Michael Gwarisa
South Africa has taken a significant step toward expanding access to next-generation HIV prevention by launching a process aimed at manufacturing lenacapavir, a long-acting injectable drug widely seen as a potential game-changer in the fight against HIV.
The initiative forms part of a broader strategy by the government to strengthen regional pharmaceutical production while ensuring that cutting-edge prevention tools reach populations most affected by the epidemic. Authorities have already issued an Expression of Interest (EOI) inviting local pharmaceutical manufacturers to indicate their capacity to produce quality-assured lenacapavir within South Africa.
Developed by pharmaceutical giant Gilead and marketed under the brand name Yeztugo, lenacapavir is administered through injection and offers long-acting protection against HIV. In 2024, Gilead issued voluntary licences to six generic drug manufacturers based in Egypt, India and Pakistan, allowing them to produce and distribute generic versions of the drug to 120 low- and middle-income countries. Health experts say adding a South African manufacturer to that supply chain would further decentralise production and improve access for the region most heavily burdened by HIV.
South Africa’s Deputy President Paul Mashatile, who also chairs the South African National AIDS Council (SANAC), said the country’s decision to pursue local manufacturing builds on decades of progress in the HIV response. He noted that South Africa has long demonstrated how political commitment, scientific innovation and community mobilisation can shift the trajectory of the epidemic. According to Mashatile, producing advanced HIV prevention tools locally would not only benefit South Africans but also support neighbouring countries by strengthening regional supply and expanding equitable access.
The government’s call for proposals is part of a coordinated national effort spearheaded by SANAC to establish production capacity for both the active pharmaceutical ingredient (API) and the final finished product within the country. If realised, the project could significantly boost pharmaceutical manufacturing capacity in sub-Saharan Africa and reduce the continent’s dependence on imported medicines.
Through the proposal process, authorities will assess companies’ technical capabilities, regulatory compliance standards and commitment to ensuring equitable access to the medicine. The goal is to identify a manufacturer capable of meeting international quality standards while supporting broader public health objectives.
Once selected, the manufacturer will collaborate with the Ad Hoc Committee on Lenacapavir Licensing, an intergovernmental and multi-stakeholder body chaired by SANAC. The committee is supported by the MedSuRe Africa regional manufacturing programme, which was established by Unitaid and is led by the United States Pharmacopeia (USP).
MedSuRe Africa works in partnership with several key institutions including the Africa Centres for Disease Control and Prevention (Africa CDC), the Africa Medicines Agency (AMA), the Medicines Patent Pool, the World Health Organization (WHO) and multiple development finance institutions. These partners are expected to provide technical expertise to support product development, ensure compliance with international manufacturing standards and facilitate regulatory approval processes, including potential WHO prequalification.
In addition to strengthening production capacity, Unitaid, USP and other partners will also help shape the market for the drug by supporting strategies aimed at accelerating uptake while keeping prices affordable and supply sustainable.
African leaders have welcomed South Africa’s push for local manufacturing, describing it as a crucial milestone in the continent’s broader quest for pharmaceutical independence.
Kenyan President William Samoei Ruto, who serves as the African Union Champion for Local Manufacturing of Health Commodities, said Africa can no longer rely solely on medicines produced elsewhere to address diseases that disproportionately affect the continent. Ruto praised South Africa’s leadership under President Cyril Ramaphosa, saying local production of lenacapavir would help strengthen supply chains, create skilled jobs and expand Africa’s scientific capacity while enabling countries to take greater control over their health responses.
Public health institutions have echoed similar sentiments, highlighting the importance of local manufacturing in strengthening health security. Dr Jean Kaseya, Director-General of the Africa CDC, said Africa bears the greatest burden of HIV yet historically has had limited control over the medicines needed to combat it. He said initiatives that expand pharmaceutical production on the continent not only improve access to life-saving treatments but also contribute to economic growth and resilience by generating jobs and building research capacity.
Regulatory oversight will also play a central role as Africa scales up pharmaceutical production. Dr Delese Mimi Darko, Director-General of the Africa Medicines Agency, emphasised that expanding manufacturing must be matched with strong and harmonised regulatory systems across the continent. According to Darko, aligning regulatory standards across African markets will ensure medicines produced locally meet global quality benchmarks while enabling them to move efficiently across borders.
Regional organisations have also thrown their support behind the initiative. Angele Makombo N’tumba, Deputy Executive Secretary for Regional Integration at the Southern African Development Community (SADC) Secretariat, described the move as a landmark moment for Southern Africa. She noted that HIV remains one of the most pressing public health challenges in the region and said regional manufacturing combined with pooled procurement could significantly lower costs and guarantee stable supply for member states.
The SADC Secretariat recently hosted a meeting in Johannesburg where ministers responsible for health and HIV programmes endorsed South Africa’s efforts to secure a voluntary licence for regional production of lenacapavir. The ministers agreed that such an approach would help ensure equitable and sustainable access to the medicine across the region.
Civil society organisations have also welcomed the initiative, saying it could usher in a new era for HIV prevention. Solly Nduku, National Chairperson of the SANAC Civil Society Forum, said the effort represents more than a programmatic intervention and should be viewed as a long-term investment in the health and future of South Africa.
Global health agencies involved in the project say strengthening regional manufacturing capacity will also help prepare countries for future health challenges. Dr Philippe Duneton, Executive Director of Unitaid, said initiatives like this help build the skills, infrastructure and regulatory systems necessary to deliver new medical innovations while ensuring countries most affected by disease are able to shape their own health responses.
Technical partners are also playing a critical role in preparing local manufacturers to meet global quality standards. Ronald T. Piervincenzi, Chief Executive Officer of USP, said the organisation is providing technical support to enhance South Africa’s manufacturing readiness and ensure that any locally produced lenacapavir meets internationally recognised standards of safety and efficacy.
SANAC Chief Executive Officer Dr Thembisile Xulu, who co-chairs the Lenacapavir Licensing Committee, said the initiative reflects an unprecedented partnership involving government, civil society, development partners and the pharmaceutical industry. She noted that collaboration across sectors will be essential to ensuring sustainable production and equitable access to new HIV prevention technologies.
For South Africa’s Department of Health, the push to manufacture lenacapavir locally is also tied to the country’s long-term HIV elimination goals. Dr Anban Pillay, Deputy Director-General for Health Regulation and Compliance Management and co-chair of the licensing committee, said improving access to effective prevention tools is key to interrupting HIV transmission.
