ISLAMABAD, Jan 30: Federal Minister for National Health Services, Regulations and Coordination, Syed Mustafa Kamal, led a high-level meeting on Friday with leaders from Huahui Health (China) and IQVIA Pakistan. The discussion focused on creating a strategic framework to tackle the rising prevalence of the Hepatitis Delta Virus (HDV) in Pakistan.
The Federal Minister emphasized the substantial clinical burden of HDV, which affects over one million people nationwide. The Ministry highlighted the high risk of rapid progression to liver cirrhosis and hepatocellular carcinoma if the disease remains unmanaged.
Data presented during the meeting revealed a critical gap in diagnostics, with around 20% of Hepatitis B patients potentially co-infected with HDV. However, routine testing remains underutilized.
Huahui Health shared updates on its investigational HDV therapy, Libevitug (HH-003), which recently successfully completed a Phase 2 multi-center, multi-country clinical study. The therapy has received regulatory approval in China due to favorable safety and efficacy data. Importantly, the U.S. Food and Drug Administration (FDA) has deemed it a Breakthrough Therapy, highlighting its potential to significantly improve existing treatments.
To ensure affordable patient access, Minister Syed Mustafa Kamal assured that the Government of Pakistan will facilitate a partnership between Huahui Health and a leading local pharmaceutical manufacturer. This initiative aims to localize the production of advanced biological products and enable technology transfer.
Dr. Obaidullah, CEO of the Drug Regulatory Authority of Pakistan (DRAP), stated, “DRAP’s regulatory mandate is to ensure that Pakistani patients have early access to life-saving innovations without compromising on safety or quality. By supporting Phase 3 trials of this breakthrough HDV therapy and facilitating technology transfer for local manufacturing, DRAP is enhancing national health security. We are committed to a transparent, science-based approval process that aligns Pakistan with international regulatory standards.”
The meeting concluded with a commitment to expedite the regulatory process for Phase 3 clinical trials in Pakistan, ensuring the innovative treatment reaches those in need under strict regulatory oversight.
