Fosun Pharma Achieves Another Breakthrough for its Artemisinin Preparation First Dihydroartemisinin-piperaquine Phosphate Product for Use in Children Receives WHO Pre-certification
【22 Nov 2019, Hong Kong】 On 21 November 2019, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”or“Group”; Stock Code: 600196.SH, 02196.HK) announced that 2 strengths of D-ARTEPP Dispersible (dihydroartemisinin-piperaquine phosphate dispersible tablets) and 2 strengths of D-ARTEPP (dihydroartemisinin-piperaquine phosphate tablets) developed by its subsidiary Guilin Pharmaceutical Co., Ltd. (“Guilin Pharma”) have is prequalified by the World Health Organization (WHO prequalification of medicine, “WHO PQ”). Among which, D-ARTEPP Dispersible (dihydroartemisiin-piperaquine phosphate dispersible tablets) is the first pediatric dihydroartemisinin-piperaquine phosphate product developed for children.
Malaria, tuberculosis and AIDS are the three epidemic diseases in the world. About half of the world’s population are living under risk of malaria, with 95% malaria cases in Sub-Saharan Africa. Over the years, malaria has been a major cause of morbidity and mortality in the region In 2017, an estimated 219 million cases of malaria occurred worldwide, with an estimated 435 000 deaths from malaria globally. Malaria is spread among people through mosquitos carrying Plasmodium parasites. Once infected with malaria, people will show symptoms of fever, chills and vomiting. Without timely and effective treatment, they will develop severe malaria, which leads to anaemia, coma, multiple organ failure and even death.
At present, antimalarial medicines are mainly procured by the World Health Organization, the Global Fund and governments of malaria endemic countries. The medicines marketed globally for the treatment of uncomplicated malaria are artemisinin-based combination therapies (ACTs) and injectable artesunate for the treatment of severe malaria. According to the World Health Organization's 2018 World Malaria Report, it is estimated that a total of 2.74 treatment courses of artemisinin-based combination therapy (ACT) were procured by countries worldwide between 2010 and 2017.
World Health Organization (WHO) has recommended the use of ACTs worldwide since 2000. In 2005, In the first edition of the WHO Guidelines for the Treatment of Malaria (the guideline) published in 2005, four ACTs were recommended.. In the second edition of the guideline published in 2010, dihydroartemisinin-piperaquine phosphate (DhA-PPQ) was added as the fifth recommended ACT..
Soon after the release of the second edition of the guideline in 2010, Guilin Pharma launched the R&D project of DHA-PPQ tablets, and was the first in the world to simultaneously initiate the development of dispersible formulation for pediatric use. In 2015, WHO’s third edition of the guideline revised the dose of DHA-PPQ based on pharmacokinetic modelling to improve the dosing accuracy, thereby reducing the occurrence of adverse reactions. D-ARTEPP Dispersible (dihydroartemisinin-piperaquine phosphate dispersible tablets) and D-ARTEPP (dihydroartemisinin-piperaquine phosphate tablets) of Fosun Pharma are the first two DHA-PPQ products in the market to adopt this new dose.
In malaria-endemic areas, people susceptible to malaria can be repeatedly infected during the malaria season. ACT is a combination of a rapidly acting artemisinin derivative with a longer-acting (more slowly eliminated) partner drug. The artemisinin component rapidly clears parasites from the blood (reducing parasite numbers by a factor of approximately 10,000 in each 48-h asexual cycle). The longer acting partner drug clears the remaining parasites and provides protection against development of resistance to the artemisinin derivative. Partner drugs with longer elimination half-lives also provide a period of post-treatment prophylaxis. Piperaquine phosphate has a half-life up to 11 days, which provides a long protection period for patients and reduces the risk of people susceptible to the disease, especially children under five being infected with malaria again, thereby decreasing the number of malaria episodes in a year and malaria related deaths .
Although the first dihydroartemisinin-piperaquine phosphate product was prequalified by WHO as early as in 2011, the use of the product on ground was limited due to the delay in launching a pediatric formulation. With the WHO prequalification of D-ARTEPP Dispersible, this child friendly dispersible medicine will become another blockbuster ACT in the fight against in Africa.
Established in 1994, Fosun Pharma is a leading healthcare group in PRC. Fosun Pharma has a globally-leading research and development platform and the manufacture of antimalarial drugs. Fosun Pharma’s antimalarial portfolio covers malaria prevention, treatment of uncomplicated malaria and severe malaria. With the prequalification of its four DHA-PPQ products, Fosun Pharma now owns 19 WHO PQ antimalarials, which makes Fosun Pharma the pharmaceutical company with the highest number of prequalified antimalaria products. Artesun® (artesunate for injection), an innovative drug for which Fosun Pharma possesses the intellectual property right is the gold standard for the treatment of severe malaria internationally and was WHO prequalified in 2010. Fosun Pharma had supplied 120 million vials of Artesun® worldwide by the end of 2018, which were estimated to treat 24 million patients with severe malaria, among which most were African children under five. The deployment of injectable artesunate has helped to decrease the global malaria mortality. In April 2019, Fosun Pharma began to supply its innovative antimalarial Artesun® (artesunate for injection) to America for the treatment of severe malaria patients in USA through a special cooperation program with the US Centers for Disease Control and Prevention.
