Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved PADCEVTM (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.

安斯泰来制药公司（TSE：4503，总裁兼首席执行官：Naoki Okamura，“安斯泰来”）今天宣布，中国国家药品监督管理局（NMPA）药品审评中心（CDE）已批准 PADCEV TM（enfortumab vedotin）用于治疗已接受含铂化疗和程序性死亡受体 1（PD-1）或程序​​性死亡配体 1（PD-L1）抑制剂治疗的局部晚期或转移性尿路上皮癌（la/mUC）成年患者。

Urothelial cancer is a debilitating and often aggressive cancer that affects both the lower urinary tract (bladder and urethra) and upper urinary tract (ureter and renal pelvis).3,4,5 Over 92,000 people were diagnosed with bladder cancer in China in 2022, and approximately 41,000 deaths were reported as a result of the disease.6 Survival rates are particularly poor with locally advanced or metastatic urothelial cancer, driving the urgent need for new therapies that extend patients’ lives.

尿路上皮癌是一种使人衰弱且往往具有侵袭性的癌症，会影响下尿路（膀胱和尿道）和上尿路（输尿管和肾盂）。3,4,5 2022 年，中国有超过92,000人被诊断出患有膀胱癌，约有 41,000 人因该疾病死亡。6局部晚期或转移性尿路上皮癌的存活率特别低，因此迫切需要新的治疗方法来延长患者的生命。

Professor Guo Jun, Principal Investigator, EV-203 trial and Director of the Department of Melanoma and Urological Oncology, Beijing Cancer Hospital, China

EV-203 试验首席研究员、北京肿瘤医院黑色素瘤和泌尿肿瘤科主任郭俊教授

“On August 13, 2024, the NMPA officially approved the use of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) after prior treatment with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. This approval, based on a global Phase 3 registration study as well as a bridging study in Chinese patients, is a milestone event where patients will now have access to this new antibody-drug conjugate (ADC) treatment in China.”

“2024 年 8 月 13 日，NMPA 正式批准使用 enfortumab vedotin 治疗接受含铂化疗和 PD-1/PD-L1 抑制剂治疗的局部晚期或转移性尿路上皮癌 (la/mUC) 成人患者。此次批准基于一项全球 3 期注册研究以及一项针对中国患者的桥接研究，是一个里程碑事件，患者现在可以在中国接受这种新型抗体-药物偶联物 (ADC) 治疗。”

Professor Dingwei Ye, Academic Leader, Department of Urology and Principal Expert, Urological Oncology MDT Management, Fudan University-Affiliated Cancer Hospital, China

叶定伟教授，复旦大学附属肿瘤医院泌尿外科学科带头人、泌尿肿瘤MDT管理首席专家

“Enfortumab vedotin will benefit patients in our country, bringing a new treatment to those with locally advanced or metastatic urothelial carcinoma (la/mUC) who have previously received platinum-containing chemotherapy and PD-1/PD-L1 inhibitors.”

“Enfortumab vedotin将使我国患者受益，为既往接受过含铂化疗和PD-1/PD-L1抑制剂治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者带来新的治疗方法。”

Professor Zhisong He, Deputy Director, Institute of Urology, Peking University First Hospital, China

北京大学第一医院泌尿外科研究所副主任何志松教授：

"Enfortumab vedotin is an ADC that is directed against Nectin-4. The approval of the EV-203 indication expands doctors’ treatment choices."

“Enfortumab vedotin 是一种针对 Nectin-4 的 ADC。EV-203 适应症的批准扩大了医生的治疗选择。”

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas

安斯泰来高级副总裁、肿瘤学开发主管 Ahsan Arozullah 医学博士、公共卫生硕士

“We remain committed to driving scientific progress that leads to meaningful changes in the course of cancer across the globe. The approval of enfortumab vedotin by the CDE provides patients in China with another treatment option for locally advanced or metastatic urothelial cancer, providing hope of better outcomes for those affected by this condition.”

“我们始终致力于推动科学进步，从而为全球癌症治疗带来有意义的改变。CDE 批准 enfortumab vedotin 为中国患者提供了另一种局部晚期或转移性尿路上皮癌治疗选择，为受此疾病影响的患者带来更好的治疗结果的希望。”

The CDE’s approval of enfortumab vedotin is supported by data from the global EV-301 and China EV-203 trials. EV-203 serves as a bridging trial to EV-301, a Phase 3 randomized trial that has supported global registrations of enfortumab vedotin. EV-203 (NCT04995419) is a single-arm, open-label, multicenter Phase 2 trial of enfortumab vedotin in Chinese patients with la/mUC who previously received a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.1 Results showed that EV-203 met its primary endpoint, demonstrating statistical significance in ORR for patients treated with enfortumab vedotin alone compared to historical controls (37.5% [n/N=15/40; 95% CI: 22.7–54.2]), as confirmed by the independent review committee.1 The efficacy and pharmacokinetic data from the trial are consistent with global data, with safety findings demonstrating that the majority of treatment related adverse events were grade 1–2.

CDE 批准 enfortumab vedotin 是基于全球 EV-301 和中国 EV-203 试验数据的支持。EV-203 是 EV-301 的桥接试验，EV-301 是一项 3 期随机试验，支持了 enfortumab vedotin 的全球注册。EV-203 ( NCT04995419) 是一项单组、开放标签、多中心的 2 期临床试验，研究 enfortumab vedotin 对中国 la/mUC 患者的作用，这些患者之前曾接受过 PD-1/PD-L1 抑制剂和铂类化疗。1结果显示，EV-203 达到了其主要终点，与历史对照相比，单独使用 enfortumab vedotin 治疗的患者的 ORR 具有统计学意义（37.5% [n/N=15/40; 95% CI: 22.7–54.2]），经独立审查委员会确认。1试验的疗效和药代动力学数据与全球数据一致，安全性结果显示大多数治疗相关不良事件为 1-2 级。

Astellas has already reflected the impact from the approval for enfortumab vedotin in China in its financial forecast for the current fiscal year ending March 31, 2025.

安斯泰来已在其截至 2025 年 3 月 31 日的本财年财务预测中反映了 enfortumab vedotin 在中国获批的影响。