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China Approves First Solid Tumor CAR-T Therapy

China Approves First Solid Tumor CAR-T Therapy

China’s National Medical Products Administration has authorized Satri-cel, the world’s inaugural CAR-T cell treatment for solid tumors. This milestone targets Claudin18.2-positive, HER2-negative advanced gastric and gastroesophageal junction adenocarcinoma, offering a new clinical pathway for patients who have exhausted at least two previous lines of standard therapeutic intervention.

The Jiahui International Cancer Center (JICC) in Shanghai is now facilitating access to this breakthrough therapy, known commercially as Kaileimei. By integrating the treatment into its multidisciplinary oncology program, the center aims to bridge the gap between complex cellular innovation and patients worldwide. The approval addresses a long-standing hurdle in oncology, as solid tumors have historically proven resistant to the CAR-T methods that revolutionized blood cancer treatment.

Dr. Linli Xuan, Chief of Medical Oncology at JICC, described the regulatory green light as a landmark achievement that underscores China’s accelerating influence in transformative cancer research. The center currently leverages a specialized infrastructure—combining precision medicine, radiation oncology, and dedicated international patient services—to manage the complex administration of cellular therapies. As global interest in Chinese oncology innovation grows, the clinic is positioning itself as a primary hub for international patients seeking access to these newly validated treatments.

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