2025-11-19

WHO Approves Fosun Pharma’s First Child-friendly Primaquine Formulations for Malaria Treatment

(19 November 2025, Shanghai, China) Recently, the World Health Organization (WHO) awarded prequalification to two child-friendly formulations of primaquine, which was independently developed by Guilin Pharmaceutical Co., Ltd., a subsidiary of Fosun Pharma. These are the first pediatric formulations of primaquine phosphate prequalified by WHO. The products are intended for the most vulnerable group, which is also the most susceptible to repeated malaria infections, and will provide more suitable and accessible treatment options for young malaria patients globally.

 

Primaquine is an antimalarial medicine recommended by the WHO Guidelines for Malaria. It plays a critical role in combatting the two main species of parasite that cause malaria in humans:

1. Plasmodium vivax[1]: administered over 7 or 14 days, primaquine helps eliminate the dormant liver stage ofP. vivaxmalaria, which can cause relapse weeks or even months after the initial infection. Without treatment, children remain vulnerable to repeated illness, leading to anaemia and missed school days, undermining both health and development.

2. Plasmodium falciparum:WHO recommends a single low dose of primaquine to block the transmission ofP. falciparummalaria[2] by killing gametocytes (the sexual stage of the parasite reproduction cycle). By preventing onward transmission from infected patients back to mosquitoes, primaquine helps limit the rise of drug resistance, one of the greatest threats to malaria elimination.

 

According to the WHO World Malaria Report 2024, in 2023there were an estimated 263 million new malaria cases in 83 countries globally, and malaria deaths reached 597,000. Over 76% of malaria deaths occurred in children under the age of five. Having quality-assured antimalaria medicines for children is crucial to achieving the global goal of malaria elimination. The WHO prequalification of the two strengths of primaquine phosphate dispersible tablets signifies that the product meets the quality standards for procurement of global public health medicines. It can now be included in the procurement lists of international agencies such as The Global Fund and UNICEF, enabling rapid supply to malaria-affected regions worldwide through the global public health supply system. This provides local pediatric malaria patients with treatment options that are easier to use and better tailored to regional needs.

 

The development of primaquine phosphate dispersible tablets project was funded by Unitaid. The products were independently developed by Guilin Pharmaceutical Co., Ltd., and implemented through the Partnership for Vivax Elimination (PAVE) and the Medicines for Malaria Venture (MMV).

 

Fosun Pharma is proud to partner with MMV on child‑friendly dispersible primaquine,” said Mr Chen Yuqing, Chairman of Fosun Pharma. “This WHO prequalification is an important step toward improving paediatric care and making effective antimalarial treatment more accessible to the children who need it.”



[1]WHO Malaria Treatment guidelines, section 5.2.1.5 Uncomplicated malaria caused byP. vivax, P. ovale, P. malariae or P. knowlesi.

[2]WHO: Policy brief on single-dose primaquine as a gametocytocide in Plasmodium falciparum malaria