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昆药集团(600422.SH):碳酸司维拉姆干混悬剂药物上市许可申请获受理

Kunming Pharmaceutical Group (600422.SH): Application for marketing licensing of sevilamycin carbonate suspensions accepted

Gelonghui Finance ·  Jan 4 17:07

On January 4, Ge Longhui Pharmaceutical Group (600422.SH) announced that its wholly-owned subsidiary Kunming Beck Norton Pharmaceutical Co., Ltd. recently received the “Notice of Acceptance” issued by the State Drug Administration, and the company's drug marketing license application for sevilamgane carbonate suspension was accepted by the State Drug Administration.

Sevelam carbonate tablets were developed by Genzyme and first approved for marketing in the US in 2007; later, the company developed dry suspensions and were approved for marketing in the US and the European Union in 2009, respectively, for the control of hyperphosphatemia in patients with chronic kidney disease. Compared to sevelam carbonate tablets, dry suspensions are more suitable for adult and pediatric patients who have difficulty swallowing. According to data from the State Drug Administration, sevilam carbonate tablets have been approved for marketing in China, and no manufacturers of dry suspensions have been approved for marketing.

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