Malaria, tuberculosis and AIDS are the three epidemic diseases in the world. About half of the world’s population are living under risk of malaria, with 95% malaria cases in Sub-Saharan Africa. Over the years, malaria has been a major cause of morbidity and mortality in the region In 2017, an estimated 219 million cases of malaria occurred worldwide, with an estimated 435 000 deaths from malaria globally. Malaria is spread among people through mosquitos carrying Plasmodium parasites. Once infected with malaria, people will show symptoms of fever, chills and vomiting. Without timely and effective treatment, they will develop severe malaria, which leads to anaemia, coma, multiple organ failure and even death.
At present, antimalarial medicines are mainly procured by the World Health Organization, the Global Fund and governments of malaria endemic countries. The medicines marketed globally for the treatment of uncomplicated malaria are artemisinin-based combination therapies (ACTs) and injectable artesunate for the treatment of severe malaria. According to the World Health Organization's 2018 World Malaria Report, it is estimated that a total of 2.74 treatment courses of artemisinin-based combination therapy (ACT) were procured by countries worldwide between 2010 and 2017.
World Health Organization (WHO) has recommended the use of ACTs worldwide since 2000. In 2005, In the first edition of the WHO Guidelines for the Treatment of Malaria (the guideline) published in 2005, four ACTs were recommended.. In the second edition of the guideline published in 2010, dihydroartemisinin-piperaquine phosphate (DhA-PPQ) was added as the fifth recommended ACT..
Soon after the release of the second edition of the guideline in 2010, Guilin Pharma launched the R&D project of DHA-PPQ tablets, and was the first in the world to simultaneously initiate the development of dispersible formulation for pediatric use. In 2015, WHO’s third edition of the guideline revised the dose of DHA-PPQ based on pharmacokinetic modelling to improve the dosing accuracy, thereby reducing the occurrence of adverse reactions. D-ARTEPP Dispersible (dihydroartemisinin-piperaquine phosphate dispersible tablets) and D-ARTEPP (dihydroartemisinin-piperaquine phosphate tablets) of Fosun Pharma are the first two DHA-PPQ products in the market to adopt this new dose.
In malaria-endemic areas, people susceptible to malaria can be repeatedly infected during the malaria season. ACT is a combination of a rapidly acting artemisinin derivative with a longer-acting (more slowly eliminated) partner drug. The artemisinin component rapidly clears parasites from the blood (reducing parasite numbers by a factor of approximately 10,000 in each 48-h asexual cycle). The longer acting partner drug clears the remaining parasites and provides protection against development of resistance to the artemisinin derivative. Partner drugs with longer elimination half-lives also provide a period of post-treatment prophylaxis. Piperaquine phosphate has a half-life up to 11 days, which provides a long protection period for patients and reduces the risk of people susceptible to the disease, especially children under five being infected with malaria again, thereby decreasing the number of malaria episodes in a year and malaria related deaths .
Although the first dihydroartemisinin-piperaquine phosphate product was prequalified by WHO as early as in 2011, the use of the product on ground was limited due to the delay in launching a pediatric formulation. With the WHO prequalification of D-ARTEPP Dispersible, this child friendly dispersible medicine will become another blockbuster ACT in the fight against in Africa.
Established in 1994, Fosun Pharma is a leading healthcare group in PRC. Fosun Pharma has a globally-leading research and development platform and the manufacture of antimalarial drugs. Fosun Pharma’s antimalarial portfolio covers malaria prevention, treatment of uncomplicated malaria and severe malaria. With the prequalification of its four DHA-PPQ products, Fosun Pharma now owns 19 WHO PQ antimalarials, which makes Fosun Pharma the pharmaceutical company with the highest number of prequalified antimalaria products. Artesun® (artesunate for injection), an innovative drug for which Fosun Pharma possesses the intellectual property right is the gold standard for the treatment of severe malaria internationally and was WHO prequalified in 2010. Fosun Pharma had supplied 120 million vials of Artesun® worldwide by the end of 2018, which were estimated to treat 24 million patients with severe malaria, among which most were African children under five. The deployment of injectable artesunate has helped to decrease the global malaria mortality. In April 2019, Fosun Pharma began to supply its innovative antimalarial Artesun® (artesunate for injection) to America for the treatment of severe malaria patients in USA through a special cooperation program with the US Centers for Disease Control and Prevention.