The world's first solid tumor CAR-T cell product with breakthrough therapy is about to be approved, with SciClone Pharmaceuticals (02171) taking the lead in breaking the deadlock.

On February 28, according to the official website of the National Medical Products Administration (NMPA) of China, today is the last day of the public announcement period for the breakthrough therapy designation process for the world's first solid tumor CAR-T cell product, Keji Pharmaceutical (02171)'s Shurui Jiolunsi injection (CT041), and approval is imminent. According to GMTEight, CT041 is an innovative therapy mainly targeting advanced gastric/esophageal junction adenocarcinoma with Claudin18.2 positive expression that has failed at least second-line treatment. If approved, it will not only have the precise targeting ability for specific tumor markers, but also represent a major leap forward for CAR-T therapy in the field of solid tumor treatment. This breakthrough not only affirms the research and development strength of Keji Pharmaceutical, but also provides a huge boost to the entire biopharmaceutical industry, indicating that there will be more possibilities for CAR-T therapy in the field of solid tumor treatment in the future, bringing new hope for solid tumor patients.