This is an individually randomized, controlled, single blind four arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ).Arm 4: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.

Start Date01 Oct 2024

Sponsor / Collaborator

Liverpool School of Tropical Medicine

[+1]

NCT06173206 / RecruitingPhase 3IIT

Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Cameroon

The Cameroon PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 900 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 450 children will be assigned to the SP group, 250 to the SPAQ group, and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.

Start Date10 Jun 2024

Sponsor / Collaborator

London School of Hygiene & Tropical Medicine

NCT06182176 / Not yet recruitingNot ApplicableIIT

Evaluating the Effectiveness and Cost-effectiveness of Integrating Mass Drug Administration for Helminth Control With Seasonal Malaria Chemoprevention in Ghanaian Children

Malaria remains a major health problem, especially among children living in sub-Saharan Africa where more than 90% of the disease and deaths occur. Adding to this high burden among the children is the co-existence of parasitic worms in their intestines and urinary tract. The combined infection of malaria and parasitic worms in these children has additive adverse effects of anaemia, poor physical and cognitive development, and death. Existing control programmes for the parasitic worms are operating sub-optimally despite the 2012 London Declaration on Neglected Tropical Diseases (NTDs) of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year as the London Declaration on NTDs has achieved more than 75% treatment coverage and prevented 75-85% of cases of uncomplicated and severe malaria in children. The remarkable success of SMC has led to the recent WHO recommendation for its extension to other at-risk age groups and in highly seasonal malaria transmission settings outside the Sahel region. This encouraging development supports the need to explore the possibility of integrating helminth control programmes with other successful delivery platforms such as SMC. However, limited empirical evidence exists on an integrated approach that integrated the control of malaria and parasitic worms in a safe, acceptable, easy-to-deliver and effective manner.
To address this knowledge gap, the investigators conducted a randomised controlled trial in the first stage of this project to establish the feasibility and safety of integrating helminth control with SMC among Senegalese children. This second stage will assess the effectiveness and cost-effectiveness of using SMC platform to deliver deworming drugs to preschool and school-aged children living in communities where the burden of malaria and parasitic worms is high in central Ghana. One thousand, two hundred children aged 1-14 years will be randomly assigned equally to two study communities where antimalarial (SMC) drugs and deworming drugs will be administered in combination to the children living in one study community, and antimalarial (SMC) drugs alone will be delivered to the children living in the second study community. The effectiveness of the combined delivery will be determined by checking whether the combined antimalarial and deworming drugs prevent anaemia in the children who receive the combined drugs compared to the children who receive antimalarial drugs only. We will also determine the cost and cost-effectiveness of this approach by estimating the incremental cost savings due to cases of moderate and severe anaemia averted by giving antimalarial and deworming drugs together to the children. The findings of this study would provide evidence to boost public health recommendations for an integrated control of malaria and parasitic worms among children living in the poorest countries of the world. The findings may also reinforce the empirical evidence that the future direction of healthcare systems in developing countries should be comprehensive health management rather than vertical management of a single disease.

Start Date27 May 2024

Sponsor / Collaborator

London School of Hygiene & Tropical Medicine

100 Clinical Results associated with Pyrimethamine/Sulfadoxine

100 Translational Medicine associated with Pyrimethamine/Sulfadoxine

100 Patents (Medical) associated with Pyrimethamine/Sulfadoxine

1,260

Literatures (Medical) associated with Pyrimethamine/Sulfadoxine

01 Jul 2024·Acta Tropica

Characterization of drug resistance genes in Indian Plasmodium falciparum and Plasmodium vivax field isolates

Article

Author: Singh, Vineeta ; Yadav, Karmveer ; Jakhan, Jahnvi ; Tamang, Suman ; Narang, Geetika

