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和鉑醫藥-B(02142.HK)完成特那西普(HBM9036)臨牀三期試驗首次期中分析
格隆匯 01-13 17:09

格隆匯1月13日丨和鉑醫藥-B(02142.HK)公吿,公司在研產品特那西普(HBM9036)在中國的三期註冊臨牀試驗已完成首次期中分析。特那西普(HBM9036)是一款全球創新型的針對成年中重度乾眼(DED)患者的腫瘤壞死因子(TNF)受體-1片段型藥物。本次試驗計劃入組674例受試者,並在試驗過程中進行兩次期中分析。

截至2021年12月28日,該試驗共187例受試者完成關鍵療效終點評估,根據試驗方案進行了首次期中分析,並由獨立數據監察委員會("IDMC")對期中數據進行審閲。基於觀察到的療效趨勢和良好的安全性,IDMC建議試驗按現行方案繼續進行。截至公吿日期,對公司而言,該試驗參與者藥物或安慰劑給藥情況仍屬盲態。

特那西普(HBM9036)是一種經過分子工程改造的TNF受體-片段,分子量僅為19kDa,被開發成滴眼液眼科局部用藥,用於緩解乾眼症狀,具有眼部滲透性良好、TNF-α中和活性強、穩定性高、副作用小、使用舒適度高等特點。該產品由HanAllBiopharma開發,根據雙方授權許可協議,和鉑醫藥擁有特那西普在中國大陸、台灣、香港和澳門的獨家開發和商業化權利。

乾眼症是多種因素引起的慢性眼表疾病,可造成視力障礙以及眼表長期損害,嚴重影響生活品質。目前我國乾眼發病率據估計已達到21%-30%。隨着全球人口老齡化加重、智能手機過度使用以及環境變化等因素,乾眼症的發病率仍將大幅增長。國內治療乾眼症主要依靠人工淚液緩解症狀,存在着巨大的未滿足的臨牀需求。

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