Anke Biotechnology(300009) announced on the evening of March 4 that its investee companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd. (collectively referred to as "Boshengji Anke"), received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The application for a new indication for its independently developed PA3-17 injection was approved, and it was agreed to conduct clinical trials for the treatment of relapsed/refractory T-lymphoblastic leukemia/lymphoma in children and adolescents.

PA3-17 injection is the world's first CD7-targeting autologous CAR-T cell therapy product independently developed by Boshengji Anke and approved for clinical trials. It has been included in the "Breakthrough Therapy" list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The product is currently undergoing a pivotal Phase II clinical trial for adult patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma.

The approval of this clinical trial for PA3-17 injection in the treatment of relapsed/refractory T-lymphoblastic leukemia/lymphoma in children and adolescents marks a significant step forward in the product's indication expansion. If this indication is approved for market launch in the future, it will further broaden the range of patients for whom the product is applicable.

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