Anke Bio Announces PA3-17, the World’s First Anti-CD7 Autologous CAR-T Therapy, on Track for Pre-NDA Submission in Q1 2027

Note: This article does not constitute any investment opinions or recommendations; please refer to official/company announcements for accuracy. This article only provides an introduction to medical and health-related drugs, not a recommendation of treatment plans (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.

November 12,ANKEBIO(300009.SZ)ANKABIO stated that the PA3-17 injection from its participating company, Bo sheng ji medicine science and technology (suzhou) co., LTD, has been designated as a breakthrough therapy and is now in the critical Phase II clinical trial. The company aims to complete patient enrollment within one year and expects to submit a pre-NDA communication application in the first quarter of 2027. In terms of indication expansion, Bo sheng ji is currently submitting an application for pediatric indications and plans to further expand into additional indications such as peripheral T-cell lymphoma, NKT-cell lymphoma, and acute myeloid leukemia after the approval of T-ALL/LBL indications.

On November 11, ANKEBIO reached a strategic cooperation with Bo sheng ji medicine science and technology (suzhou) co., LTD, signing the "Exclusive Agency Framework Agreement for CD7-CAR-T (PA3-17 Injection) and Other Products," which stipulates the relevant matters of the exclusive agency in Greater China after the PA3-17 Injection product is launched.

According to the agreement,ANKEBIOProposes to subscribe for its additional registered capital of RMB 11.9062 million with RMB 30 million of its own funds.

PA3-17 Injection is independently developed by Bo sheng ji medicine science and technology (suzhou) co., LTD, a wholly-owned subsidiary.The world's first autologous CAR-T cell therapy product targeting CD7, with the first indication for the treatment of adult relapsed or refractory CD7-positive hematologic and lymphatic system malignancies.. This collaboration aims to integrate the advantageous resources of both parties, enrich the company's product portfolio, and enhance core competitiveness in the innovative drug market.

In the first three quarters of 2025, ANKEBIO achieved revenue of 1.963 billion yuan and a net profit attributable to shareholders of 551 million yuan.

References:

ANKEBIO