GSK plc (LSE/NYSE: GSK) and Medicines for Malaria Venture (MMV) today announce that the first single-dose medicine for the prevention of relapse of Plasmodium vivax (P. vivax) malaria – tafenoquine, co-administered with chloroquine for radical cure, has now been launched in both Thailand and Brazil, in support of malaria elimination efforts..

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）和疟疾药物投资公司（MMV）今天宣布，第一种用于预防间日疟原虫（间日疟原虫）疟疾复发的单剂量药物-他非诺喹，与氯喹联合用于根治性治疗，现已在泰国和巴西推出，以支持消除疟疾的努力。。

P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa1. It is characterised by clinical relapses, with patients repeatedly falling sick unless the latent liver-stage infection is treated. This takes a considerable physical, economic and social toll on patients and communities, perpetuating cycles of poverty.

P、 间日疟原虫是撒哈拉以南非洲以外大多数国家的主要疟疾寄生虫1。它的特征是临床复发，除非治疗潜伏性肝期感染，否则患者会反复生病。这给患者和社区带来了相当大的物质、经济和社会损失，使贫困周期永久化。

In some cases, relapses can lead to severe malaria and death. Relapses also increase the disease burden and the potential for onward transmission, ultimately impeding global efforts to eliminate malaria..

在某些情况下，复发可能导致严重的疟疾和死亡。复发还会增加疾病负担和传播潜力，最终阻碍全球消除疟疾的努力。。

Tafenoquine is an 8-aminoquinoline, antimalarial drug targeting the liver-stage of P. vivax malaria. When used in combination with chloroquine for the blood-stage infection, tafenoquine provides what is known as radical cure: the treatment of both the blood- and liver-stages of the disease. Tafenoquine, like all 8-aminoquinolines, has the potential to cause acute haemolytic anaemia in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency, therefore a G6PD test must be performed before prescribing..

他非诺喹是一种8-氨基喹啉类抗疟药物，针对间日疟原虫的肝脏阶段。当与氯喹联合用于血液阶段感染时，他非诺喹可提供所谓的根治性治疗：治疗疾病的血液和肝脏阶段。与所有8-氨基喹啉一样，他非诺喹有可能在葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症患者中引起急性溶血性贫血，因此在开具处方之前必须进行G6PD检测。。

The Ministries of Health in both Thailand and Brazil sponsored feasibility studies on the routine use of tafenoquine after point-of-care G6PD testing within their public health systems, with the support of MMV. Evidence from these real-world studies has informed their decisions to introduce these anti-malarial tools in their drive to help eliminate malaria..

泰国和巴西卫生部在MMV的支持下，赞助了在公共卫生系统内进行G6PD即时检测后常规使用他非诺喹的可行性研究。这些现实世界研究的证据表明，他们决定在帮助消除疟疾的过程中引入这些抗疟疾工具。。

Thomas Breuer, Chief Global Health Officer, GSK said: “Today’s news underscores GSK’s long-standing commitment to malaria and we are proud that tafenoquine, co-administered with chloroquine, the first radical cure medicine for P. vivax malaria is now launched in both Brazil and Thailand, taking us another step closer to our shared goal of eliminating malaria.

葛兰素史克首席全球卫生官托马斯·布鲁尔（ThomasBreuer）表示：“今天的新闻突显了葛兰素史克对疟疾的长期承诺，我们感到骄傲的是，与氯喹（第一种治疗间日疟原虫疟疾的根治药物）共同服用的他非诺喹（tafenoquine）现已在巴西和泰国推出，使我们更接近消除疟疾的共同目标。

Working together with MMV and PATH through the Partnership for Vivax Elimination (PAVE) to optimize this new treatment option has been fundamental to countries being able to introduce this new tool.”.

通过消除间日疟原虫伙伴关系（PAVE）与MMV和PATH合作，优化这一新的治疗方案，对于各国能够引入这一新工具至关重要。”。

Dr Marcus Lacerda, Tropical Medicine Foundation Dr. Heitor Vieira Dourado (FMT-HVD) and Principal Investigator for the Tafenoquine Rollout STudy (TRuST), said: “The launch of tafenoquine in Brazil marks a significant step forward in our country’s mission to eliminate malaria by 2035. We recognize the unique challenges faced by vulnerable communities, including Indigenous populations, who are disproportionately affected by malaria.

热带医学基金会Heitor Vieira Dourado博士（FMT-HVD）和塔非诺喹推广研究（TRuST）首席研究员马库斯·拉瑟达博士说：“塔非诺喹在巴西的推出标志着我国到2035年消除疟疾的使命向前迈出了重要一步。我们认识到包括土著居民在内的弱势社区所面临的独特挑战，他们受到疟疾的影响尤为严重。

This treatment option helps to address these challenges head-on and we are determined to ensure that it reaches those who need it the most.”.

这种治疗方案有助于正面应对这些挑战，我们决心确保它能够惠及最需要它的人。”。

In response to the ongoing public health emergency within the Yanomami Special Indigenous Health District (DSEI), where P. vivax malaria accounts for almost seventy percent of all malaria cases, the government of Brazil accelerated the introduction of tafenoquine in March 2024. The roll out of this new testing and treatment option has now begun within the wider public health system (SUS)..

