麗珠醫藥(01513.HK)：司美格魯肽注射液境內生產藥品註冊臨牀試驗獲藥監局受理
格隆匯9月14日丨麗珠醫藥(01513.HK)公佈，近日，公司控股附屬公司麗珠集團新北江製藥股份有限公司收到國家藥品監督管理局下發的《受理通知書》，新北江製藥申請的司美格魯肽注射液的境內生產藥品註冊臨牀試驗獲藥監局受理。
司美格魯肽注射液歷經2年研發，活性成分司美格魯肽（Semaglutide）為胰高血糖素樣肽-1（GLP-1）受體激動劑，屬多肽類物質，主鏈有31個氨基酸，並帶有脂肪側鏈，是天然GLP-1進行改造得來，與人GLP-1具有94%的同源性。GLP-1受體激動劑（GLP-1RA）能夠通過模擬生理性GLP-1激活其受體，以葡萄糖依賴性的方式增強胰島素分泌、抑制胰高血糖素分泌。此外，司美格魯肽還可通過延遲餐後胃排空從而降低血糖。
本品是一種新型長效胰高血糖素樣肽-1受體激動劑，適應症為：用於在飲食控制和運動基礎上，接受二甲雙胍和/或磺脲類藥物治療血糖仍控制不佳的成人2型糖尿病患者的血糖控制，及降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件（心血管死亡、非致死性心肌梗死或非致死性卒中）風險。本品為預充式注射筆，皮下注射，起始劑量為每週0.25mg；在4周後，劑量應增加至每週0.5mg；如果需要進一步控制血糖，再至少4周後可將劑量增加至每週1mg。
截至本公吿披露日，司美格魯肽注射液研發累計直接投入的金額為人民幣3,130.96萬元。根據藥監局及藥品審評中心網站數據庫顯示，截至本公吿披露日，司美格魯肽注射液目前國內僅有原研1家產品上市，未見其他廠家獲批臨牀試驗。根據IQVIA抽樣統計估測數據，2020年糖尿病用藥國內終端銷售金額為人民幣346.09億元，其中GLP-1激動劑藥物2018年-2020年的國內終端銷售金額分別為人民幣3.48億元、6.80億元及9.95億元。
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