SHANGHAI, June 22, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that as informed by the National Medical Products Administration ("NMPA") today, the New Drug Application ("NDA") of satricabtagene autoleucel ("satri-cel"), the proprietary autologous humanized Claudin18.2 CAR T-cell therapy product, was approved for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. Satri-cel is the world's first approved CAR T-cell therapy product for the treatment of solid tumors.
Gastric cancer is one of the malignancies with the highest disease burden worldwide, ranking fifth in both incidence and mortality globally, with approximately 970,000 new cases and 660,000 deaths annually [1]. More than 70% of new and fatal cases occur in Asia [2], and Chinese patients account for approximately 47% of the global gastric cancer burden [3]. According to statistics from the National Cancer Center of China, there were approximately 360,000 new cases and 260,000 deaths from gastric cancer in China in 2022, ranking fifth in cancer incidence and third in cancer-related mortality [4]. Despite continuous advances in surgical techniques and comprehensive treatment modalities, gastric cancer is insidious in onset. In China, the proportion of early-stage gastric cancer diagnosis remains below 20%, and the 5-year survival rate for advanced gastric cancer is only about 10% [5]. Gastric cancer is characterized by high incidence, low early diagnosis rate, high heterogeneity, and high mortality. Conventional chemotherapy drugs have reached a plateau, targeted therapy options are limited, and the proportion and magnitude of benefit from immunotherapy still urgently need to be improved. Therefore, patients with unresectable or metastatic gastric cancer still face substantial unmet medical needs, and there is an urgent demand to drive the discovery and exploration of more precision therapies and novel anti-tumor agents.
