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恆瑞醫藥(600276.SH):3款注射液獲得藥物臨牀試驗批准通知書
格隆匯 07-27 15:42

格隆匯7月27日丨恆瑞醫藥(600276.SH)公佈,公司及子公司蘇州盛迪亞生物醫藥有限公司、廣東恆瑞醫藥有限公司近日收到國家藥品監督管理局核准簽發關於HR17031注射液、SHR-1701注射液、SHR-1906注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

HR17031注射液是公司自主研發的基礎長效胰島素與GLP-1類似物的固定比例複方注射液,擬用於治療2型糖尿病,已獲得美國食品藥品監督管理局臨牀試驗資格,將於近期開展臨牀試驗。經查詢EvaluatePharma數據庫,2020年Xultophy100/3.6全球銷售額約為3.74億美元,Soliqua100/33全球銷售額約為1.84億美元。

截至目前,HR17031相關項目累計已投入研發費用約為1.14億元。

SHR-1701可以促進效應性T細胞的活化,同時還可有效改善腫瘤微環境中的免疫調節作用,最終有效促進免疫系統對於腫瘤細胞的殺傷。SHR-1701注射液已在中國開展多項實體瘤臨牀試驗,並在澳洲開展I期臨牀試驗。

截至目前,SHR-1701相關項目累計已投入研發費用約為1.88億元。

SHR-1906注射液通過阻斷靶蛋白與多種細胞因子、生長因子的結合,影響下游信號通路減少細胞增殖和遷移,阻斷纖維化疾病進程和惡性腫瘤進展。目前全球尚未有同類藥物獲批上市,亦無相關銷售數據。

截至目前,SHR-1906注射液相關研發項目累計已投入研發費用約為5077萬元。

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