PA3-17 Injection Achieves IND Approval for Pediatric and Adolescent Indications,

Bringing New Hope to Young Patients

March 4, 2026 – PersonGen-Anke, an affiliate of Anhui Anke Biotechnology (Group) Co., Ltd. (AnkeBio), today announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application (acceptance No. CXSL2501040) for its autologous CD7-targeted CAR-T cell therapy, PA3-17 injection, for the treatment of pediatric and adolescent patients with relapsed/refractory T-cell lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). This milestone extends this first-in-class CD7 CAR-T therapy to high-risk young patients while the pivotal adult trial advances, offering new survival hope for a population in urgent need of novel therapies.

The rapid approval of the pediatric and adolescent indication is supported by compelling adult clinical data. The completed Phase I registrational trial in adult R/R T-ALL/LBL demonstrated a breakthrough dual efficacy profile: an overall response rate (ORR) of 85% and a minimal residual disease (MRD)-negative complete response (CR) rate of 95%. These exceptional results validate PA3-17’s mechanism of action and safety, providing a robust scientific basis for expansion into younger patients. Meanwhile, the pivotal Phase II trial for the adult indication is progressing steadily across multiple centers nationwide, with the first patient already dosed.

As the world’s first CD7-targeted CAR-T product to enter clinical development, PA3-17 employs a proprietary non-gene-editing approach that successfully overcomes the long-standing challenge of T-cell fratricide in CAR-T therapy. The product received IND clearance in August 2021, was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA in August 2025, and has obtained Orphan Drug Designation from both the U.S. FDA and the European Commission.