Annual Report 2022

Annual Report 2022

CONTENTS

01

Message from CEO & Chair

03

GHIT Fund Portfolio

05

Featured Story“Arpraziquantel”, a potential Pediatric Treatment
Option for Schistosomiasis:
European Medicines Agency (EMA) Scientific
Review Application validated and in progress

07

Clinical Candidates
Phase I Trial-Phase III Trial

09

Invested Partnerships in FY 2022

15

Strategic Plan FY 2018-FY 2022 Results

19

Highlights in FY 2022

21

Dialogue
Reflections on GHIT’s catalytic role

23

Finances

25

Leadership

27

Funding Partners & Sponsors

29

Overview30

02

Message from CEO & Chair

Partnerships: GHIT Fund s Most Valuable
Asset in the Fight Against Infectious Diseases
Toward the Next 10 Years
In 2023, the Global Health Innovative Technology FundFirst Drug to Reach Regulatory Approval Since the(GHIT Fund) celebrates its 10th anniversary. We are

GHIT Fund’s Establishment

grateful to our funding partners and sponsors for theirsupport and collaboration over the past decade, to our“Arpraziquantel,” a new treatment option for

product development partners for their passion and tirelessschistosomiasis for preschool children (3 months to 6

efforts in the fight against neglected infectious diseases, andyears old) developed by the Pediatric Praziquantel

to the global health community for its solidarity andConsortium, completed the application process forpartnership.

approval with the European Medicines Agency (EMA) in
December 2022. The GHIT Fund is honored to have

The concept of the GHIT Fund was born from notes written

supported the Consortium since 2013, facilitating

on a paper napkin by the late Dr. Tachi Yamada and thesuccessful product development by Consortium partners

GHIT Fund’s founding CEO, Dr. BT Slingsby, in 2013.

Astellas Pharma of Japan, Merck of Germany, Lygature

Since then, we have been fighting neglected diseases in lowof the Netherlands, and Farmanguinhos of Brazil.

and middle-income countries by connecting ideas, people,

Japanese innovation and technology are inextricably

and innovations from around the world. In our experience,linked to arpraziquantel’s development journey, and its

passion and vision are more powerful tools than most people

R&D advancement through global partnerships truly

may realize. Each new drug in development or nearing

embodies the mission of the GHIT Fund. When approved,

approval has the potential to save tens of millions of lives.

this new pediatric formulation will bring health and hope
to more than 50 million children. This achievement would

Cumulative investments over the past 10 years have totaled

not have been possible without the cooperation of theapproximately 30 billion yen, supporting more than 100

children, their families, and communities who joined in

R&D projects. More than 50 projects are currently

the clinical trial in addition to the ceaseless efforts of theunderway, of which 12 are in clinical development.

Consortium. We would like to express our sincere
gratitude to many people for their tremendous support

The second phase of our second Strategic Plan FY 2018-FY

over the years (pages 7-8).

2022 set goals for each stage of R&D, from lead compound
discovery to clinical development, delivering significant

Together, in Partnership at Every Step

progress at almost every stage. In particular, the number of

03

diagnostics and discovery/preclinical projects significantly

Our partnerships, cultivated and nurtured with care andexceeded achievement targets, and despite the impact of themutual appreciation and admiration over the past decade,

COVID-19 pandemic, we made steady progress in primary

are our most valuable assets. With more than 110 global

product development through close collaboration with ourpartners and 60 partners in Japan, the GHIT Fund has

product development partners (pages 19-20).

accelerated global health R&D innovation bymeaningfully connecting Japanese pharmaceuticalquick delivery of the therapeutics, vaccines, and diagnostics

companies and universities with global partners. We arethat result from our development partnerships will savealso proud to have helped further advance the global

countless lives and prevent untold suffering and stigma.

health R&D field in Japan.
The GHIT Fund remains committed to promoting innovation
Our strategic partnerships have also notably evolved. For

and R&D from Japan and fighting neglected infectious

example, we strengthened our collaboration with thediseases through global partnerships. We remain steadfast in

Coalition for Epidemic Preparedness Innovations (CEPI)

our mission to reduce the suffering caused by neglectedin May 2022, through a mutual commitment to explore

infectious diseases that afflict more than a billion people, inopportunities in strategic vaccine development andsupport of a healthy world for all. We are honored toinvestment platforms. Additionally in February 2023, weembrace this work together with you, as partners.

signed a cooperation framework agreement with Unitaid,
which focuses on addressing complex challenges such as

We look forward to your continued support and cooperation.

the emergence of drug resistance in tuberculosis andmalaria, vector-borne diseases that may recur andproliferate due to climate change, as well as accelerating
global health product access (pages 21-22).

The Promise of the Next Decade
Developing new medicines is no easy task, requiring an
average of over ten years of painstaking effort and tens ofbillions of yen to develop a single medicine. But as all of us
in the global health R&D community understand, the timeand investment are worth it. It means a great deal to us that
the GHIT Fund’s projects, which have been created andnurtured over the past decade, are about to bear fruit. The

Osamu Kunii

Hiroki Nakatani

CEO & Executive Director

Chair & Representative Director

04Portfolio
Discovery
Drugs / Vaccines

Target Research

Diagnostics

Target ResearchPreclinical
Screening

Hit-to-Lead

Lead Optimization
Product Design

Buruli ulcer

Chagas disease

Chagas disease, Leishmaniasis

Chagas disease

Soil-transmitted helminths

Leishmaniasis

NTDs
Leishmaniasis

Malaria

Tuberculosis

USD

95.3

12.8
18.9

05

2013

101.2

76.0

51.1
29.7
46.0

32.4
63.7

250.0

98.6

2014

2015

2016

200.0

56.8
131.9
2017

169.9

350.0
300.0

69.1

Co-investment

GHIT investment

98.1

209.2

261.4

276.3

291.0

150.0
100.0
50.0

2018

2019

2020

2021

2022

US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.

0

Cumulative investments USD (in millions)

392M

400.0

Please visit the GHIT Fund’s website to find out more about each project and partner’s innovations.
https://www.ghitfund.org/investment/portfolio/en

Drug

ClinicalPreclinical

VaccinePhase I

Phase II

Phase III

Registration

Product Development

Product Validation

Product Validation

Registration

Dengue fever

Buruli ulcer

Lymphatic filariasis, Onchocerciasis

Chagas disease

Schistosomiasis

Visceral leishmaniasis

Cutaneous leishmaniasis

Onchoserciasis

Leishmaniasis

Diagnostics

Mycetoma

Schistosomiasis

As of March 31, 2023

Investment Overview

DiseaseFY 2013-2022

FY 2022Development
Stage

Intervention

Malaria

43.6%

Drugs

67.8%

Discovery

17.6%

Tuberculosis

10.4%

Vaccines

22.8%

Preclinical

51.4%

NTDs

46.1%

Diagnostics

9.5%

Clinical

30.9%

118

Total invested
partnerships

170

Total productdevelopment partners
59 Japanese partners
111 Non-Japanese partners

USD

14 M

Total investments

7

Invested partnerships

1

New Japanese partner

3

New non-Japanese partners
06

Featured Story“Arpraziquantel”, a potential Pediatric Treatment Option for Schistosomiasis:
European Medicines Agency (EMA) Scientific Review Application
validated and in progress

