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以嶺藥業(002603.SZ):化藥創新藥“G201-Na膠囊”臨牀試驗申請獲得批准
格隆匯 04-05 16:44

格隆匯4月5日丨以嶺藥業(002603.SZ)公佈,公司於2023年4月4日收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,藥物名稱為G201-Na膠囊。

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2023年1月19日受理的G201-Na膠囊符合藥品註冊的有關要求,同意本品開展臨牀試驗,具體為評價G201-Na膠囊在中國健康成年男性受試者中單次給藥的單中心、隨機、雙盲、安慰劑對照、劑量遞增的安全性、耐受性及藥代動力學的Ia臨牀研究(方案編號:G201-PC-1001)。

G201-Na膠囊項目是公司自主研發、具有獨立知識產權的1類化學新藥,其藥品分類為抗腫瘤藥物。

本品為小分子促性腺激素釋放激素(GnRH)受體拮抗劑。前列腺癌細胞的生長增殖都依賴於體內的雄激素,在男性患者體內藥物通過與垂體GnRH受體競爭性結合,抑制下丘腦-垂體-性腺軸信號傳導,減少內源性促黃體生成素(LH)和促卵泡激素(FSH)的生成和釋放,進而降低雌激素或雄激素水平,用於治療激素依賴性相關疾病,如前列腺癌等。臨牀前研究表明,G201-Na藥效確切、安全性良好,具有較高的臨牀開發價值。

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