GHIT 3.0 Strategic Plan
FY2023-FY2027

VISION
Our vision is a world free ofneglected infectious diseases that affect over a billion
people with the aim of achieving health equity.

MISSION
We leverage Japanese innovation andleadership to fight against neglected infectious diseases
through investing in research anddevelopment and promoting global partnerships.

Message from CEO and Chair
Celebrating 10 Years Since Our Founding

international organization that promotes innovation and productdevelopment for neglected diseases prevalent mainly in low andIn 2023, the Global Health Innovative Technology Fund (GHIT

middle-income countries.

Fund) celebrates its 10th anniversary. We are grateful to ourfunding partners and sponsors for their support andDeveloping new medicines is no easy task, requiring an average ofcollaboration over the past decade, to our product development

over ten years of painstaking effort and tens of billions of yen topartners for their passion and tireless efforts in the fight against

develop a single medicine. But the time and investment are worth

neglected infectious diseases, and to the global healthit. GHIT’s projects, which have been created and nurtured over thecommunity for its solidarity and partnership.

past decade, are about to bear fruit. By delivering the therapeutics,
vaccines and diagnostics that result from our development

The concept of the GHIT Fund was born from notes written on apartnerships to sick patients as quickly as possible, we will save

paper napkin by the late Dr. Tachi Yamada and GHIT’s founding

countless lives and prevent untold suffering and stigma from theCEO, Dr. BT Slingsby, in 2013. Since then, we have been fighting

complications of neglected diseases.

neglected diseases in low and middle-income countries byconnecting ideas, people, and innovations from around the world.

At the GHIT Fund, we will continue to promote innovation andIn our experience, passion and vision are more powerful tools thanR&D from Japan and fight neglected infectious diseases throughmost may realize. Each new drug in development or nearing

global partnerships. We remain steadfast in our mission to reduce

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

the suffering caused by neglected infectious diseases that afflict
more than a billion people, in support of a healthy world for all.

Cumulative investments over the past 10 years have totaled

We leap into this work together with you, as partners.

approximately 30 billion yen, supporting more than 100 R&Dprojects. More than 50 projects are currently underway, of which

We look forward to your continued support and cooperation.

12 are in clinical development. As of April 1, 2023, GHIT’s
family of active Japanese and global partners is 170-strong, allsupporting our mission to connect Japanese pharmaceuticalcompanies and universities with global partner institutions toaccelerate global health innovation.

GHIT 3.0 Strategic Plan
In our third phase of operations (FY2023 – FY2027), we willcontinue to promote the development of therapeutics, vaccines anddiagnostics through global collaboration, aiming for greater
efficiency and acceleration of R&D than ever before. Our third
five-year plan, “GHIT 3.0”, features three strategic pillars:
Galvanize Innovation, Catalyze Partnerships and Maximize
Impact. The work under these pillars reinforces our role as anOsamu Kunii

Hiroki Nakatani

CEO and Executive Director

Board Chair & Representative Director

2023.5Value of the GHIT FundJapanese Innovation

Global Partnership

Support Globalization

Improving global health byidentifying and investing inJapanese innovation

Facilitating cross-border &cross-sector partnership toaccelerate product development

Advancing the Globalization ofJapan's pharmaceutical industry andreinforcing ESG management

GHIT Product Development Partners
JapaneseOrganizations

59

Non-Japanese
Organizations

111■ = Clinical Candidates and GHIT Partners
As of April 1, 2023

2023.8Investment Scope
Malaria

247 million 619,000
Infected in 2021

Deaths in 2021

Malaria is caused by a parasite called Plasmodium and istransmitted to humans through the bite of a female Anopheles
mosquito carrying this parasite. There are five types of parasites
which cause malaria in humans, and among these, the Plasmodium
falciparum and the Plasmodium vivax have become a threat.

Tuberculosis

10.6 million 1.6 million
Infected in 2021

Deaths in 2021

Tuberculosis (TB) is one of the 10 leading causes of deathglobally. It is caused by bacteria (Mycobacterium tuberculosis),which most often show symptoms in the lungs, and spread throughairborne transmission. TB is the leading cause of death among
HIV-positive people. Multidrug-resistant TB (MDR-TB) also
remains a public health crisis and a threat to health security.

Neglected TropicalDiseases: NTDs

1.6 billion

Infected in 2021

Buruli ulcer

Chagas disease(Americantrypanosomiasis)

Dengue fever

Echinococcosis

Leishmaniasis

Lymphatic filariasis(elephantiasis)

Mycetoma

Onchoserciasis(river blindness)

Schistosomiasis(bilharziasis)

Soil-transmitted
helminthiases(intestinal parasitic worms)

Dracunculiasis(guinea-wormdiseases)

Foodborne
trematode
infections

Human African
trypanosomiasis(sleeping sickness)

Leprosy

RabiesscabiesSnakebite envenoming

Cysticercosis

Endemic
treponematoses(including yaws)

Neglected Tropical Diseases (NTDs)– a group of 20
communicable diseases prevalent in tropical and subtropicalconditions in approximately 150 countries – affect more than one
billion people and cost developing economies billions of dollars
every year. Populations living in poverty, without adequate
sanitation, and in close contact with infectious vectors, domestic
animals, and livestock are those worst affected.

