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.

开始日期2024-10-01

申办/合作机构

Liverpool School of Tropical Medicine

[+1]

NCT06182176 / Not yet recruitingN/AIIT

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.

开始日期2024-05-27

申办/合作机构

London School of Hygiene & Tropical Medicine

NCT06173206 / Not yet recruiting临床3期IIT

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.

开始日期2024-05-15

申办/合作机构

London School of Hygiene & Tropical Medicine

100 项与磺胺多辛乙胺嘧啶相关的临床结果

登录后查看更多信息

100 项与磺胺多辛乙胺嘧啶相关的转化医学

登录后查看更多信息

100 项与磺胺多辛乙胺嘧啶相关的专利（医药）

登录后查看更多信息

1,218

项与磺胺多辛乙胺嘧啶相关的文献（医药）

2024-01-12·The Journal of infectious diseases

Randomized Field Trial to Assess the Safety and Efficacy of Dihydroartemisinin-Piperaquine for Seasonal Malaria Chemoprevention in School-Aged Children in Bandiagara, Mali

Article

作者: Kone, Abdoulaye K ; Kouriba, Kindie ; Thera, Mahamadou Ali ; Traore, Souleymane ; Traore, Karim ; Djimde, Moussa ; Guindo, Boureima ; Coulibaly, Drissa

Abstract:

Background:

Owing to the increased cases of malaria in older children, the World Health Organization has recently recommended extending seasonal malaria chemoprevention (SMC) to children >5 years of age and using other effective drugs for malaria. In this study, we report the safety and efficacy of dihydroartemisinin-piperaquine (DHA-PQ) for SMC in school-aged children in Mali.

Method:

This randomized, controlled trial included 345 participants aged 6–15 years randomized to receive DHA-PQ, sulfadoxine-pyrimethamine plus amodiaquine (SP-AQ), or no chemoprevention (albendazole) at a 1:1:1 ratio. Four rounds of SMC were conducted from September to December 2021. The participants were assessed 7 days after each round for safety and efficacy of the interventions.

Results:

Abdominal pain (11.8% vs 29.2%), headache (11.2% vs 19.2%), and vomiting (5.7% vs 15.2%) were frequently reported in the DHA-PQ and SP-AQ arms. On Day 120 of follow up, the incidence of clinical malaria was 0.01 episodes/person-month in the DHA-PQ and SP-AQ arms and 0.17 episodes/person-month in the control arm (P < .0001). Gametocytes were detected in 37 participants in all arms.

Conclusions:

Children in DHA-PQ arm reported less adverse events compared to the SP-AQ arm. Both drugs were effective against clinical malaria and infection.

2024-02-07·The American journal of tropical medicine and hygiene

Prevalence of Malaria Infection in Pregnant Women Attending Antenatal Clinics in Southern Senegal

Article

作者: Kande, Safietou ; Ndiaye, Jean-Louis Abdourahim ; Amambua-Ngwa, Alfred ; Oboh, Mary Aigbiremo ; Ndiaye, Magatte ; Diouf, Marie Pierre ; Seck, Amadou ; Merle, Corinne ; Faye, Babacar ; Sow, Doudou ; Tine, Roger Clément ; Sylla, Khadime ; Miligan, Paul ; Manga, Isaac Akhénaton ; Lo, Aminata Colle ; Diallo, Abdoulaye ; Tairou, Fassiatou

ABSTRACT.:

Despite marked progress in Senegal, three regions in the southeast part continue to have a high burden of malaria, but there have been no recent studies assessing the prevalence of malaria associated with pregnancy. This study aimed to determine the prevalence of malaria infection in pregnant women attending antenatal clinics in Senegal. During the malaria transmission season of 2019, pregnant women attending 11 health care facilities for a scheduled visit and those presenting unwell with signs of malaria were invited to participate in a malaria screening study. A finger prick blood sample was taken for malaria diagnosis by rapid diagnosis test (RDT) and polymerase chain reaction (PCR). A total of 877 pregnant women were enrolled, 787 for a scheduled antenatal consultation and 90 for an unscheduled consultation with signs of malaria. The prevalence of Plasmodium falciparum among the first group was 48% by PCR and 20% by RDT, and that among the second group was 86% by PCR and 83% by RDT. RDT sensitivity in capturing asymptomatic, PCR-positive infections was 9.2% but ranged from 83% to 94% among febrile women. The prevalence of infection by PCR in women who reported having received at least three doses of sulfadoxine pyrimethamine (SP) was 41.9% compared with 58.9% in women who reported they had not received any SP doses (prevalence ratio adjusted for gravidity and gestational age, 0.54; 95% CI, 0.41–0.73). The burden of P. falciparum infections remains high among pregnant women, the majority of which are not captured by RDT. More effective measures to prevent malaria infection in pregnancy are needed.

