Rise in Incidence and Prevalence of Hepatitis B
China carries the world's largest burden of hepatitis B virus (HBV) infection, with approximately 75 million people living with chronic HBV, representing nearly one-third of the global total. According to the fourth national serological survey conducted in 2020 and published in The Lancet in 2024, the HBsAg prevalence in China's general population stands at 5.86%, with significant regional variations—the eastern region showing the highest prevalence at 4%.
While vaccination programs have dramatically reduced pediatric infection rates to 0.3% among children under five, the adult population remains heavily affected, with prevalence reaching 7.54% among those aged 30 and above. The WHO Global Hepatitis Report 2024 confirms that China alone accounts for 31.5% of global hepatitis B infections. Despite declining incidence rates among younger cohorts, the sheer size of the infected population—combined with an aging demographic transitioning into higher-risk age brackets ensures sustained demand for treatment and management services. The China CDC reports that acute hepatitis B incidence continues to show declining trends, yet chronic infection management remains critical as approximately 30 million HBV-positive individuals remain unaware of their infection status, creating a substantial latent market for diagnosis and treatment services.
Government Initiatives and Policies
The Chinese government has implemented comprehensive policy frameworks to combat hepatitis B, creating a favorable environment for market expansion. The "Healthy China 2030" initiative explicitly targets hepatitis elimination, with the National Disease Control and Prevention Administration releasing action plans in 2024 aiming to raise antiviral treatment rates for newly reported cases to at least 80% by 2030. The National Health Commission's 2022 guidelines expanded treatment eligibility criteria, lowering ALT initiation thresholds to 30 U/L for males and 19 U/L for females, potentially qualifying 94% of patients with detectable HBV DNA for treatment. The National Volume-Based Procurement (NVBP) policy has been transformative—achieving price reductions of up to 98.61% for tenofovir disoproxil fumarate and 98.50% for entecavir, while increasing procurement volumes by 38 million DDDs. This policy has reduced monthly treatment costs from 1,500 CNY to below 10 CNY, fundamentally improving accessibility. Additionally, the "4+7" centralized procurement program and subsequent national expansions have prioritized hepatitis B medications, ensuring sustained government commitment to treatment accessibility. The 2024-2025 period has seen accelerated policy momentum with the integration of hepatitis B screening into routine healthcare services and expanded insurance coverage for antiviral therapies.
Advancements in Treatment Options
China's hepatitis B treatment landscape has witnessed remarkable innovation, positioning the country at the forefront of functional cure research. In October 2025, China approved Pegbing (developed by Amoytop Biotech), the world's first domestically developed drug targeting functional cure, achieving 31.4% clinical cure rates in combination therapy. The National Medical Products Administration (NMPA) has granted conditional approval to multiple breakthrough therapies including pradefovir mesylate (Xinshumu) in 2024—a liver-targeted nucleotide analog demonstrating comparable efficacy to tenofovir with improved renal and bone safety profiles. The approval of libevitug in January 2026 marked China's first-in-class treatment for hepatitis D virus co-infection, addressing a critical unmet need among the 75 million chronic HBV patients
Chinese pharmaceutical companies are leading global clinical trials for novel therapeutic approaches including antisense oligonucleotides (AHB-137, bepirovirsen), siRNA therapies (xalnesiran, BRII-835), and therapeutic vaccines. The China Center for Drug Evaluation (CDE) has established accelerated approval pathways for hepatitis B functional cure candidates, with over 30 innovative therapies in various stages of clinical development. These advancements represent a paradigm shift from lifelong suppression toward finite-duration curative regimens, fundamentally expanding market potential.
Growing Healthcare Infrastructure
China's healthcare infrastructure expansion provides robust support for hepatitis B service delivery. By the end of 2024, the total number of medical institutions reached 1.09 million (increasing by 22,800 year-on-year), with 38,700 hospitals nationwide. Healthcare personnel expanded to 13 million, with 9.4 million working in hospitals, representing 4.3% year-on-year growth. Total national health expenditure reached 9.09 trillion yuan (approximately $1.27 trillion) in 2024, accounting for 6.7% of GDP, with projections indicating growth to 20.5 trillion yuan by 2030. The hospital bed capacity increased to 7.32 beds per 1,000 people in 2024. Critically, primary and secondary-level hospitals now account for 66.6% of all medical visits, with township health centers and community clinics recording 4 billion visits annually.
This infrastructure expansion facilitates decentralized hepatitis B care delivery, enabling the implementation of "Screening-Diagnosis-Treatment-Management" integrated systems recommended in China's 2025 World Hepatitis Day action plan. The National Healthcare Security Administration reports that basic medical insurance covers over 95% of the population, with innovative drugs expected to account for 60% of drug expenditures by 2030.