Since 2014, the Global Health Initiative Technology Fund

250 million people, including more than 100 million(GHIT Fund) has supported the Pediatric Praziquantel

children, are infected worldwide. It is estimated that

Consortium’s development of arpraziquantel, which, once

approximately 200,000 people die annually fromapproved, has the potential to be a transformational newcomplications of the disease.

therapeutic option for the treatment of schistosomiasis inpreschool children (3 months to 6 years old). In November

The Pediatric Praziquantel Consortium aims to reduce the2022, Merck, on behalf of the Consortium, submitted theglobal burden of schistosomiasis by developing,regulatory application to the European Medicines Agency

registering, and ensuring patient access to arpraziquantel(EMA), which has initiated its scientific review. A

for the very young population that, until now, did not havescientific opinion is expected by the end of 2023.

a suitable pediatric treatment. Arpraziquantel’s

Arpraziquantel represents the first investigational drug todevelopment and potential availability (once registered)reach the regulatory phase amongst the different projects

forms a critical pillar of the fulfillment of World Healthsupported by GHIT Fund.

Organization’s pledge to eliminate schistosomiasis.

Objective: Control Neglected Tropical Diseases (NTDs)

A Cross-sector, Cross-border Journey: Development of an

Schistosomiasis is a chronic NTD transmitted by parasites.

07

Easy-to-Administer Pediatric Treatment

It has the second highest incidence rate in the world andPraziquantel, the current standard treatment forover 90% of infections occur in Africa. Approximately

schistosomiasis, is safe and highly effective, and available

Côte d’Ivoire
UgandaKenya

Disease: Schistosomiasis
Intervention: Pediatric Drug
Development Stage: Registration, Access
Country: Ivory Coast, Kenya, Uganda and other endemic countries.

Photo credit: SCI Foundation/Uganda

for school-age children and adults. However, at present,
around 50 million preschool-aged children have been left

Delivering Innovation: Ensuring Access for Young Children

untreated in public health programs primarily due to theAn access and delivery strategy that aligns with the uniquelack of an appropriate child-friendly medication.

contexts in endemic countries is essential to ensuring thatthe impact of this innovation reaches its full potential. In

In response, in the context of Pediatric Praziquantel

recognition, the Pediatric Praziquantel Consortium is

Consortium, Japan’s Astellas Pharma Inc. developed

exploring a new procurement mechanism for providing

arpraziquantel, a pediatric formulation of praziquantel. The

equitable and sustainable access to arpraziquantel (onceformulation was then optimized by Merck in Germany andapproved); it also launched the ADOPT program - a 5-year

transferred to Farmanguinhos in Brazil for manufacturing(2021-2025) implementation research program to informclinical supply. Arpraziquantel is small at 150mg,

future large-scale delivery programs in endemic countries.

(oro)-dispersible, and has an acceptable taste. Critically, it* Reference: World Health Organization (WHO) :https://www.who.int/en/news-room/fact-sheets/detail/schistosomiasis

can also withstand the heat and humidity that characterize theenvironments in which schistosomiasis is most prevalent.

"At the end of 2022, the European Medicines Agency
Phase III Study Completed, EMA Begins Scientific Review

validated our application and started the scientific review
process for the potential new pediatric treatment option

The confirmatory Phase III Study on the efficacy and safety

for schistosomiasis. Having reached this milestone afterof arpraziquantel for children aged 3 months to 6 years

more than 10 years of intense and collaborative work

infected with schistosomiasis was successfully concluded

makes me very proud. We are now close to our common

in Ivory Coast and Kenya.

goal of improving children’s health witha potential innovative and suitable

Following this milestone, Merck, on behalf of the Pediatrictreatment option for the very young

Praziquantel Consortium, submitted a request for an EMA

patients in need.”scientific review under the EU-M4all procedure for highpriority medicines intended for use outside the European

Dr. Jutta Reinhard-Rupp

Union (EU). A positive EMA scientific opinion would

Chair of the Pediatric Praziquantel Consortium Board
Head of the Global Health Institute at Merck

expedite WHO prequalification, and inclusion on the
Model List of Essential Medicines for Children.

08

Clinical Candidates
Phase I Trial - Phase III Trial

Tuberculosis / Diagnostics
FUJIFILM SILVAMP TB LAM

Development Stage: Product verification
Country: South Africa, Malawi, Zambia,

Tanzania, Uganda, Vietnam,
ThailandTuberculosis (TB) is the number one infectious disease killer in the world. Although thedisease is curable with early diagnosis and treatment, conventional sputum-based diagnostic
methods have led to delayed diagnosis and high morbidity and mortality rates due to thedifficulty of sputum collection in some patients, such as children and patients with severe HIV
infection. FUJIFILM SILVAMP TB LAM, jointly developed by Fujifilm and FIND, is adiagnostic test that detects LAM (lipoarabinomannan) antigen in urine with high sensitivity,
enabling rapid, inexpensive and highly sensitive diagnosis. A prospective evaluation study ofthe prototype kit (FUJIFILM SILVAMP TB LAM) was conducted with samples collectedfrom 1,624 HIV-positive patients with the aim of establishing clinical evidence, and the results
were published (Rita Székely, 2022*). Fujifilm has completed registration as a CE-IVD andcompliance with Japanese export regulations, and is now planning to produce and conductclinical evaluations of an updated design-locked product, FUJIFILM SILVAMP TB LAM II.
* doi: https://doi.org/10.1101/2022.09.07.22278961

Tuberculosis / Diagnostics
Lung Flute ECODevelopment Stage: Product Validation
Country: Cameroon

There are frequently occurring problems with the inability to obtain proper sputum for diagnosis,
especially from vulnerable population like women, children and people living with HIV, even if there
are abnormalities found in chest x-rays of active tuberculosis detection programs (tuberculosis
screening). The Lung Flute is a small, light-weight device used to help remove sputum stuck on wallsof airways through the resonance of sound waves. The use of the Lung Flute leads to improvementsin the quality and quantity of sputum collected. It does not just improve one aspect of bacteriologicalexamination of tuberculosis (TB), but also contributes to the improvement in accuracy of all
examinations. The Lung Flute ECO, an inexpensive version of the Lung Flute, is made of paper, and it is expected
to be a disposable tool to assist in sputum induction under limited resources. Furthermore, sputum contains alarge amount of deep lung pathological information, and in addition to tuberculosis infections, it may contributeto the diagnosis of bacterial infections and malignant tumors. This study aims to evaluate the performance of theLung Flute and Lung Flute ECO to improve sputum-based TB diagnosis, primarily in vulnerable groups, in a
TB endemic setting. A large prospective comparative study is currently underway in Cameroon. The study will
specifically test the effectiveness of Lung Flute ECO in increasing sputum quality and quantity. It will evaluate
the proportion of presumptive TB clients who test positive in anti-acid smear and Xpert MTB/RIF Ultra
between groups with and without Lung Flute ECO. The study will also assess the significance of Lung FluteECO use and its potential contribution to safety, acceptability and cost-effectiveness.
09

Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Malaria / Drug
SJ733

Development Stage: Phase II Clinical Trial
Country: Peru

Malaria is an infectious disease that kills an estimated 620,000 people annually,
despite the fact that it is preventable and treatable. The emergence of resistance to theinsecticides and antimalarials used in endemic countries is a major concern, and weare aiming to develop SJ733, an ATP4 inhibitor, as a malaria treatment that is lesslikely to become resistant. In Phase Ia and Ib studies, SJ733 showed excellent safety
and good oral absorption. In the Phase IIa study, the drug was evaluated in terms of
Plasmodium vivax killing rate, minimum inhibitory concentration, the relationshipbetween pharmacokinetics and pharmacodynamics (PK/PD), and the possibility of
stopping transmission. Between March 2021 and April 2022, 22 patients participated.
SJ733 was highly effective and fast-acting against Plasmodium vivax malaria.