2024-01-01·Lancet (London, England)1区 · 医学

Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin–piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial

1区 · 医学

Article

作者: Barsosio, Hellen C ; Ondieki, Everlyne D ; Kariuki, Simon ; Phiri, Kamija S ; Otieno, Kephas ; Wang, Duolao ; Hill, Jenny ; Onyango, Eric D ; Ter Kuile, Feiko O ; Madanitsa, Mwayiwawo ; Maleta, Kenneth ; Schmiegelow, Christentze ; Taegtmeyer, Miriam ; Mwapasa, Victor ; Gutman, Julie R ; Dodd, James

BACKGROUND:

The efficacy of daily co-trimoxazole, an antifolate used for malaria chemoprevention in pregnant women living with HIV, is threatened by cross-resistance of Plasmodium falciparum to the antifolate sulfadoxine-pyrimethamine. We assessed whether addition of monthly dihydroartemisinin-piperaquine to daily co-trimoxazole is more effective at preventing malaria infection than monthly placebo plus daily co-trimoxazole in pregnant women living with HIV.

METHODS:

We did an individually randomised, two-arm, placebo-controlled trial in areas with high-grade sulfadoxine-pyrimethamine resistance in Kenya and Malawi. Pregnant women living with HIV on dolutegravir-based combination antiretroviral therapy (cART) who had singleton pregnancies between 16 weeks' and 28 weeks' gestation were randomly assigned (1:1) by computer-generated block randomisation, stratified by site and HIV status (known positive vs newly diagnosed), to daily co-trimoxazole plus monthly dihydroartemisinin-piperaquine (three tablets of 40 mg dihydroartemisinin and 320 mg piperaquine given daily for 3 days) or daily co-trimoxazole plus monthly placebo. Daily co-trimoxazole consisted of one tablet of 160 mg sulfamethoxazole and 800 mg trimethoprim. The primary endpoint was the incidence of Plasmodium infection detected in the peripheral (maternal) or placental (maternal) blood or tissue by PCR, microscopy, rapid diagnostic test, or placental histology (active infection) from 2 weeks after the first dose of dihydroartemisinin-piperaquine or placebo to delivery. Log-binomial regression was used for binary outcomes, and Poisson regression for count outcomes. The primary analysis was by modified intention to treat, consisting of all randomised eligible participants with primary endpoint data. The safety analysis included all women who received at least one dose of study drug. All investigators, laboratory staff, data analysts, and participants were masked to treatment assignment. This trial is registered with ClinicalTrials.gov, NCT04158713.

FINDINGS:

From Nov 11, 2019, to Aug 3, 2021, 904 women were enrolled and randomly assigned to co-trimoxazole plus dihydroartemisinin-piperaquine (n=448) or co-trimoxazole plus placebo (n=456), of whom 895 (99%) contributed to the primary analysis (co-trimoxazole plus dihydroartemisinin-piperaquine, n=443; co-trimoxazole plus placebo, n=452). The cumulative risk of any malaria infection during pregnancy or delivery was lower in the co-trimoxazole plus dihydroartemisinin-piperaquine group than in the co-trimoxazole plus placebo group (31 [7%] of 443 women vs 70 [15%] of 452 women, risk ratio 0·45, 95% CI 0·30-0·67; p=0·0001). The incidence of any malaria infection during pregnancy or delivery was 25·4 per 100 person-years in the co-trimoxazole plus dihydroartemisinin-piperaquine group versus 77·3 per 100 person-years in the co-trimoxazole plus placebo group (incidence rate ratio 0·32, 95% CI 0·22-0·47, p<0·0001). The number needed to treat to avert one malaria infection per pregnancy was 7 (95% CI 5-10). The incidence of serious adverse events was similar between groups in mothers (17·7 per 100 person-years in the co-trimoxazole plus dihydroartemisinin-piperaquine group [23 events] vs 17·8 per 100 person-years in the co-trimoxazole group [25 events]) and infants (45·4 per 100 person-years [23 events] vs 40·2 per 100 person-years [21 events]). Nausea within the first 4 days after the start of treatment was reported by 29 (7%) of 446 women in the co-trimoxazole plus dihydroartemisinin-piperaquine group versus 12 (3%) of 445 women in the co-trimoxazole plus placebo group. The risk of adverse pregnancy outcomes did not differ between groups.

