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上海醫藥(02607.HK):SPH8216(TK216)注射液獲得 II 期臨牀試驗批准通知書
格隆匯 04-27 17:11

格隆匯 4 月 27日丨上海醫藥(02607.HK)公佈,近日,公司以及全資子公司 Shanghai Pharmaceutical(USA) Inc.(以下簡稱"上藥美國")開發的"SPH8216(TK216)注射液"(以下簡稱"該項目")收到國家藥品監督管理局(以下簡稱"國家藥監局")核准簽發的《藥物臨牀試驗批准通知書》,將於近期啟動國內 II 期臨牀試驗,該項目為美國 OncternalTherapeutics, Inc.(以下簡稱"Oncternal")公司開發。

據悉,SPH8216(TK216)注射液是一種 first-in-class 小分子藥物,具有抑制尤文氏肉瘤細胞增殖、促進細胞凋亡的腫瘤治療效果。在美國進行的該項目治療復發或難治性尤文氏肉瘤患者的臨牀研究中,該項目表現出良好的耐受性和安全性。FDA 已授予該項目孤兒藥稱號,並批准該項目獲得快速審批通道資格。2020 年10 月,FDA 授予該項目治療尤文氏肉瘤兒童罕見病資格。

2018 年 9 月,上藥美國通過參股 Oncternal,獲得該項目在中國開發和商業化的獨家權益。2021 年 2 月,該項目遞交的臨牀試驗申請獲得國家藥監局正式受理。近日,該項目獲得國家藥監局核准簽發《藥物臨牀試驗批准通知書》,同意按照已提交的方案開展新藥臨牀試驗。

截至目前,該項目公司已累計投入研發費用約 671.7 萬元人民幣。

根據我國藥品註冊相關的法律法規要求,該項目在獲得臨牀試驗通知書後,還需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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