Malaria / Vaccine
AnAPN1Development Stage: Phase I Clinical Trial
Country: Gabon (Planned)

Malaria parasites Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) infecthumans through transmission by Anopheles mosquitoes. A “Transmission-Blocking
Vaccine” (TBV) that can block the transmission of parasites from humans tomosquitoes is therefore a very promising tool for reducing malaria infections. This
project aims to develop a universal TBV effective against both Pf and Pv by targeting
the Anopheles midgut luminal surface protein AnAPN1. Targeting a mosquito protein
receptor for Plasmodium rather than the parasite itself enables blocking of different
Plasmodium species using a single antigen. With the support of the GHIT Fund, AnAPN1
was optimized to achieve high immune responses. By administering the optimized
antigen (UF6b) to mice and monkeys, a strong transmission-blocking activity was
induced. After completion of the toxicity study of UF6b, a Phase IA/B clinical trial will
be conducted in the Republic of Gabon to evaluate safety, tolerability, andreactogenicity of the vaccine, as well as analyzing patient samples to measure theimmune response. The study protocol was reviewed and approved by the Comité
National d'Ethique pour la Recherche, Gabon in February 2023, and patient
enrollment is expected to start in June 2023. All other requirements have been
initiated and we are expecting to receive the first set of results of the clinical trial inAugust 2024 (interim report), and full analysis with the accompanying study reportwill be completed by June 2025, which are key milestones in the development of thisimportant universal malaria TBV.
10

Mycetoma / Drug
Fosravuconazole

Development Stage: Phase II Clinical Trial
Country: Sudan

Mycetoma is a chronic infection which can be transmitted through the skin and thus common
among those who walk barefoot, such as agricultural workers and herders in developing
countries, and it is particularly prevalent in Sudan. While antibiotics are effective against
bacterial mycetoma (actinomycetoma), there is currently no effective treatment for the fungal
type of mycetoma (eumycetoma). The long duration of treatment, poor efficacy and high cost,
are factors, among others, that result in poor outcome, including recurrence and amputation. Dueto development of mass and amputation of limbs, the disease has severe socio-economic
consequences including stigma. Fosravuconazole, an antifungal drug, approved in Japan foronychomycosis, was shown to have a potent in vitro activity against Madurella mycetomatis, themost common fungus that causes eumycetoma. Fosravuconazole can be administered once aweek and has favorable safety profiles. Since 2017, a Phase II clinical trial was conducted in
Sudan by DNDi, in partnership with Eisai Co., Ltd., and the Mycetoma Research Center (MRC),
Sudan. The database lock for the clinical trial was conducted in March 2022. The top-line results
were presented at the 21st Congress of the International Society for Human and Animal
Mycology (ISHAM) held in September 2022 in New Delhi, India. The clinical study report was© Purushottam Diwakar-DNDi

finalized in February 2023. An observational study is currently ongoing at the MRC to determine
the possibility of long-term recurrence of eumycetoma after initial successful treatment.

Cutaneous leishmaniasis / Drug
CpG-D35

Development Stage: Phase I Clinical Trial
Country: United Kingdom, Colombia

Leishmaniasis is one of the 20 neglected tropical diseases (NTDs) designated by the World HealthOrganization (WHO). Cutaneous leishmaniasis (CL) is the most common form of leishmaniasis. It
is prevalent mainly among the poor in developing countries, and WHO estimates that there are
between 700,000 and 1,000,000 new patients each year. Although this disease is not life
threatening, stigma and economic loss caused by disfigurement have been a problem. Currently,
limited drugs are available for the treatment of cutaneous leishmaniasis, and they all have serious
drawbacks. CpG-D35 is expected to accelerate the re-epithelialization of lesions on patients,
minimize scarring and reduce recurrence rates and the risk of drug resistance when used in
combination with chemotherapy. A single ascending dose (SAD) study, a randomized,
double-blind, placebo-controlled, single-center study with CpG-D35 administered subcutaneously
to healthy subjects, has been completed in the UK and proved the safety and tolerability of
CpG-D35 after single dose compared to a matching placebo. In addition, CpG-D35's PK and PD
after single dose were also assessed, showing that although CpG-D35 has a very short life, it
stimulates the production of several Th1 cytokines. The multiple ascending dose (MAD) study isunder preparation. It will be a randomized, open label, multiple-dose escalation study to investigate
safety, tolerability, and immunogenicity of CpG-D35 in patients with CL lesions in Colombia.
11© Sydelle Willow Smith-DNDi

Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Lymphatic filariasis,
Onchocerciasis / Drug
AWZ1066S

Development Stage: Phase I Clinical Trial
Country: United Kingdom,

Cameroon (planned)
Lymphatic filariasis and Onchocerciasis are neglected tropical diseases, affecting morethan 72 million people around the world. Existing drugs primarily act only on larvae, so
there is a need for a safe, new drug that will kill adult worms, interrupting thetransmission of long-living parasites. It has been demonstrated that the use of doxycycline
can kill adult worms by eliminating the Wolbachia mutualistic bacteria within theparasite, but its use is restricted by long-term drug supply and contraindications forchildren and pregnant women. AWZ1066S is a new drug candidate that acts on
Wolbachia mutualistic bacteria more rapidly and efficiently than doxycycline, and has
been shown to be safe in preclinical studies. Subsequently, a series of Phase I clinical
trials evaluating human safety were initiated in December 2021. Currently, an analysis of
the results of randomized, double-blind, placebo-controlled single ascending dose studyof AWZ1066S-HCL in healthy adult participants is being conducted. AWZ1066S-HCL
has potential for use by all people including children and pregnant women, and it isexpected to make a significant contribution to people and society suffering from

Photo credit: Kate Dodd

lymphatic filariasis and onchocerciasis.

