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雲南白藥(000538.SZ):雲核醫藥的INR102注射液獲得藥物臨牀試驗批准
格隆匯 04-08 17:39

格隆匯4月8日丨雲南白藥(000538.SZ)公佈,公司全資子公司雲核醫藥(天津)有限公司(簡稱“雲核醫藥”)於近日收到國家藥品監督管理局下發的《藥物臨牀試驗批准通知書》(通知書編號:2025LP01012),經審查,雲核醫藥的INR102注射液(以下簡稱“本品”)臨牀試驗申請符合藥品註冊的有關要求,同意本品開展前列腺癌的臨牀試驗。

本品為雲核醫藥研發的化學1類放射性治療類創新藥,擬用於治療已經接受過雄激素受體通路抑制劑和紫杉烷類藥物化療的前列腺特異性膜抗原(PSMA)陽性的轉移性去勢抵抗性前列腺癌(mCRPC)成人患者。本品活性分子結構包含靶向配體、放射性同位素鑥[177Lu],靶向配體可特異性結合PSMA表達陽性的癌細胞,攜帶的鑥[177Lu]衰變過程中可發射β射線,導致癌細胞DNA損傷,最終誘導細胞死亡。截至目前,該產品已投入研發費用約人民幣2,332.5萬元。

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