A high-level meeting in Islamabad chaired by Federal Minister Syed Mustafa Kamal brought together Huahui Health, IQVIA Pakistan and DRAP to set a strategic course against Hepatitis Delta. The discussions focused on urgent measures to widen access to effective therapies and strengthen local preparedness for the rising clinical burden of this infection in Pakistan.
Representatives from Huahui Health updated officials on the investigational therapy HH-003 (Libevitug), which has completed successful Phase 2 multi-country clinical studies and obtained regulatory approval in China. The treatment has also earned Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential significance for patients with Hepatitis Delta.
Speakers underscored the scale of the challenge in Pakistan, where estimates suggest more than one million people could be affected and roughly 20 percent of Hepatitis B patients may be co-infected with Hepatitis Delta. Officials warned that delayed diagnosis and treatment can accelerate progression to liver cirrhosis and hepatocellular carcinoma, emphasizing the need to close diagnostic gaps across the country.
The government committed to facilitate a partnership between Huahui Health and a leading local pharmaceutical manufacturer to promote localized production, technology transfer and affordable supply of advanced biologics. Expanding domestic manufacturing capacity is intended to ensure sustainable access to HH-003 and other cutting-edge therapies while building national capacity in biopharmaceutical production.
Dr. Obaidullah of DRAP reiterated the regulator’s commitment to a transparent, science-based approval process that adheres to international standards. All parties agreed to expedite the regulatory pathway for Phase 3 clinical trials in Pakistan so that the therapy can reach eligible patients under strict oversight and monitoring.
With coordinated action between the Ministry of Health, DRAP, Huahui Health and local partners, authorities aim to fast-track clinical evaluation and local supply chains for Hepatitis Delta treatment. The move seeks to deliver timely, quality care to patients while maintaining regulatory rigor and long-term affordability for the health system.