Buruli Ulcer / Diagnostics
BU-MYCOLAC

Development Stage: Product Development
Country: Cameroon, Ivory Coast

Buruli ulcer is an infectious disease common in Africa, but there are reports ofinfections from over 33 countries around the world, including cases identified inAustralia and Japan. Early diagnosis and treatment are effective at preventing
after-effects such as deformity, and joint contracture, and there is a need for a simple
diagnostic method that can be conducted close to the patient. The Buruli Ulcer
pathogen produces a toxin called mycolactone, which penetrates the subcutaneous
fatty tissue and causes necrosis, resulting in the formation of deep skin ulcers. This
project aims to develop and evaluate a rapid diagnostic test for Buruli ulcer targeting
mycolactone, to enable early diagnosis for Buruli ulcer patients especially living inregions where medical care is limited. A field-ready prototype BU-MYCOLAC RDT
employing mycolactone-specific monoclonal antibodies and biotinylated mycolactone
probes in a competitive assay format, was evaluated in BU-endemic areas (Cameroon
and Cote d’Ivoire), to assess its operational characteristics, usability and initialdiagnostic performance against the reference standard IS2404 PCR. Samples were
evaluated using the IS2404 PCR, and mycolactone ELISA, and the concentrations of
mycolactone determined to inform performance of the RDT.
12

Chagas disease / Diagnostics
Chagas-LAMP

Development Stage: Product Validation
Country: Argentina, Bolivia, Paraguay

According to the Pan American Health Organization (PAHO), an estimated 1.12 million women ofchildbearing age are infected by Trypanosoma cruzi (T. cruzi), and around 9,000 infected babies
are born each year, accounting for more than 20% of all new cases of Chagas disease in the region.
Because drugs administered to T. cruzi-infected newborns in the early stages of infection arehighly efficacious, the validation of highly sensitive and specific diagnostics that allow early
diagnosis of newborns will greatly contribute to the control of this disease. However, detection ofcongenital T. cruzi infection requires either cumbersome and skilled microscopic examination ormolecular biological diagnostic methods that are not well equipped in endemic areas. A field
validation study of the prototype diagnostic kit Chagas-LAMP developed by Eiken Chemical Co.,
Ltd., is currently underway at nine maternity hospitals in Argentina, Bolivia, and Paraguay, withthe aim of providing a point-of-care (POC) test suitable for diagnosing congenital Chagas
disease. To date, more than 7,500 women have been screened and more than 630 newborns havebeen enrolled. Newborns born to mothers who test positive are being followed for several
months with liquid whole blood samples collected to compare and evaluate the Chagas-LAMP
prototype (and qPCR). In addition, we plan to evaluate Chagas-LAMP on dried blood spot

Photo credit: CONICET-INGEBI

samples from newborns. If the overall validation confirms the performance of the prototype, it
could lead to the future adoption of this technology in healthcare systems and become a gamechanger in the fight against mother-to-child transmission. The follow-up of newborns isscheduled for completion in September 2023.

Leishmaniasis / Diagnostics
Leishmanin Skin Test（LST）
Leishmaniasis is one of the Neglected Tropical Diseases (NTDs) with 350 million
people at risk of infection worldwide. The Leishmanin Skin Test (LST) had been used
for decades to verify exposure and immune response to Leishmania infection,although Leishmanin antigens used for the LST are currently unavailable. This
project aims to revive and reintroduce the LST widely used in the past. Toward the
production of Leishmanin antigens from Leishmania donovani protozoa, a protocol
was established. Some of the highlights of progress in 2022 were the completion of
the production of GMP cell bank of L. donovani, optimization of the parameters for
producing Leishmanin antigen, and validation of GLP grade Leishmanin in animalmodels.
Discussions are ongoing with WHO’ NTDs Department regarding providing
Leishmanin globally. In addition, LST may also be an effective surrogate marker for
determining the efficacy of the auspicious Leishmania vaccine currently underdevelopment.
13

Development Stage: Product Development
Country: India and in Africa (Planned)

Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Schistosomiasis / Diagnostics
SCH CAA RDT

Development Stage: Product Development
Country: Kenya, Philippines

Schistosomiasis (SCH) is one of the major neglected tropical diseases (NTDs), and the WHO
NTD roadmap calls to eliminate it as a public health problem from all SCH endemic countries
by 2030. Approximately 90% of the 220 million people who are infected reside in sub-SaharanAfrica; the disease affects the poorest and the most marginalized communities. Current WHO
guidelines for the diagnosis of SCH recommends microscopy-based methods. Whilst they areuseful in areas where moderate to high intensity infections occur, in settings where prevalence
and intensity have been driven down by mass administration campaigns, these assays become
futile due to their poor sensitivity. This project aims to develop a highly sensitive, accurate,easy-to-use and affordable SCH rapid diagnostic test (RDT), which will be able to provide
results within 20 minutes using a drop of finger-prick blood. The partners in this project haveconducted preliminary field evaluations of a prototype. Further development and optimisation
is currently underway with field evaluations expected in Q4 2023, prior to design-lock andtransfer to manufacturing. Once manufactured, validation of the RDT will be conducted, todetermine its suitability as a replacement of current microscopy-based diagnostic assays. In
parallel, the partners have developed an access strategy to bring the product to market.
Ultimately, the SCH circulating anodic antigen RDT is critical in the fight against the disease
to support the overall WHO SCH 2030 target of elimination, which can be achieved by making
better use of available treatments by directing to those communities where SCH is present.

14

Invested Partnerships in FY 2022
From Discovery to Preclinical
Malaria / Vaccine
Development of a potent Pvs230 mRNA vaccine toblock transmission of P. vivax
Ehime University, Mahidol University
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Dr. Wang Nguitragool
Mahidol University

Malaria caused by Plasmodium vivax persists for a long time because the parasite lies dormant in the liver for several months after whichtime it can cause a relapse of malaria. Because these relapses repeatedly occur even after treatment, new interventions are required,including new vaccines that block parasite transmission and reduce the population of parasite carriers in affected areas. Althoughvaccines are the most cost-effective tools to fight many infectious diseases, a malaria vaccine targeting P. vivax is still not available.
The project led by Mahidol and Ehime Universities seeks to develop new mRNA vaccines that block transmission of P. vivax.
The vaccine target is the parasite protein called Pvs230, a well-known vaccine candidate expressed during the sexual-stage
development of the parasite. The vaccine will promote powerful and long-term immunity in humans as well as induce antibodies
that block transmission of the parasite from humans to mosquitoes.
Since Pvs230 is a large protein, the project will first screen several Pvs230 fragments to identify the subdomain that induces the strongest
functional immunity. Then the project will employ both the classical linear nucleoside-modified mRNA and the team s newly developed
circular mRNA to devise the best performing vaccine construct. Vaccine efficacy will be determined by the ability of the vaccine to induce
antibodies that block transmission of the parasite from humans to mosquitoes using antibodies induced in mice by mRNA immunity.
Over the long-term, the project aims to eventually combine potent transmission-blocking vaccine with a pre-erythrocytic vaccine
in a multi-valent vaccine formulation to block transmission both from humans to mosquitoes and from mosquitos to humans.
Such a combination vaccine is expected to accelerate malaria eradication.

