On April 16, Amoytop Bio announced that it had signed a Licensing Agreement with Aligos Therapeutics, Inc.

According to the agreement, Amoytop Bio will obtain an exclusive, non-transferable intellectual property license from Aligos to develop, manufacture, and commercialize Pevifoscorvir sodium ( also known as ALG-000184) in the licensed territories (Mainland China, Hong Kong SAR, Macao SAR, and Taiwan) and in the licensed fields (treatment, prevention, or relief of human hepatitis B virus infection or human hepatitis B virus/hepatitis D virus co-infection) , and will have the right to sublicense as stipulated in the agreement. In return, Amoytop Biotech will pay Aligos an upfront payment of US$25 million upon the agreement's effective date , and will also pay regulatory milestone fees (up to US$85 million ), sales milestone fees (up to US$335 million ), and royalties calculated as a single-digit percentage of net sales, based on the progress of clinical and regulatory approvals and sales performance as stipulated in the agreement. If Amoytop Biotech sublicenses as stipulated in the agreement and generates revenue, it will be required to pay Aligos a percentage of the sublicensing revenue. Amoytop Bio pointed out that this collaboration will complete its pipeline layout in the field of chronic hepatitis B treatment , which is in line with the company's overall development strategy.
Pevifoscorvir sodium is an investigational small molecule capsid assembly modulator (CAM-E) that is expected to be a best-in-class oral agent for the treatment of chronic hepatitis B virus (HBV) infection . Through a dual mechanism of action, it has the potential to not only block HBV replication and prevent HBV DNA integration, but also reduce the covalently closed circular DNA reservoir. It is a novel drug designed to improve clinical outcomes by influencing the entire HBV life cycle .
Phase I clinical trials showed that the drug, when administered as monotherapy for 96 weeks, demonstrated good efficacy in inhibiting HBV DNA and HBV RNA and reducing hepatitis B virus-related antigens. Subjects tolerated the drug well after single and multiple daily doses, with no safety signals observed. The drug also exhibited linear PK and good antiviral activity. No virological breakthrough was observed in any subject, and no known CAM resistance mutations were found.
In HBeAg-positive subjects, after 96 weeks of daily oral monotherapy with 300 mg ALG-000184, 100% of subjects achieved sustained HBV DNA suppression (<10 IU/mL) ; in HBeAg-negative subjects, 11 subjects achieved 100% HBV DNA suppression at week 24 and maintained it for up to 96 weeks. At week 96, 8 out of 9 subjects (89%) had a further decrease in HBV DNA to <LLOQ (10 IU/mL, TND) .
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