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Mustafa Kamal Flags Hepatitis Delta as Major Health Risk

Islamabad: Pakistan’s Ministry of National Health Services, in coordination with the Drug Regulatory Authority of Pakistan (DRAP), has taken a major step toward strengthening global cooperation and local manufacturing in the fight against Hepatitis Delta Virus (HDV), amid growing public health concerns across the country.

A high-level meeting chaired by Federal Health Minister Mustafa Kamal brought together senior officials and representatives of leading Chinese pharmaceutical firm Huahui Health (China) to review Pakistan’s preparedness and response to the rapidly spreading HDV infection.

During the briefing, Huahui Health shared progress on its advanced HDV therapy, HH-003, which has recently successfully completed Phase-II international clinical trials. The company confirmed that the treatment has already received regulatory approval in China based on its safety and efficacy profile, while the U.S. Food and Drug Administration (FDA) has designated the therapy as a “Breakthrough Therapy,” reflecting its clinical significance.

The meeting focused on developing a strategic partnership framework between Huahui Health and leading Pakistani pharmaceutical companies, aimed at promoting local production of advanced biological medicines and facilitating technology transfer to Pakistan. The initiative is intended to ensure long-term sustainability, affordability, and national self-reliance in critical healthcare solutions.

Minister Mustafa Kamal described Hepatitis Delta as an emerging and serious public health threat in Pakistan, explaining that HDV is a unique and highly dangerous virus that affects the liver and can only cause disease in individuals already infected with Hepatitis B Virus (HBV).

Given Pakistan’s large HBV patient population, HDV poses a significant national health challenge. Official estimates suggest that over one million people nationwide may already be affected, while around 20 percent of Hepatitis B patients could also be infected with HDV. However, the minister noted that routine diagnostic screening remains limited, leaving many patients undiagnosed and untreated.

He warned that delayed diagnosis and lack of treatment can lead to severe complications, including liver cancer, making early detection, coordinated treatment strategies, and integrated national planning essential.

The federal government, he said, is working on comprehensive measures to ensure the affordable and sustainable availability of the new therapy, emphasizing that providing safe, high-quality, life-saving modern medicines to the public remains a top national priority.

Minister Kamal further assured that DRAP will ensure a transparent, science-based, and internationally compliant regulatory process, while all stakeholders agreed to fast-track regulatory procedures for Phase-III clinical trials in Pakistan. This will allow the new treatment to reach eligible patients as early as possible, under strict monitoring and in line with global clinical standards.


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