One of the major challenges for malaria control and elimination is the spread and emergence of antimalarial drug resistance. Mutations in Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) field isolates for five drug resistance genes viz. crt, mdr1, dhps, dhfr and kelch known to confer resistance to choloroquine (CQ), sulfadoxine-pyrimethamine (SP) and artemisinin (ART) and its derivatives were analyzed. A total of 342 symptomatic isolates of P. falciparum (Pf) and P. vivax (Pv) from 1993 to 2014 were retrieved from malaria parasite repository at National Institute of Malaria Research (NIMR). Sample DNA was extracted from dried blood spots and various targeted single nucleotide polymorphisms (SNPs) associated with antimalarial drug resistance were analysed for these isolates. 72S (67.7%) and 76T (83.8%) mutations along with SVMNT haplotype (67.7%) predominated the study population for Pfcrt. The most prevalent SNPs were 108N (73.2%) and 437G (24.8%) and the most prevalent haplotypes were ACNRNI (51.9%) and SAKAA (74.5%) in Pfdhfr and Pfdhps respectively. Only two mutations in Pfmdr1, 86Y (26.31%) and 184F (56.26%), were seen frequently in our study population. No mutations associated with Pfk13 were observed. For Pv, all the studied isolates showed two Pvdhps mutations, 383G and 553G, and two Pfdhfr mutations, 58R and 117N. Similarly, three mutations, viz. 958M, 908L and 1076L were found in Pvmdr1. No variations were observed in Pvcrt-o and Pvk12 genes. Overall, our study demonstrates an increase in mutations associated with SP resistance in both Pf and Pv, however, no single nucleotide polymorphisms (SNPs) associated with ART resistance have been observed for either species. Various SNPs associated with CQ resistance were seen in Pf; whereas only Pvmdr1 associated resistant SNPs were observed in Pv. Therefore, molecular characterization of drug resistance genes is essential for timely monitoring and prevention of malaria by identifying the circulating drug resistant parasites in the country.

28 Jun 2024·Parasites & vectors

Efficacy and safety of single-dose artesunate plus sulfalene/pyrimethamine combined with praziquantel for the treatment of children with Schistosoma mansoni or Schistosoma haematobium in western Kenya: a randomised, open-label controlled trial.

Article

Author: Obonyo, Charles O ; Muok, Erick M O ; Rawago, Fredrick O ; Makworo, Nicholas K

BACKGROUNDReliance on praziquantel for the treatment and control of schistosomiasis is likely to facilitate the emergence of drug resistance. Combination therapy targeting adult and juvenile schistosome worms is urgently needed to improve praziquantel efficacy and delay the potential development of drug resistance. We assessed the efficacy and safety of single-dose praziquantel combined with single-dose artesunate plus sulfalene-pyrimethamine in the treatment of Kenyan children with schistosomiasis.METHODSThis was an open-label, randomised clinical trial involving 426 school-aged children (7-15 years old) diagnosed with Schistosoma mansoni (by Kato-Katz) or S. haematobium (by urine filtration). They were randomly assigned (1:1:1) to receive a single dose of praziquantel (40 mg/kg), a single dose of artesunate plus sulfalene-pyrimethamine (12 mg/kg artesunate) or combination therapy using a single dose of praziquantel (40 mg/kg) combined with a single dose of artesunate plus sulfalene-pyrimethamine (12 mg/kg artesunate). The primary outcome was cure and egg reduction rates at 6 weeks post-treatment in the available case population. Adverse events were assessed within 3 h after treatment.RESULTSOf the 426 children enrolled, 135 received praziquantel, 150 received artesunate plus sulfalene-pyrimethamine, and 141 received combination therapy. Outcome data were available for 348 (81.7%) children. For S. mansoni-infected children (n = 335), the cure rates were 75.6%, 60.7%, and 77.8%, and the egg reduction rates were 80.1%, 85.0%, and 88.4% for praziquantel, artesunate plus sulfalene-pyrimethamine, and combination therapy, respectively. For S. haematobium-infected children (n = 145), the corresponding cure rates were 81.4%, 71.1%, and 82.2%, and the egg reduction rates were 95.6%, 97.1%, and 97.7%, respectively. Seventy-one (16.7%) children reported mild-intensity adverse events. The drugs were well tolerated and no serious adverse events were reported.CONCLUSIONSA single oral dose of praziquantel combined with artesunate plus sulfalene-pyrimethamine cured a high proportion of children with S. haematobium but did not significantly improve the treatment efficacy for either urinary or intestinal schistosomiasis. Sequential administration of praziquantel and artesunate plus sulfalene-pyrimethamine may enhance the efficacy and safety outcomes.

28 Jun 2024·Journal of global health

The readiness of malaria services and uptake of intermittent preventive treatment in pregnancy in six sub-Saharan countries.

