Corporate Profile

SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-0027 JAPANTEL +81-3-3272-0671 FAX +81-3-3278-8774
URL https://www.sekisuimedical.jp/english
2024-0089
2024.07Brand Promise

Our Vision

To create a healthy, sustainable world

Providing intelligent solutions
with science, we contributeto the realization of a healthyand sustainable world.

Our vision encapsulates what we ultimately hope to achieve through our business.
It is a long-term guiding principle for achieving our objectives.
We will realize this vision through our business, which contributes to everyone's health.

Our Mission

To provide intelligent solutions to enhance life with
science and improve the health of all people
This is the mission we must accomplish in order to realize our vision
throughout society. It is the very reason for our existence.

Our Values
To carry out our mission, we at SEKISUI Medical Group,
base our decisions and actions on the following six values.

Integrity
Integrity

Quality

Sekisui Medical aims to contribute to the realization of a healthy and sustainable world
by providing intelligent solutions with science that improve the health of people around the world.

Quality

Our company was established through the merging of the Medical Products Division of Sekisui Chemicalwith Daiichi Pure Chemicals in 2008, and has become the core company in Sekisui Chemical’s life
sciences business. In addition to consolidating and expanding our key diagnostics and pharmaceutical

Customer
Focus

1

We listen, anticipate, and address our customers’ needs.
We strive for quality and service to build a relationship of trust with our customers.

GrowthGrowthAs individuals, we embrace professional growth; as a division,
we pursue diverse opportunities to grow our business and increase its impact on healthcare.

Diversity & Inclusion

In recent years, social and consumer needs for medical care have been diversifying in line with the dramatictransformations of the global medical environment.

Our dedication to quality is our highest priority.
Accuracy, precision, and reliability inspire our customers’ confidence in us.

Customer Focus

sciences businesses here in Japan, we are accelerating our global business expansion in regions such as
North America, Europe and Asia.

We conduct business honorably, ethically, and authentically in all our professional interactions.

Diversity &Inclusion

We value and respect differences among all employees, and promote a trusting, collaborative, andproductive working environment that enables us to operate our global workplace with a sense of unity.

Our decades-long legacy of proven expertise and global synergies among our global group companies help us

Creativity & Innovation

to provide intelligent solutions.

We encourage original thinking and value the passion to learn, explore, and improve.

Creativity &Innovation

We create innovative solutions that impact the health of all people.

2

Our Business
Diagnostics BusinessPharmaceutical Sciences BusinessWe conduct manufacturing and sales for a wide range of analytical equipment including fully-automated blood

The company's three business portfolios — the Pharma & Enzymes Business Department, the Drugcoagulation analyzers, plastic vacuum blood collection tubes which are essential for clinical analysis, and clinicalDevelopment Solutions Business Department, and the SMCL Center — underpin the foundations of thediagnostic reagents with a focus on blood coagulation, lifestyle diseases, and infectious diseases. The Diagnostics

Medical field.

Business Group serves as the core business of our company. We mainly develop, manufacture and market in vitro

We contribute to improving the health and quality of life of all people by providing support for the creation ofdiagnostics for hospital laboratories and clinical test centers. As a pioneer of biochemical testing, Sekisui Medical has

new medical solutions, such as the manufacture of active pharmaceutical ingredients and pharmaceuticalalways played a leading role with regard to in vitro diagnostics for the biochemical sector. In particular, the originality

intermediates essential to drug development, the conduct of Preclinical and Clinical Study, the contract testingof the core technologies we apply in the lipids field keeps us way ahead of our competitors. The reagents we haveand the development of tests in collaboration with pharmaceutical companies and medical institutions.

developed to directly measure HDL-C and LDL-C hold a large amount of shares both in Japan and overseas.

Pharmaceuticals and Enzymes BusinessCharacteristics of Our BusinessWe contribute to the realization of a healthy and sustainable society by providing high-quality products through contract manufacturing of APIs and intermediates in compliance with GMP.

