South Africa launches bid to enable local production of long-acting HIV prevention drug, lenacapavir

South Africa launches bid to enable local production of long-acting HIV prevention drug, lenacapavir

Unitaid and USP provide technical and market support to strengthen regional manufacturing and supply resilience

The Government of South Africa today announced that it is engaging with Gilead Sciences to pursue an agreement that would enable local production of lenacapavir, a revolutionary long-acting HIV prevention drug. As part of this effort, and in collaboration with Unitaid, USP and other partners, the government has published a call for expression of Interest that would assist in identifying South African pharmaceutical manufacturers capable of producing quality-assured lenacapavir.

Originally developed by Gilead, lenacapavir is a twice-yearly injection that has demonstrated near-complete effectiveness in preventing HIV. It is widely considered one of the most promising new tools to reduce infections, particularly in high-burden countries.

In October 2024, Gilead granted six voluntary licenses to generic manufacturers across Egypt, India, and Pakistan, allowing them to produce and supply generic lenacapavir to 120 low- and middle-income countries, an important step toward expanding access.

A seventh license for a South Africa-based manufacturer would further diversify global supply and align production more closely with the region that carries the highest HIV burden. Producing lenacapavir closer to where it is most needed could accelerate the pathway from innovation to access and help ensure more predictable, sustainable supply. It would also strengthen the region’s ability to respond to its own health priorities, especially as countries move toward longer-term domestic financing

The newly launched expression of interest forms part of a coordinated national effort led by the South African National AIDS Council (SANAC) that aspires to produce both the active pharmaceutical ingredient and the finished product in South Africa. If successful, this would expand regional manufacturing capacity in sub-Saharan Africa and strengthen long-term supply resilience.

Through this request for proposals, South Africa will assess manufacturers’ technical capabilities, regulatory compliance, and commitment to equitable access.

The selected manufacturer will work with the Adhoc Committee on Lenacapavir Licensing, a multi-stakeholder, intergovernmental body chaired by SANAC and supported by the Unitaid-established MedSuRe Africa regional manufacturing programme, which is led by USP in collaboration with partners including Africa CDC, Africa Medicines Agency, development financing institutions, the Medicines Patent Pool, WHO and funding agencies. Together, they will strengthen product development, ensure alignment with international quality standards, and support regulatory approval, including WHO prequalification where applicable.

Unitaid, USP and their partners will also provide market-shaping support to help accelerate uptake and ensure sustainable and affordable supply.

Deputy President Paul Mashatile, Chairperson of the South African National AIDS Council (SANAC): “For decades, South Africa has demonstrated that political will, scientific excellence, and community leadership can change the course of an epidemic,” said Deputy President Paul Mashatile, Chairperson of the South African National AIDS Council (SANAC). “Today, we build on that legacy by taking steps to ensure that the next generation of HIV prevention tools can be produced here at home—not only for South Africans but in partnership with, and for the benefit of, our region. In doing so, we strengthen regional resilience, expand equitable access, and advance our shared commitment to ending HIV.”

His Excellency Dr. William Samoei Ruto, C.G.H., President of the Republic of Kenya and African Union Champion for Local Manufacturing of Health Commodities: “Africa can no longer rely on medicines produced elsewhere for diseases that affect us most. South Africa’s bold step under President Ramaphosa to pursue local production of lenacapavir reflects the transformative action our continent needs. By manufacturing on African soil, we strengthen supply chains, create skilled jobs, build scientific capacity, and take ownership of our health. I commend President Ramaphosa and call on partners to support this effort. This is how we end HIV on African terms.”

His Excellency Dr. Jean Kaseya, Director-General of the Africa Centres for Disease Control and Prevention (Africa-CDC): “Africa carries the heaviest burden of HIV, yet has historically had the least control over the medicines needed to fight it. South Africa’s bold step to pursue local production of lenacapavir changes that narrative. At Africa CDC, we believe that health security and manufacturing sovereignty go hand in hand. When Africa produces the medicines its people need, we are not just improving access, we are building resilience, creating jobs, and asserting our right to shape our own health future. We strongly commend South Africa’s leadership and stand ready to support this effort as part of our broader continental mission to strengthen Africa’s pharmaceutical ecosystem.”

Her Excellency Dr. Delese Mimi Darko, Director General of the African Medicines Agency (AMA): Local manufacturing must ultimately serve one purpose: better, faster access to safe and effective medicines for African patients. As Africa expands manufacturing of innovations such as lenacapavir, strong and harmonised regulatory systems are essential to ensure quality, safety and public trust and to prevent fragmentation across markets. When quality standards are aligned and regulatory oversight is rigorous, medicines manufactured on the continent can move efficiently across borders and reach the communities that need them most. AMA stands ready to support this effort, strengthening regulatory excellence so that African patients benefit fully from Africa’s manufacturing ambition.

