AstraZeneca's First-in-Class CD8-Biased TCE AZD6621 Receives First Clinical Approval in China for Metastatic Prostate Cancer

Aug 28, 2025 18:30 CST Updated 18:30

AstraZeneca

Biopharmaceutical Manufacturer

On August 28, the CDE website showed that AstraZeneca had filed a Class 1 new drug.AZD6621 Approved for Clinical Use in China, forMetastatic Prostate Cancer. Public information shows that this is the drugFor the first timeApproved for clinical use in China.

Screenshot source: CDE official website

AZD6621 is AstraZeneca's first-in-class CD8-biased TCE.Improved the therapeutic index in 3 ways, includingTargeted Tumor-Restricted STEAP2 Antigen（STEAP2）, optimize the affinity of the CD3 binding domain, and integrate the CD8 binding domain.

Screenshot source: AACR Conference

At the 2025 AACR Annual Meeting, AstraZeneca announcedIn vivo and in vitro data of AZD6621:

AZD6621 mediates potent STEAP2-dependent cytotoxicity in vitro,Cytotoxicity EC50 value less than 10 pM；
AZD6621 induces the activation of CD8+ T cells preferentially over CD4+ T cells, with CD8+ T cells showingMaximum activation increased by approximately 5 times, and cytokine release was significantly reduced;
In humanized mice, AZD6621 as a monotherapy mediates in subcutaneous xenograft models of 22Rv1 expressing STEAP2.Complete tumor regression；
AZD6621 was also observed in the C4-2 tibial xenograft model.In vivo anti-tumor activity；
In addition, in the intravenous 22Rv1 xenograft model, compared with conventional TCE, AZD6621-treated mice showedSignificant reduction in systemic cytokine levels。

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