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賽升藥業(300485.SZ):1.1類創新藥HM-3獲得醫學倫理委員會審查批件
格隆匯 04-29 11:55

格隆匯4月29日丨賽升藥業(300485.SZ)公佈,近日,公司研製的“安替安吉肽(HM-3)”獲得醫學倫理委員會審查批件。該藥品適應症為肺癌、胃癌等實體腫瘤治。

該項目此次取得醫學倫理委員會審查批件將開展HM-3單次和多次給藥在晚期實體瘤患者中安全性、耐受性、藥代動力學與初步療效的單中心、開放的劑量遞增Ia期臨牀試驗,方案已經通過審核確定。該項目尚需通過Ia、Ib期臨牀、II期、III期臨牀研究並經國家藥品審評部門審批通過後方可上市。

“HM-3(安替安吉肽)”產品是具有整合素親和性的高效血管抑制劑合成多肽,單獨使用或聯合用藥可以有效抑制人的肺癌、肝癌和胃癌的發生和發展,該產品生物活性顯著,能有效抑制人的非小細胞肺癌、肝癌、胃癌增殖,還能夠顯著抑制黑色素瘤及乳腺癌的轉移;HM-3是公司研發的化學1.1類創新藥,國內外尚無同類產品上市。

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