上市不是终点,还需接受2026年“大考”。撰文丨Melissa11月26日,大冢制药旗下的Sibeprenlimab(斯贝利单抗,商品名Voyxact)获美国FDA加速批准,用于治疗有疾病进展风险的成人原发性免疫球蛋白A肾病(IgAN)的患者。这个是全球首款靶向APRIL(增殖诱导配体)的疗法,为IgAN患者提供新的治疗选择。此次加速批准是基于其多中心、随机、双盲、安慰组对照的III期临床试验,...
Source Link上市不是终点,还需接受2026年“大考”。撰文丨Melissa11月26日,大冢制药旗下的Sibeprenlimab(斯贝利单抗,商品名Voyxact)获美国FDA加速批准,用于治疗有疾病进展风险的成人原发性免疫球蛋白A肾病(IgAN)的患者。这个是全球首款靶向APRIL(增殖诱导配体)的疗法,为IgAN患者提供新的治疗选择。此次加速批准是基于其多中心、随机、双盲、安慰组对照的III期临床试验,...
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