The world’s first producer of WHO prequalified artesunate for injection for severe malaria

Guilin Pharmaceutical, China

Guilin Pharmaceutical has been producing intravenous (IV) artesunate for patients with severe malaria since 1987. But without WHO prequalification or stringent regulatory approval, it could not be purchased by international organizations or donor funds and was thus not reaching this vulnerable group. When approached by Guilin, MMV decided to use its R&D know how in a more unconventional way. Instead of developing a new high-quality product from scratch the team worked with Guilin to achieve WHO prequalification for the existing medicine, enabling it to reach more patients. This newly prequalified artesunate injection will be available at the same affordable price as the current non-GMP1 material.

Mr. Yu, President of Guilin Pharmaceutical Company

Guilin Pharmaceutical has been producing antimalarial drugs for a long time. What led to your partnership with MMV?

We started research on artesunate in the 1980s and were awarded National Certification in 1987. As our aim was to develop a medicine that met the needs of African countries, we needed to obtain prequalification from the WHO to make it available to public sector healthcare outlets in Africa and to be considered for purchase by international procurement agencies. In the beginning, learning and understanding the WHO standards was a challenge for us. MMV was able to provide us with the consultation, guidance and training we needed. Partnering with MMV helped us to improve our capabilities.

What was the greatest challenge Guilin Pharmaceutical encountered during the process of applying for WHO prequalification?

I think the greatest challenge we encountered was human resource training. The enhancement of worker skills, establishing a code of conduct, and stimulating our staff to think globally were all challenging issues for us. MMV has played a significant role in training, on-site guidance, and the design of our renovation programme.

Mr. Long, Head of the Guilin office of the State Food and Drug Administration

Guilin Pharmaceutical became the first Chinese enterprise to be awarded prequalification by the WHO for their artesunate for injection. What does this mean for global malaria control?

The prequalification means a lot to Guilin Pharmaceutical. It demonstrates that treatment for severe malaria can now move from quinine to artesunate injection made in China. In African countries, the incidence of malaria is extremely high. After WHO prequalification, we will be able to provide artesunate for injection to these countries and help reduce the malaria death rate. Through partnership with MMV, we were able to connect with the international community. I would like to thank MMV for their help, and I hope we will be able to work together more closely in the future to achieve even better results.

Mr. Wu, Vice Mayor of Guilin City, who is responsible for Health and Education

Collaborating with MMV has made Guilin Pharmaceutical the first WHO prequalified pharmaceutical company worldwide to produce artesunate for injection. Why is this significant?

The Guilin Government attaches great importance to the development of the bio-pharmaceutical industry. The WHO prequalification is significant to us in three ways. First it demonstrates that it is possible for enterprises in Guilin to connect with the world. Second, it shows that every enterprise must strengthen its internal management and R&D; these are the driving forces for sustainable development. Finally, it is necessary for the government to provide a favorable environment and necessary services for enterprise development. The prequalification of Guilin Pharmaceutical’s artesunate for injection by the WHO shows that when government collaborates with enterprise it is possible to take industry to the next level.

1. Good Manufacturing Practice

MMV's Tim Wells and Jörg Möhrle visited the manufacturing facilities at Guilin Pharmaceutical in Guilin, China. They were impressed by the resources and time invested by Guilin to upgrade its facilities. It is now the first ever WHO-prequalified facility to produce artesunate for injection. 

“…This proves that it's worth investing the time and energy with the right partnership. We have been approached by several people to fund their production of GMP artesunate – but Guilin have been the only ones who committed to achieve Prequalification at a price that is affordable in Africa.” - Tim Wells, CSO, MMV