石藥集團(01093.HK)：1類新藥JMT103治療不可切除或手術困難的骨鉅細胞瘤關鍵臨牀試驗達到預設終點
格隆匯3月21日丨石藥集團(01093.HK)公吿，公司附屬公司上海津曼特生物科技有限公司的1類新藥JMT103用於治療不可切除或手術困難的骨鉅細胞瘤關鍵臨牀試驗達到預設終點。
JMT103為創新型全人源RANKL單克隆抗體，通過對同靶點藥物地舒單抗的結構進行優化，在增強親和力的同時簡化了生產工藝。本集團在中國開展了兩項臨牀研究(JMT103CN03和JMT103CN03-1)作為JMT103治療不可切除或手術困難骨鉅細胞瘤的關鍵臨牀試驗，用於支持該產品上市申報。
JMT103CN03研究是一項II期單臂關鍵註冊臨牀研究，評價JMT103治療不可切除或手術困難的骨鉅細胞瘤患者的有效性和安全性。整個研究共納入139例骨鉅細胞瘤受試者，主要療效指標為腫瘤反應率(基於組織學反應和12周內影像學評估結果)。
JMT103CN03-1研究是一項基於真實世界數據的回顧性研究，收集不可切除或手術困難的骨鉅細胞瘤患者接受地舒單抗或非地舒單抗治療的真實世界醫療環境的臨牀數據作為兩個外部對照組，結合JMT103CN03研究的結果，對JMT103單臂試驗組與兩個外部對照組的療效進行比較。
JMT103CN03研究結果顯示：JMT103治療不可切除或手術困難的骨鉅細胞瘤有較好的臨牀療效，腫瘤反應率高達93.5%，起效時間較快；治療後提高了可以手術切除的骨鉅細胞瘤患者比例；骨鉅細胞瘤患者疼痛程度得到緩解，生活質量得到改善。JMT103CN03-1研究結果顯示：JMT103的腫瘤反應率顯著優於非地舒單抗組，同時呈現出高於地舒單抗組的趨勢。此外，JMT103也顯示了良好的安全耐受性。基於以上研究結果， 集團已向中華人民共和國國家藥品監督管理局遞交了上市前溝通交流的申請。
集團擁有JMT103的知識產權，已在中國(包括香港和澳門)獲得專利保護。RANKL靶點的藥物於2021年在全球範圍呈現廣闊的市場前景。根據安進公司公開的年度財務報吿，2021年同靶點藥物地舒單抗在全球的銷售額為52.6億美元。
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