South Africa’s National Aids Council (Sanac) has asked local drug companies to submit applications by 7 April to make generic versions of the anti-HIV jab that could end Aids by 2043 in the country – if 31m HIV-negative people take it for at least a year each between now and then, writes Bhekisisa’s Mia Malan, who explains just why success is so crucial for Africa.
The original version of the six-monthly shot – lenacapavir, or LEN – produced by Gilead Sciences, is almost foolproof in stopping uninfected people from getting the virus, and was registered in South Africa in October.
Locally-made shots could be available as soon as next year, but only if Gilead decides to award a South African company, or companies, with a generic licence(s).
The renewed effort, led by Sanac in collaboration with the Health Department; the Department of Trade, Industry & Competition (DTI); the Science, Technology & Innovation department; and the National Treasury, comes South African companies Aspen Pharmacare, Pharmacare and Cipla Medpro failed to secure generic licences in 2024.
Instead, Gilead awarded licences to six generic companies in India, Pakistan and Egypt, who are expected to bring generics to the market in 2027.
How will the Sanac-led effort work?
Sanac will submit a shortlist of successful applicants, who met the requirements of the Council’s expression of interest call, to Gilead by July, CEO Thembisile Xulu told Bhekisisa. The applicants will be evaluated by a local manufacturing steering committee.
Gilead will then review Sanac’s list for potential licences granted directly to the companies to make LEN from start to finish, including the production of the active pharmaceutical ingredient, or API.
International health organisation Unitaid and United States Pharmacopeia (USP) will help South African companies – to which Gilead does decide to issue licences – to master manufacturing processes, adhere to quality standards, and give them “market-shaping support”, like financial help via volume guarantees, to make LEN at a price equal to what the government pays for a daily HIV prevention pill (around $40 per year).
The pill is already available free in almost all government clinics.
Two of the six generic companies which already have licences, Hetero and Dr Reddy’s from India, have received grants from Unitaid and the Gates Foundation to help them make LEN at $40 for a year’s supply.
Unitaid will therefore provide South African companies to whom Gilead issues licences with similar support to help them compete with such markets.
Within the next two weeks, there will be a webinar for applicants to answer any questions and the adjudication process will be one month, says Xulu.
Applicants will be scored out of 100; 60 points will be for their “technical capability”. Those who get a score of 45/60 or more, will progress to an assessment of their “access and implementation potential”, which will be scored out of 40. This part of the evaluation will look at their ability to “expand access, improve affordability and promote continuous quality improvement”.
Xulu says Sanac is using “structured multi sectoral engagements” with Gilead to make the process run smoothly. In its expression of interest Sanac states: “The resulting shortlist will inform subsequent engagements with Gilead as part of efforts to secure a seventh voluntary licence agreement that supports regional manufacturing and equitable access.”
Can SA make LEN’s main ingredient?
Making LEN’s API is a complex 28-step process requiring specialised pharmaceutical processes and facilities, something many local drugmakers will struggle to manage.
When Gilead evaluated Aspen Pharmacare, Pharmacare and Cipla Medpro for generic licences in 2024, they mostly didn’t make the cut because they couldn’t make the API.
But, says Xulu, Gilead’s new assessment, based on the list of applicants that Sanac will submit to them, will also look at the South African drugmakers’ ability to produce LEN tablets that have to be taken alongside the first injection and how well they’re able to formulate both the pills and jabs.
Xulu says if Gilead’s assessment finds no local company is able to make the API, the multinational pharmaceutical company has agreed to allow successful licensees to import the API during “the initial phase” of local production, until they’re able to make it through technical transfer, meaning Gilead helping and training them, along with Unitaid and USP, on mastering the processes.
The “initial phase”, Xulu says, could be anything between three months and around a year, based on how long it takes for the technology transfer with the six companies who already have licences.
The purpose of Sanac’s call is to “secure a license from Gilead and help create an enabling environment for regional production”, Unitaid’s director of programmes, Robert Matiru, told Bhekisisa. “In practice this could involve two or three manufacturers with complementary roles.
“For example, one company may produce oral loading tablets [which must be taken with the first LEN jab] while another focuses on the injectable formulation. Or one may be selected which could manufacture both.”
Locally-made LEN could be here within a year
Matiru says locally-made LEN could be available as soon as next year if regulatory approvals are accelerated by using regional bodies like the African Medicines Agency. But such “expedited regulatory processes” will only allow the companies to supply South Africa and other sub-Saharan African countries with the medicine.
But for South African manufacturers to meet “global regulatory standards”, which will enable them to sell the medicine to donors like the Global Fund to Fight Aids, TB and Malaria, as well as other countries beyond sub-Saharan Africa (should the licences Gilead issues them with allow them to do that), it could take between two and three years, says Matiru.
“The exact timelines will depend on the companies selected through the request for proposals and the level of technical and financial support required to produce at scale and meet the necessary quality standards.”
Why the state, Unitaid are helping expedite LEN licence
The Health Department will will start to roll out LEN later this year with a two-year supply of stock paid for by the Global Fund, but the donations, enough to cover around 456 000 people in 2026 and 2027, are only 3% of the doses the country needs to end Aids by 2043.
Tens of millions more doses are needed, and fast.
South Africa has around 170 000 new HIV infections annually. To end Aids as a public health threat, the country needs to bring down new infections to 65 000 per year, to reduce the rate of new infections to 0.1% or below.
The six generic companies who already have licences from Gilead to make LEN will be able to sell their products to 120 countries, including South Africa.
But none is based in sub-Saharan Africa.
Ultimately, when – and if – South Africa becomes the first African country to make LEN, it will help the continent to respond to its own “health priorities”, says Unitaid, especially as countries move towards increasing their budgets to fund their own health problems.
“Africa carries the heaviest burden of HIV, yet has historically had the least control over the medicines needed to fight it,” said Jean Kaseya, DG of the Africa Centres for Disease Control and Prevention.
“South Africa’s bold step to pursue local production of lenacapavir changes that narrative.”
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