Article

Author: Mpembeni, Rose ; Huang, Jiayan ; Liang, Di ; Xu, Xinfang ; Olenja, Joyce ; Zhao, Jinkou ; Yam, Esabelle Ly

BackgroundMalaria infection during pregnancy is associated with an increased risk of maternal death, as well as adverse birth outcomes. Intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) is known to improve pregnancy outcomes. However, the coverage of IPTp-SP in antenatal care (ANC) in sub-Saharan Africa remains well below the target. This study aims to estimate to what extent malaria service readiness affects the uptake of IPTp-SP during ANC visits in sub-Saharan African countries.MethodsThis study included 3267 pregnant women attending ANC for the first time and 2797 pregnant women who had attended ANC more than a month ago in six sub-Saharan African countries. The readiness of malaria services at each institution includes four indicators: the presence of IPTp-SP guidelines, SP availability, integration of IPTp-SP service into ANC, and provider training on IPTp-SP. The outcome variable indicates whether a pregnant woman received IPTp-SP at her current ANC visit. A modified Poisson regression model estimated the associations between malaria service readiness and IPTp-SP uptake for women eligible for the first and subsequent doses.ResultsFor women eligible for their first dose, visiting an institution with available SP was associated with an increased probability of receiving IPTp-SP (risk ratio (RR) = 1.43; 95% confidence interval (CI) = 1.22 to 1.67, P < 0.001). For women who were eligible for their next dose, the availability of SP (RR = 1.17; 95% CI = 1.04 to 1.32, P = 0.008) and integration of IPTp-SP service into ANC (RR = 1.82; 95% CI = 1.21 to 2.74, P = 0.004) in the institution were associated with increased likelihood of IPTp-SP uptake. Counterfactual predictions indicated that enhanced provider training could boost IPTp-SP uptake in high-uptake countries, while better SP availability and IPTp-SP integration into ANC would significantly impact low-uptake countries.ConclusionsFor better IPTp-SP coverage, strategies should be customised. High uptake countries should focus on provider training, while low uptake ones should ensure IPTp-SP availability and service integration.

News (Medical) associated with Pyrimethamine/Sulfadoxine

26 Apr 2024

·www.prnewswire.com

Fosun Pharma's Self-developed Artemisinin Medicines Inject New Impetus to Malaria Prevention and Treatment in Africa

