ISLAMABAD, July 19 (ABC): Pakistan has moved closer to introducing a breakthrough therapy for Hepatitis Delta (HDV) after discussions held during the Pakistan-China B2B Health Conference advanced plans to make the treatment available through the Emergency Use Authorization (EUA) pathway.

The development follows efforts led by Federal Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal, who has been working over the past seven months with leading hepatologist Prof. Dr. Saeed Hamid and clinical research expert Syed Munawar Ali to improve access to innovative treatment options for Hepatitis Delta patients.

The therapy has previously received the Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA) for the treatment of Hepatitis Delta, recognizing its potential to address a serious disease with significant unmet medical need.

According to the Ministry of National Health Services, discussions during the Pakistan-China B2B Health Conference brought the chief executive officer of the Chinese biotechnology company developing the therapy to Pakistan.
During the visit, meetings were held with Drug Regulatory Authority of Pakistan (DRAP) Chief Executive Officer Dr. Obaid Ullah Malik to facilitate the Phase III clinical development programme in Pakistan through an accelerated regulatory pathway while simultaneously advancing the legal and scientific review required for Emergency Use Authorization.

The regulatory efforts are being carried out in collaboration with LCI Pharma, led by Chief Executive Officer Atif Siddiqui, to support the approval process and help make the treatment available to Pakistani patients at the earliest possible opportunity.

Speaking on the initiative, Minister Mustafa Kamal said Hepatitis Delta is among the most serious forms of viral hepatitis and warned that without timely intervention, the disease could continue to spread and pose severe liver complications, particularly for people with weakened immune systems.

Health experts estimate that Pakistan may have more than one million suspected Hepatitis Delta patients, many of whom remain undiagnosed. Officials believe the initiative could strengthen the country’s response to the disease by improving access to advanced therapies while expanding clinical research capacity.

The breakthrough medicine has already completed Phase II clinical evaluation in China, the United States, Mongolia and Pakistan, where it demonstrated a favourable safety profile during clinical development. Pakistan’s participation in the programme reflects its growing role in international medical research and efforts to bring advanced treatments to local patients.

The Ministry of National Health Services, DRAP, clinical researchers and industry partners reaffirmed their commitment to completing the remaining regulatory requirements as quickly as possible while ensuring all scientific, safety and legal standards are fully met before the therapy becomes available in Pakistan.