AstraZeneca's CD3/CLDN18.2 Bispecific Antibody AZD5863 Becomes Fifth Candidate to Enter Clinical Application in China

On May 16, the CDE website showed that AstraZeneca's CD3/CLDN 18.2 bispecific antibody AZD5863 was submitted for clinical trial in China. This product is the fifth CD3/CLDN 18.2 bispecific antibody to be submitted for clinical trial in China.

AZD5863 (original R&D code: HBM7022) is a fully human bispecific antibody developed by HBM Biopharma using its proprietary HBICE (HCAb-based Immune Cell Engager) technology platform. It adopts a structure with bivalent high-affinity anti-CLDN 18.2 and monovalent low-affinity anti-CD3, which ensures high cytotoxic activity while reducing the risk of cytokine storm.

In April 2022, AstraZeneca reached an agreement with Harbour BioMed for a total transaction value of $350 million to obtain global exclusive rights to AZD5863.

Preclinical studies show that AZD5863 not only has significant efficacy in CLDN 18.2-positive gastric cancer, but also demonstrates strong effectiveness in pancreatic cancer and CLDN 18.2-mutated gastric cancer.

Currently, there are 11 CD3/CLDN 18.2 bispecific antibodies under development globally, four of which have entered clinical stages: AMG 910 (Amgen/BeiGene), ASP2138 (Astellas/Xencor), IBI389 (Innovent Biologics), and QLS31905 (Qilu Pharmaceutical).

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