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ISLAMABAD, Jan 30 (APP):Federal Minister for National Health Services, Regulations and Coordination, Syed Mustafa Kamal, convened a high-level consultative meeting on Friday with the leadership of Huahui Health (China) and IQVIA Pakistan. The session focused on establishing a strategic framework to address the escalating prevalence of the Hepatitis Delta Virus (HDV) in Pakistan.
During the session, the Federal Minister highlighted the significant clinical burden of HDV with estimates suggesting over one million affected individuals nationwide.
The Ministry emphasized the high risk of rapid disease progression to liver cirrhosis and hepatocellular carcinoma if left unmanaged.
Data presented during the meeting indicated a critical diagnostic gap; approximately 20% of Hepatitis B patients in Pakistan may be co-infected with HDV, yet routine testing remains underutilized.
Huahui Health shared key updates regarding its investigational HDV therapy, Libevitug (HH-003), which recently concluded a successful Phase 2 multi-center, multi-country clinical study. The therapy has received regulatory approval in China based on favorable safety and efficacy data. Notably, the U.S. Food and Drug Administration (FDA) has granted it Breakthrough Therapy Designation, underscoring its potential to provide substantial improvement over existing treatments.
To ensure sustainable and affordable patient access, Minister Syed Mustafa Kamal assured that the Government of Pakistan will facilitate a partnership between Huahui Health and a premier local pharmaceutical manufacturer. This initiative is aimed at localizing the production of advanced biological products and enabling technology transfer.
Dr. Obaidullah, CEO of Drug Regulatory Authority of Pakistan (DRAP), remarked: “DRAP’s regulatory mandate is to ensure that Pakistani patients have early access to life-saving innovations without compromising on safety or quality. By facilitating the Phase 3 trials of this breakthrough HDV therapy and enabling technology transfer for local manufacturing, DRAP is strengthening national health security. We are committed to a transparent, science-based approval process that aligns Pakistan with international best regulatory practices.”
The meeting concluded with a mutual commitment to expedite the regulatory roadmap for Phase 3 clinical trials in Pakistan, ensuring that this innovative treatment reaches those in need under stringent regulatory oversight.