South Africa Bids to Manufacture Gilead’s Game-Changing HIV Prevention Drug at Home

South Africa is pushing to secure a domestic licence to manufacture lenacapavir, Gilead Sciences’ revolutionary twice-yearly HIV prevention injection, marking a potentially historic shift in how the continent produces and accesses the medicines it most urgently needs. The move, announced on March 5, 2026, places Africa’s most HIV-burdened nation at the front of a global effort to localise production of what many infectious disease specialists have called a once-in-a-generation prevention breakthrough.

The South African government is working with Unitaid and the United States Pharmacopoeia — a nonprofit that develops standards for medicines — to identify domestic pharmaceutical manufacturers capable of producing a quality-assured version of the drug. Once a suitable company is identified, the government will recommend it directly to Gilead, which will then assess whether quality standards can be met before deciding whether to extend a seventh voluntary licence. A formal call for expressions of interest has been published as part of the process, according to a joint press release issued on March 5.

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“Gilead will review the proposals and assess whether required quality standards can be met before any voluntary license is granted,” the company said in a statement. Gilead added that it has been open to extending an additional voluntary licence for local manufacturing in Sub-Saharan Africa — a signal that the deal has genuine momentum behind it, not merely political aspiration.

The Drug at the Centre of It All

Lenacapavir is unlike anything that has come before in HIV prevention. It is a first-in-class HIV-1 capsid inhibitor — a molecule that interferes with the HIV virus at multiple stages of its lifecycle, rather than targeting just one, giving it a formidable resistance profile and an unusually long-acting mechanism. Administered as a subcutaneous injection twice a year, it removes one of the single biggest barriers to PrEP adherence: the need to take a daily pill, which half of oral PrEP users discontinue within six to twelve months.

The clinical data behind it are extraordinary. In the PURPOSE 1 Phase 3 trial, which enrolled 5,300 cisgender women in Uganda and South Africa, lenacapavir demonstrated 100% efficacy in preventing HIV infection — not a single participant in the lenacapavir arm acquired the virus. The PURPOSE 2 trial, which followed a more diverse population including cisgender men, transgender women, transgender men, and gender-nonbinary individuals, showed a 96% reduction in HIV incidence compared to background infection rates, and superiority over daily oral tenofovir-based PrEP. Only two new HIV infections were recorded among the 2,179 participants in the lenacapavir arm. The results, published in the New England Journal of Medicine, set a new benchmark for HIV prevention science.

In June 2025, the U.S. Food and Drug Administration approved lenacapavir for PrEP, and the CDC’s PrEP Guidelines Work Group issued a strong recommendation for its use. The WHO had already recognised the drug’s potential, calling for an assessment of global scalability. Several African regulators moved quickly: Kenya, Uganda, Mozambique, and Namibia all granted regulatory approval in January 2026, and the drug has already reached Eswatini and Zambia through early supply arrangements with the Global Fund and PEPFAR.

Why South Africa Wants to Make It Locally

The push for domestic manufacturing is rooted in a hard lesson learned repeatedly across the African continent: when lifesaving drugs are made elsewhere, access is always conditional, often delayed, and chronically insufficient.

South Africa carries the world’s single largest HIV burden. Around 8 million people — roughly one in five South African adults — are living with the virus. Every week, approximately 1,000 adolescent girls and young women in the country become newly infected. Despite having one of the world’s largest antiretroviral treatment programmes, the country has never fully closed the gap between infections and prevention coverage.

South Africa’s Health Minister, Dr Aaron Motsoaledi, has been direct about the government’s ambition, committing at a national round table in October 2025 to make lenacapavir “a public good — accessible, affordable and locally produced.” The Minister highlighted that the drug’s clinical trials had shown remarkable results, and called for coordination between government, the private sector, and international partners to ensure no one is left behind.

Paul Mashatile, chair of the South African National AIDS Council (SANAC) and deputy president, has framed the case in even broader terms, arguing that local production would benefit not just South Africa but the entire southern African region. The sentiment was echoed by Kenyan President William Ruto, who serves as the African Union lead on local manufacturing of health commodities. “Africa can no longer rely on medicines produced elsewhere for diseases that affect us most,” Ruto said.

This is not merely rhetoric. During COVID-19, South Africa and the continent at large watched as vaccine doses were hoarded by wealthier nations while Africa received scraps. The pharmaceutical sector has drawn clear conclusions. As Aspen Pharmacare’s Stavros Nicolaou — who leads the Pharmaceutical Manufacturers in South Africa industry body — told a regional health conference in October 2025: “We import significant and vast sums of our antiretrovirals. We have the largest HIV population of any country in the world… and yet we continue to import most of our antiretrovirals.”