为应对亚诺马米特别土著卫生区（DSEI）内持续的公共卫生紧急情况，间日疟原虫疟疾占所有疟疾病例的近70%，巴西政府于2024年3月加速引入塔非诺喹。这一新的检测和治疗方案现已在更广泛的公共卫生系统（SUS）内开始推广。。

In Thailand, reported cases of malaria have increased significantly in recent years, more than doubling between 2021 and 20222. The region bordering Myanmar accounts for most of these additional cases, where displaced populations from the neighbouring country can more easily access healthcare. This has increased the demand for malaria diagnosis and treatment resources in Thailand2 and the roll-out of tafenoquine will have significant impact..

在泰国，近年来报告的疟疾病例大幅增加，2021年至20222年间增加了一倍多。与缅甸接壤的地区是这些新增病例的主要地区，来自邻国的流离失所者可以更容易地获得医疗保健。这增加了泰国对疟疾诊断和治疗资源的需求2，塔非诺喹的推出将产生重大影响。。

Dr Martin Fitchet, CEO of MMV said: “Seeing this medicine get into the hands of patients who need it is a cause for celebration. This demonstrates real leadership by the governments of Brazil and Thailand in bringing innovation to accelerate the elimination of malaria, MMV is proud to have collaborated with GSK and PATH on the development of this important medicine.”.

MMV首席执行官Martin Fitchet博士表示：“看到这种药物进入需要它的患者手中是一个值得庆祝的理由。这表明巴西和泰国政府在带来创新以加速消除疟疾方面发挥了真正的领导作用，MMV很骄傲能够与GSK和PATH合作开发这种重要的药物。”。

Approvals for tafenoquine have been granted in the US, Australia, Brazil, Ethiopia, Guyana, Peru, Thailand, Colombia and the Philippines, and the drug is undergoing marketing authorisation evaluation in a number of other countries where P. vivax is endemic. Submissions have included evidence on the safety and efficacy; real world feasibility; a qualitative study on patient and health worker perceptions of G6PD testing and single-dose tafenoquine; a cost-effectiveness analysis and a budget impact analysis..

美国、澳大利亚、巴西、埃塞俄比亚、圭亚那、秘鲁、泰国、哥伦比亚和菲律宾已批准他非诺喹，该药正在间日疟原虫流行的许多其他国家进行上市许可评估。提交的材料包括关于安全性和有效性的证据；；对患者和卫生工作者对G6PD检测和单剂量他非诺喹的认知进行定性研究；成本效益分析和预算影响分析。。

About Tafenoquine

Tafenoquine

Tafenoquine is an 8-aminoquinoline derivative with activity against all stages of the P. vivax lifecycle, including hypnozoites. It was first synthesised by scientists at the Walter Reed Army Institute of Research in 1978. GSK’s legacy in the research and development of tafenoquine as a potential medicine for malaria commenced over 20 years ago.

Tafenoquine是一种8-氨基喹啉衍生物，对间日疟原虫生命周期的所有阶段都有活性，包括hypnozoites。它于1978年由沃尔特里德陆军研究所的科学家首次合成。葛兰素史克（GSK）在研究和开发他非诺喹（tafenoquine）作为治疗疟疾的潜在药物方面的遗产始于20多年前。

In 2008, GSK entered into a collaboration with the not-for-profit drug research partnership, MMV, to develop tafenoquine as an anti-relapse medicine for patients infected with P. vivax. The tafenoquine clinical programme is part of GSK’s global health programme aimed at improving healthcare for vulnerable populations.

2008年，GSK与非营利药物研究合作伙伴MMV合作，开发他非诺喹作为间日疟原虫感染患者的抗复发药物。tafenoquine临床计划是葛兰素史克全球健康计划的一部分，旨在改善弱势人群的医疗保健。

The STANDARD G6PD test was developed in collaboration between SD Biosensor and PATH. The handheld device provides a measure of a patient’s G6PD enzyme activity levels in two minutes based on a drop of blood from a finger-prick..

标准G6PD测试是在SD生物传感器和PATH之间合作开发的。手持式设备可以根据手指刺破的一滴血，在两分钟内测量患者的G6PD酶活性水平。。

Important safety information

重要安全信息

Tafenoquine can cause hemolytic anaemia in patients with G6PD deficiency. The most common side effects are difficulty sleeping, headache, dizziness, nausea and vomiting. Allergic hypersensitivity reactions can occur after taking the drug. Please refer to the Consumer Medicine Information (CMI) summary for important dosage, administration, and safety information available at this link: kozenis-cmi-au.pdf (gsk.com).

