SOUTH SAN FRANCISCO, Calif., July 6, 2026
Aligos Therapeutics has received a $25 million upfront payment from Xiamen Amoytop Biotech Co., Ltd. (Amoytop) under their exclusive licensing agreement covering pevifoscorvir sodium in Greater China for the treatment of chronic hepatitis B virus (HBV) infection. The company also announced that pevifoscorvir sodium has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), representing a significant regulatory milestone that could accelerate the therapy’s development and review in China.
Licensing Agreement Includes Up to $420 Million in Future Milestone Payments
The licensing agreement provides Aligos with the opportunity to receive up to $420 million in additional clinical, regulatory, and commercial milestone payments, along with tiered high single-digit royalties on net sales generated within Amoytop’s licensed territories. Under the agreement, Amoytop holds exclusive rights to develop and commercialize pevifoscorvir sodium across Greater China, while Aligos retains all development and commercialization rights in the United States, Europe, Japan, South Korea, and the rest of the global markets. The transaction strengthens Aligos’ regional commercialization strategy by leveraging Amoytop’s expertise in one of the world’s largest hepatitis B markets.
Breakthrough Therapy Designation May Accelerate Regulatory Review
The Breakthrough Therapy Designation awarded by China’s CDE is reserved for investigational medicines targeting serious diseases that have demonstrated promising preliminary clinical evidence. The designation enables closer regulatory engagement and makes pevifoscorvir sodium eligible for priority review of a future New Drug Application (NDA) in China. Aligos also confirmed that a joint steering committee has been established with Amoytop to coordinate development activities and advance the clinical program efficiently throughout the licensed territory.
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Partnership Expands Aligos’ Chronic Hepatitis B Development Strategy
Beyond pevifoscorvir sodium, Aligos and Amoytop continue to broaden their collaboration through the planned clinical development of ALG-170675, Aligos’ investigational antisense oligonucleotide (ASO) therapy for chronic hepatitis B. The company expects Amoytop to initiate clinical studies of ALG-170675 in China during the third quarter of 2026. Together, the two investigational therapies represent complementary next-generation approaches aimed at improving treatment outcomes for patients living with chronic HBV infection. The latest financial and regulatory milestones reinforce Aligos’ strategy of combining innovative antiviral development with regional licensing partnerships to accelerate global commercialization opportunities.
Source: Aligos Therapeutics press release
