Fortrea’s ALG-000184 tablets proposed to be included in breakthrough therapy
On May 26, according to the latest announcement on the CDE official website, ALG-000184 tablets submitted by Fortrea were proposed for breakthrough therapy designation, with the indication being treatment‑naïve or untreated chronic hepatitis B virus (HBV) infection, aiming to achieve long‑term stable virological control in patients and bring new hope for functional cure of hepatitis B.
ALG-000184 tablets (pevifoscorvir sodium) is a novel, oral, small‑molecule capsid assembly modulator (CAM‑E) with a differentiated dual antiviral mechanism, representing a mechanism upgrade over traditional nucleos(t)ide analogues. The drug not only potently blocks HBV replication and inhibits HBV DNA integration, but also effectively consumes and reduces the cccDNA viral reservoir – directly targeting the root cause of HBV relapse. By addressing the fundamental mechanism, it helps patients achieve long‑term viral control and overcomes the limitations of existing therapies.
In terms of clinical development, the global clinical progress of this drug is advancing steadily. Multiple Phase I and Phase II overseas clinical studies have been successfully completed or are ongoing, and trial data from various dose‑exploration studies have been presented at international liver disease conferences. Existing clinical results demonstrate that ALG-000184 monotherapy exhibits excellent and robust antiviral activity, with outstanding safety and efficacy, highlighting its strong R&D potential.
Regarding rights in China, in April 2026, a major collaboration was reached with Aligos Therapeutics. With a total deal value of up to USD 445 million, the partner obtained exclusive rights to develop, manufacture, and commercialize ALG-000184 in Greater China. Subsequently, **Fortrea** under the partner is fully responsible for the domestic submission and clinical advancement of this product, accelerating the introduction of this globally innovative hepatitis B new drug into China.
As a rare differentiated CAM‑E candidate in the field, ALG-000184 offers convenient administration and is well‑suited for long‑term treatment scenarios. Its active metabolite precisely targets key steps in the HBV life cycle, with a mechanism of action completely different from traditional anti‑HBV drugs, granting it unique antiviral advantages and curative potential. The proposed breakthrough therapy designation by the CDE is a strong recognition of the drug’s ability to address unmet medical needs and its excellent early clinical efficacy. It will also accelerate its domestic R&D, review, and market approval process, positioning ALG-000184 as a potential new core therapy for chronic hepatitis B.
