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綠葉製藥(02186.HK):米美欣(羥考酮納洛酮緩釋片)在中國獲批上市
格隆匯 07-04 19:04

格隆匯7月4日丨綠葉製藥(02186.HK)公吿,集團鎮痛領域新產品-米美欣(羥考酮納洛酮緩釋片,LY021702)已於2024年6月28日獲得中國國家藥品監督管理局的上市批准,適用於成人需阿片類鎮痛藥才能充分控制的重度疼痛(癌痛和非癌痛)。其優勢是加入阿片受體拮抗劑納洛酮,通過阻斷羥考酮對腸道阿片受體的作用來緩解阿片類藥物引起的便祕(opioid-induced constipation,OIC)症狀。中國對於麻醉藥品和精神藥品的研製和生產具有嚴格的管理制度,研製和定點生產企業的資質均需經過批准且實行總量控制,准入門檻高。

米美欣是當前唯一一款在國內獲批上市、具有高技術壁壘的國產羥考酮納洛酮緩釋片。米美欣在幫助患者控制疼痛的同時,有效降低阿片類藥物引起的便祕,單次用藥鎮痛時間可維持12小時;此外,米美欣的獨特鎖藥技術可有效防止藥物濫用。

米美欣是羥考酮納洛酮的口服緩釋複方製劑,通過強阿片受體激動劑羥考酮發揮鎮痛作用,且由於納洛酮的口服生物利用率低,在不影響鎮痛效果的同時,可通過直接與胃腸道阿片受體結合對抗羥考酮引起的便祕。大量臨牀研究結果表明:與單方羥考酮緩釋製劑相比,羥考酮納洛酮緩釋複方製劑在規定的同等劑量下鎮痛療效相當,且可顯著改善腸道功能紊亂,降低OIC的發生率與嚴重程度。此外,《NCCN成人癌痛臨牀實踐指南(2024.V2)》、《ESMO成人癌痛管理臨牀實踐指南》均指出:羥考酮納洛酮緩釋複方製劑可顯著緩解長期應用阿片類藥物治療的癌痛患者的OIC。

公司相信,米美欣解決了當前的臨牀需求,在中國具備良好的市場潛力。同時,該產品可與集團的抗腫瘤產品形成豐富的產品組合,並協同腫瘤領域現有的資源與優勢,加速推動公司在該領域佈局和發展。

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