Trachoma

Source：World Health Organization (WHO) https://www.who.int/news/item/30-01-2023-morecountrieseliminate-neglected-tropical-diseases-but-investments-key-to-sustain-progress

2023.5Strategic Plan FY2018-FY2022
Advancement of Investments in R&D and Product Development
Objective

Leverage
innovations fromJapanese biopharma
and academia

Advance R&D
investment pipeline andprioritize late-stage
candidates

R&D milestone

Targeted byMarch 2023

Achieved byMarch 2023

Diagnostics

Innovative diagnostics
technologies identified
and funded

511ed
Ach iev

Lead Identification

Hit-to-lead programs
funded517ed
Ach iev

PreclinicalPreclinical candidatesidentified

814ed
Ach iev

Phase IFirst-in-human clinical
trials conducted

56ed
Ach iev

Phase II - Phase III

Proof of concept
achieved

34ed
Ach iev

Registration

Approval from astringent regulatory
authority

2

1
As of March 31, 2023

GHIT Fund has played the pivotal role inpromoting research and development to fightneglected diseases by making most ofJapanese technology and innovation andpromoting global partnership between
academia, public and private sector.

Peter Piot, MD, PhD
Professor of Global Health,London School ofHygiene & Tropical Medicine
Special Advisor on COVID-19
to the President of theEuropean Commission

At the end of 2022, the European Medicines
Agency validated our application and started
the scientific review process for the potential
new pediatric treatment option forschistosomiasis. Having reached this milestone
after more than 10 years of intense andcollaborative work makes me very proud.

Dr. Jutta Reinhard-Rupp
Chair of the PediatricPraziquantel Consortium
Board Head of the Global
Health Institute at Merck

GHIT's achievements are not limited to promoting
research and development, but also include
contributing to the globalization and humanresource development of researchers in the field of
infectious diseases in Japan. I believe that GHIT's
unique investment in joint research between
Japanese and foreign organizations further
strengthens the research capabilities andpartnerships of Japanese research institutions.

Prof. Kiyoshi Kita
Dean, Graduate School of
Tropical Medicine and Global
Health, Nagasaki University

2023.8

GHIT 3.0 Strategic Plan
Galvanize Innovation

Accelerate Late-Stage Product Development

Strategic Plan FY2023-FY2027
Objective

R&D milestone

Leverage
innovations frombiopharma andacademia

Lead Identification

PreclinicalPhase I

Advance R&Dinvestment pipeline andprioritize late-stage
candidates

Phase II - Phase III

Registration

Targeted byMarch 2027

512633
1

Hit-to-lead-programs funded

Preclinical candidates identified

First-in-human clinical trials conducted

Proof of concept achieved

Products approved bystringent regulatory authority

Local program implementation of a productPromote Open, Collaborative R&D● Co-creation of products through international joint research and transparency in sharing findings between various
industries of academia, research institutes, pharmaceutical companies, SMEs and Japanese and international startups.

2023.8

GHIT 3.0 Strategic Plan
Maximize Impact

Optimize Portfolio

GHIT 1.0
FY2013-FY2017

GHIT 2.0
FY2018-FY2022

GHIT 3.0
FY2023-FY2027

Phase I : Creation● Establish an innovative funding mechanism to create international
public goods from Japan through public-private partnership(Japanese government × private companies × foundations).
● Launch R&D projects utilizing Japanese drug discovery
technologies and innovations.

Phase II : Growth● Advance product development pipelines through active
management of existing portfolio alongside proactive newinvestments in innovative technologies applicable to global health.
● Support access and delivery through close collaboration withinternational organizations.

Phase III : Harvest● Accelerate product development for malaria, tuberculosis and NTDs.
● Optimize portfolio and resources to maximize the investment
impact and further strengthen institutional development.
● Foster and promote domestic and international partnerships aimed
at sparking innovation.

Leverage Resources● Continue to leverage limited resources byexploring various funding mechanisms andprioritizing sustainability.

Enhance Governance and Institutional Management● Further enhance corporate governance andinstitutional development.
● Ensure organizational sustainability throughdeployment of appropriate HR management
and financial strategies.

2023.5

GHIT 3.0 Strategic Plan
Catalyze Partnerships

Create an Enabling Environment for Access & Delivery
GHIT works proactively with product development partners to help them develop robust launch strategies and establish strategic,
product-focused partnerships for appropriate, timely access and delivery of their innovations. Key considerations are illustrated below.

Access & Delivery
Regulatory

Patient

Financing

Demand Forecast

Manufacturing

Procurement &Supply Chain

Policy & Advocacy
Regulatory Harmonization, Capacity Building(UNDP-led Access and Delivery Partnership (ADP))

GHIT facilitates strategic partnerships
for Access and Delivery
Top-down approach:Create a platform for aligned
action across the innovation–access–delivery continuum.

