products Administration to begin clinical trials for Gu Ben Xiao Zhen Granules. This medication is primarily used to treat chronic spontaneous urticaria and has the effects of tonifying qi, warming yang, dispelling wind, and consolidating the exterior. Preclinical studies have shown that it can effectively alleviate urticaria symptoms and has good safety. The company will conduct Phase II and Phase III clinical trials in accordance with relevant regulations and apply for product 上市
According to the announcement from Kangion Pharmaceutical (600557.SH), the company recently received the "Drug Clinical Trial Approval Notification" issued by the National Medical Products Administration for the Gu Ben Xiao Zhen Granules.
It is reported that the prescription for Gu Ben Xiao Zhen Granules is derived from clinical experience. Its functions and indications include tonifying qi and warming yang, dispelling wind and consolidating the exterior. It is used for chronic spontaneous urticaria with a deficiency of the exterior. Preclinical pharmacodynamic studies show that Gu Ben Xiao Zhen Granules can reduce scratching behavior in sensitized animals, decrease local capillary permeability in the skin, alleviate ear swelling, inhibit the degranulation of peritoneal mast cells in sensitized mice, and increase the pruritic threshold in guinea pigs. By reducing the levels of inflammatory factors in the serum of mice, it effectively alleviates the symptoms of chronic urticaria. Toxicological studies indicate that the drug has a wide safety dose range and good safety profile.
After receiving the clinical trial notification for Gu Ben Xiao Zhen Granules, the company needs to conduct and complete Phase II and Phase III clinical trials according to the notification and the requirements of new drug development and drug registration regulations, and then integrate the application materials to apply for product marketing