Total Investment of Approx. USD 8.5 Million in Malaria and NTD R&D Projects With Partners Including MMV, GSK, Tanabe Pharma, Eisai and DNDi

TOKYO, April 22, 2026 /PRNewswire/ — The Global Health Innovative Technology (GHIT) Fund announced today a total investment of approximately JPY 1.37 billion (USD 8.5 million1) in five R&D projects for the development of drugs for malaria and neglected tropical diseases (NTDs).2

Investment of approx. JPY 700 million (USD 4.4 million

1

) for preclinical development of an antimalarial drugMalaria is a serious infectious disease that affects more than 280 million people and claims approximately 610,000 lives worldwide each year. Over 95% of all malaria cases occur in Africa, with more than 75% of those affected being children under the age of 5.3 Countermeasures against Plasmodium falciparum malaria, which has a particularly high case fatality rate, and Plasmodium vivax malaria, which is prevalent in Southeast Asia and the Americas, are an urgent priority. To end the epidemics of malaria, new drugs with novel modes of action which overcome known resistance associated with existing therapeutics are needed. It is crucial to develop compounds that can block transmission and be used for chemoprevention, acute treatment, and treatment of relapsing malaria are especially valuable to drive eradication.

To address this issue, the GHIT Fund is investing approximately JPY 700 million (USD 4.4 million1) in a global partnership aimed at the preclinical development of an antimalarial drug which could be used for treatment, chemoprevention or Single Encounter Radical Cure and Prophylaxis (SERCAP) of malaria. This project is being led by Medicines for Malaria Venture (MMV), Tanabe Pharma Corporation in Japan, and the University of Georgia in the United States. The investment builds on a prior GHIT-supported project3 that received approximately JPY 600 million (USD 3.8 million1) between 2015 and 2025. Through this project, there is also the prospect of developing a long‑acting injectable that can provide three or more months of protection against recurrent Plasmodium vivax malaria.

Investment of approx. JPY 330 million (USD 2 million

1

) in global evaluation in Kenya, Senegal and India and regulatory registration for EumycetomaEumycetoma is a severely neglected tropical disease that causes chronic, destructive infections, often leading to disability, amputation, loss of income, and social stigma. It affects tens of thousands of people in resource-constrained rural communities across Africa, Asia, and Latin America, with the highest burden reported in the so-called «mycetoma belt» between latitudes 15° S and 30° N. Although underreported, global estimates suggest that more than 100,000 people may be living with the disease, with thousands of new cases annually. Despite its significant impact, current treatments remain limited and are often toxic and poorly tolerated.

The GHIT Fund has been investing in a collaboration between Eisai Co., Ltd. and Drugs for Neglected Diseases initiatives (DNDi) to develop a treatment for mycetoma since 2017. This support began with a Phase II randomized clinical trial conducted in Sudan and, since 2023, has extended to supporting the registration of fosravuconazole based on the trial results as well as a cohort study providing controlled early access to fosravuconazole for patients with eumycetoma in Sudan. To the best of our knowledge, no drug for mycetoma has been evaluated through randomized controlled trials in patients diagnosed with the disease prior to the initiation of the GHIT Fund-supported trial in Sudan.

Building on the results obtained in the study, the GHIT Fund has decided to invest approximately JPY 330 million (USD 2 million1) in a project to conduct multi-country, open‑label clinical trials in Kenya, Senegal, and India to generate additional evidence for the WHO recommendation and regulatory registration of fosravuconazole for eumycetoma. The new trial will address limitations of the earlier study, including small sample size, single‑country population, and limited pathogen diversity.

In addition, the GHIT Fund will invest a total of approximately JPY 340 million (approx. USD 2.1million1) in the following three R&D projects:

Please refer to Appendix 1 for detailed descriptions on these projects and their development stages.

As of March 31, 2026, there are 42 ongoing projects, including 20 discovery projects, 13 preclinical projects, and 9 clinical trials5 in the GHIT Fund’s portfolio. The total amount of investments since 2013 is JPY 43.9 billion (USD 274 million1) (Appendix 2).

1 USD 1 = JPY 159.90, the approximate exchange rate on March 31, 2026.2 These awarded projects were selected and approved as new investments from among proposals to RFP2023-001, RFP2025-001 and RFP2025-002 for the Target Research Platform, the Screening Platform, the Hit-to-Lead Platform, and the Product Development Platform, , which were open for applications from October 2022 to June 2025.3 WHO: https://www.who.int/news-room/fact-sheets/detail/malaria4 Project details: G2023-104 https://www.ghitfund.org/investment/portfoliodetail/detail/211/G2018-202: https://www.ghitfund.org/investment/portfoliodetail/detail/136H2016-101: https://www.ghitfund.org/investment/portfoliodetail/detail/93S2014-212: https://www.ghitfund.org/investment/portfoliodetail/detail/565 This number includes projects in the registration phase.

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 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.https://www.ghitfund.org/

Appendix 1. Project Details

ID: G2025-102

Project Title
Preclinical development of a target-based series with potential for treatment, SERCAP and chemoprevention of malaria.