SHANGHAI, April 26, 2024 /PRNewswire/ -- World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly endanger health and cost lives, but it also perpetuates a vicious cycle of inequity. People living in the most vulnerable situations including pregnant women and children under 5 years of age continue to be disproportionately impacted. Artemisinin medicines developed with China's scientific research efforts have become a ticket for China's innovative medicines to go global. According to the WHO World Malaria Report 2023, globally in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths. Sub-Saharan Africa accounted for more than 95% of the global malaria cases and deaths. Globally, an estimated 11.7 million malaria deaths were averted in the period 2000-2022. Among them, the average malaria mortality rate (number of deaths per 100,000 population at risk) in Africa decreased from 0.14% per 100,000 population to 0.055%, from 142.6 per 100,000 population in 2020 to 55.5 in 2022. The widespread use of artemisinin medicines is one of the key success factors. Several global multi-center phase III clinical studies and real-world data have shown that artesunate injection is effective in reducing malaria mortality rate. Self-developed Artemisinin medicines covering from prevention to severe disease treatment As a leading global R&D and production enterprise of anti-malaria drugs, anti-malaria drugs produced under the R&D and innovation of Fosun Pharma cover malaria prevention, general malaria treatment and severe malaria treatment. A total of 33 products in the anti-malaria series were approved by WHO pre-qualification (WHO PQ), which have made significant contribution to malaria prevention and treatment in countries and regions such as Africa. In 2010, Artesun®, an artesunate for injection independently developed and manufactured by Fosun Pharma, was approved by WHO PQ. Since 2011, it has been recommended by WHO as a first-line drug for the treatment of severe malaria in children and adults. At the same time, Fosun Pharma is also a supplier of anti-malaria drugs of the Global Fund, UNICEF, WHO and African governments. By the end of 2023, Fosun Pharma has supplied over 340 million doses of artesunate for injection across the world, treating more than 68 million severe malaria patients worldwide. Meanwhile, Fosun Pharma went deep into the remote areas of African villages and meet the needs of clinicians through continuous innovation. Through process optimization, it has independently developed and launched the second generation of artesunate injection (trade name: Argesun®), which is the first one-step preparation passing the WHO PQ in the world. The preparation time of the drug was reduced from 3 minutes to 1 minute, which can save the time for treating patients with severe malaria. Meanwhile, the concentration of Argesun® was standardized for intravenous and intramuscular injections, which makes it more convenient and safer for clinical purposes. Artemisinin-based combination therapies (ACTs) are recognized by WHO as the best available treatment. However, in recent years, drug resistance to these therapies has also begun to emerge in Plasmodium falciparum, which is becoming a major threat to malaria control. The global multicenter Phase III clinical trial project led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia has also received attention from all parties, and the Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced in December 2023 that it will invest approximately US$3.3 million (approximately 500 million yen[1]), to accelerate the development and commercialization of this new drug. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R) which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia[2] and to some extent in several African countries, including Rwanda and Uganda. Further improving the accessibility of second generation of Artesunate for injection to benefit remote areas of Africa From April 21 to 27, the 8th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference was held in Kigali-Rwanda. As one of the main sponsors of the conference, Fosun Pharma showcased its full range of antimalarial products and successfully hosted the academic symposium "Improving antimalarial treatment for severe P. falciparum malaria" on April 23. The symposium introduced the recent trends in the global and particularly African burden of severe malaria and the latest treatment and clinical management strategies to over 300 malaria researchers, clinicians, malaria control officials, and NGO representatives from Africa and around the world. The session was co-chaired by Professor Olugbenga A Mokuolu from Nigeria (Co-Chair of RBM Case Management Working Group; Strategic Adviser on Malaria Elimination to the Honorable Minister of Health Nigeria) and Professor Marielle Bouyou Akotet from the Université des Sciences de la Santé Gabon. Professor Arjen Dondorp and Professor Joel Tarning from the University of Oxford, and Dr. Samwel Gesase from the National Institute for Medical Research in Tanzania, respectively, presented the important contributions of injectable artesunate in the treatment of severe malaria patients from the epidemiological, clinical pharmacological, and pharmacoeconomic perspectives. They also highlighted the clinical advantages of Fosun Pharma's second-generation of artesunate injection with one-step preparation in the management of severe malaria. The 1.5 hours scientific session was ended by an introduction of the post-discharge malaria chemoprevention, PDMC by Professor Kamija Phiri from Kamuzu University of Health Sciences Malawi. The attendees highly appreciated the academic professionalism of Fosun Pharma's symposium on severe malaria and recognized Fosun Pharma's commitment to affordable innovation in bringing a new generation of artesunate injection with one-step preparation to Africa. The experts agreed that " artesunate injection is currently the most effective drug for the treatment of severe malaria. The new generation of artesunate injection with one-step preparation will further enhance the convenience of clinical use and reduce the clinical cost of severe malaria treatment, benefiting critically ill children with malaria in remote areas of Africa where medical conditions are poor." From treatment to prevention, effectively reducing the incidence of severe malaria in children According to the WHO, children under 5 years old are still the most vulnerable population to malaria infection. in 2022, an estimated 4 out of 5 malaria-related deaths in the African Region were among children under 5 years of age. Inequities in access to education and financial resources further exacerbates risk: children under 5 years of age from the poorest households in sub-Saharan Africa are 5 times more likely to be infected with malaria than those from the wealthiest households. To improve this situation, Fosun Pharma, in collaboration with the National Malaria Control Program in Africa, continued to carry out the "Promoting Malaria Prevention Knowledge among Children Program" in 14 malaria-prone countries in Africa, targeting at the community level, in order to raise the awareness of malaria prevention among the local population in Africa, and to help reduce the incidence rate of malaria and interrupt the transmission of malaria in the community. In August 2018, Fosun Pharma's SPAQ-CO® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was approved by WHO PQ . By the end of 2023, more than 258 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa. Promoting the localization of pharmaceutical production and helping to enhance the healthcare capacity of developing countries Based in China and with a global presence, Fosun Pharma has always been committed to providing high-quality medical solutions to patients worldwide. It actively expands its business in emerging markets, including Africa, India and Southeast Asia, to improve the accessibility of medicines in developing countries. By the end of 2023, Fosun Pharma had established five regional distribution centers in emerging markets. The overseas commercialization team consists of approximately 1,000 people, dedicated to enhancing the accessibility of pharmaceutical products. To achieve localized pharmaceutical manufacturing and supply in Africa and to enhance the accessibility and affordability of pharmaceutical and healthcare products in the African region, Fosun Pharma's Cote d'Ivoire park project was initiated in November 2022. The project is planned to be carried out in three phases, with the first phase expected to be completed in 2024. Upon completion of the project, the production capacity of the park will be expanded to 5 billion tablets per year and include a warehouse with a storage capacity of 10,000 pallets, which is expected to bring nearly 1,000 job opportunities to the Greater Bassam area and effectively promote the development of the pharmaceutical industry in Cote d'Ivoire. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Fosun Pharma's innovative products mainly covered core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease). Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: SOURCE Fosun Pharma