Malaria / Drug
Irresistible series as anti-malarial agent
Takeda Pharmaceutical Company Limited, Medicines for Malaria Venture (MMV)
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Dr. Stephen Brand
MMV

There is an urgent need to provide access to affordable medicines that prevent or treat malaria in order to reduce the number ofdeaths and eradicate the disease to every extent possible. To overcome this issue, development is continuing around the world
on new drugs for treatment of malaria that are single dose combinations with improved dosing regimen and lower cost comparedto the Standard of Care. The key is to continuously create candidates for new treatments.
MMV1579683 is an Irresistible Benzimidazole identified from a phenotypic screen of a Takeda compound library against P.
falciparum blood stages.
The GHIT Fund has invested approximately 130 million yen in this project, which seeks to create new malaria treatments
focusing on the properties of benzimidazole compounds. The project team comprising experts from Takeda Pharmaceutical
Company Limited along with synthesis chemists and biologists from MMV will optimize compound structures based on theinformation obtained from the SAR study. The objective will be to identify a lead compound that meets GHIT Fund andMMV s Early Lead criteria* in preparation for the next stage of development by assessing physiological activity,
physicochemical properties, pharmacokinetics, and toxicity, and verifying that it has sufficient physicochemical properties
suitable for oral administration and physiological activity that satisfies the criteria.
This project will contribute to new options for malaria treatments by identifying novel malaria treatment compounds withextremely attractive properties that do not induce drug resistance.
* MMV Frontrunner template: early leads
https://www.mmv.org/frontrunner-templates15

Malaria / Drug
A Hit-to-Lead study of screening hits for novel
antimalarial compounds
Shionogi & Co., Ltd., Nagasaki University, Medicines for Malaria Venture (MMV)
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Dr. Ken-ichi Matsumura
Shionogi

In recent years, healthcare practitioners and patients alike have desired highly safe and effective novel treatments against
drug-resistant malaria strains. Shionogi & Co., Ltd. and Nagasaki University are conducting joint research in the field of
infectious diseases with a focus on malaria. Through this partnership, 80,000 compounds from Shionogi s chemical library werescreened with a novel phenotypic method. With the support of Medicines for Malaria Venture (MMV), five structurally novel
hit series were identified.
The objective of this Hit-to-Lead project is to identify a novel lead series that could overcome existing drug resistance issues andsatisfy the MMV s early lead criteria* by conducting structure activity relationship (SAR) studies for these five novel hit series.
In the first six months of the project, all five hit series will be explored through the SAR studies to understand their potential forhigher potency, safety and the activity on known drug resistance strains of malaria. In the remaining 18 months, priority will begiven to series that show particular promise, as the project will continue to confirm further potency and characterization of theseries through an efficacy study in mice.
The novel hit series in this project have novel chemical structures as antimalarials and are potentially working with novel
mechanism of action, which is important to ensure the activity on drug resistant parasites. In this project, the GHIT Fund has
invested approximately 130 million yen in order to identify a novel lead series from these hit series that could help to solve theissue of drug resistant malaria strains.
* MMV Frontrunner template: early leads
https://www.mmv.org/frontrunner-templates

Lymphatic filariasis / Onchocerciasis / Drug
Phase II Clinical Development of AWZ1066S, a Small
Molecule anti-Wolbachia Candidate Macrofilaricide Drug
Eisai Co. Ltd., Liverpool School of Tropical Medicine (LSTM), University of Liverpool(UoL), University Hospital of Bonn (UKB), University of Buea (UoB)
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Prof. Stephen Ward
LSTM

Lymphatic filariasis (elephantiasis) and onchocerciasis (river blindness) are two neglected tropical diseases that are caused byparasitic worms. These diseases affect more than 72 million people globally. Existing drugs principally target the young worms,
not the adult worms. This means that sustained and prolonged delivery is required to break the transmission cycle of thelong-living adult worms.
An investment project by the GHIT Fund, which started in 2013, has already demonstrated that adult worms can be killed byeliminating Wolbachia, a symbiotic bacterium the worms contain.
The objective of this project is to further develop this drug candidate by completing a Phase II clinical trial to assess its
effectiveness in patients suffering from onchocerciasis. The project will involve completion of essential preclinical safety studies
prior to the start of the clinical trial, completion and registration of the clinical trial protocol, and completion of the Phase II trial
in line with international requirements for licensing new drugs to assess the new drugs effectiveness in patients suffering withonchocerciasis. This is an essential step in the development of a new drug and brings us closer to a new treatment for these
diseases. For this reason, the GHIT Fund has invested approximately 790 million yen in the project.

16Mycetoma / Drug
Fosravuconazole treatment in eumycetoma:
corroborating study outcomes, preparing for access
Eisai Co., Ltd. and Drugs for Neglected Diseases Initiative(DNDi)
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Dr. Borna Nyaoke
DNDi

Mycetoma is one of the most neglected tropical diseases (NTDs). It is an infectious disease that slowly destroys tissues andcauses severe damage, resulting in severe deformity and disability; as a result it also brings psychosocial consequences and maylead to stigma. Fosravuconazole is an oral azole antifungal discovered by Eisai Co., Ltd. (Eisai) , and developed by Eisai and apartner company as a treatment for onychomycosis. It has been shown to have potent in vitro activity against Madurella
mycetomatis, the most common fungus that causes eumycetoma. The first randomized clinical trial (RCT) for patients witheumycetoma conducted in Sudan demonstrated good cure rates of fosravuconazole.Based on the results of the RCT, preparations
for the application for approval of fosravuconazole in Sudan will be undertaken.
The project will also conduct a cohort study providing early access to treatment with fosravuconazole in a controlled manner,
whilst monitoring treatment outcome and patient safety. Furthermore, a strategic plan will be developed. To understand theneeds and opportunities in other endemic areas (e.g. India and Senegal), field visits and expert meetings will be organized,
followed by outlining the next steps for use of fosravuconazole as a monotherapy or potentially in combination therapy in severe
eumycetoma.
In response to the desperate need for new treatments against eumycetoma, fosravuconazole is expected to be an improvement
over existing treatments considering its once weekly administration, its favorable safety profile, and that it can be taken without
food or drink, in addition to the good cure rates shown by the recently completed RCT.

Onchocerciasis / Drug
Preclinical development of DNDI-6166 (or CC1076166)
a selective macrofilaricide for the treatment of river blindness
BoZo Research -ITR, Drugs for Neglected Diseases initiative (DNDi), The
Mahidol Oxford Tropical Medicine Research Unit, The UKB University of Bonn
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Product Development Platform

Mr. Ivan Scandale
DNDi

Onchocerciasis, also known as river blindness, is the main cause of blindness in many African countries. The disease is alsoprevalent in Latin America. The World Health Organization (WHO) s roadmap to 2030 for the control, suppression anderadication of neglected tropical diseases (NTDs) cites the need for antiparasitic drugs for onchocerciasis. This requires anintegrated approach to antiparasitic development and treating dermal NTDs. Current control strategies are based on preventive
chemotherapy programs administered to the population at risk as a whole via mass drug administration (MDA) of ivermectin.
While successful, these programs need to be repeated for 10-12 years because the drug only kills juvenile worms – not the adultworms, which can live for more than ten years in the human body. Given the shortcomings of current therapies and the high rate
at which R&D is terminated, adding novel compounds with new mechanisms of action to the pipeline is critical.
DNDI-6166 treatment has the potential to prevent specific side effects observed in patients with both onchocerciasis and loiasis
because it does not targetthe filaria larva and therefore it could be administered in regions endemic with loiasis.

Tuberculosis / Drug
Screening projectDaiichi Sankyo RD Novare Co., Ltd. and TB AllianceTarget Research Platform

17

Screening Platform

Hit-to-Lead Platform

Product Development Platform

18

Strategic Plan FY 2018-FY 2022 Results
We and our product development partners have progressed steadily toward key R&D milestones, despite the
far-reaching impact of the pandemic.
In FY 2022, the final year of the GHIT 2.0, we continued to identify and fund projects aligned withstrategic goals.

