NEW YORK — Quality Chemical Industries Limited (Qcil), a Ugandan pharmaceutical manufacturer, has signed a sublicence agreement with the Medicines Patent Pool (MPP) to develop, manufacture and supply a generic version of baloxavir marboxil, a single-dose oral antiviral medicine used to treat influenza.
The agreement was announced in New York during a side event at the United Nations General Assembly organised by the Medicines Patent Pool and supported by Roche.
The sublicence follows a voluntary licence agreement signed between MPP and Roche in May 2026. The agreement allows selected generic manufacturers to develop, produce and supply baloxavir marboxil in 129 low- and middle-income countries, creating additional supply options for seasonal influenza treatment and pandemic preparedness.
Baloxavir marboxil works by blocking influenza viruses from multiplying early in an infection. It is recommended in the World Health Organisation’s clinical practice guidelines for influenza and has been approved by the European Medicines Agency and the United States Food and Drug Administration, although 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 oral dose of baloxavir reduced the odds of influenza transmission to household contacts by 32% compared with placebo.
The medicine is also active against some influenza strains that are resistant to other classes of antiviral medicines.
Under the MPP-Roche licence, Roche will support sublicensees through MPP by providing a foundational data package, reference products for bioequivalence studies and necessary regulatory waivers.
Qcil will independently undertake the product development, manufacturing and regulatory processes required to produce the generic medicine. Supply will begin only after all applicable development, quality and regulatory requirements have been met.
Qcil has more than two decades of experience manufacturing quality-assured, WHO-prequalified medicines for HIV and malaria. The new sublicence expands the company’s manufacturing portfolio into influenza treatment while contributing to more geographically diverse pharmaceutical production for seasonal outbreaks and future pandemics.
“This sublicence gives Qcil an opportunity to apply its manufacturing and regulatory experience to an important influenza treatment for low- and middle-income countries,” said Ajay Kumar Pal, Chief Executive Officer of Qcil.
“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. This partnership can widen access to treatment while strengthening manufacturing capacity in Africa and preparedness for future influenza outbreaks,” he said.
Qcil thanked MPP and Roche for using voluntary licensing to support wider access to baloxavir marboxil and strengthen the supply of influenza antivirals in low- and middle-income countries.
About Qcil
Quality Chemical Industries Limited is a publicly listed Ugandan pharmaceutical manufacturing company established in 2005 and dedicated to producing high-quality, affordable medicines.
Qcil manufactures WHO-prequalified treatments for HIV and malaria and supplies medicines in Uganda and other African markets. Its vision is to become a centre of excellence in manufacturing quality, affordable and accessible medicines for Africa.
About the Medicines Patent Pool
The Medicines Patent Pool is a United Nations-backed public health organisation that works to increase access to and facilitate the development of medicines and other health technologies for low- and middle-income countries.
MPP partners with patent holders and public health stakeholders to license priority health products, support generic manufacturing and enable the development of needed formulations. It was founded by Unitaid, which remains its principal funder