Phase 3Drug Approval

14 Dec 2023

·www.prnewswire.com

Fosun Pharma's Global Multi-Center Phase III Clinical Trial Project for A New Antimalarial Drug Receives 500 Million Japanese Yen Investment from GHIT Fund to Jointly Improve the Global Accessibility of Antimalarial Drugs

SHANGHAI, Dec. 14, 2023 /PRNewswire/ -- The Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen[1]) in a global multicenter Phase III clinical trial project (the "Program") led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia, to accelerate the development and commercialization of this new drug. The Project will be jointly conducted by Fosun Pharma, a major Chinese pharmaceutical and healthcare company, Marubeni, a leading Japanese integrated trading and investment business conglomerate, a Thailand-based research collaboration of universities, Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV), which provides technical support and market access expertise. This is the first time GHIT Fund has invested in a research project led by a Chinese pharmaceutical company. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R) which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia[2] and to some extent in several African countries, including Rwanda and Uganda. Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children[3]. Malaria is an infectious parasitic disease transmitted by mosquitos that affects approximately 250 million people annually and was responsible for approximately 620,000 deaths in 20213. Infection in the African region constitutes 95% of the total global malaria cases, and children under the age of 5 account for 80% of all malaria deaths in this region. The GHIT Fund invests in innovative drug development with the aim of contributing to global health through facilitating collaboration between Japanese and global institutions' technology and innovation to address these neglected infectious diseases. Wen Deyong, CEO of Fosun Pharma, said, "We are very pleased to work with GHIT Fund to promote the clinical research on this antimalarial innovator drug. The collaboration will accelerate the launch of this new drug so as to actively respond to the threat of artemisinin partial resistance and partner drug resistance of Plasmodium falciparum parasites and save more lives from malaria. Fosun Pharma is committed to further improving the accessibility and affordability of antimalarial drugs through continuous innovation and our global operational capabilities, so as to continuously strive for a malaria-free world." Dr. Osamu Kunii, CEO of the GHIT Fund, said "We are very excited to have Marubeni and FOSUN PHARMA as our new product development partners. It is an important step forward to invest in the development of antimalarial drugs in late-phase clinical trials to advance commercialization. The number of malaria cases and deaths in children under 5 years old is an urgent issue. This investment will make a significant contribution to reducing the burden of malaria globally, especially among young children." The antimalarial drug independently developed by Fosun Pharma has been used to treat more than 60 million patients with severe malaria worldwide The artemisinin based antimalaria medicines originated from China have made significant contributions to global malaria prevention and control. In Sub-Saharan Africa alone, about 240 million people benefit from artemisinin-based combination therapies every year. The artesunate for injection (Artesun®) independently developed by Fosun Pharma is the first-line treatment of severe malaria for both adults and children recommended by the WHO since 2011. It has become a well-known Chinese innovator drug in Africa and the world. So far, Artesun® has been used to treat more than 60 million patients with severe malaria worldwide, most of whom were African children under five years old. In June 2023, the second-generation artesunate for injection (Argesun®) independently developed by Fosun Pharma was prequalified by the WHO (WHO-PQ), becoming the first injectable artesunate presented with a single solvent system approved by WHO-PQ. It greatly improves the convenience of clinical use and is particularly practicable for remote areas in Africa with backward medical conditions to save more lives. Up to now, the product has been registered and marketed in 18 countries. The deployment of Fosun Pharma's new generation Argesun® has further improved the accessibility of high-quality antimalarial innovator drugs in Africa, providing a convenient solution for primary medical institutions to treat sever malaria patients and save lives. Fosun Pharma was therefore recognized on Fortune 2023 China's Most Admired Company List. Effectively reduce the incidence rate of severe malaria in children from treatment to prevention As an innovation-driven global pharmaceutical and health industry group, Fosun Pharma has independently developed innovative antimalarial products covering malaria prevention and treatment, as well as the rescue of critically ill patients. From "treatment" to "prevention", Fosun Pharma continues to provide more prevention and treatment solutions for malaria patients, especially children. In August 2018, Fosun Pharma's SPAQ-CO® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was prequalified by WHO. Fosun Pharma has actively carried out community-oriented "Child Malaria Prevention Knowledge Popularization Projects" in 14 malaria-endemic countries in Africa. These projects aim to enhance local awareness of malaria prevention among African populations, thus helping to reduce the incidence of malaria and interrupt community transmission of the disease. By the end of June 2023, more than 245 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa. About GHIT Fund The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: . SOURCE Fosun Pharma

