The World’s First CAR-T Cell Therapy for Solid Tumors – Kailimei® (Sorrentide Autologous Cell Injection, CT041) Approved for Marketing

Recently, based on CT041-ST-01, the world’s first confirmatory randomized controlled trial of CAR-T therapy for solid tumors led by Professor Shen Lin’s team from Peking University Cancer Hospital, Sorrentide Autologous Cell Injection (CT041, brand name Kailimei®) has been approved for marketing by the National Medical Products Administration (NMPA) of China. Its indicated use is for advanced gastric or gastroesophageal junction adenocarcinoma with positive Claudin 18.2 expression and negative human epidermal growth factor receptor 2 (HER2), in patients who have failed at least two lines of prior therapy (subject to the drug insert). Following its launch, Jiahui International Cancer Center will be among the first institutions to deploy this innovative therapy.

Gastric cancer ranks among the most prevalent malignant tumors worldwide. As a country with a high incidence of gastric cancer, China accounts for nearly half of all new cases and deaths globally each year. Most Chinese gastric cancer patients are diagnosed at an advanced stage with heavy tumor burden, leading to poor prognosis. CAR-T therapy, a breakthrough immunotherapy for cancer, has achieved remarkable outcomes in hematological malignancies for years. However, its efficacy remained limited when applied to solid tumors such as gastric, pancreatic and liver cancers.

The approval of CT041 marks a milestone in the treatment of advanced gastric cancer and ushers in a new era of CAR-T cell therapy for solid tumors. It represents a historic leap for China’s cell therapy sector for solid tumors, shifting from a follower to a global leader in this field.

Dr. Xuan Linli, Director of the Department of Medical Oncology at Jiahui International Cancer Center, commented: “We have accumulated extensive clinical experience in CAR-T treatment, having cared for numerous patients from China, Singapore, the United States, New Zealand and Pakistan. The approval of Kailimei® undoubtedly opens a new chapter for solid tumor treatment. We are deeply honored that Jiahui International Cancer Center is among the first facilities to offer this revolutionary therapy.”

Jiahui International Cancer Center delivers one-stop, full-cycle oncology care integrating domestic and international medical resources, covering cancer prevention, early screening, diagnosis, treatment, rehabilitation and palliative care. The center treats all types of cancers, bringing together renowned specialists from home and abroad. Leveraging a multidisciplinary treatment model alongside cutting-edge technologies and novel pharmaceuticals, we craft personalized treatment regimens for every patient.