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Anke Biotechnology: PA3-17 Injection Receives Clinical Trial Approval for New Indication
Anke Bio announces that the clinical trial application for an additional indication of PA3-17 injection, independently developed by its affiliated companies Bosengji Medical Technology (Suzhou) Co., Ltd. and Bosengji Anke Cell Technology Co., Ltd., has been approved by the National Medical Products Administration. The approval allows for clinical trials to treat children and adolescents with relapsed/refractory T lymphoblastic leukemia/lymphoma. PA3-17 injection is the world’s first targeted CD7 autologous CAR-T cell therapy to receive approval for new drug clinical trials and has been designated as a “breakthrough therapy.” Currently, a pivotal Phase II clinical trial for adult patients is underway. This approval marks a significant milestone in expanding the product’s indications. If approved for market launch in the future, it will further broaden the applicable patient population.