R&D: Investments in Product Development
Further leverage innovations from Japanese biopharma and academia# targetedby March2023# achievedby March
2023

Diagnostics

Lead Identification

Preclinical

5

5

8

Diagnostics identified
and funded11

Hit-to-lead programsed
Ach iev

17

Preclinical candidates
identifieded
Ach iev

14

ed
Ach iev

Our actions in FY 2018-FY 2022 to advance innovation
Strategic Partnerships• Collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to strengthen investment
portfolios and accelerate technology collaboration including vaccine platform development• Cooperation framework with Unitaid to strengthen ties to improve access to critical health tools
Over 170 product development partners• 59 domestic and 111 overseas institutions/partners participate in our product development• The GHIT Fund plays an important role as a bridge that connects Japanese innovation with overseas institutions
Proactive portfolio management• Timely risk identification and mitigation through semiannual progress report reviews and calls
Access and Delivery Strategy• Continued engagement with global stakeholders through Uniting Efforts for Innovation, Access and Delivery, a global platform
launched by the Government of Japan, the UNDP-led Access and Delivery Partnership (ADP) and the GHIT Fund

• Enhanced coordinated engagement with Access Delivery Partnership (ADP) with the Government of Japan and the19

United Nations Development Programme (UNDP)

Advance R&D investment pipeline and prioritize late-stage candidates
Phase I

Phase II 〜 Phase III

Registration

5

3

2

First in Humanclinical trial conducted

6

Proof of Concept achieved

Approved by stringent
regulatory authority

4

1

ed
Ach iev

As of March 31, 2023

GHIT Fund has a two-pronged approach in its Access Strategy: A bottom-up approach where GHIT supports
product developers in developing access strategies that ensure equitable access and affordability for
GHIT-funded products, and a top-down approach where GHIT works with other global stakeholders exploring
solutions to the systemic barriers to access. Both approaches leverage and catalyze the creation of strategic
and sustainable partnerships between innovators, product developers, funders, private sector, communities,
implementers (including governments) to ensure an end-to-end R&D ecosystem.

Isaac T. Chikwanha
Senior Director, Investment Strategy, Portfolio Development & Innovations

GHIT is in daily communication with many of our partners. With investment strategies and portfolios in
mind, we act and advance together with our partners to deliver positive results in developing the productsthat meet the unmet global health needs in a reliable and timely manner.

Minako Funakubo
Associate Director, Investment Strategy, Portfolio Development & Innovations
20

Highlights in FY 2022
Forbes Japan Joins GHIT as a New Sponsor
In May 2022, Forbes Japan (operated by linkties Co., Ltd.) concluded a sponsorshipprogram agreement to become a new sponsor of the GHIT Fund. Mr. Yutaro
Tsunoda, President of linkties Co., Ltd., said, “Many leaders across sectors whowant to make the world a better place come together on the Forbes JAPAN platform.
Delivering information on the importance of global health issues and GHIT’s workto our network will combine diverse insights in creative ways to help meet the SDGs
and facilitate cross-sector partnerships. We are delighted to collaborate with GHIT tobe part of a great force to achieve SDGs.” Forbes JAPAN's strong influence andbroad network will help Japanese people across fields and industries learn about
global health issues, great initiatives in Japan and abroad, and GHIT’s mission.
Furthermore, the GHIT looks forward to the diversity and global healthcollaborations this partnership can potentially foster.

Strengthening Collaboration with CEPI to Advance the Development of Tools
On May 18, 2022, the Coalition for Epidemic Preparedness Innovations (CEPI) and the
GHIT Fund signed a Memorandum of Understanding (MoU) which will strengthen
collaboration between the two organizations as they work to advance the development oftools to fight infectious diseases. This new collaboration will support both organizations todeliver their respective missions by enabling them to draw on each other’s comparative
strengths and areas of expertise in the field of vaccine development. The partnership also
aims to enhance vaccine and therapeutic development capabilities in Japan, furthering
Japan’s participation in global efforts to counter the threats of infectious diseases throughcompanies, universities and research institutions. The partners will now plan opportunities
for practical cooperation in more detail including strengthening both organizations’investment portfolios by jointly identifying promising vaccine development platforms andtechnologies and collaborating (to include potential co-funding or coordinated funding) on
vaccine R&D for priority pathogens and virus families of mutual interest. In October 2022,
members of CEPI’s R&D leadership team including CEO Dr. Richard Hatchett visited the
GHIT Fund to discuss future strategic platforms for vaccine development and investment.

Strengthening Collaboration with Unitaid to Improve Access to Critical Health Tools
In February 2023, the GHIT Fund and global health agency Unitaid signed acooperation framework that aims to strengthen collaboration between the two
agencies to increase cooperation between the Japanese research and development
industry and the broader global health response. This partnership will focus on
tackling complex challenges such as emerging drug resistance in tuberculosis (TB)
and malaria and shifting patterns of vector-borne diseases due to climate change. By
reinforcing links between the GHIT Fund’s research and development pipeline andUnitaid’s expertise in product introduction and access, the framework will further
efforts to connect partners and ideas dealing with topics of health innovation, access,and scale. The agreement unites the two agencies at a broad strategic level andcreates a channel for continuous collaboration, scanning the innovation pipeline forlate-stage products that address the most pressing global health needs. This work willfurther efforts to ensure that vulnerable and underserved populations have access tobetter health products and support progress toward universal health coverage.

21

World NTD Day: United with Partners
The World Health Organization (WHO) has designated January 30 as World
Neglected Tropical Diseases (NTD) Day. In 2023, the GHIT Fund and its partners inJapan held an online seminar called Roadmap to Achieve the 2030 SDGs andControl NTDs. On the day of the event, close to 200 people participated online. The
GHIT Fund’s CEO Osamu Kunii said, “The key to success is partnership. The GHIT
Fund would like to unite in partnership with the NTDs community to accelerate
research and development.” Additionally, valuable presentations were made byglobal organizations, the Government of Japan, academia, and NTD patients on thecurrent state of NTDs and expectations for future actions. Participants were united inlaunching preparations from Japan for worldwide action on NTDs ahead of the G7
Hiroshima Summit.

Public Seminar: Game Changers-Japanese Innovation in Combatting Infectious Diseases
On the occasion of the executive director of the Global Fund, Peter Sands, visit to Japan,
the GHIT Fund together with The Friends of the Global Fund, Japan (FGFJ) jointly heldan event called Game Changers-Japanese Innovation in Combatting Infectious Diseases
on March 1, 2023 using a hybrid online and in-person format. At the event, Mr. Sands
talked about the technological innovation required to overcome barriers on the frontlineof the fight against infectious diseases and shared his expectations that there are many
areas where new Japanese technologies and products can contribute.
At the panel discussion called Deploying Game-Changing Innovation on the Groundmoderated by the GHIT Fund’s CEO Osamu Kunii, Yoshihiro Okada of FUJIFILM
Corporation (General Manager, In Vitro Diagnostics Division) talked about the Rapid
Diagnostic Test for Tuberculosis and other programs fighting tuberculosis, while
Masanori Kawasaki of Otsuka Pharmaceutical Co., Ltd. (Global Project Leader,Anti-Tuberculosis Project, Pharmaceutical Division) explained the company’s initiatives
to develop an anti-tuberculosis drug. The panel held meaningful discussions on
accelerating drug development and speeding up approvals for patients in need.