Four key areas to meet a wide rangeof needs

We have a support system that
respond swiftly to customer requests.

we have also launched a new latex reagent created by combining

Our Customer Support functions as a consultation service to provide support for

diagnostics development techniques (LTIA method) with latex technology

medical care. We see ourselves as a partner who provides laboratories withthat is based upon microparticle technology. Our product lineups focus on

reliable information and technologies. We respond to customers' requests via a

Four key areas (biochemistry, blood coagulation, diabetes, and infectious

support system that covers all aspects of testing, and includes technical support

diseases), and we aim to win the top market share in each of theseto solve any questions you may encounter when you consider using our products,

sectors. In addition, we are expanding our lineup of specialized analyzers

technical and scientific support to ensure trouble-free use, a maintenance service

in each key area. We offer a system of diagnostics and analyzers to meetfor specialized analyzers, and comprehensive support regarding diagnostics anda wide range of customer needs.

analyzers. Our maintenance service for specialized analyzers consists of a callcenter dedicated to dealing with inquiries about equipment and a maintenanceoffice. It has a system in place to respond swiftly to your queries or requests.

Our products · Our services

Contract manufacturing services for active pharmaceuticalingredients and pharmaceutical intermediates

Clinical Chemistry, Immunoassay & Diabetes

Point of Care Testing (POCT)

We offer a full lineup of reagents for

We offer easy-to-use rapid test kits anduse in automated testing equipment inreaders that swiftly indicate test results.

various fields, including lifestyle-related

Our lineup of testing reagents is also useful

diseases tests such as HDL-cholesterol,

for making quick decisions on treatment

LDL-cholesterol, and HbA1c, as well as

methods for illnesses such as heart disease,

CRP, PSA, and MMP-3.

thrombosis, sepsis, and respiratory infections.

With over 40 year's experience andtechnology, we provide diagnostic enzyme andbiopharmaceutical raw materials to the global
diagnostic and pharmaceutical companies.

In response to requests from pharmaceutical companies, we manufacture active
pharmaceutical ingredients (APIs) and intermediates in compliance with GMP for clinical
trials and commercial purposes, and supply them globally.

Drug Development Solutions Business
We utilize advanced technological capabilities to provide comprehensive support to pharmaceutical companies, academia and institutions involved in drug development.
Our products · Our services

Preclinical Study/
Clinical Study
Our products · Our services

BioPharma CDMO

As a contract research organization(CRO), we provide a wide rangeof services from preclinical toclinical stages to help optimizing
the lead compound to submission
and post-marketing surveillanceof drugs.

Preclinical Study
Exploratory
Stage

Clinical Study

Preclinical
Stage

Early Exploratory
Clinical Stage

Clinical Stage Phase
1, Phase 2, Phase 3

New Drug Application/ PostmarketingsurveillancePreclinical - New DrugApplication/
Postmarketingsurveillance

Screening Study
Synthesis of Radiolabeled Compounds
Pharmacokinetic Study
Pharmacological
Study

Radiolabeling Active Pharmaceutical Ingredients
Clinical Pharmacokinetic study
Analysis of Clinical Samples

Safety Study

Products for
Preclinical Researches
We offer a wide range of products
for preclinical researches including
hepatocytes and subcellular fractions
prepared by Xenotech. A BioIVT
Company which has over 25 years ofexperience in providing the highest
quality products.

SMCL Center
Based on the philosophy of "creating New clinical value through special clinical laboratory testing and contributing to medical and the company's business", weare actively introducing new assay technologies and new biomarkers. We will provide medical technology to improve the health and quality of life of all people,

Coagulation

Vacuum blood collection tubes

We o f f e r m e a s u r e m e n t r e a g e n t s

We offer plastic vacuum blood collection

automated analyzers for testing andtubes, as well as components such as

monitoring coagulation and fibrinolytic

serum-separating gel and blood clotting

problems.

accelerant (BCA).

from newborns to children, including those with growth disorders and dementia.
Our products · Our services

Child Health CareContract testing

As part of Child Health Care, which aims to support
healthy growth of the next generation from pregnancy
through clinical tests, we propose the contract and sale ofexpanded newborn screening tests.

We exmaine osteoporosis and rheumatism.

Screening for the mild cognitive impairment

Contract resarch
For contract research, it is possible to construct assay systems,
measurement validation, measurement of clinical specimens.

We measure dementia-related tests.

