Antengene Corporation Limited (Antengene) announced that China’s National Medical Products Administration has approved the Investigational New Drug application for ATG-201, a CD19/CD3 bispecific T-cell engager antibody. The clearance enables the company to begin a Phase I clinical study in China for B-cell-related autoimmune diseases. Parallel preparation for clinical development in Australia is under way.

ATG-201 is part of Antengene’s AnTenGager® TCE 2.0 platform, which incorporates “2+1” bivalent binding, steric-hindrance masking and proprietary CD3 sequences designed to reduce cytokine release syndrome while enhancing efficacy. The platform supports programs in autoimmune disorders, solid tumors and hematological malignancies.

Management reiterated that successful development and commercialization of ATG-201 remain uncertain. Shareholders and potential investors are urged to exercise caution when dealing in the company’s shares.

Corporate snapshot: Antengene, an R&D-driven and commercial-stage biotech, has accumulated 33 IND approvals across the United States and Asia and secured new drug application approvals in 10 Asia-Pacific markets. Its lead marketed product, XPOVIO® (selinexor), is authorized in Mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and is listed in the national insurance schemes of five of those markets.