We leverage Japanese innovation and fight neglecteddiseases through partnerships.

Members of the GHIT Fund
22

Dialogue: Reflections on GHIT’s catalytic role
In January 2023, the GHIT Fund’s Selection Committee (SC) met in person for the first time in three years. This welcome
reunion, overlapping with the institution’s 10th anniversary, sparked meaningful reflection on the GHIT Fund’s evolution
and achievements, as well as expectations for the future. The GHIT Fund’s Hayato Urabe sat down with SC Co-Chairs
Naoto Uemura and Ann Mills-Duggan to capture these reflections and thoughts, specifically exploring the Fund’s key
differentiators, its role in helping develop global health R&D talent, and its evolution over the past 10 years.
Urabe: What do you see as GHIT’s key

led to a significant portfolio of projects,

differentiators as an institution?

but it has also created a model for how

Mills-Duggan: The format of theencouraging to see.

other organizations and countries can

Uemura: GHIT is a vital organization,

tackle the fight against NTDs.

that, while led by Japan, represents apartnership that underpins GHIT is key,

truly international team of scientists

and it has been a catalyst for global

The variety of therapeutic-style projects

and investors. The innovative tools

health R&D partnership in other

we’ve seen come to GHIT amazes me.

we have helped catalyze and develop

countries. Japan, with its leading role in

GHIT’s investments in R&D ranges

over the past 10 years owe a great

global health, led the development offrom identifying novel targets,deal to the international nature ofthis new kind of partnership between

screening novel compounds, optimizing

GHIT’s public-private partnershipgovernment, pharmaceuticallead compounds to developing products

structure. And conversely, thatcompanies, and charitable foundations

tested in local clinical trials nearing

structure will make the products weworking together in a way that hadn’tlicensure. This broad spectrum ishelp develop in the future all the morebeen seen before. And this has not only

absolutely fascinating and reallypowerful and impactful. Japan’sability to nurture and lead such a teamand its cross-border collaboration is a
big part of GHIT’s contribution to theneglected disease field.
Urabe: What is unique about thecollaboration that GHIT supports
between Japan and overseas partners?
Uemura: In my experience, academic
research institutions and departments

Naoto Uemura, MD, PhD (Professor, Department of Clinical Pharmacology and Therapeutics Oita University
Faculty of Medicine)23

within pharmaceutical companies canoften be rather insular. While oneExternal Reviewers, and these groups
need to continue to grow, both to keep
perspective fresh and energized, butalso to meet growing demand. It would
be interesting to facilitate more ongoing
dialogue (and deeply leveragecollective expertise) among the
researchers, Selection Committee
members, and the management team(outside regular meetings) to cometogether around R&D process

Ann Mills-Duggan, PhD (Independent Consultant)challenges. The collective expertise ofparticular area of research may besenior member of a research team,

unique and cutting edge, its practicaland that senior person would answer

potential will often remain unrealized

all the questions. Now, more andMills-Duggan: During these first 10

without collaboration. GHIT creates

more proposals are being presented

years there have been a lot ofmany opportunities by supportingby younger members of the team whoachievements. GHIT now has a large

collaboration between academic

participate actively during theportfolio of projects—a lot of them ininstitutions in Japan and around theinterview.

clinical trials. We’re very close tothese groups is astounding.

getting our first drug onto the market. I

world.
Uemura: GHIT certainly plays a role inlook forward to seeing that portfolio

Mills-Duggan: The fact that Japan’s

helping Japanese researchers frame

fulfill its promise, especially in areas

pharmaceutical companies, academia,

projects differently than they may be

where no other tools or innovation are

and research institutes are all willing toused to - with a clear, simple question

available. It will be game-changing to

put forward their research and findings

to answer or problem to solve, and solidbring one of those projects to patients.

towards GHIT-funded projects—andhypotheses to structure the research. Sothat we are able to source the science

many proposals we review arefrom this amazing pool of research

unnecessarily complex; manyoccurring across multiple different

researchers (especially in Japan) are notkinds of institutions in Japan—is alsotaught to frame their approach more

an incredible strength.

succinctly, and that kind of education
may be needed in the future.

Urabe: How has GHIT helped develop
global health research talent?

Urabe: What are your hopes andexpectations for GHIT 3.0?

Mills-Duggan: The cross-border

Hayato Urabe, PhD, MPIA (Senior Director,
Investment Strategy, Portfolio Development &Innovations)partnerships that GHIT facilitates takes

Uemura: I think GHIT can go muchresearchers out of their comfort zones

further in raising awareness among

and challenges teams to do and think

Japanese and foreign global health

GHIT has evolved significantly. It is

about things in new ways. This not only

researchers about the incredible

different and bigger than when it firstbrings the basic building blocks ofopportunity it provides. We have astarted out. We are now taking accountscientific projects together more

solid group of wonderfulof things like access, where we’reinnovatively, but it also benefits thedevelopment partners, but we needpaving the way by helping research

product development team members

to get the word out to potential newteams to actually think about what

and the broader scientific environment.

partners and grow that community.

needs to come next, what needs tohappen. Let’s keep evolving as the

When I first came on board, proposals

Additionally, GHIT has built a fantastic

portfolio progresses, while maintaining

would generally be presented by a

Selection Committee and group of

our core strengths.

24

Finances
FY 2022 Financial Summary
Balance Sheet
Assets (in millions)

JPY

USD

Current Assets
Fixed Assets

73.5
5,530.2

0.6
41.4

Total Assets

5,603.7

42.0

Liabilities (in millions)

JPY

USD

Current Liabilities
Non-current Liabilities

66.5
1.0

0.5
0.0

Total Liabilities

67.5

0.5

Net Assets (in millions)

JPY

USD

Designated Net Assets
General Net Assets

5,536.2-

41.5-

Total Net Assets
Total Liabilities and Net Assets

5,536.2
5,603.7

41.5
42.0

The US dollar amounts in this section represent translations of Japanese yen, solely for the reader’s convenience, at JPY133.54 = USD1, the exchange
rate as of March 31, 2023.
This financial summary is an excerpt from the GHIT Fund's audited financial statements, which are audited by Ernst & Young ShinNihon LLC.. The GHIT
Fund is a Pubic Interest Incorporated Association and is registered in Japan. The GHIT Fund also received in-kind support from its sponsors.