Phase 3Drug Approval

08 Nov 2023

·www.fiercepharma.com

Strides African unit nabs WHO first with nod to produce malaria treatment

Global malaria cases have been on the rise in recent years, according to the World Health Organization. Universal Corporation Limited, a unit of Strides Pharma Science, became the first African drug manufacturer to snare a World Health Organization (WHO) pre-qualification (PDF) to produce the anti-malarial drug sulfadoxine-pyrimethamine and amodiaquine (SPAQ). The treatment is a combination regimen used to prevent malaria in children living in areas with seasonal malaria transmission. The WHO's pre-qualification program is designed to set standards of quality, safety and efficacy in manufacturing medicines. With the designation, Kenya-based UCL will look to boost regional production and access to essential medicines on the African continent, where about 95% of all malaria cases and 96% of deaths from malaria occur, the company said in a Nov. 6 press release. “Universal Corporation is committed to advancing the fight against malaria and improving the health and well-being of communities across Africa,” Perviz Dhanani, founder and managing director of UCL, said in the release. “The WHO prequalification of our SPAQ production is a significant step forward in achieving these goals.” In 2022, WHO began to recommend SPAQ for any child at high risk of severe malaria in areas with seasonal malaria transmission. This recommendation resulted in more than 48 million children being protected from malaria, significantly reducing the burden of this deadly disease, the organization said. According to WHO, the reported cases of malaria hit 247 million in 2021, compared with 245 million in 2020 and 232 million in 2019. In an unrelated but recent move, Strides in September said it planned to spin off its CDMO and soft gelatin businesses into a single entity that will be known as OneSource. The goal of the spinoff, which is expected to happen in the next year, is to establish a specialty pharmaceutical CDMO company that offers services for biologics, oral softgels, complex injectables, sterile injectables and other complex drug delivery systems.

