By Fineline Cube Amoytop Biotech Co., Ltd. (SHA: 688278), a leading Chinese biopharmaceutical company, has entered into a definitive licensing agreement with US-based Aligos Therapeutics, Inc. The deal grants Amoytop exclusive rights to develop, manufacture, and commercialize pevifoscorvir sodium for the treatment, prevention, or alleviation of hepatitis B virus (HBV) and HBV/hepatitis D virus (HDV) co-infection in Greater China.
Transaction Summary
| Item | Detail |
|---|---|
| Licenser | Aligos Therapeutics, Inc. (USA) |
| Licensee | Amoytop Biotech Co., Ltd. (SHA: 688278) |
| Asset | Pevifoscorvir sodium (oral CAM-E) |
| Indication | Chronic HBV infection & HBV/HDV co-infection |
| Territory | Greater China (Mainland China, Hong Kong, Macau, Taiwan) |
| Upfront Payment | USD 25 million |
| Total Potential Value | Up to USD 445 million (incl. milestones & royalties) |
| Royalties | Single-digit % of net sales |
Asset Profile & Clinical Data
- Molecule: Pevifoscorvir sodium, a potential best-in-class oral small-molecule capsid assembly modulator (CAM-E).
- Dual Mechanism:
- Blocks HBV replication and prevents viral DNA integration.
- Reduces the persistent covalently closed circular DNA (cccDNA) reservoir, a key barrier to a functional cure.
- Phase I Results: Demonstrated good tolerability with once-daily dosing, no safety signals, linear pharmacokinetics (PK), and promising antiviral activity.
Strategic Rationale
The agreement provides Amoytop with a highly differentiated, late-preclinical/early-clinical asset targeting the root cause of chronic HBV infection. With over 70 million chronic HBV carriers in China, the market represents one of the largest unmet medical needs globally. This acquisition aligns with Amoytop’s strategy to build a leading portfolio in liver diseases.
For Aligos, the deal offers a significant non-dilutive capital injection and de-risks the development of pevifoscorvir by leveraging Amoytop’s extensive clinical development and commercial capabilities in its home market. The substantial milestone structure ties future payments directly to the asset’s success.
Forward-Looking Statements
This brief contains forward-looking statements regarding the development, regulatory approval, and commercial potential of pevifoscorvir sodium. Actual results may differ materially due to risks inherent in clinical drug development and commercialization.-Fineline Info & Tech