3

4

Our Strengths

Business foundation for providing
safe, secure, high-quality and innovative medical solutions1
2
3

Compliance and Assurance
System for Absolute Safety

Quality Assurance Management for All Business Units

North America

EuropeAsia

We are responsible for the management of quality assurance systems for
all the business units; Diagnostics, Pharmaceuticals and Enzymes, Drug
Development Solutions.

Diagnostics Business

Enzyme Business/Diagnostics Business

Diagnostics Business

Ensuring an Appropriate Response to the Constantly
Evolving Business Environment
We are responsible to ensure that regulatory compliance is adhered to inorder to respond appropriately to changes of applicable laws and regulations,international standards and the business environment we work in.

Production to continuously
provide high-quality products

Diagnostics BusinessPharmaceuticals and Enzymes Business

Drug Development Solutions BusinessWe ensure that global operations for our medical
devices continue to expand by satisfying registration
requirements for each market, including ISO13485
certification, and the establishment of compliancein line with regulations specified by the authorities,
including the FDA.

We ensure that our high purity pharmaceutical raw materials are globally distributed through the continuous
improvement of a GMP system required for active pharmaceutical ingredients (API) and intermediates, and theestablishment of regulatory compliance in line with theJapanese Pharmaceutical Authorities and the FDA.

We ensure that high quality studies are implemented for
global customers developing new pharmaceutical products
through the continuous improvement of a GLP system
required for contracted studies.
In addition, we will maintain a contract manufacturing systemand provide high-quality investigational medicinal drugs.

Tsukuba Plant

Tokyama Plant

Iwate Plant

The Drug Development Solutions Center

The Tsukuba Plant is certified in ISO9001, ISO13485 andprovides high-quality products to our customers. The site has
also acquired the ISO14001 (environmental management
system) certification and engages in environmental conservation
activities. In addition, we
have achieved ISO 45001(Occupational Health and
Safety Management System)
to strengthen our health andsafety.

The Tokyama Plant has built a quality management system
based on ISO 13485 certification and have established a stablesupply system by operating an integrated automated production
line from raw tube molding to final product packing of vacuum
blood collection tubes. In
addition, Sekisui Medical
has also produced columns
for diabetes testing andcomponents for various
medical devices.

The Iwate Plant was established in 1979 as a manufacturing
facility for active pharmaceutical ingredients (APIs),
intermediates, and pharmaceutical-grade amino acids.
Based on our experience through inspections by the PMDA,
FDA (USA), EDQM(Europe),and domestic/overseas
pharmaceuticalcompanies, we work
toward an optimal cGMP
system.

The Drug Development Solutions Center is a researchfacility located in Tokai-mura, Ibaraki. The Centerhas undergone GLP compliance survey by the PMDA
(Pharmaceuticals and Medical Devices Agency) and is fully
accredited by AAALAC
International (Association
for Assessment andAccreditation ofLaboratory Animal Care
International).

Clinical Chemistry, Immuno-assay,
Coagulation, Diabetes, Infectious Diseases(POCT) are the core areas of our R&D.

●

Research & Development
structure to continuously
generate new solutions

5

Compliance & Assurance Department is responsible for quality assurance, regulatory affairs, and the quality management system to ensure
the compliance with applicable laws and regulations for SEKISUI MEDICALCO.,LTD's and its group companies' worldwide business.

We are responsible for the management of quality assurance systems at all
global sites located in Japan, North America, Europe and Asia.

We are responsible for quality assurance,regulatory affairs,
and the quality management system to ensure the compliancewith applicable laws and regulations for SEKISUI MEDICAL
CO.,LTD's and its group companies' worldwide business.

In order to contribute to the realization of a healthyand sustainable world, we precisely capture current
diversified medical needs, and we will continue
to create high quality and prominent products
through R&D that make full use of our technologicalcapabilities cultivated over many years as well as
leverages our core technologies of each R&D site to
the fullest through global collaboration.

SEKISUI MEDICAL CO., LTD Compliance & Assurance Department

Quality Assurance Management at all Global Sites

Diagnostics
Business

●

●

Drug
Development
Solutions
Business●

Expansion of clinical trials using Radioisotopes.

●

Development of highly sensitive measurement technologies
utilizing molecular and immunology for the development ofpharmaceutical products.

