NMPA Grants Conditional Approval to Pucelocels Injection for Treatment of Relapsed/Refractory CD19+ B-ALL in Patients Aged 3–21

The pivotal Phase II clinical trial of Pucel-cel was jointly led by Professor Wang Tianyou (Beijing Children's Hospital) and Professor Zhang Yicheng (Tongji Hospital, Huazhong University of Science and Technology), and conducted in collaboration with more than ten top hospitals across China. The study results showed^[2], the optimal CR/CRi rate reached 90.63% (58/64) within 3 months, with a complete response (CR) rate of 78.13% (50/64), and 12.5% of participants achievedComplete Remission/Complete Remission with Incomplete Hematologic Recovery(CRi). Among patients achieving CR/CRi, the bone marrow minimal residual disease (MRD) negativity rate was as high as 98.27%, indicating an excellent depth of tumor clearance. The CR/CRi rate at 3 months remained at 76.56% (49/64), with a median overall survival (OS) of 23.92 months (95% CI: 9.86 - not reached).