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Sanofi’s experimental multiple sclerosis (MS) drug, tolebrutinib, encountered two significant challenges on Monday. The company announced that the drug failed to meet its primary endpoint in a Phase III clinical trial for secondary progressive MS (SPMS), a more advanced form of the disease. Additionally, the U.S.

赛诺菲的实验性多发性硬化症（MS）药物tolebrutinib在周一遇到了两个重大挑战。该公司宣布，该药物在其针对继发进展型多发性硬化症（SPMS）的III期临床试验中未能达到主要终点，这是该疾病更为严重的形式。此外，美国。

Food and Drug Administration (FDA) delayed its decision on Sanofi’s approval application for the same treatment..

美国食品药品监督管理局（FDA）推迟了对赛诺菲相同治疗方案的批准申请的决定。

The Phase III trial aimed to evaluate the efficacy of tolebrutinib in slowing disability progression in patients with SPMS. However, results showed that the drug did not achieve statistically significant improvement compared to placebo. On top of this setback, Sanofi disclosed that the FDA extended its review timeline for tolebrutinib’s approval application.

III 期试验旨在评估 tolebrutinib 在减缓 SPMS 患者残疾进展方面的疗效。然而，结果显示，与安慰剂相比，该药物未达到统计学上的显著改善。在此挫折之上，赛诺菲还透露，FDA 延长了对 tolebrutinib 的审批申请的审查时间。

The agency cited ongoing concerns and requested additional data before making a final determination. These developments mark a challenging moment for Sanofi as it seeks regulatory approval and clinical validation for one of its key pipeline candidates targeting MS..

该机构援引了持续存在的问题，并要求在做出最终决定之前提供更多的数据。这些进展对赛诺菲来说标志着一个具有挑战性的时刻，因为该公司正寻求为其针对多发性硬化症的关键管线候选药物之一获得监管批准和临床验证。

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Date: December 15, 2025

日期：2025年12月15日

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