●

Development of concentration measurement technologies
using ultrasensitive techniques to measure nucleic acids.

R&D in new areas of priority: Cancer
and Molecular Testing.
Expansion of global pipelines.

Pharmaceuticals& Fine Chemicals
Business●

Development of peptide
manufacturing technologies using
new peptide synthesis method.

Research & Development Sites

We are establishing a global product pipeline by strengthening the collaboration between our domestic and overseas development
sites. This allows us to expand the core segments of each business unit and to develop products that satisfy unmet customer needs.

Tsukuba Research Institute

Tsukuba Research Institute, Ami Research Facility

Tsukuba Research Institute, PAS Development Group

Focusing on the fields of clinical chemistry/immunoassay,
coagulation, diabetes and infectious diseases, we conduct R&D
of reagents for automated analyzers using enzyme analyticalmethods and latex immunoturbidimetric methods, as well ascolumns for diabetes testing
based on separation technology
with polymer microparticles,
and develop clinical diagnostics
products with our proprietary
technology.

Utilizing our immunoassay, molecular analysis andcell culture technologies, we development for new
biomarkers, develop IVD products using highly sensitive
immunoassays as well as point-of-care tests in the fieldof infectious diseases.

Utilizing polymerization, molding, blending and assembly
technologies, which are also all core technologies of the
Sekisui Chemical Group, we conduct R&D for vacuum
blood collection tubes and other related equipment used in
the field of pre-analytical IVD
process.

Drug Synthesis R&D Center

Pharmaceuticals Analysis Group, Tsukuba Research Institute

SEKISUI DIAGNOSTICS, LLC. Group Development Sites

We develop manufacturing techniques focused on specialty
peptides based on our proprietary peptide synthesis technology.
We also develop manufacturing
processes for investigational
drugs through the development
and implementation ofefficient synthesis methods
and purification systems for
peptides.

We develop new evaluation systems and related products
for biomarkers, etc. in the non-clinical and clinical fields ofpharmaceutical development
through the use of our pioneering
immunoassay, molecular analysis
and instrumental analysis
technologies.

We conduct R&D for IVD products in the fields of clinicalchemistry, coagulation and infectious diseases that meet theneeds of our customers in the
US and Europe. Furthermore,clinical trials are conducted inorder to introduce Japanese IVD
products to US/EU markets.

6Our Value

01
Automation allows us to contribute to efficiency in clinical setting
and quality of testing for patients

Maximizing the value ofpharmaceutical sciences
through "Diagnostics”
From pre-treatment to post-treatment monitoring.
Diagnostics using specimen in the clinical setting play an important role in theearly detection and the follow-up of treatment in various diseases such as
malignant tumors, infectious diseases, and obstetric disorders. Sekisui Medical
hopes that many people will obtain appropriate diagnoses through diagnostics
and gain the best treatment efficiency. With this in mind, we are daily efforts
towards our hopes.

For providing accurate treatment procedures
Clinical diagnostics, which are essential for pharmaceutical sciences, are performed
in various situations, including diagnosis for prevention, diagnosis of pathologicalconditions, selection of treatment policies, measurement of medication efficiencies
and prevention of deterioration during treatment, and monitoring after treatment.
Diagnostics using specimen are essential for knowing the condition of each patientand choosing the best treatment. In our business of diagnostics using specimen,
we provide automated analyzers and diagnostic reagents to clinical institutions
worldwide. Especially in the segment of the coagulation testing, we have built a

Test results may vary depending on when the test was performed, evenfor the same patient. This means that diagnostics must be absolutely
reliable to provide stable results. For approximately 30 years, Sekisui
Medical has worked for automate diagnostics by partnership with
instrument manufacturers , while producing reagents for automatedanalyzers and testing. The latest analyzer allows us to measure samples
400 times per hour, which significantly increases the measurement
efficiency, reduces burden on clinical institutions' staff, accuracy andsafety of the diagnostics have also greatly improved. For more than 20
years since their introduction, our products have helped improve theefficiency and quality of diagnostics in many clinical settings.

