Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") announced that China's National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment.

Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported from the disease in 2022. As early symptoms are often hard to detect, approximately 60% of Chinese patients are diagnosed at the advanced stage of the disease⁶ where treatment options are limited and outcomes are often poor. The average five-year survival rate for patients with advanced gastric cancer in China is 9.1%, driving the urgent need for novel therapeutic options that can slow disease progression and extend lives.⁷

Professor Xu Ruihua, Lead Primary Investigator of the Phase 3 GLOW Study, Director of the Cancer Prevention and Treatment Center of Sun Yat-sen University, President of the Chinese Society of Clinical Oncology (CSCO): 
"Approximately 30% of patients enrolled in the global Phase 3 GLOW trial were from mainland China. The results of this study demonstrated that the combination of zolbetuximab and chemotherapy provided significant survival benefits to patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction (GEJ) cancers. The analysis of the China subgroup data showed that Chinese gastric cancer patients benefited substantially in terms of both survival and quality of life. We are excited that the NMPA has approved zolbetuximab, which will provide a valuable and effective first-line treatment option for patients with advanced gastric cancer in China."

Professor Xu Jianming, Lead Primary Investigator of the Phase 3 SPOTLIGHT Study in China, Fifth Medical Center of the Chinese People's Liberation Army General Hospital:
"We are extremely encouraged that the NMPA has approved zolbetuximab in China. The SPOTLIGHT study explored the efficacy and safety of zolbetuximab combined with chemotherapy as a first-line treatment for patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction cancer. The results showed statistically significant differences in key endpoints such as progression-free survival and overall survival. The survival and safety benefits seen in the China subgroup were consistent with the global trial population, and the results are expected to have far-reaching implications for meeting the clinical needs of Chinese patients with advanced gastric cancer. The trial provides valuable insights to guide the first-line treatment of advanced gastric cancer in China."