AB&B BIO-TECH-B (ASX: 02627) has announced that, following the approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation (CDE) of China's National Medical Products Administration has also approved the IND application for the company's self-developed mRNA monkeypox vaccine candidate. The approval was granted on June 21, 2026.

Monkeypox is caused by the monkeypox virus, which belongs to the Orthopoxvirus genus of the Poxviridae family. This genus includes a wide range of viruses, such as vaccinia virus, variola virus (smallpox), and mousepox virus.

In preclinical studies, the company's investigational mRNA monkeypox vaccine candidate elicited significantly higher levels of monkeypox-neutralizing antibodies compared to the attenuated live smallpox vaccine strain (Tiantan strain) used in China. Furthermore, it demonstrated broad-spectrum cross-reactivity against multiple Orthopoxvirus antigens.

When compared to internationally licensed replication-deficient monkeypox vaccines, the company's mRNA vaccine candidate has shown superior immunogenicity. This profile makes it a potentially more suitable option for immunocompromised individuals, such as those who are HIV-positive.

This vaccine candidate is reported to be the first mRNA-based monkeypox vaccine candidate globally to have its IND application approved by both the U.S. FDA and China's CDE.