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This sBLA is based on data from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA demonstrated a significant improvement in progression-free survival (PFS) compared to brentuximab vedotin (BV), a current standard of care in this patient population.
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主要疗效数据显示，pralsetinib在经含铂化疗的RET融合阳性的非小细胞肺癌（NSCLC）的中国患者中显示出了优越和持久的抗肿瘤活性
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The sNDA was based on results from the Phase III THALES trial, which showed aspirin plus Brilinta 90mg used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.
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一旦获批，Aducanumab将成为首个能够减缓阿尔茨海默病患者临床衰退的疗法，并将成为首个证明清除β-淀粉样蛋白可以带来更佳临床结果的疗法。
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