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舒泰神(300204.SZ):三諾佳邑終止STSG-0002注射液臨牀試驗及後續開發
格隆匯 12-11 17:07

格隆匯12月11日丨舒泰神(300204.SZ)公佈,公司及全資子公司北京三諾佳邑生物技術有限責任公司(簡稱“三諾佳邑”)研發的STSG-0002注射液處於Ib/II期階段。近日,基於該藥物已取得的臨牀試驗初步研究結果,並對後續開發投入等多種因素進行綜合評估後,為了合理配置研發資源、聚焦研發管線中的優勢項目,三諾佳邑決定終止STSG-0002注射液臨牀試驗及後續開發。

STSG-0002注射液是具有自主知識產權的國家I類治療用生物製品,臨牀試驗的適應症為:慢性乙型肝炎。STSG-0002注射液為攜帶靶向HBV基因組P區和X區的shRNA序列表達框的肝嗜性複製缺陷重組腺相關病毒。

根據Ia及Ib/II期臨牀試驗及長期隨訪結果顯示,STSG-0002注射液安全性和耐受性良好,未發生SAE,未發生3級以上不良事件。經與主要研究者充分溝通現有臨牀試驗數據後認為,目前觀察到的初步有效性數據未達到預期,後續受試者繼續接受試驗藥物獲益有限,為降低受試者風險,三諾佳邑和主要研究者共同決定終止該項目的相關臨牀試驗。

臨牀試驗終止後,該臨牀試驗將停止入組,已經入組的受試者將繼續按照臨牀試驗方案進行隨訪和長期隨訪,已入組受試者的權益將得到充分保障。

截至公吿日,STSG-0002注射液研發投入共計15,043.00萬元(未經審計)。

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