Gilead’s Existing Licences and Their Gaps

In October 2024, Gilead granted six voluntary licences to generic manufacturers in Egypt, India, and Pakistan, allowing them to produce and supply generic lenacapavir to 120 low- and middle-income countries. South Africa was included as a recipient country — meaning it can access the drug — but no South African manufacturer was included as a licensed producer. That omission drew criticism from health advocates and policymakers who argued that a country carrying 17% of the world’s HIV-positive population deserved a seat at the production table.

A seventh licence for a South African company would, in the words of the joint press release, “further diversify global supply and align production more closely with the region that carries the highest HIV burden.” The logic is straightforward: production capacity in sub-Saharan Africa would mean shorter supply chains, faster delivery, and greater resilience if global logistics or geopolitics disrupted supply from Asia.

Pricing is also a critical factor. At launch in high-income countries, lenacapavir carried a list price of around $28,000 per person per year — a figure entirely out of reach for public health systems in Africa. South Africa’s Health Minister has highlighted that through voluntary licensing and Gilead’s not-for-profit supply arrangement, the cost has been brought down to approximately $40 per person per year for lower-income country markets — a reduction of 700 times. Generic manufacturing in South Africa would aim to sustain and build on those gains, with the potential to extend access to countries currently excluded.

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Middle-Income Countries and the Access Gap

One of the more consequential dimensions of the South African push is its potential spillover effect on middle-income countries that were excluded from Gilead’s original voluntary licensing geography. Countries like Brazil — a major HIV-affected nation with a middle-income classification that placed it outside the 120-country coverage zone — have faced criticism of the existing access framework.

Unitaid’s director of programme Robert Matiru said a South African company could try to expand access to these excluded middle-income countries. “It’s an opportunity to open the door further,” he said, while emphasising that securing the South African licence itself remained the primary goal. Brazil received FDA-equivalent regulatory approval from ANVISA in January 2026, meaning the drug is cleared for use — but affordable supply at scale remains a challenge in the absence of a licensed generic manufacturer serving that market.

Local Manufacturing Capacity and the Road Ahead

South Africa has the pharmaceutical infrastructure to make this ambition credible. Several domestic companies already manufacture HIV treatments or sterile injectables — a prerequisite given that lenacapavir is a subcutaneous injection requiring rigorous sterile production standards. Aspen Pharmacare, the continent’s largest drug manufacturer, has a long history of producing generic antiretrovirals, having pioneered Africa’s first generic ARV in 2003. The company operates 24 manufacturing facilities across 15 sites with regulatory approvals from the U.S. FDA, Australia’s TGA, and the European Directorate for the Quality of Medicines — a strong international quality pedigree.

However, the path from interest to licensed production is not straightforward. Lenacapavir is a complex molecule. Manufacturing a quality-assured injectable version requires specialised technical transfer, formulation expertise, and capacity for the kind of cold-chain logistics that subcutaneous injectables demand. The process of identifying a suitable manufacturer, conducting technical assessments, and negotiating a licence agreement with Gilead will take time — though the involvement of Unitaid and the United States Pharmacopoeia in an advisory role is designed to accelerate and de-risk those steps.

Nicolaou’s warnings at the CPHIA 2025 conference about regulatory bottlenecks are relevant context. He noted that African manufacturers can face a six-year qualification process before reaching market — a timeline that, if repeated here, would drastically slow the realisation of what South Africa’s government is trying to achieve. Reforming that timeline runs in parallel with the push for the Gilead licence.

A Broader Signal for African Health Sovereignty

Beyond the specifics of lenacapavir, South Africa’s move sends a signal that Africa is no longer willing to accept a passive role in the global pharmaceutical supply chain for diseases that disproportionately affect its population. The African Union’s broader Agenda 2063 goals include building continental pharmaceutical manufacturing capacity, and the COVID-19 pandemic lent those ambitions significant political urgency.

If South Africa succeeds in securing a seventh voluntary licence and begins domestic production of lenacapavir, it would mark a milestone: the first time a sub-Saharan African manufacturer holds a licence to produce one of the most scientifically significant HIV prevention drugs in the 44-year history of the pandemic. And if the drug lives up to the extraordinary promise of the PURPOSE trials — with efficacy that experts say could help bring an end to new HIV infections — producing it at home would ensure that the region most in need is not the last to benefit.

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By: Montel Kamau

Serrari Financial Analyst

6th March, 2026