Quality Chemical Industries Limited (Qcil), a Ugandan pharmaceutical manufacturer, has signed a sublicence agreement with the Medicines Patent Pool (MPP) to develop and supply a generic version of baloxavir marboxil. This single-dose oral antiviral treatment targets influenza. The agreement was announced in New York during a side event at the United Nations General Assembly. It aims to expand access to influenza treatment in countries covered by the licence. The partnership also seeks to strengthen regional pharmaceutical manufacturing and pandemic preparedness.
The sublicence follows a voluntary licence agreement between MPP and Roche in May 2026. This licence allows selected generic manufacturers to develop, produce, and supply baloxavir marboxil in 129 low- and middle-income countries. The goal is to create additional supply pathways for seasonal influenza treatment and future pandemic response. Baloxavir marboxil works by blocking influenza viruses from multiplying early during an infection. It is recommended in the World Health Organization’s clinical practice guidelines for influenza.
Baloxavir marboxil has been approved by both the European Medicines Agency and the United States Food and Drug Administration. However, approved uses and eligible age groups vary by country. A Phase III CENTERSTONE trial, published in the New England Journal of Medicine, found that treatment with a single oral dose of baloxavir reduced the odds of influenza transmission to household contacts by 32% compared with placebo. The medicine also demonstrates activity against influenza strains resistant to some 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 development, manufacturing, and regulatory work required to produce a generic version of the medicine. Commercial supply will begin only after meeting the applicable development, quality, and regulatory requirements.
The new sublicence expands Qcil’s portfolio into influenza treatment. It could contribute to more geographically diverse manufacturing capacity for seasonal outbreaks and future pandemics. According to Ajay Kumar Pal, Chief Executive Officer of Qcil, this sublicence gives the company an opportunity to apply its manufacturing and regulatory experience to an important influenza treatment for low- and middle-income countries.
Pal added that working with MPP, and with support from Roche under the voluntary licence, Qcil will now begin the development work required for a quality-assured generic version. The partnership could help widen access to influenza treatment while strengthening pharmaceutical manufacturing capacity in Africa. Qcil’s next steps will focus on the development, quality, manufacturing, and regulatory requirements needed before the generic product can be supplied in eligible countries.
The collaboration between Qcil and MPP marks a significant step towards enhancing access to essential medicines in low- and middle-income countries. By leveraging MPP’s licence with Roche, Qcil aims to make a generic version of baloxavir marboxil available, ultimately contributing to improved public health outcomes in the region. The company’s efforts align with global initiatives to address health disparities and ensure equitable access to life-saving treatments.
Key points
- Qcil partners with Medicines Patent Pool to develop generic influenza treatment
- The partnership aims to expand access to influenza treatment in low- and middle-income countries
- The sublicence agreement supports efforts to strengthen regional pharmaceutical manufacturing and pandemic preparedness
