Astellas Pharma has announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC).Enfortumab Vedotin will provide a new treatment option for patients who have already received platinum-based chemotherapy and PD-1/PD-L1 inhibitors.Enfortumab vedotin is an ADC targeting Nectin-4, a protein found on the surface of certain cancer cells, particularly in bladder cancer.

Astellas Pharma宣布，中国国家医药产品管理局（NMPA）已批准PADCEV™（enfortumab vedotin）用于局部晚期或转移性尿路上皮癌（la/mUC）的成年患者。Enfortumab Vedotin将为已经接受铂类化疗和PD-1/PD-L1抑制剂的患者提供新的治疗选择。Enfortumab vedotin是一种靶向Nectin-4的ADC，Nectin-4是一种在某些癌细胞表面发现的蛋白质，特别是在膀胱癌中。

This approval expands the treatment options available to doctors, providing new hope for patients battling this challenging disease.This approval is specifically for those who have previously undergone treatment with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.The approval of enfortumab vedotin is a significant milestone.

这项批准扩大了医生可用的治疗选择，为与这种具有挑战性的疾病作斗争的患者提供了新的希望。该批准专门针对先前接受过铂类化疗和PD-1或PD-L1抑制剂治疗的患者。enfortumab vedotin的批准是一个重要的里程碑。

This decision, based on global and local studies, will now make this new antibody-drug conjugate (ADC) available to patients in China.Urothelial cancer is a serious and aggressive condition that can affect both the lower and upper urinary tract, including the bladder and urethra, as well as the ureter and renal pelvis.

这项基于全球和当地研究的决定现在将使这种新的抗体-药物偶联物（ADC）可供中国患者使用。尿路上皮癌是一种严重的侵袭性疾病，可影响下尿路和上尿路，包括膀胱和尿道，以及输尿管和肾盂。

In 2022, over 92,000 people in China were diagnosed with bladder cancer, resulting in around 41,000 deaths. The survival rates for those with locally advanced or metastatic urothelial cancer are particularly low, highlighting the need for new treatments.The approval is supported by data from the global EV-301 trial and the China-based EV-203 trial.

2022年，中国有92000多人被诊断出患有膀胱癌，导致约41000人死亡。局部晚期或转移性尿路上皮癌患者的生存率特别低，这突出表明需要新的治疗方法。该批准得到了全球EV-301试验和中国EV-203试验数据的支持。

The EV-203 trial, conducted in Chinese patients, confirmed the drug’s efficacy and safety, with the majority of treatment-related adverse events being mild to moderate. Astellas has already accounted for the financial impact of this approval in its forecast for the fiscal year ending March .

在中国患者中进行的EV-203试验证实了该药物的有效性和安全性，大多数与治疗相关的不良事件为轻度至中度。Astellas已经在其截至3月的财政年度预测中考虑了这一批准的财务影响。