他非诺喹可引起G6PD缺乏症患者的溶血性贫血。最常见的副作用是睡眠困难、头痛、头晕、恶心和呕吐。服用该药后可能发生过敏性超敏反应。有关重要的剂量，给药和安全信息，请参阅消费者药物信息（CMI）摘要，网址为：kozenis-CMI-au.pdf（gsk.com）。

About Plasmodium vivax malaria

关于间日疟原虫疟疾

The Plasmodium parasite is a complex organism with a lifecycle spanning both humans and mosquitoes. After an infected mosquito bite, the P. vivax parasite infects the blood and causes an acute malaria episode. It also has the ability to lie dormant in the liver (in a form known as hypnozoite) from where it periodically reactivates to cause relapses of P.

疟原虫是一种复杂的生物体，其生命周期跨越人类和蚊子。。它还能够休眠在肝脏中（以一种称为hypnozoite的形式），在那里它会定期重新激活，导致P复发。

vivax malaria. Hence, a single P. vivax infection can give rise to multiple episodes of malaria, in the absence of a new mosquito bite. These relapses can occur weeks, months or even years after the initial infection. The dormant liver forms of the parasite cannot be readily treated with most anti-malarial treatments active against the blood-stage parasite.

间日疟原虫。因此，在没有新的蚊子叮咬的情况下，一次间日疟原虫感染可引起多次疟疾发作。这些复发可能发生在初次感染后数周，数月甚至数年。大多数针对血液阶段寄生虫的抗疟治疗都不容易治疗休眠的肝脏形式的寄生虫。

The current treatment (primaquine) for the dormant liver stage must be taken for 7 to 14 days to be effective, a regimen that is associated with poor compliance in unsupervised patients 3,4,5..

目前用于休眠肝期的治疗（伯氨喹）必须服用7至14天才能有效，这种方案与无监督患者的依从性差有关3,4,5。。

The use of a medicine that targets the dormant liver forms of the parasite, co-administered with a medicine to treat the blood stage, is known as radical cure.

使用针对寄生虫休眠肝脏形式的药物，与药物共同治疗血液阶段，被称为根治性治疗。

P. vivax malaria has a significant public health and economic impact, primarily in South-Asia, South-East Asia, Latin America and the horn of Africa. The disease is estimated to cause around 8.5 million clinical infections every year. The clinical features of P. vivax malaria include fever, chills, vomiting, malaise, headache and muscle pain, and in some cases, can lead to severe malaria and be fatal..

P、 间日疟对公共卫生和经济产生重大影响，主要发生在南亚、东南亚、拉丁美洲和非洲之角。据估计，该疾病每年会导致约850万例临床感染。间日疟原虫疟疾的临床特征包括发烧，发冷，呕吐，不适，头痛和肌肉疼痛，在某些情况下，可能导致严重的疟疾并致命。。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，其宗旨是联合科学、技术和人才，共同战胜疾病。了解更多信息，请访问 gsk.com。

About Medicines for Malaria Venture

关于疟疾药物风险

MMV is a Swiss-based not-for-profit organization working to deliver a portfolio of accessible medicines with the power to treat, prevent and eliminate malaria. Born in 1999, out of a need for greater health equity, we close critical gaps in research, development and access – working “end-to-end” to expand the use of existing antimalarials and innovate new compounds to protect public health.

MMV是一家总部位于瑞士的非营利性组织，致力于提供一系列可获得的药物，具有治疗、预防和消除疟疾的能力。我们于1999年出生，出于对更大健康公平的需求，我们弥合了研究、开发和获取方面的关键差距，致力于“端到端”扩大现有抗疟药物的使用，并创新新化合物以保护公众健康。

This starts with women and children..

这从妇女和儿童开始。。

It’s working. As of 2023, MMV-supported products have effectively treated an estimated 680 million people and saved around 15.4 million lives. We cannot stop now.

它正在工作。截至2023年，MMV支持的产品有效治疗了约6.8亿人，挽救了约1540万人的生命。我们现在不能停止。

With a quarter of a billion malaria cases and more than 600,000 deaths reported in 2022, progress towards disease elimination has stalled. MMV is part of an ecosystem of partners determined to change this. Bringing public and private sector partners together, we pioneer new solutions that align with local and global health priorities and promote the equitable development of effective and affordable products that work to help end malaria and advance health for all..

2022年报告的疟疾病例有25亿，死亡人数超过60万，消除疾病的进展已经停滞。MMV是决心改变现状的合作伙伴生态系统的一部分。我们将公共和私营部门的合作伙伴聚集在一起，开创符合当地和全球卫生优先事项的新解决方案，并促进公平开发有效和负担得起的产品，以帮助消除疟疾并促进所有人的健康。。

About PAVE

关于铺装

PAVE is the PArtnership for Vivax Elimination led by MMV and PATH bringing together National Malaria Programmes, researchers, funders, and other organizations to eliminate P. vivax malaria. The goal of PAVE is to support countries in accelerating the elimination of P. vivax malaria.

PAVE 是消灭间日疟伙伴关系（PArtnership for Vivax Elimination），由 MMV 和 PATH 领导，汇集了国家疟疾计划、研究人员、资助者和其他组织，以消灭间日疟。PAVE 的目标是支持各国加速消灭间日疟原虫疟疾。