Strengthen Strategic Partnerships,Focusing on LICs & LMICs● Continue to extend institutional presence in

Bottom-up approach:
Ensure launch strategies for GHIT-invested
clinical candidates

Demonstrate End-to-End R&D/A&D
Ecosystems● Leverage UNDP and other global networks toLICs and LMICs and explore innovations

ensure seamless connectivity betweenfrom the ground up.

innovation (R&D) and access and delivery(A&D).

2023.8

LeadershipCouncilComposed of representatives of the Japanese government, global foundations and private companies which contribute funding, GHIT's Council votes onimportant affairs, such as the election 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 OfficerWellcome

Kenji YasukawaRepresentative 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 Officerand CEO

Isao Teshirogi, PhD
Representative Director,
President and CEO

Ambassador, Assistant Minister,
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 to the President of the European
Commission on European & Global Health SecurityCEO, GHIT FundHiroki Nakatani, MD, PhD, MHPEd

Peter Piot, MD, PhD

Mahima Datla

Satoshi Ezoe, MD, MPH, MPA, PhD

Managing Director
Biological E. LimitedDirector, Global Health Strategy DivisionInternational Cooperation Bureau
Ministry of Foreign Affairs

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

Supervisory Board Member

Saori Nakamura

Attorney at Law
Hirayama Nagareya Shirai Law Office

Ex-Officio

Supervisory Board Member

Ko-Yung Tung, JD

Former Senior Vice President and GeneralCounsel, World Bank
Former Lecturer on Law, Harvard and Yale
Law Schools
International lawyer

Osamu Kunii, MD, PhD, MPH

Tetsuya ItaniDirector
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
Director, Vaccines Development
Bill & Melinda Gates Foundation

Richard Seabrook, PhD, MBA

Independent Senior Advisor, Wellcome
CEO, 360Biomedical Ltd
Sector Specialist - Expert in Residence University of Bristol

As of March 31, 2024

Leadership
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, theSelection Committee (SC) examines and evaluates applications and progress reports from program applicants and recommends investment opportunities to theBoard of Directors. To avoid any conflict of interest between our backers and development partners, the SC does not include private sector representatives.

Ken Duncan, PhD

Ken Ishii, MD, PhD

Independent Consultant

Deputy Director
Discovery & Translational Sciences
Bill & Melinda Gates Foundation

Timothy Jinks, PhD

Paul Jorgensen, BSHiroo Koyama, PhD

Karen L. Menge, PhD

Anna-Karin Tidén, PhD, MRSC

Naoto Uemura, MD, PhD

Chair

Ann Mills-Duggan, PhD

Head, Infectious Diseases Interventions
Wellcome

Independent Consultant

Independent Consultant

Independent Medicinal Chemistry Expert*Retired on March 22, 2024

Professor, Institute of Medical Science
University of Tokyo

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

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

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, and implements administrative tasks.

Osamu Kunii, MD, PhD, MPH

Eriko Mugitani

Shin Sakai

Kazue Seki

Miho Takazawa, MBA

Hayato Urabe, PhD, MPIA

CEODirector, External Affairs &Corporate Development

Associate Director,
Brand Communications

Senior Director, Finance & Operations

Associate Vice President,
Corporate Operations

Associate Vice President, Investment Strategy
Portfolio Development & Innovations

As of March 31, 2024

Funding Partners and Sponsors
GHIT Fund is a Japan-based global public-private partnership fund for global health R&D. We invest in nonprofit product development for malaria,
tuberculosis, and Neglected Tropical Diseases (NTDs). GHIT’s sponsor companies provide in-kind services or otherwise in support of GHIT’s mission.

Government

Foundation

FullPartners

FullPartners
Ministry ofForeign Affairs

Ministry of Health,Labour and Welfare

United Nations
Development Programme

Astellas Pharma Inc.

Chugai PharmaceuticalCo., Ltd.

Daiichi SankyoCo., Ltd.

Fujirebio Holdings, Inc.

Otsuka PharmaceuticalCo., Ltd.

Remedy & Company
Corporation

FUJIFILM Corporation

Kyowa Kirin Co., Ltd.

Burson Cohn &Wolfe Japan Inc.

Diligent Japan Ltd.

Salesforce
Japan Co., Ltd.

ZVC JAPAN K.K

Bill & Melinda
Gates Foundation

Wellcome

Eisai Co., Ltd.

Shionogi & Co., Ltd.

Takeda Pharmaceutical
Company Limited

Merck KGaA

Mitsubishi Tanabe
Pharma Corporation

Sumitomo
Pharma Co., Ltd.

EIKEN CHEMICAL Co., Ltd.

Forbes JAPANMori Building Co., Ltd.

Private Companies

Full
Partners

AssociatePartners

AffiliatePartners

Sponsors

Morrison &Foerster LLP

As of March 31, 2024