綠葉製藥(02186.HK):CDE正式受理新藥LY09606臨牀試驗申請
格隆匯 3 月 7日丨綠葉製藥(02186.HK)發佈公吿,集團的2類新藥鹽酸羅哌卡因脂質體混懸注射液(“LY09606”)臨牀試驗申請,已獲中國國家藥品監督管理局藥品審評中心(“CDE”)正式受理。
羅哌卡因是第一個純左旋體長效醯胺類局麻藥,有麻醉和鎮痛雙重效應,大劑量可產生外科麻醉,小劑量時則產生感覺阻滯(鎮痛)僅伴有侷限的非進行性運動神經阻滯。LY09606是一種包載羅哌卡因的多囊脂質體制劑,其獨特的多囊結構對於包載的藥物具有良好的緩釋效應,而這是國內首個申報臨牀的羅哌卡因多囊脂質體注射液,可用於手術後鎮痛。多囊脂質體的製備技術要求高,工藝難度大,顯示集團在脂質體研發和製造領域的關鍵技術能力。
全球每年有超過3億手術患者,羅哌卡因為局部麻醉藥的常規用藥。根據IQIVA資料,局部麻醉藥在2019年於中國市場規模達到23.6億元人民幣,從2017年至2019年以23.3%的年複合增長率上升。
公吿表示,集團重視脂質體制劑的研發和生產,建成了新型脂質體平台、高端載體材料平台、產業化研究平台等多個新技術平台。集團脂質體研發平台被納入長效和靶向製劑國家重點實驗室。集團已建成智慧化的脂質體生產線,產業化能力持續提升。
集團脂質體平台已取得多項重要成果。注射用紫杉醇脂質體是目前全球首個及唯一獲批上市的紫杉醇脂質體產品,用於治療非小細胞肺癌、卵巢癌、乳腺癌。鹽酸伊立替康脂質體注射液(“LY01610”)處於中國臨牀II期階段;伊立替康氟脲苷脂質體注射液(“LY01616”)已在中國拿到臨牀批准,即將開展臨牀研究。除此之外,集團多項脂質體產品處於臨牀前研究階段。董事會相信,LY09606將進一步豐富集團中樞神經領域的產品線,從而持續推進集團在中樞神經領域的發展。
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