Our Funding Partners & Sponsors
Full Partners

PublicFull Partners

25

PrivateNet Assets Variation Statement
Change in General Net Assets (in millions)
Ordinary Income

JPY

USD

Grants Received
Contribution Received
Exchange Gain
Misc. Income

3,002.0
519.5
44.3
1.6

22.5
3.9
0.3
0.0

Total Ordinary Income

3,567.4

26.7

Operating Expenses
Management Expenses

3,424.0
143.4

25.6
1.1

Total Ordinary Expenses

3,567.4

26.7

Extraordinary Loss

0.1

0.0

Total Extraordinary Loss

0.1

0.0

Change in Designated Net Assets (in millions)

JPY

USD

Grants Received and Others
Governments, NGOs, Multilateral Organizations
Foundations
Contributions Received

776.0
1,157.4
829.4

5.8
8.7
6.2

Total Grants and Contributions Received

2,762.8

20.7

Ordinary Expenses

Extraordinary Loss

Full Partners

Associate Partners

Affiliate Partners

Sponsors

As of March 31, 2023
26

LeadershipCouncilComposed of representatives of the Japanese government, global foundations and private companies which contribute funding, GHIT's Council votes on important affairs, such as theelection and dismissal of governors, amendments to the articles of incorporation, and the approval of financial statements.

Takeshi Akahori

Eiji Hinoshita, MD, Ph.D, MSc.

Trevor Mundel, MD, PhD

Cheryl Moore

Astellas Pharma Inc.

Chugai Pharmaceutical Co., Ltd.

Chief Research Programmes Officer
Wellcome

Kenji Yasukawa
Representative Director,
Chairman of the Board

Osamu Okuda, PhD
Representative Director, President & CEO

Daiichi Sankyo
Company, Limited

Eisai Co., Ltd.

Shionogi & Co., Ltd.

Haruo Naito
Representative Corporate Officer
and CEO

Isao Teshirogi, PhD
Representative Director,
President and CEO

Ambassador, Director-General for
Global Issues Ministry of Foreign Affairs

Sunao Manabe, Ph.D
Representative Director,
Executive Chairperson & CEO

Assistant Minister for Global Health and Welfare
Ministry of Health, Labour and Welfare

President, Global HealthBill & Melinda Gates Foundation

Takeda Pharmaceutical
Company Limited
Christophe Weber
Representative Director
President and CEO

Board of Directors
Composed of global health and management experts, GHIT's Board of Directors oversees the work of the leadership team and votes on important affairs related to business management,such as the approval of important regulations, mid-term strategies, annual plans, budgets, and investment opportunities.

Chair & Representative Director

Vice Chair

Executive Director

Professor of Global Health, London School ofHygiene & Tropical Medicine
Special Advisor on COVID-19 to the Presidentof the European Commission

CEO, GHIT FundHiroki Nakatani, MD, PhD, MHPEd

Peter Piot, MD, PhD

Mahima Datla

Satoshi Ezoe, MD, MPH, MPA, PhD

Daikichi Momma

Ann M. Veneman, JD

Vice Chairman
Institute for International Economic Studies

Former Executive Director, UNICEF
Former Secretary
United States Department of Agriculture

Visiting Professor
Keio University School of Medicine

Managing Director
Biological E. Limited

Supervisory Board Member

Saori Nakamura

Attorney at Law
Hirayama Nagareya Shirai Law OfficeDirector, Global Health Policy DivisionInternational Cooperation Bureau
Ministry of Foreign Affairs

Supervisory Board Member

Ko-Yung Tung, JD

Lecturer on Law, Harvard Law School,
Former Senior Vice President
and General Counsel, World BankEx-Officio

Richard Seabrook, PhD, MBA

Independent Senior Advisor, Innovations,
Wellcome CEO 360Biomedical Ltd
Royal Society Entrepreneur in Residence University of Bristol

27

Osamu Kunii, MD, PhD, MPH

Tetsuya Itani

Director
Office of Global Health Cooperation
Ministry of Health, Labour and Welfare

Supervisory Board Member

Hikaru Ishiguro, LLM
Statutory Auditor
INSPiRE Corporation

Ex-Officio

Katey Einterz Owen, PhD

Director, Neglected Tropical Diseases
Pharmaceutical Industry Leadership
Engagement
Bill & Melinda Gates Foundation

Selection Committee
Composed of domestic and foreign experts with a wealth of knowledge and experience in R&D of therapeutic agents, vaccines, and diagnostic agents, the Selection Committee (SC)examines and evaluates applications and progress reports from program applicants and recommends investment opportunities to the Board of Directors. To avoid any conflict of interest
between our backers and development partners, the SC does not include private sector representatives.

Co-Chair

Co-ChairSophie Allauzen, PhD

Ann Mills-Duggan, PhD

Naoto Uemura, MD, PhD

Ralf Clemens, MD, PhD

Ken Duncan, PhD

Ken Ishii, MD, PhD

Timothy Jinks, PhD

Hiroo Koyama, PhD

Karen L. Menge, PhD

Gerd Michel, PhD

Dennis Schmatz, PhD

Anna-Karin Tidén, PhD, MRSC

Independent Consultant

Independent Vaccine Expert

Head, Infectious Diseases Interventions
Wellcome

Independent Consultant

Professor, Department of ClinicalPharmacology and Therapeutics
Oita University Faculty of Medicine

Deputy Director
Discovery & Translational Sciences
Bill & Melinda Gates Foundation

Platform Unit Leader
Drug Discovery Chemistry Platform Unit
RIKEN Center for Sustainable Resource Science

Former Vice President of R&D,
Merck Research Labs, USA
Former Site Head - Merck ResearchLabs, Japan

Independent Diagnostic Expert

Professor, Institute of Medical Science
University of Tokyo

Independent Consultant

Independent Medicinal Chemistry Expert

Rieko Yajima, PhD

Director, Drug Discovery Innovation
SPARK Program in Translational Research
Stanford University School of Medicine

Leadership TeamThe leadership team facilitates the development of business, investment, and organizational growth strategies, executes strategies based on the approval of the Board of Directors, andimplements administrative tasks.

Osamu Kunii, MD, PhD, MPH

Kio Yamabe, MBA

Kei Katsuno, MD, MPH

Eriko Mugitani

Kazue Seki

Miho Takazawa, MBACEO

Associate Director,
Brand Communications

COO

Director, External Affairs &Corporate Development

Senior Director, Investment Strategy
Business Development

Senior Director, Finance & Operations

Hayato Urabe, PhD, MPIA
Senior Director, Investment Strategy
Portfolio Development & Innovations

As of April 1, 2023
28

Funding Partners & Sponsors
Support from our generous funding partners and sponsors helps GHIT’s investments and operations advance and create meaningful impact.

Full Partners

Associate Partners

Affiliate Partners

Sponsors

As of March 31, 2023
29

Fight Neglected Diseases through Partnerships

Overview
Name

Global Health Innovative Technology Fund (GHIT Fund)

AddressArk Hills Sengokuyama Mori Tower 25F, 1-9-10 Roppongi, Minato-ku, Tokyo 106-0032
TEL：+81-36441-2032

FAX：+81-36441-2031

Launched

November 6, 2012 (Operations started in April 2013)

Chair & Representative
Director

Hiroki Nakatani

CEO & Executive
Director

Osamu Kunii

Activities

1. Facilitation of global R&D partnerships for the discovery and developmentof new health technologies for the developing world
2. Investment in these global R&D partnerships through a grant-making mechanism
3. Advancement of Japan’s contribution to global health

Websitehttps://www.ghitfund.org/en

30

Global Health Innovative Technology FundArk Hills Sengokuyama Mori Tower 25F, 1-9-10 Roppongi, Minato-ku, Tokyo 106-0032, Japan

TEL: +81-36441-2032 FAX: +81-36441-2031