Home NMPA Conditionally Approves Puki Olun赛 Injection (Pulidekai) for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia in Pediatric and Young Adult Patients

NMPA Conditionally Approves Puki Olun赛 Injection (Pulidekai) for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia in Pediatric and Young Adult Patients

Nov 07, 2025 18:09 CST Updated 18:09
Precision Biotech

Gene and Cell Therapy Developer

Source: Beijing Daily Client

Recently, the National Medical Products Administration (NMPA) granted conditional approval for the listing of Prgiolec Injection (brand name: Pulidekai), submitted by Chongqing Precision Biotech Co., Ltd., through a priority review and approval process. The drug is indicated for treating patients aged 3 to 21 with CD19-positive refractory or relapsed (relapse after 12 months of initial remission requires salvage chemotherapy) acute B lymphoblastic leukemia. The availability of this product provides a new treatment option for relevant patients.

Source: National Medical Products Administration