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100 Million Vials for Severe Malaria Treatments Supplied by Fosun Pharma, Estimated to Have Saved Over 20 Million Lives Worldwide

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Shanghai, China-November 5th, 2017-- Guilin Pharma, a member of Fosun Pharma (stock codes: 600196. SH; 02196, HK), has supplied 100 million vials of Artesun® (Artesunate for injection 60mg) worldwide, which are estimated to have cured more than 20 million patients with severe malaria, among which most are African children under five1,2,3. It was a milestone for Artesun® in treating severe malaria after the drug was prequalified by the World Health Organization (WHO) in 2010.

 

Malaria, tuberculosis and AIDS are the world’s top 3 public health threats. Nearly half of the world’s population is at risk of malaria, and sub-Saharan Africa continues to carry a disproportionately high share of the global malaria burden. In 2015, there were roughly 212 million malaria cases in the world with an estimated number of 429,000 malaria deaths. Malaria is an infectious disease caused by Plasmodium parasites spreading to humans through the bites of infected mosquitoes. Once infected, people usually develop nonspecific symptoms such as fever, chills, and nausea or vomiting. If not treated promptly with effective antimalarial drugs, uncomplicated malaria will deteriorate into severe malaria and cause severe complications and even death.

 

The scale-up of effective tools in malaria prevention and control measures, including the adoption of injectable artesunate have led to a reduction of the world’s malaria burden, especially in Africa. The WHO World Malaria Report 2016 shows that since 2010, malaria morbidity and mortality rates had fallen by 29% among all age groups, and by 35% in children under five.

 

Guilin Pharma, a member of Fosun Pharma, is a leading pharmaceutical company in the world specialized in the research, development and manufacture of antimalarial drugs. The products of Guilin Pharma range from those for malaria prevention to those for the treatment of uncomplicated and severe malaria. In order to make injectable artesunate available for treating patients with severe malaria around the world, Fosun Pharma started a five-year effort for the prequalification of Artesun® (artesunate for injection) by the WHO in 2005. On November 5th, 2010, Artesun® officially became the first recommended drug for treating severe malaria prequalified by the WHO.

 

Artesun® (artesunate for injection), an innovative drug of Fosun Pharma, is fully IP-protected with guaranteed quality recommended by the WHO for severe malaria treatment. It has become the internationally recognized reference drug for treating severe malaria and has been widely adopted in 58 countries and regions around the world1.

 

“Closely related to the health of nearly half of the world’s population, malaria is one of the most serious public health issues worldwide,” said Mr. Chen Qiyu, Co-president of Fosun Group and Chairman of Fosun Pharma. “We have always seen the fight against malaria a part of our corporate social responsibility. This is our belief throughout the life cycle of our antimalarial drugs. The success of Artesun® in Africa is a huge encouragement to us, inspiring us to provide patients with more effective and affordable products and services to achieve a ‘malaria-free world’.”

 

During the entire lifecycle of Artesun®, Fosun Pharma has continued to improve its applicability and safety. To meet the special needs of young children suffering from severe malaria, the company developed a pediatric pack of Artesun® (30mg) and optimized its dosage for children less than 20kg based on scientific evidences and pharmacokinetic modeling. Fosun Pharma is one of the first Chinese pharmaceutical companies investing in post-marketing drug safety monitoring. In 2013, the company created a global pharmacovigilance system for its innovative pharmaceutical products such as Artesun®, to track post-marketing drug safety for all the innovative products it has launched globally.

 

Artesun® has been approved in 37 countries and marketed in 32 sub-Saharan African countries. It has also been made available to malaria-endemic areas through charitable programs of international government and non-government organizations such as The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund), UNTAID, Médecins Sans Frontières (MSF),and China-Aid. The extensive adoption of Artesun® has contributed to lowering malaria mortality rate among children. As such, the drug is said to be “The most cost-effective measure among 29 interventions to improve the life quality of children in Africa in the 21stCentury4”.

 

“The tremendous accomplishment of delivering 100M vials of this life-saving medicine has been achieved thanks to Fosun Pharma’s vision and longstanding commitment to developing WHO-prequalified medicines for malaria,” said Dr. David Reddy, CEO of Medicine for Malaria Venture (MMV). “This commitment has helped radically improve outcomes for the critically ill patients at risk of death from severe malaria. Fosun Pharma’s success is also testament to the power of partnerships, with MMV bringing both technical expertise as well as its international network of donors and partners to the table, forming a long-lasting collaboration that has successfully helped make this drug available to those in need.  MMV is proud to be associated with Fosun Pharma and this significant global health achievement.”

 

About WHO Prequalification of Medicine (“WHO PQ”)

In order to cope with the inadequate supply issues of premium medicine for the treatment of widespread epidemics in developing countries, WHO has worked to organize and establish a Prequalification of Medicine Project since 2001, pursuant to which, WHO PQ team can secure a qualified market accession and procurement process for medicine of great quality while with a relatively lower price through its verification and on-site assessment on the documents filed by the applicants, so as to better save life and serve the interest of public health.

 

About Injectable Artesunate (Artesun®)

Injectable Artesunate is currently the only commercialized water soluble derivatives of artemisinin. Injected through vein and muscle, it can save different suffering groups from encephalic malaria and other fatal malaria illnesses. Results from a number of large scale clinical trials show that injectable artesunate is safe and effective among special groups, such as pregnant women and underage children2, 5, 6. Artesun® was approved by the WHO PQ in 2010, and now is registered and marketed in 37 countries around the world. The drug is also acceptable in the European Union countries, Canadian and Australian through different special access programs such as Named Patient Supply.

 

Bibliography:

  1. World Malaria Report 2016. Geneva: World Health Organization; 2016. Licence: CC BY-NC-SA 3.0 IGO.
  2. Dondorp AM, Fanello CI, Hendriksen ICE, et al. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet 2010; 376: 1647–57.
  3. Lubell, Yoel et al. Cost-effectiveness of parenteral artesunate for treating children with severe malaria in sub-Saharan Africa. []. , 89, 7, pp.504-512. ISSN 0042-9686.
  4. Horton S, Gelband H, Jamison D, Levin C, Nugent R, Watkins D (2017) Ranking 93 health interventions for low- and middle-income countries by cost-effectiveness. PLoS ONE 12(8): e0182951.
  5. World Health Organization, Guidelines for the Treatment of Malaria Third Edition, 2015
  6. Stephanie D. Kovacs, Marcus J. Rijken, Andy Stergachis, et al. Treating Severe Malaria in Pregnancy: A Review of the Evidence. Drug Saf 2015; 38:165–181, DOI 10.1007/s40264-014-0261-9.

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