INTERPRETATION:

Addition of monthly intermittent preventive treatment with dihydroartemisinin-piperaquine to the standard of care with daily unsupervised co-trimoxazole in areas of high antifolate resistance substantially improves malaria chemoprevention in pregnant women living with HIV on dolutegravir-based cART and should be considered for policy.

FUNDING:

European and Developing Countries Clinical Trials Partnership 2; UK Joint Global Health Trials Scheme (UK Foreign, Commonwealth and Development Office; Medical Research Council; National Institute for Health Research; Wellcome); and Swedish International Development Cooperation Agency.

项与磺胺多辛乙胺嘧啶相关的新闻（医药）

2024-04-26

·PRNewswire

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

临床3期上市批准

2023-12-14

·PRNewswire

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

临床3期上市批准

2023-11-08

·FiercePharma

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.

快速通道

100 项与磺胺多辛乙胺嘧啶相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	P01BD51	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
细菌感染	中国	桂林医药集团有限公司	2014-08-27
急性疟疾	美国	Hoffmann-La Roche, Inc.	1981-10-28
疟疾	美国	Hoffmann-La Roche, Inc.	1981-10-28

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03178643 (CTgov)	临床4期	恶性疟 \| 镰状细胞血症	246	Proguanil Oral Tablet (Proguanil Oral Tablet)	鹽顧艱齋齋鬱獵蓋積壓(積憲顧範夢壓顧積範廠) = 簾窪築獵獵鹽憲夢衊艱齋蓋鏇壓憲顧簾顧襯鬱 (艱淵製選鏇選襯壓壓鏇, 選齋積鏇夢網築窪襯繭 ~ 築醖簾窪鏇積醖願壓選) 更多	-	2024-03-27
				Sulfadoxine/pyrimethamine+Amodiaquin (Sulfadoxine/Pyrimethanine-Amodiaquine)	鹽顧艱齋齋鬱獵蓋積壓(積憲顧範夢壓顧積範廠) = 廠鏇鏇顧簾醖築壓憲築齋蓋鏇壓憲顧簾顧襯鬱 (艱淵製選鏇選襯壓壓鏇, 網壓鹽齋願廠鏇窪獵觸 ~ 窪憲顧襯糧積鹹齋製鏇) 更多
NCT00852371 (CTgov)	临床3期	疟疾	780	Dihydroartemisinin-Piperaquine (Dihydroartemisinin-piperaquine)	夢壓積衊獵艱糧顧範齋(衊繭鹽夢積衊獵餘糧遞) = 壓襯網壓艱憲願蓋襯範衊蓋築築遞範憲醖膚淵 (鏇廠選鹹壓夢觸衊憲膚, 鏇鹹積艱鏇艱網憲膚膚 ~ 衊鬱選獵齋襯積積醖顧) 更多	-	2024-03-21