Meeting customer needs and creating a new value
Why have we been able to leverage our strengths in the segment of
diagnostics for coagulation? The reason is that, from the beginning of thedevelopment phase, we have always considered what performance would
be beneficial to patients and easy to use for clinical staff, and thoroughly
developed our products. Our work is not completed when we deliver
instruments and reagents to clinical institutions; the true value of our work is
tested when users use our products. We, therefore, focus on customer support
after the delivery of products and strive every day to respond to their inquiries
and consultations to respond to their questions and requests.
In 2020, we established a company-wide New Product Development Planning
Committee to cross-functionally link customer needs and opinions into thedevelopment for all products, including those in the segment of coagulation
testing.

trusted relationship with our customers and have contributed to the pharmaceuticalsciences in this segment for more than 20 years by providing analyzers and reagentsfor the measurement of coagulation factors and their breakdown products in the
blood.

Leveraging our strengths to create new value

What is a diagnostics for coagulation?
The diagnostics for coagulation, one of our strengths, is intended totheir complex molecular composition. They have a wide concentration

measure the activity of protein breakdown products in the blood andrange due to differences between patients and changes in pathologicalsubstances involved in the clotting process. It is mainly used to monitor

conditions. Since the diagnostics for coagulation is considered the firstthe presence and severity of blood clots. This diagnostics is also used tostep in understanding a patient's condition and characteristics anddetermine the condition of the body such as bleeding that does not stop

determining future treatment guidelines, analyzers and reagents are

before surgery, or to monitor therapeutic drugs.

required to provide fast and accurate results.

Among the indicators of proteins indicating thrombosis formation,
FDP and D-dimer have been considered difficult to measure due to7

Since the time when Sekisui Medical introduced automated products
20 years ago, the coagulation testing segment has evolved significantly.
Nowadays, we are required to deliver products which provide not only thefaster and more accurate test result, but also provide values that go beyond
that. We take on a variety of challenges to leverage the resources andexpertise we have accumulated so far. Our company helps to reduce theburden on clinical settings by improving the efficiency of not only the tests
themselves, but also their management. To make the results easier to obtain,
we have also released a simple desktop analyzer for medical practitioners
that can display numerical results after the blood is dripped and placed into
the analyzer. This analyzer can be used in a variety of clinical institutions
including the hospital bedside and the medical practitioner's office. In addition
to the existing diagnostics, we are working to address unmet medical needsin order to develop diagnostics that can test for rare diseases.

8

Our Value02
To detect diseases that arelife-threatening if not detected early

SMA treatment timing and motor function
NormalMotor function

Treatment at
the time of 1

Sekisui Medical has developed and marketed NeoSMAAT T/K/S, a diagnostic test kit, which
simultaneously screens for two diseases: primary immunodeficiency and spinal muscularatrophy. The overall incidence is 1:10,000 live births for primary immunodeficiency and
1:20,000 live births for spinal muscular atrophy; it is considered important to perform

Discovering invisible
diseases and creating
the smiles of tomorrow22

screening tests in the neonatal period to confirm the presence of these diseases to maximize
the effectiveness of treatment. It is no exaggeration to say, therefore, that this screening test

1

will have a significant impact on the future lives of infants and young children.

Infancy

3

3

SMA
Childhood

Adolescence

Adulthood

From Sumner CJ, et al. J Clin Invest. 2018

To achieve faster, more accurate test results SMA treatment timing and motor function

NormalFor everyon’s healthMotor function

Due to the nature of rare disease, the diagnostic tests and treatment may take longer than for other
Screening for the mild
diseases. Thus, the test results should be shown as quickly and accurately as possible. We havecognitive impairment
We measure dementiadeveloped a test method that allows testing directly from dried blood spot to successfully reduce theNo matter how medical science advance, there are still somediseases that cannot be completely treated. We believe that "every
disease should be treatable." With this in mind, Sekisui Medicalhas been working in a daily basis to increase the value of the"diagnostics" that is used in the preliminary stage of treatment,
to maximize the efficiency of treatment, and to increase thepossibility of overcoming the disease as much as possible.

Child
HealthTreatment
at Caretheselltimeof 1screeningWe
newborn(NBS) test reagents andperform contract tests.

related tests.

testing time by approximately half. At the same time, this process reduction can reduce the risk oferrors and the cost of testing. We have been able to lower the bar in terms of test accuracy and costand make this screening test available to more newborns.

