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<p>Adagene Inc.（ADAG）宣布，FDA 已将 muzastotug 与默克的抗 PD-1 疗法 KEYTRUDA 联合使用，指定为针对无当前或活跃肝转移的微卫星稳定转移性结直肠癌成年患者的快速通道产品。该公司指出，快速通道认证使 FDA 的互动更加频繁，并可能允许对未来市场申请进行滚动审查，因为 Adagene 正在继续进行随机的 2 期临床试验，并为计划于 2027 年开始的注册试验做准备。</p>
<p>Adagene 的首席执行官兼研发总裁 Peter Luo 表示：“我们对 muzastotug 与 pembrolizumab 联合使用所带来的反应感到深受鼓舞，并相信这种疗法有潜力通过为患者提供延长生存和改善生活质量的机会来重塑治疗范式。我们期待在接下来的几个月中分享更新的 1b/2 期临床数据，因为我们将继续以紧迫感和目标推进该项目。”</p>
<p>Adagene 的股价在周二的盘前交易中上涨了 16%，至 1.95 美元。</p>
<p>欲获取更多健康新闻，请访问 rttnews.com。</p>
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<p>Adagene Inc.（ADAG）宣布，FDA 已授予 muzastotug 与默克的 KEYTRUDA 联合使用的快速通道认证，用于治疗某些结直肠癌患者。该认证允许与 FDA 进行更频繁的互动，并可能加快未来的市场申请。Adagene 的首席执行官对该疗法的潜力表示乐观。Adagene 的股票在盘前交易中上涨了 16%</p>

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</div><p>Adagene Inc. (ADAG) announced that the FDA has designated muzastotug, in combination with Merck's anti-PD-1 therapy, KEYTRUDA, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer without current or active liver metastases. The company noted that the Fast Track Designation enables more frequent FDA interactions and may allow for rolling review of future marketing applications as Adagene continues the ongoing randomized Phase 2 and prepares for the registration trial, planned to begin in 2027.</p>
<div class="lb-trans"><p>Adagene Inc.（ADAG）宣布，FDA 已将 muzastotug 与默克的抗 PD-1 疗法 KEYTRUDA 联合使用，指定为针对无当前或活跃肝转移的微卫星稳定转移性结直肠癌成年患者的快速通道产品。该公司指出，快速通道认证使 FDA 的互动更加频繁，并可能允许对未来市场申请进行滚动审查，因为 Adagene 正在继续进行随机的 2 期临床试验，并为计划于 2027 年开始的注册试验做准备。</p>
</div><p>Peter Luo, CEO and President of R&amp;D at Adagene, said: &#34;We are deeply encouraged by the responses we are seeing with muzastotug in combination with pembrolizumab and believe this therapy has the potential to reshape the treatment paradigm by offering patients an opportunity for extended survival with an improved quality of life. We look forward to sharing updated topline Phase 1b/2 clinical data over the next few months as we continue advancing this program with urgency and purpose.&#34;</p>
<div class="lb-trans"><p>Adagene 的首席执行官兼研发总裁 Peter Luo 表示：“我们对 muzastotug 与 pembrolizumab 联合使用所带来的反应感到深受鼓舞，并相信这种疗法有潜力通过为患者提供延长生存和改善生活质量的机会来重塑治疗范式。我们期待在接下来的几个月中分享更新的 1b/2 期临床数据，因为我们将继续以紧迫感和目标推进该项目。”</p>
</div><p>Shares of Adagene are up 16% to $1.95 in pre-market trade on Tuesday.</p>
<div class="lb-trans"><p>Adagene 的股价在周二的盘前交易中上涨了 16%，至 1.95 美元。</p>
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为什么天演药业在盘前交易中上涨？