Pharmaceutical business
Overview
JT is committed to the research and development of world-class, innovative drugs.
We operate the pharmaceutical business based on our Purpose, “Respecting science, technology
and people, we will contribute to patients’ lives.”
As this business has a direct impact on human health and life, we not only strictly comply with alllaws, regulations, and industry standards, but are also guided by a strong sense of ethics andresponsibility. This is particularly the case in areas such as clinical trials and promoting drugs, aswell as animal experiments and managing chemical substances.
JT concentrates on R&D, while Torii Pharmaceutical Co., Ltd. is in charge of sales and promotion in
the Japanese domestic market.
Note: Regarding manufacturing, we outsource the entire process of manufacturing operations tocontracted factories. Outside of Japan, we do not have a sales function, but we do license drugs toother pharmaceutical manufacturers.

Our pharmaceutical business value chain** This diagram represents the value chain of products developed by JT, and sold and promoted by Torii
Pharmaceutical.

Pharmaceutical business sustainability strategyWe operate the pharmaceutical business based on our Purpose, “Respecting science, technology
and people, we will contribute to patients’ lives.” In 2019, we selected the three focus areas below
and set five specific targets for these focus areas.

Focus areas

Products and services

PeopleAspirational goals

We will create innovative, original drugs to support patients in the shortest timepossible.

We will strive to nurture talent development which enables us to create first-inclass (FIC) drugs.

Product safety andWe will strictly comply with all relevant laws, regulations, and industry standards

responsibility

in order to deliver safe drugs to patients.

Our pharmaceutical business is working towards five specific targets in order to meet
the JT Group sustainability strategy.
Respecting human rights
Investing in people
Improving our social impact
Environment

Pharmaceuticals andsustainability
We operate the pharmaceutical businessbased on our Purpose, “Respecting science,technology and people, we will contribute topatients’ lives.”
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Pharmaceuticals

Pharmaceuticals

Information byand sustainability

businesssegment pharmaceuticalbusiness-Copyright© Japan Tobacco Inc. All rights reserved.

Pharmaceuticals andsustainability
Educating

EthicalQuality

Promotion

Transparen

employees

integrity

assuranceof drugs

cyEducating employees
We strictly adhere to specific processes toensure that our pharmaceutical businessactivities are always carried out in a
responsible and appropriate way. We provide
e-learning to help employees understand theimportance of drug safety and quality
assurance. All of the employees in ourpharmaceutical business complete a
mandatory e-learning course every year.
Employees based at JT’s Central Pharmaceutical Research Institute regularly attend educational
programs in areas such as animal experiments, the ethics of research on human tissue samples,managing chemical substances, and environmental management. This helps to keep their skills andknowledge up-to-date.

R&D that ensures ethical integrity
Our research activities are carried out in an ethical manner and comply with all relevant laws,regulations, and industry standards.
We have established in-house regulations on animal experiments based on government legislation.
Our Institutional Animal Care and Use Committee ensures that we follow the ‘3R’ concept: Replacing
laboratory animals with other research materials where possible; Reducing the number of animals
used; and Refining experiments to prevent animals from suffering unnecessary pain and distress.

We carry out periodic in-house inspections and assessments to ensure that we comply withregulations. Our practices are accredited by the Japan Pharmaceutical Information Center.
When utilizing human tissue samples, our Ethical Review Committee, which follows the relevantJapanese guidelines and consists of both internal and external members, examines the ethicaljustification and scientific validity of the research.
We have built a chemical management system that manages every process centrally, from themoment we take delivery of the chemicals through to their storage, use, and eventual disposal. Thissystem allows us to manage the quantity of chemical substances and adhere to the latest
regulatory and safety information. Our employees undergo regular training on chemical safety risks
so that they know how to handle chemicals in an appropriate manner.
Torii Pharmaceutical separates chemicals into categories requiring different levels of management,
and has specific rules and procedures according to the characteristics and safety risks of eachcategory of chemicals.
We publish quarterly clinical development status updates on our website. In 2022, we spent 29.8
billion Yen on our R&D activities.

Quality assurance in the production of pharmaceuticalproducts
We have developed our own guidelines on
how to conduct annual inspections to ensurethat our production methods fully comply
with government recommendations. We
started annual inspections in accordancewith these guidelines in 2017. Since 2018,
we have been operating inspections at all ofour contracted factories.

Responsible promotion of drugs
We have our own standard on the ethical promotion of prescription drugs, based on the guidelines
on sales information provision activities by the Ministry of Health, Labour and Welfare.
Medical Representatives of our subsidiary company Torii Pharmaceutical Co., Ltd. provide andgather information on pharmaceutical drugs to/from medical professionals appropriately, andregularly participate in training programs to ensure adherence to these guidelines. Through internal
communication, we provide relevant and detailed information to our Medical Representatives tokeep them up to date with the latest guidelines. Furthermore, after completing their initial training,
all Medical Representatives take a mandatory e-learning course once a month.
We also conduct training sessions, which include case studies of violations that have occurred inJapan and important points to consider when providing lectures for medical professionals.

Transparency of partnerships
In order to develop more effective drugs, we build partnerships with research institutes, universities,
and medical institutions. When we make financial contributions to our partners, we strive to ensuretransparency by disclosing these payments on our website.

Case study

Case study

For the Patients Project
We have an internal educational activity to foster employees’ ethical awareness and sense ofresponsibility towards saving patients.
We offer this program continuously, both internally and externally, by engaging in dialogue withmedical experts. Every year, around 10 employees participate in this program as a facilitator andlearn more about patients’ medical needs. Their knowledge and findings are then shared across ourbusiness operations through reporting sessions and/or internal communication.

Case study

Patient input informs clinical development patient-centricity*1
As part of our ongoing clinical development efforts, and in the spirit of continuously improving thepatient experience, we gathered input from patients in the form of a ‘patient’s voice’ program.
(1) Interactive communications
We conducted a satisfaction survey for patients and the CRC (Clinical Research Coordinator) withthe aim of creating an informed consent form template to ensure that participants would fully
understand the content of the clinical trial*2. We then reported the survey results at the 22ndConference on CRC and Clinical Trials 2022. We took the opportunity to gather helpful feedback
from medical and pharmaceutical experts attending the conference.

(2) Key developments in 2022■

We encouraged our department to adopt a patient-centric approach and shared related
information internally.

■

We send a thank-you letter to clinical trial participants.

■

We set up opportunities for patients from our target groups to tell us about their difficulties withdisease and what they expect from the new drugs.

We want our clinical trials to be developed in line with patient feedback; this will make it easier andmore satisfactory for patients who are interested in clinical trials to confidently take part.

*1 Read more about patient-centricity (patient-focused drug development) on the FDA website.

*2 Tests performed on humans at the final stage of pharmaceutical development in order to collect and/or
assess data concerning the results of a clinical study, including data on efficacy and safety. Humanclinical trials are mandatory for “candidate drugs” to be approved by governments.

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