Ugandan pharmaceutical manufacturer Quality Chemical Industries Limited (Qcil) has signed a sublicence agreement with the Medicines Patent Pool (MPP) to develop, manufacture and supply a generic version of baloxavir marboxil, an oral antiviral treatment for influenza.
The agreement was announced in New York during a side event held on the margins of the United Nations General Assembly and organised by the Medicines Patent Pool with support from Roche.
The sublicence follows a voluntary licensing agreement between MPP and Roche signed in May 2026. Under that agreement, selected generic manufacturers are permitted to develop, produce and supply baloxavir marboxil in 129 low- and middle-income countries.
The arrangement is intended to expand potential supply of the influenza treatment while contributing to preparedness for seasonal influenza outbreaks and future pandemics.
Baloxavir marboxil is a single-dose oral antiviral that works by inhibiting the replication of influenza viruses early in an infection. It has been approved by the United States Food and Drug Administration and the European Medicines Agency, while the World Health Organization recommends its use in its clinical practice guidelines for influenza. Approved uses and eligible age groups vary by country.
Evidence from the phase III CENTERSTONE trial, published in the New England Journal of Medicine, found that treating an infected person with a single dose of baloxavir reduced the odds of influenza transmission to household contacts by 32 percent compared with placebo.
The medicine has also demonstrated activity against influenza strains that are resistant to some other classes of antiviral medicines.
Qcil to lead product development
Under the licensing arrangement, Roche will support the sublicensees through MPP by providing a foundational data package, reference products for bioequivalence studies and relevant regulatory waivers.
Qcil will undertake the product development, manufacturing and regulatory work required to produce the generic version.
The company said supply will only begin after the necessary development, quality and regulatory requirements have been fulfilled.
Qcil has more than two decades of experience in pharmaceutical manufacturing and produces quality-assured and WHO-prequalified treatments for HIV and malaria.
The new sublicence expands the company’s manufacturing portfolio into influenza treatment and could contribute to a more geographically diversified supply base for influenza medicines.
Qcil Chief Executive Officer Ajay Kumar Pal said the agreement would allow the company to apply its existing manufacturing and regulatory experience to the development of the generic treatment.
“This sublicence gives Qcil an opportunity to apply its manufacturing and regulatory experience to an important influenza treatment for low- and middle-income countries,” Pal said.
He said the company would now begin the development work required to produce a quality-assured generic version.
“Working with MPP, and with support from Roche under the voluntary licence, we will now begin the development work required for a quality-assured generic version.”
Pal added that the partnership could have implications beyond access to the medicine itself by contributing to pharmaceutical manufacturing capacity in Africa.
“This partnership can widen access to treatment while strengthening manufacturing capacity in Africa and preparedness for future influenza outbreaks,” he said.
Qcil welcomed the voluntary licensing arrangement between MPP and Roche, saying it could support broader access to baloxavir marboxil and strengthen the supply of influenza antivirals in low- and middle-income countries.
The agreement marks a new area of activity for Qcil as the Ugandan manufacturer seeks to apply its established pharmaceutical production and regulatory capabilities to influenza treatment.
Commercial supply of the generic medicine remains subject to completion of product development, quality assurance and regulatory approvals in the countries covered by the licence.