Fast Track

100 Deals associated with Pyrimethamine/Sulfadoxine

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	P01BD51	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bacterial Infections	CN	Guilin Pharmaceutical Group Co., Ltd.	27 Aug 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03178643 (EPiTOMISE, CTgov)	Phase 4	Malaria, Falciparum \| Anemia, Sickle Cell	246	Proguanil Oral Tablet (Proguanil Oral Tablet)	zfnrnhdtiu(oarnrjxvwo) = dcacaztjul dmqbzszcfy (zgmmjcizgn, mtkxvvwpre - mhefojaugo) View more	-	27 Mar 2024
				Sulfadoxine/pyrimethamine+Amodiaquin (Sulfadoxine/Pyrimethanine-Amodiaquine)	zfnrnhdtiu(oarnrjxvwo) = fwrscxjodj dmqbzszcfy (zgmmjcizgn, nboggpaqmj - nxzvkmpyad) View more
NCT00852371 (CTgov)	Phase 3	Malaria	780	Dihydroartemisinin-Piperaquine (Dihydroartemisinin-piperaquine)	achmnetnlu(esrhctkoue) = gjdkzzpuby ogbgftbycn (cnkesrbzxb, mkfgbmjayz - vgvepjwrmp) View more	-	21 Mar 2024
				sulfadoxine-pyrimethamine+amodiaquine (Combination of Amodiaquine +Sulfadoxine-pyrimethamine)	achmnetnlu(esrhctkoue) = kwcarsndng ogbgftbycn (cnkesrbzxb, ukilsantas - mozdmeebog) View more
Pubmed \| Clin Pharmacol Ther	Not Applicable	Pregnancy Complications, Infectious	956	IPTp-DHP	rvsjmbnbwx(nxsauzikrj) = pfphtttipg zyyblecuvd (zouhbhygpn )	Positive	23 Apr 2021
				IPTp-SP	rvsjmbnbwx(nxsauzikrj) = ftwlxatquu zyyblecuvd (zouhbhygpn )
NCT02793622 (CTgov)	Phase 3	Malaria	782	Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy (Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy)	vbfmjwndwf(gjbxilphll) = qfsgfpiang oununfvmgh (sfbiyniqbv, ujisajwqot - fennjkuknh) View more	-	14 Apr 2021
				Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy (Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy)	vbfmjwndwf(gjbxilphll) = krvsblvpji oununfvmgh (sfbiyniqbv, wxtkdugdqs - cdlhjvgfvj) View more
ISRCTN69800930 (Pubmed \| J Infect Dis)	Not Applicable	Malaria, Falciparum	-	IPTp with SP	khiqodcaih(zbngzqfnwe): MD = 252 (95% CI, 46 - 457), P-Value = 0.017	-	23 Jul 2020
				Antenatal Sulfadoxine-Pyrimethamine (Intermittent screening by rapid diagnostic tests (ISTp))
NCT02793622 (Pubmed \| Lancet Glob Health)	Phase 3	-	1,617	Sulfadoxine-pyrimethamine	bndkanlkbe(hwsboumqpg) = wytbzdxveg rzaphwcbqt (qziblxpypq ) View more	-	01 Jul 2020
				Dihydroartemisinin-piperaquine	lerkwjinaq(wtybffjmvm) = esybfmoxes iihvnjagmd (ncakbppdda )
NCT02211729 (Pubmed \| Br Dent J) Manual	Phase 3	Malaria	19,578	sulfadoxine-pyrimethamine plus amodiaquinesulfadoxine-pyrimethamine plus amodiaquineamodiaquine+amodiaquine+Azithromycin	tdrbpyemrm(rmdynmkqor) = gevpyjttvg fibeqknbbq (ustlinyeth ) View more	Negative	06 Jun 2019
				sulfadoxine-pyrimethamine plus amodiaquinesulfadoxine-pyrimethamine plus amodiaquineamodiaquine+amodiaquine+Placebo	tdrbpyemrm(rmdynmkqor) = vbllqalqbb fibeqknbbq (ustlinyeth ) View more
NCT02163447 (CTgov)	Phase 3	Malaria	300	3-monthly dihydroartemisinin-piperaquine (DP) for infants+3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy (3 Dose SP Pregnancy / 3 Monthly DP Infancy)	aeexgisvwp(japwaiwxjk) = xehvnzmkpa hhwcvmdvgu (pvizgqtvrr, ytzwxpteuq - wckjvkinst) View more	-	14 Nov 2018
				3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy (3 Dose DP Pregnancy / 3 Monthly DP Infancy)	aeexgisvwp(japwaiwxjk) = jolybqbhhl hhwcvmdvgu (pvizgqtvrr, iaozrlfoor - uioqmtwtph) View more
ACTRN12613000945729 (Pubmed)	Not Applicable	Malaria, Falciparum First line \| Second line	-	Artemether-lumefantrine	lgzrkazegt(tzpsdpnlgq) = yyzevoehza ykqdsybvko (pkkbwgsjqs )	-	21 May 2016
				Artesunate + sulfadoxine-pyrimethamine	lgzrkazegt(tzpsdpnlgq) = reqfhxqhkg ykqdsybvko (pkkbwgsjqs )
NCT00811421 (Pubmed \| PLoS Med)	Not Applicable	Malaria	5,820	Sulfadoxine-pyrimethamine (SP)	znsugfmtux(cdgqgifzvy) = oqqktoymyv nzecclwero (blyvneiupv ) View more	-	01 Sep 2014
				Mefloquine (MQ)	znsugfmtux(cdgqgifzvy) = cnjyhlgxgu nzecclwero (blyvneiupv ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis