SHANGHAI, Aug. 5, 2026 /PRNewswire/ -- Shanghai SinoUnited Hospital today announced the availability of satricabtagene autoleucel ("satri-cel"), the world's first chimeric antigen receptor (CAR) T-cell therapy approved for the treatment of solid tumors, for eligible patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have failed at least two prior lines of therapy.

This milestone marks a historic breakthrough in oncology by extending CAR-T therapy from hematologic malignancies to solid tumors for the first time, while also highlighting Shanghai SinoUnited Hospital's ability to rapidly introduce innovative oncology therapies and apply advanced immunotherapies in clinical practice.

Gastric cancer remains one of the most prevalent and deadly malignancies worldwide. Despite progress in chemotherapy, targeted therapy, and immunotherapy, outcomes for patients with relapsed or refractory disease remain poor, underscoring a significant unmet medical need.

The approval of satri-cel represents a major advancement in precision immunotherapy. CAR-T therapy, which involves genetically engineering a patient's own T cells to recognize and eliminate tumor cells, has transformed the treatment landscape for hematologic malignancies. However, its application in solid tumors such as gastric cancer has historically been limited by the complexity of the tumor microenvironment and immune evasion mechanisms. The successful development and approval of CT041 mark a critical step forward in overcoming these challenges.

Clinical evidence from the pivotal CT041-ST-01 randomized controlled trial demonstrated meaningful efficacy in heavily pretreated patients. In the modified intention-to-treat population, satri-cel achieved an objective response rate of 41% compared with 4% in the control group, along with a disease control rate of 81% versus 27%. The treatment significantly improved progression-free survival, reducing the risk of disease progression or death by up to 70%. Overall survival analysis further demonstrated a 53 to 63% reduction in mortality risk after statistical adjustment, highlighting its potential to deliver clinically meaningful benefit in a population with extremely limited treatment options.

As one of China's leading private medical institutions, Shanghai SinoUnited Hospital is now among the select clinical centers providing access to satri-cel under approved indications. The hospital has established a structured multidisciplinary oncology framework to support advanced cellular therapies, including comprehensive patient evaluation, molecular diagnostics, individualized treatment planning, infusion coordination, and continuous post-treatment monitoring. Its clinical focus spans a broad range of tumor types, including gastrointestinal, lung, breast, thyroid, gynecologic, urologic, and soft tissue sarcomas, with a strong emphasis on multidisciplinary decision-making and personalized treatment strategies.

"The availability of satri-cel represents a transformative milestone in the treatment of advanced gastric cancer and signals the beginning of a new era in solid tumor immunotherapy, " said Dr. Kathy Shi, Founder and CEO of SinoUnited Health, "As CAR-T therapy continues to expand beyond hematologic malignancies, our institution remains committed to ensuring that patients have timely access to innovative therapies supported by strong clinical evidence and delivered through an integrated, multidisciplinary care model."

Shanghai SinoUnited Hospital has previously established clinical experience in the application of CAR-T therapy in hematologic malignancies. Over the past year, the hospital has treated more than 30 patients with hematologic cancers using CAR-T therapy and has provided consultation and evaluation services to over 100 patients considered for CAR-T treatment. Through this experience, the hospital has developed comprehensive expertise in CAR-T-related patient management, including toxicity monitoring, risk stratification, and multidisciplinary supportive care, enabling the safe and effective delivery of cellular immunotherapies in complex clinical settings.

The introduction of satri-cel at Shanghai SinoUnited Hospital underscores the hospital's ongoing commitment to advancing precision oncology and cellular immunotherapy. By integrating global innovation with clinical practice, the hospital aims to accelerate the translation of scientific breakthroughs into accessible treatment options for patients with advanced and previously refractory cancers.

As CAR-T therapy enters a new developmental era for solid tumors, Shanghai SinoUnited Hospital will further enhance its clinical diagnosis and treatment capacity, boost multidisciplinary collaboration, keep pace with the clinical application of novel anti-cancer agents, and deepen exchange and cooperation with medical institutions at home and abroad, so as to advance cancer care standards across China and worldwide.

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Contact:
SinoUnited Health
internationalcare@suh.cn