Ms. Angele Makombo N’tumba, Deputy Executive Secretary: Regional Integration, Southern African Development Community (SADC) Secretariat: “The Republic of South Africa’s initiative to pursue regional manufacturing of lenacapavir is a landmark moment for our region, HIV remains one of the most significant health challenges facing Southern Africa, and regional manufacturing combined with pooled procurement across SADC Member States creates a powerful opportunity to drive down costs, strengthen negotiating power, and ensure reliable supply of this life-saving medicine. The SADC Secretariat fully supports this effort as a cornerstone of our broader regional pharmaceutical manufacturing agenda. In their recently concluded meeting in Johannesburg, the SADC Ministers of Health and Ministers responsible for HIV supported the Republic of South Africa’s efforts towards securing a voluntary licence for local and regional manufacturing of Lenacapavir to ensure equitable, affordable, and sustainable access across the SADC region.”

Alankar Malviya, UNAIDS Director, South Africa, Lesotho and Eswatini: “This is exactly the kind of bold, nationally-led action that will define the next chapter of the HIV response. South Africa has long been at the forefront of ensuring its people can access treatment, and now it is staking a claim to produce prevention tools at home, for the region. Lenacapavir has the potential to be transformative, but only if supply keeps pace with need. A South African manufacturer in the global supply chain is not a luxury – it is a necessity. UNAIDS stands firmly behind this effort and urges all parties to move with the urgency this moment demands.”

Mr. Solly Nduku, National Chairperson of the SANAC Civil Society Forum: “We stand on the brink of the next phase in HIV prevention – the real prevention revolution we’ve been long calling for. This is not just a programmatic intervention but a long-term investment in the health, well-being, and future of our nation. We can now confidently say we are on course to eliminate HIV as a public health threat in South Africa.”

Dr. Philippe Duneton, Unitaid Executive Director: “We commend South Africa’s leadership in strengthening regional manufacturing and exploring the possibility of a voluntary license to produce lenacapavir. By investing in local production capacity, this initiative helps build the skills, infrastructure and regulatory strength needed to deliver not only this innovation, but future health solutions as well. It is a meaningful step toward empowering countries at the center of the HIV epidemic to shape and sustain their own health responses.”

Ronald T. Piervincenzi, Ph.D., Chief Executive Officer of USP: “Ensuring that innovative medicines are not only available but also meet internationally accepted quality standards is essential. USP is proud to provide technical support to strengthen South Africa’s manufacturing readiness for the rollout of lenacapavir and to help establish a strong foundation for regional production of this important HIV prevention medicine.”

Dr. Thembisile Xulu, SANAC CEO & Co-Chair of the Ad Hoc Committee on Lenacapavir Licencing “SANAC is pleased to coordinate this pioneering initiative to advance local manufacturing of Lenacapavir. It represents an important step towards strengthening Africa’s capacity to produce life-saving health technologies, and to expand equitable access across the region. The initiative also reflects a strategic partnership between government, civil society, development partners, and the local pharmaceutical industry working together to deliver sustainable impact and access.”

Dr. Anban Pillay, Co-Chair of the Ad Hoc Committee on Lenacapavir Licencing & Deputy Director General: Health Regulation and Compliance Management at the RSA Department of Health: “South Africa is committed to accelerating access to the most effective HIV prevention commodities for the most vulnerable populations. Interrupting the cycle of transmission is one of the critical interventions that will enable the country to eliminate HIV as a public health threat by 2030.”

About SANAC
The South African National AIDS Council (SANAC), as the highest national coordinating body for the HIV, TB, and STI response, is mandated to convene government, civil society, development partners, and the private sector to advance South Africa’s national health priorities. Central to this mandate is ensuring that policy, scientific evidence, and implementation strategies align to enable equitable access to life-saving innovations.

In collaboration with the National Department of Health (NDoH), Department of Trade, Industry and Competition (DTIC), Department of Science Technology and Innovation (DSTI) and National Treasury (NT), SANAC is leading a coordinated national process to position South Africa for future manufacturing opportunities and to strengthen readiness for local production of lenacapavir injection, tablet, and the active pharmaceutical ingredient (API).

About Unitaid
Unitaid saves lives by making new health products affordable and available in low- and middle-income countries. Collaborating with partners, Unitaid identifies innovative treatments, tackles market barriers, and quickly delivers solutions to those in need. Since 2006, Unitaid has unlocked over 100 health products, addressing HIV, TB, malaria, women’s and children’s health, and pandemic preparedness. Every year, these products benefit more than 300 million people. Unitaid is a hosted partnership of the World Health Organization. www.unitaid.org

About USP
USP is an independent scientific organization that collaborates with scientific experts and global stakeholders to develop science-based standards and solutions that help strengthen regulatory systems, simplify complex manufacturing supply chains, enhance supply reliability, and support adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in helping increase the availability of quality medicines, supplements and food ingredients for billions of people worldwide.

About MedSuRe

MedSuRe Africa (Medicines Supply Resilience Africa) is a Unitaid-funded program led by the U.S. Pharmacopeia (USP) that strengthens regional pharmaceutical manufacturing across Africa. The initiative supports local production of quality-assured medicines for HIV, malaria, and postpartum hemorrhage, helping reduce reliance on imports and improve long-term supply resilience. By providing technical support, regulatory strengthening, and market entry assistance, MedSuRe Africa aims to expand sustainable, affordable access to essential health products across the continent.

For further information or media inquiries, please contact:

Kyle Wilkinson
Communications officer
+41 79 445 17 45
wilkinsonk@unitaid.who.int