Anke Bio's PA3-17 injection accepted for new pediatric cancer trial

Anhui Anke Biotechnology Group announced today that its participating companies, Biosun-Gen Medical Technology (Suzhou) Co., Ltd., and Biosun-Gen Anke Cell Technology Co., Ltd., have received acceptance for a clinical trial application for a new indication of their self-developed PA3-17 injection. The new indication targets relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) in children and adolescents.

The PA3-17 injection is a global first-in-class CD7-targeted autologous CAR-T cell therapy product, which was granted breakthrough therapy designation by the CDE in August 2025. It is currently undergoing a key Phase II clinical trial for adult patients with R/R T-ALL/LBL. This acceptance marks a significant milestone in expanding the product's applicable patient population.

Anke Biotechnology emphasizes that the acceptance of this clinical trial application is a preliminary achievement in new drug development. The approval for further clinical trials and eventual market launch remains uncertain. Investors are advised to exercise caution and be aware of potential investment risks.