中國生物製藥(01177.HK)與清普生物簽署關於QP001的獨家合作協議
格隆匯3月6日丨中國生物製藥(01177.HK)發佈公吿，集團與南京清普生物科技有限公司就其研發的國家2類新藥QP001在中國大陸地區達成獨家合作協議。集團預計該產品將於近期獲中國國家藥品監督管理局批准上市。
QP001是目前唯一一款註冊分類為國家2類新藥的美洛昔康注射液，是一種長效、強效的針對術後疼痛的新型非甾體抗炎藥(NSAID)，已在中國和美國申報上市。相較於傳統非選擇性NSAIDs，QP001是一種選擇性環氧合酶-2 (COX-2)抑制劑，通過抑制炎症和疼痛部位上調的COX-2活性，減少或阻斷患處前列腺素(PGs)的合成，從而起到抗炎和鎮痛的作用，且對廣泛表達於人體各種組織並對維持正常生理功能起重要作用的環氧合酶-1 (COX-1)影響較小。
QP001單次注射即可實現24小時的持續強效鎮痛，是中國首款一日一次的長效鎮痛NSAID注射液。兩項III期臨牀研究顯示，QP001在藥效末期（即18-24小時）仍可保持顯著鎮痛效果。目前臨牀常用於術後鎮痛的注射藥物需要一日多次注射，或通過留置導管持續給藥。QP001可以有效解決給藥間隙疼痛的問題，尤其是術後住院過程的夜間疼痛，從而顯著提升患者的依從性、節約醫護資源。同時，QP001安全性優，未來輕度腎功能損傷患者、老年患者等特殊人羣也可正常使用。
目前，國內尚無用於治療術後疼痛的美洛昔康注射液。術後疼痛是臨牀最常見的急性疼痛之一，一般持續3–7天。據統計，住院手術患者的術後疼痛發生率高達91.8%，其中79.1%的患者經歷了中度、重度或極重度疼痛。2022年，中國住院病人手術超過8200萬人次。但目前國內術後鎮痛的普及率偏低，即使三級甲等醫院的鎮痛率也僅約30%4。國內外多項指南共識均推薦將NSAIDs作為術後多模式鎮痛的基石，長效NSAIDs可以進一步縮短住院時間、提高住院週轉率。QP001憑藉其安全、強效、長效的特性，有望解決術後鎮痛領域巨大的未被滿足的臨牀需求。
QP001有望接力氟比洛芬酯注射液（商品名：凱紛)成為集團鎮痛領域的下一款重磅產品，集團將依託其強大的商業化能力，全力提升藥物可及性，爭取惠及更多患者。
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