四環醫藥(00460.HK)：醋酸奧曲肽注射液獲頒藥品補充申請批件
格隆匯12月1日丨四環醫藥(00460.HK)宣佈，集團的醋酸奧曲肽注射液(1毫升：0.3毫克)已獲得中國國家藥品監督管理局頒發的《藥品補充申請批準通知書》，批準該藥品按已獲批通過一致性評價的規格的生產工藝進行生產。
醋酸奧曲肽爲國家醫保乙類藥品，是人工合成的天然生長抑素的八肽衍生物，較天然生長抑素半衰期明顯延長且有相同的藥理作用，包括抑制生長激素功能，抑制胃酸、胰酶、胰高血糖素和胰島素的分泌，減少內臟血流量，降低胃腸道運動等。與天然生長抑素相比，奧曲肽半衰期長，對生長激素分泌的抑制比對胰島素分泌的抑制更強，選擇性更佳，而且不引起激素的反彈性高分泌。
集團生產的醋酸奧曲肽適應症爲：(一)肝硬化所致食道—胃靜脈曲張出血的緊急治療，與特殊治療(如內窺鏡硬化劑治療)合用；(二)預防胰腺術後併發症；(三)緩解與胃腸胰內分泌腫瘤有關的症狀和體徵；及(四)經手術、放射治療或多巴胺受體激動劑治療失敗的肢端肥大症患者，可控制症狀，降低生長激素(GH)及生長素介質C的濃度，也適用於不能或不願手術的肢端肥大症患者，以及放射治療尚未生效的間歇期患者。
根據IQVIA數據，奧曲肽2019年在國內銷售額約人民幣19億元，2020年在疫情影響下銷售額爲約人民幣18億元，市場規模巨大。
公告稱，集團研發的醋酸奧曲肽注射液（1毫升：0.3毫克)該次獲得藥品補充申請批件，將有利於該藥品未來的市場銷售和市場競爭，並將進一步惠及廣大患者，對集團的經營業績產生積極影響。
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