News
HKUMed launches world-leading gene-related therapy clinical trials to eradicate chronic hepatitis B infection

Facebook Twitter
10 July 2025

Researchers in gastroenterology and hepatology at the LKS Faculty of Medicine, the University of Hong Kong (HKUMed), have initiated multiple clinical trials exploring pioneering gene-related therapy for chronic hepatitis B infection, potentially allowing patients to discontinue long-term medication. This positions HKUMed as one of only three global sites conducting these groundbreaking trials, alongside counterparts in Europe and New Zealand. 

‘The first participant in the Hong Kong trial was dosed in March this year, organised by the University of Hong Kong Clinical Trials Centre (HKU-CTC), yielding encouraging results,’ said Professor Yuen Man-fung, Li Shu Fan Medical Foundation Professor in Medicine, Chair Professor and Chief of the Division of Gastroenterology and Hepatology, and Deputy Chairperson, Department of Medicine, School of Clinical Medicine, HKUMed, who is leading this global project.

As the trials progress, they underscore Hong Kong's status as a leader in global scientific medical research, offering hope to millions affected by chronic hepatitis B. ‘With an expected enrollment of 30 to 40 participants by the end of 2026, the future looks promising for those seeking respite from this persistent and deadly infection,’ Professor Yuen added.

Chronic hepatitis B affects over 300 million people worldwide and is a leading cause of liver cirrhosis, cancer and liver failure. In Hong Kong, approximately 6.2% of the population is affected. ‘Current antiviral therapies can manage the virus but fail to eradicate it, leaving patients reliant on lifelong treatment and still at risk for liver cancer,’ explained Dr Loey Mak Lung-yi, Clinical Assistant Professor from the same department, who is involved in the trials. ‘The urgency for innovation is clear, with over 50 novel compounds currently in development to combat viral persistence.’

Gene-related therapy is emerging as a revolutionary approach in the treatment of hepatitis B. ‘Unlike existing treatments, these innovative compounds aim to silence or remove the virus's genetic material within infected liver cells without altering the human genome,’ Professor Yuen Man-fung noted. ‘Preclinical studies demonstrated promising efficacy, paving the way for these clinical trials.’

‘Only three sites globally have launched gene-related therapy clinical trials for chronic hepatitis B, and we are proud to be one of them,’ said Professor Yuen. ‘Our highly reputable and experienced researchers, supported by our well-equipped HKU-CTC, are crucial for running these complex first-in-human studies. Teamwork has been vital in bringing this initiative to fruition.’

Since 2020, the Gastroenterology and Hepatology team at HKUMed has led the way in clinical trials for chronic liver diseases, conducting 41 phase I-III hepatitis B disease treatment trials with 468 participants to date. The new gene-related therapy trials hold promise for a potential cure and aim to reduce healthcare costs by minimising complications associated with hepatitis B.

Because of the advanced therapeutic nature of gene-related therapy, the developers of the novel compounds have provided essential resources e.g. scientific data and results to stakeholders, including the ethics review committee and the Department of Health, to ensure a comprehensive understanding of the trials.

‘Overall, gene-related therapy for chronic hepatitis B is expected to alleviate the healthcare burden while reinforcing Hong Kong's status as a global leader in scientific research,’ elaborated Professor Walter Seto Wai-kay, Simon KY Lee Professor in Gastroenterology, Clinical Professor in the same department and Assistant Dean (Interdisciplinary Collaboration), HKUMed.

About the research team
The clinical trials are led by Professor Yuen Man-fung, Li Shu Fan Medical Foundation Professor in Medicine, Chair Professor and Chief of Division of Gastroenterology and Hepatology, Deputy Chairperson, Department of Medicine, School of Clinical Medicine, HKUMed, and in his team Professor Walter Seto Wai-kay, Simon KY Lee Professor in Gastroenterology and Clinical Professor; Dr Loey Mak Lung-yi, Clinical Assistant Professor and Dr Rex Hui Wan-hin, Clinical Researcher.

Acknowledgements
The clinical trials are conducted in collaborations with Tune Therapeutics, Precision BioSciences and Epigenic Therapeutics.

 

 

Media enquiries

Please contact LKS Faculty of Medicine of The University of Hong Kong by email (medmedia@hku.hk).

Researchers in gastroenterology and hepatology at HKUMed are pioneering gene-related therapy for chronic hepatitis B infection, potentially enabling patients to discontinue long-term medication and offering new hope to those affected by the disease. The research team, pictured in white coats from right, includes Dr Loey Mak Lung-yi, Professor Yuen Man-fung, Professor Walter Seto Wai-kay, and Dr Rex Hui Wan-hin, alongside Mr Cheung (middle), a patient who has completed his medication.
Professor Yuen Man-fung, the lead researcher on this global research, emphasises that unlike existing treatments, these innovative compounds aim to silence or remove the virus’s genetic material within infected liver cells without altering the human genome. Preclinical studies have demonstrated promising efficacy, paving the way for these clinical trials.