Collaboration
1. Medicines for Malaria Venture (MMV)

Partners
2. Tanabe Pharma Corporation (Japan)

3. University of Georgia

Disease
Malaria

Intervention
Drug

Stage
Pre-clinical

Awarded Amount
JPY 698,830,300 (USD 4.4 million)

Status
Continued project

Summary
[Project objective]

The key project aim is to complete the IND-enabling preclinical development studies on MMV172 targeting monthly single oral dose chemoprevention. The project will also continue to determine the
efficacy of MMV172 in the primate model of relapsing P. vivax malaria to develop an understanding of the anti-hypnozoite PK/PD relationship required to determine if MMV172 also meets the dose
criterion for SERCAP (Single Encounter Radical Cure and Prophylaxis) or, if necessary, to guide selection of alternative compounds from the series that may be better suited. The second aim of
the project is to deliver one or more differentiated Late Lead(s) against a second target product profile; either an oral treatment for relapsing P.vivax malaria or a long-acting injectable
for chemoprevention, depending on the outcome of profiling studies and the eventual indication for MMV172. Those compounds would be potential back-up if MMV172 is not meeting TPP (Target
Product Profile) criteria.

[Project design]
A multi-disciplinary project team has been assembled, utilizing the inputs and diverse skills and experiences of experts in medicinal chemistry, biology, parasitology, pharmacokinetics,
toxicology, formulation and scale-up chemistry. MMV will also draw on the know-how of its global network of scientific experts to support the activities and review the progress of the
project.

Starting with the confirmed Late Lead MMV172, the necessary candidate profiling and preclinical development studies will be performed to confirm the compound meets the desired candidate profile
and has the necessary data package required to obtain authorization from regulatory authorities to progress into first in human study.

Additional parasitology, efficacy, ADME and PK studies will be performed on other compounds to determine their potential to address attrition of MMV172 and/or to meet differentiated target
product profiles, and to collect the necessary data package required to confirm them as new Late Lead(s).

Project Detail

https://www.ghitfund.org/investment/portfoliodetail/detail/258/en

ID: G2025-211

Project Title
Global Evaluation and Registration of Fosravuconazole for Eumycetoma: Translating Research into Patient Impact

Collaboration
1. Drugs for Neglected Diseases initiatives (DNDi)

Partners
2. Eisai Co., Ltd. (Japan)

Disease
Mycetoma

Intervention
Drug

Stage
Clinical Phase III

Awarded Amount
JPY 331,404,733 (USD 2 million)

Status
Continued project

Summary
[Project objective]

The project will generate clinical evidence across diverse endemic regions – Senegal, Kenya, and India – to confirm the efficacy, safety, and pharmacokinetics of fosravuconazole, including
against causative organisms beyond Madurella mycetomatis. This follows Phase II results showing good efficacy and a favorable safety profile of fosravuconazole and aims to generate further
scientific evidence.

To support global introduction, the project will also implement a comprehensive regulatory strategy, including engagement under consideration with several agencies including the WHO and
Swissmedic, and prepare for WHO Pre-Qualification (PQ).

[Project design]
A multi-country, open-label prospective clinical trial will be conducted in Kenya, Senegal, and India to evaluate the efficacy, safety, and pharmacokinetics of fosravuconazole 200 mg in
patients with eumycetoma. The trial uses a non‑comparative, open‑label design developed in consultation with the WHO, to accelerate access to a promising therapy with advantages over currently
available treatments. Participant recruitment will take approximately 12 months, followed by 12 months of treatment and follow‑up for enrolled patients to ensure complete and reliable clinical
data in line with ethical and scientific standards.

To support regulatory readiness, DNDi and Eisai will seek scientific advice from a stringent regulatory authority, currently planned with Swissmedic through the Marketing Authorisation for
Global Health Products (MAGHP) procedure, which enables participation from endemic countries and the WHO PQ team. Together, DNDi and Eisai will develop a global regulatory strategy to
facilitate WHO recommendation and registration in endemic countries, supported by early consultations with the WHO.

Project Detail

https://www.ghitfund.org/investment/portfoliodetail/detail/263/en

ID: G2022-210

Project Title
Prolyl tRNA Synthetase Inhibitors as New Antimalarials

Collaboration
1. Medicines for Malaria Venture (MMV)

Partners
2. GlaxoSmithKline Investigacion y Desarrollo, S.L. (GSK)

3. The University of Tokyo (Japan)

Disease
Malaria

Intervention
Drug

Stage
Lead Optimization

Awarded Amount
JPY183,557,100 (USD 1.1 million)

Status
Continued project

Summary
[Project objective]

The ultimate objective of this drug discovery collaboration is to deliver a Preclinical Candidate which targets Plasmodium ProRS and meets MMV’s candidate criteria for either prophylaxis (TCP-
4) or treatment (TCP-1) shown here; https://www.mmv.org/frontrunner-templates. The objective of this two-year proposal is to initiate optimization of the lead pyridylpyrrolidones series
to deliver a Late Lead which meets MMV’s criteria for prophylaxis (TCP-4) and is endorsed by MMV ESAC for entry into candidate profiling studies. The Late Lead could be potentially considered
for treatment (TCP-1) if the resistance profile of the late lead improves. In more detail the objectives of the lead optimization project aim to achieve:

1. Increased parasite potency (i.e. 3D7 EC50 MIC for 7d (minimum) or a single dose MIC for 28d (ideal).

3. Addressing the hERG inhibition

4. Confirming selectivity for Pf versus Hu ProRS >1000-fold according to appropriate functional biochemical and cellular assays

5. Determination of the parasitological profile, including rate of kill, potency against lab and clinical strains, efficacy in the SCID model, determination of resistance risk (MIR) etc.

