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迪哲醫藥(688192.SH):DZD8586獲得藥物臨牀試驗批准通知書
格隆匯 01-05 18:09

格隆匯1月5日丨迪哲醫藥(688192.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的關於DZD8586的《藥物臨牀試驗批准通知書》,同意批准在中國境內開展復發難治性B細胞非霍奇金淋巴瘤(NHL)的臨牀試驗。公司將盡快在中國境內啟動復發難治性B細胞非霍奇金淋巴瘤(NHL)的I期臨牀試驗。

DZD8586是公司自主研發的一種口服、高選擇性、可穿透血腦屏障的小分子靶向藥物,是公司基於轉化科學核心技術平台研發出來的一款全球創新藥,用於治療腫瘤及其它重要疾病,現已獲得國家藥監局批准開展復發難治性B細胞非霍奇金淋巴瘤(NHL)的臨牀試驗。臨牀前研究顯示,DZD8586各項成藥指標都達到設計預期,具有良好的安全性和穿透血腦屏障的能力,可以有效抑制B細胞非霍奇金淋巴瘤細胞的生長。DZD8586已於2021年10月獲得美國FDA臨牀試驗許可,正在美國開展健康受試者的臨牀試驗。

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