2

ElderlypeopleNewborn2baby

3

1InfancyChildhood

SMCL
domainexpansion

Adolescence

3
SMA
Adulthood

From Sumner CJ, et al. J Clin Invest. 2018

Adult

Contract resarchContributing to the health of all people
and society through screening tests

Treatment begins with "Diagnostic Tests""To provide intelligent solutions to enhance life with science and improve the health of all

In Japan, newborn screening tests are performed after the birth to determine whether the newborn has had a congenital disease or not. Currently,anewborn screening test examines 20 congenital diseases, allowing newborns who are found to have the disease to receive appropriate treatment.
However, the current situation is that such rare diseases are still poorly treated. We will provide a supportive service related to child growth throughclinical diagnostics accumulated in our history. For this purpose, Sekisui Medical has developed research reagents for screening rare diseases incollaboration with the National Center for Child Health and Development. The reagents have begun to be distributed to research institutions, hospitals
and communities as diagnostics for expanded newborn screening. With our diagnostics, we can achieve early detection and treatment of rare diseases,
recovery of symptoms and prevention of serious illness, thereby saving the lives of patients who can be saved and improving their quality of life thereafter.

people" With this mission, Sekisui Medical will also contribute to the health of adults andthe elderly through screening tests in this diagnostics segment. Moreover, we will offer

Contract testing

We measure new biomarkers
For everyon’s
and reseachhealthmeasurement.

We exmaine osteoporosis
and rheumatism.

Screening for the mild
cognitive impairment

Child Health Care
We sell newborn screening(NBS) test reagents andperform contract tests.

We measure dementiarelated tests.

Elderlypeoplediagnostics that uses technology to screen for a variety of diseases including dementia,

Newbornbaby

SMCL
domainexpansionas well as one that diagnoses the therapeutic efficiency on rheumatoid arthritis andosteoporosis. Treatment begins with "Diagnostic Tests." Sekisui Medical will continue to
strive to expand the diagnostics segment and improve its efficiency so that its products
and services provide value to patients, their families and society as a whole.

Adult

Contract resarch
We measure new biomarkers
and reseach measurement.

Expanded newborn screening and Sekisui Medical services
What is an expanded newborn screening test?

Services provided by Sekisui Medical

Voices in the clinical setting

Making life the best for newborns and their families

Recently, the development of new

We currently have two proposals: contracting tests of expanded newborn

Early detection and treatment of the rare diseases targeted by the xpanded newborne screening test are important andtherapeutic agents has led to thescreening and marketing of reagents. In the contracting tests, we receive

have great significance for newborns and their families. As a clinician, I have encountered newborns whose screening

initiation of expanded newborn

requests for the tests from laboratories and perform clinical tests using thetests revealed severe immunodeficiency or lysosomal storage disease and found them to be thriving and healthy

screening tests for diseases

clinical diagnostics in our company. In the reagent marketing service, we

thereafter with the early intervention. So, I am acutely aware of the value and importance of these screening tests on afor which the prognosis can besupply our proprietary products to clinical institutions.

daily basis. I believe that the value of these tests is wide-ranging, as the results of tests are not limited to the newborn,

improved if they are detected
before the onset and treated early.

Target disease
Marketing of reagents · Contract testing •Primary immunodeficiency •Spinal muscular atrophy
Contract testing •Lysosomal storage disease(Fabry disease, Pompe disease, Gaucher disease,
Mucopolysaccharidosis types I and II, etc.)

9

Voice

Contract testing
We exmaine osteoporosis
and rheumatism.

but may also lead to health care for his/her family. But the further penetration of the screening tests into the familiesof newborns and into actual medical practice is a major challenge for the future. It is also true that there are disparities
among regions and clinical institutions that perform these tests. Accordingly, I'd like to strongly accelerate our efforts with
Sekisui Medical to promote understanding of the screening tests so that as many newborns as possible can receive them.