6. Identification and mitigation of additional developability and safety risks; Ames, CYP inhibition, CMC.

[Project design]

A multi-disciplinary drug discovery approach will be used by the project, utilizing the inputs and diverse skills of the project team which has expertise in medicinal chemistry, molecular
modeling, parasitology, DMPK and pharmacometrics, toxicology, formulation and scale-up chemistry. Starting from the Early Lead, rational and systematic modifications will be made to further
improve the overal properties based on state-of-the-art capabilities and data generated at MMV, GSK and the University of Tokyo. As the target of these molecules is an enzyme essential to
the growth of the malaria parasite, and structural information is available, a structure-based drug design (SBDD) approach will be applied.

Project Detail

https://www.ghitfund.org/investment/portfoliodetail/detail/260/en

ID: H2025-102

Project Title
Hit-to-Lead development of a series of Daiichi Sankyo inhibitors of the novel multi-lifecycle stage target PfPFN (Profilin).

Collaboration
1. Medicines for Malaria Venture (MMV)

Partners
2. DAIICHI SANKYO COMPANY, LIMITED (Japan)

Disease
Malaria

Intervention
Drug

Stage
Lead Identification

Awarded Amount
JPY 129,679,263 (USD 0.8 million)

Status
Continued project

Summary
[Project objective]

The primary objective is to develop a compound series that meets GHIT HTLP/MMV Early Lead criteria. This includes demonstrating in vivo proof-of-concept efficacy and optimizing compounds for
potency, stability, and drug-like properties suitable for further development.

[Project design]
The project involves iterative cycles of compound design, synthesis, and testing. The design strategy focuses on improving metabolic stability, maintaining high potency, and optimizing
physicochemical properties. The team will explore scaffold modifications and structure-activity relationships (SAR) around key molecular positions to enhance drug-like characteristics while
preserving efficacy.

Project Detail

https://www.ghitfund.org/investment/portfoliodetail/detail/261/en

ID: S2025-111

Project Title
Targeting Malaria through Inhibition of Serine Hydroxymethyltransferase (SHMT)

Collaboration
1. Eisai Co., Ltd. (Japan)

Partners
2. Medicines for Malaria Venture (MMV)

Disease
Malaria

Intervention
Drug

Stage
Screening

Awarded Amount
JPY YEN26,589,376 (USD 0.17 million)

Status
New project

Summary
[Project objective]

The primary objective of the project is to identify validated hit compounds that selectively inhibit the activity of plasmodial SHMT.

[Project design]

TropIQ Health Sciences (TropIQ) will lead a primary screen of compounds from Eisai Co., Ltd.’s (Eisai) compound library using a probe-based biochemical assay. To confirm target selectivity of
actives, counter-screening against human SHMT will subsequently be performed in the early stage of the project. Hits showing reproducible inhibition and selectivity of plasmodial SHMT over
human SHMT will be further assessed using secondary assays.

Confirmed hits will be further assessed by a series of secondary assays. Biochemical assays will be used to further validate actives and generate dose-response curves. To assess biological
relevance, compounds will be tested against multiple malaria life cycle stages, including whole parasite asexual blood stage replication, gametocyte and liver stage assays. To exclude toxic
compounds, cytotoxicity will be evaluated. All assays will be performed according to TropIQ’s established protocols.

Eisai, Medicines for Malaria Venture (MMV), and TropIQ will review the top hits and assess for clusters of structurally related chemotypes to define chemical series for future work and to
establish an early structure-activity relationship.

Project Detail

https://www.ghitfund.org/investment/portfoliodetail/detail/262/en

*All amounts are listed at an exchange rate of USD 1 = JPY 159.90, the approximate exchange rate on March 31, 2026.

Appendix 2. Investment Overview (as of March 31, 2026)

Investments to date Total investments: JPY 43.9 billion (USD 274 million1)Total invested projects: 146 (42 active projects and 104 completed projects)

To learn more about the GHIT Fund’s investments, please visitInvestment Overview: https://www.ghitfund.org/investment/overview/enPortfolio: https://www.ghitfund.org/investment/portfolio/enAdvancing Portfolio: https://www.ghitfund.org/investment/advancingportfolio/enClinical Candidates: https://www.ghitfund.org/investment/clinicalcandidates/en

For more information, contact:Katy Lenard at +1-301-280-5719 or [email protected] Eriko Mugitani at +81-36441-2032 or [email protected]

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