Pakistan Advances New Hepatitis Delta Therapy Access Plan
Pakistan has moved a step closer to introducing an advanced therapy for Hepatitis Delta, as health authorities and private-sector partners push forward a regulatory pathway aimed at expanding treatment access for patients across the country. The development was highlighted after the Pakistan-China B2B Health Conference in Islamabad, where officials reviewed plans to bring the therapy into Pakistan through an Emergency Use Authorization route.
The initiative is being led by Federal Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal, who has been working with senior medical and clinical research experts to address the disease burden. The proposed treatment has previously received Breakthrough Therapy Designation from the United States Food and Drug Administration, a status linked to medicines considered potentially important for serious illnesses with unmet treatment needs.
According to the report, discussions during the conference focused on accelerating Pakistan’s participation in the next phase of the therapy’s clinical development. Officials explored how the Drug Regulatory Authority of Pakistan could support a lawful and scientifically reviewed process for Phase III trials while also examining requirements for possible emergency use approval.
Health Minister Mustafa Kamal described Hepatitis Delta as one of the most severe forms of viral hepatitis and warned that delayed intervention could expose vulnerable patients to worsening liver complications. His remarks reflected growing concern that many infected people in Pakistan may remain undiagnosed, leaving them outside formal care until their illness becomes more advanced.
A key part of the latest progress came after the chief executive of the Chinese biotechnology company developing the therapy visited Pakistan during the health conference. The company’s engagement with DRAP Chief Executive Officer Dr. Obaid Ullah Malik centered on regulatory steps, safety review, clinical evidence and the framework needed before the medicine can be made available to patients.
The effort also includes collaboration with LCI Pharma, led by Chief Executive Officer Atif Siddiqui, which is supporting the regulatory and scientific process in Pakistan. Officials and partners are expected to work on documentation, trial facilitation and compliance requirements to ensure that any approval follows medical, legal and safety standards.
Hepatitis Delta is considered particularly dangerous because it occurs in people already infected with Hepatitis B and can accelerate serious liver disease. In Pakistan, health experts estimate that suspected cases may exceed one million, making access to effective therapy a public health priority alongside screening, diagnosis and disease awareness.
The therapy has already undergone Phase II clinical evaluation in China, the United States, Mongolia and Pakistan, where it reportedly showed a favorable safety profile during development. Pakistan’s involvement in the clinical program is being presented as evidence of the country’s growing role in international medical research and its ability to participate in advanced treatment trials.
For Pakistan’s health system, the potential introduction of this therapy could strengthen the national response to viral hepatitis, reduce long-term pressure on liver-care services and encourage further investment in clinical research. The next phase will depend on DRAP’s review, completion of remaining scientific requirements and the ability of health authorities to create a safe access pathway for eligible patients.