Amoytop Biotech's ACT201 Injection Clinical Trial Application Approved by National Medical Products Administration

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Amoytop Biotech announced that the clinical trial application for its innovative antisense oligonucleotide drug ACT201 injection has been approved by the National Medical Products Administration. The drug features significantly enhanced antiviral activity and moderately increased human TLR8 agonist activity, and has been selected for the 2025 National Science and Technology Major Project for innovative drug research and development. Preclinical study data show that in the AAV-HBV mouse model, ACT201 demonstrates superior inhibitory activity against hepatitis B surface antigen and higher liver drug exposure levels compared to current similar products, along with a better safety profile, positioning it as a potential best-in-class drug in this field. In the first quarter of 2026, Amoytop Biotech achieved revenue of 798 million yuan and net profit attributable to the parent company of 164 million yuan.

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Clinical trial approval for innovative drug ACT201 with best-in-class potential and government project selection.

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