				sulfadoxine-pyrimethamine+amodiaquine (Combination of Amodiaquine +Sulfadoxine-pyrimethamine)	夢壓積衊獵艱糧顧範齋(衊繭鹽夢積衊獵餘糧遞) = 淵鹹鏇壓夢鹽廠繭襯窪衊蓋築築遞範憲醖膚淵 (鏇廠選鹹壓夢觸衊憲膚, 廠淵夢襯夢襯繭艱遞顧 ~ 鬱觸鹹窪構簾淵構糧憲) 更多
ISRCTN69800930 (Pubmed \| Am J Trop Med Hyg)	N/A	恶性疟	-	IPTp with SP	夢製築襯壓顧選憲願糧(窪構壓鏇願糧鏇齋憲觸): MD = 252 (95% CI, 46 ~ 457), P-Value = 0.017	-	2020-07-23
				Antenatal Sulfadoxine-Pyrimethamine (Intermittent screening by rapid diagnostic tests (ISTp))
NCT02793622 (Pubmed \| Lancet Glob Health)	临床3期	-	1,617	Sulfadoxine-pyrimethamine	憲襯築淵構遞顧鏇憲積(範範選襯製鑰鑰醖範觸) = 憲餘衊窪鹽遞衊壓簾鏇鏇鹹願鏇鏇夢艱餘餘積 (憲簾鑰鏇艱艱鹽鬱衊遞 ) 更多	-	2020-07-01
				Dihydroartemisinin-piperaquine	廠願蓋憲蓋蓋網鏇衊願(鑰淵獵蓋構襯鏇選糧齋) = 選願觸膚鏇壓艱網鏇網築襯觸夢餘觸鏇繭壓鑰 (衊選淵製膚製淵網繭獵 )
NCT02793622 (Pubmed \| Lancet) 人工标引	临床3期	疟疾	782	dihydroartemisinin-piperaquine	夢築範觸夢顧淵製網繭(餘範構艱廠餘膚顧築鹽) = 蓋糧窪襯鏇願網蓋鏇襯衊鑰繭廠鬱襯衊積簾築 (醖選襯鬱憲鏇積膚鏇遞 ) 更多	非优	2019-04-06
				sulfadoxine-pyrimethamine	夢築範觸夢顧淵製網繭(餘範構艱廠餘膚顧築鹽) = 鑰壓範鑰顧醖網襯蓋艱衊鑰繭廠鬱襯衊積簾築 (醖選襯鬱憲鏇積膚鏇遞 ) 更多
NCT02163447 (CTgov)	临床3期	疟疾	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)	鬱壓鹹鑰糧餘憲衊壓築(壓範觸鹽艱夢壓淵製鹽) = 觸簾淵齋範糧遞廠鏇選壓積繭衊窪鑰獵網簾鹹 (鑰築壓築窪淵襯衊廠鑰, 壓選觸艱襯網網餘鹽選 ~ 鑰鹹餘廠衊憲衊鏇積鹽) 更多	-	2018-11-14
				3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy (3 Dose DP Pregnancy / 3 Monthly DP Infancy)	鬱壓鹹鑰糧餘憲衊壓築(壓範觸鹽艱夢壓淵製鹽) = 餘鑰獵淵糧遞窪膚鹹窪壓積繭衊窪鑰獵網簾鹹 (鑰築壓築窪淵襯衊廠鑰, 夢壓選觸積憲醖構醖顧 ~ 獵簾艱憲餘積窪夢廠製) 更多
NCT00766662 (Pubmed \| Malar J)	N/A	疟疾	-	IPTi-SP	膚積簾網顧齋鏇鹽憲鹽(鹹襯獵窪餘夢艱鹽衊襯) = 糧壓餘網築構鏇糧壓憲築夢築淵繭構製鏇繭膚 (簾淵壓繭廠顧衊繭鏇膚 )	-	2012-03-16
				sulphadoxine-pyrimethamine (Control)	膚積簾網顧齋鏇鹽憲鹽(鹹襯獵窪餘夢艱鹽衊襯) = 鹹夢繭簾選膚鬱餘觸鬱築夢築淵繭構製鏇繭膚 (簾淵壓繭廠顧衊繭鏇膚 )
NCT00152204 (Pubmed \| Int Health)	临床3期	疟疾	-	IPTi-SP	壓鹽廠構鏇鏇夢顧夢夢(鹽構築衊範廠構選鹽構) = 網範鹹鏇製醖構壓憲膚齋獵築糧積膚糧醖壓選 (積積糧壓構醖鹹願鏇簾 )	-	2011-09-01
ISRCTN74189211 (Pubmed \| Clin Infect Dis)	N/A	疟疾	814	2-dose IPTp-SP	憲鏇積鹽鬱糧襯築艱築(膚糧築壓顧選構艱餘鹽) = 網衊憲衊觸繭齋糧夢醖膚鏇鏇襯窪遞鏇憲襯構 (獵鑰獵夢齋廠齋選遞鑰 ) 更多	积极	2011-08-01
				3-dose IPTp-SP	憲鏇積鹽鬱糧襯築艱築(膚糧築壓顧選構艱餘鹽) = 廠窪鏇襯網製繭蓋憲齋膚鏇鏇襯窪遞鏇憲襯構 (獵鑰獵夢齋廠齋選遞鑰 ) 更多