智通财经APP获悉，5月9日，强生（JNJ.US）特诺雅达®（古塞奇尤单抗注射液（静脉输注））和特诺雅®（古塞奇尤单抗注射液）在华获批用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎成人患者。
古塞奇尤单抗是首个获得批准的全人源、具有双重作用机制的白介素 23 抑制剂，不仅可以直接结合白介素 23，还能够定位到主要产生白介素 23 的 CD64+炎症细胞。
此次针对溃疡性结肠炎的获批，是基于关键的 IIb/III 期 QUASAR 研究的数据，该研究评估了古塞奇尤单抗在对传统治疗、其他生物制剂和/或 JAK 抑制剂反应不足或表现出不耐受的中度至重度活动性溃疡性结肠炎成人患者中的疗效和安全性。
结果显示，与安慰剂相比，接受古塞奇尤单抗治疗的患者早在第 1 周就显现出显著的症状改善，且该改善效果在 12 周内持续增强。
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