云南白药(000538.SZ):INR102注射液获得药物临床试验批准

智通财经
08 Apr

智通财经APP讯,云南白药(000538.SZ)发布公告,公司全资子公司云核医药(天津)有限公司(“云核医药”)于近日收到国家药品监督管理局下发的《药物临床试验批准通知书》(通知书编号:2025LP01012),经审查,云核医药的INR102注射液临床试验申请符合药品注册的有关要求,同意本品开展前列腺癌的临床试验。

公告显示,本品为云核医药研发的化学1类放射性治疗类创新药,拟用于治疗已经接受过雄激素受体通路抑制剂和紫杉烷类药物化疗的前列腺特异性膜抗原(PSMA)阳性的转移性去势抵抗性前列腺癌(mCRPC)成人患者。本品活性分子结构包含靶向配体、放射性同位素镥[177Lu],靶向配体可特异性结合PSMA表达阳性的癌细胞,携带的镥[177Lu]衰变过程中可发射β射线,导致癌细胞DNA损伤,最终诱导细胞死亡。

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