Department of Pediatrics,
Niigata University Medical and Dental Hospital

Dr. Hiromi Nyuzuki

10

Our Value

03
Supporting the development carried out by pharmaceuticalcompanies and raising the possibility for new drugs
The origin of our pharmaceutical development lies in the technologies that
we have developed over the years for the synthesis of amino acids and the

Delivering safe and reliable
medicines to patientsas quickly as possible
As medical needs are diversified, and different
treatments are required, the roles of medicines
have become very important and diverse.
We have responsibilities to deliver safe andreliable medicines to patients immediately.

production of optically active compounds. We have used these technologies
to transform our business into APIs manufacturing to expand the scope of ourcontributions to drug development. Currently, we have developed contract
manufacturing of active pharmaceutical ingredients (APIs) and pharmaceuticalintermediates. As a CMO, we support drug development from a manufacturing
perspective so that new medicines can reach patients quickly and safely,
helping to cure diseases and improve patients' quality of life.

Absolute security, guaranteed fast delivery
We collaborates with pharmaceutical companies to bring new medicines tomarket as quickly as possible for many patients who are waiting for them,as well as to achieve their health. Therefore, we must ensure the absolutesafety and high quality of our APIs and intermediates. In order to achievethese goals, we comply with regulations of each country, strictly adhere to
GMP-based manufacturing procedures and quality control, and pass global
inspections and audits during manufacturing.
In addition, we have established a top-class data integrity system in Japanthat is used for quality control of various APIs and intermediates. For
these electronic records, we are prepared to ensure the protection andaccessibility of accurate and complete records for a specified retention
period, and to provide high quality and security at all times.

Building a foundation for a new drug development
As medical needs have diversified with the evolution of pharmaceutical sciences, we are expected to respond to various types of disease.
Under such circumstance, the roles and expectations of medicines which protect lives are growing, there is a constant need for absolute safety,
security, and speed to deliver them as quickly as possible. Society also demands that we develop medicines with new efficacy for diseases thatcannot be treated before with conventional medicines. As a contract manufacturing organization in this pharmaceutical field, we support thefoundation to produce active pharmaceutical ingredients (APIs), which form the basis of drugs, and investigational drugs for clinical trials to support
the development of new medicines.

Meet all needs andmaximize value for patients
In order to respond to various diseases, more emphasis has beenplaced on shortening the time from R&D of drugs with new efficacies tomarketing and delivery to patients. Therefore, the CMOs must have theability to develop and manufacture in a timely manner in accordancewith the pharmaceutical company's development plan. We have many

Flow of Contract Manufacturing Organizations and Sekisui Medical's domain

R&D, manufacturing staff and a variety of equipment. In 2023, We haveincreased our production capacity to meet additional medical needs andnew contracts from customers with the addition of the intermediates

What is a Contract Manufacturing Organization?
Contract manufacturing organizations (CMOs) are companies that

manufacturing plant. We also have multiple production lines for APIs

(including investigational drugs and over-the-counter drugs). Thus,

scales from investigational to commercial manufacturing. By providing

R&D

clinicaltrial

launchLaboratory study

Investigational drug manufacturing

Commercial manufacturing

pharmaceutical companies, which incur huge costs to develop
new drugs, outsource the manufacturing process to CMOs in

conform to GMP, including investigational drugs, to meet demand at all

The Drug Development Process and the Role of CMOs

contract with pharmaceutical companies to manufacture drugs

patients

support from R&D to commercial manufacturing, We will continue torespond to customer and medical needs and contribute to the realization of
new medical solutions.

order to focus their resources on drug discovery and clinicaldevelopment. To produce pharmaceutical products, we musthave quality systems and equipment that meet manufacturing
standards called Good Manufacturing Practice (GMP).

11

Our domain•API manufacturing •Pharmaceutical intermediate manufacturing•Investigational drug manufacturing

12

Sustainability
To achieve sustainable growth, Sekisui Medical engages in sustainability activities to improve the quality of our businesswhile fulfilling our social responsibilities and creating value according to the SEKISUI CHEMICAL Group Vision.

For the global environment

the Sekisui Medical Environmental Charter
We strive to be a company that creates a healthy
environment, and that achieves sustainable growthwith 'the environment' as our cornerstone.
To achieve this goal:

Initiatives for society1) E ach one of us pays due consideration to the environment in ouractions at work.
2) E ach one of us also engages in environmentally-friendly action athome and in the local community.

Our approach to Quality
CS Quality Management
CS Quality is our management cornerstone. In all of our business activities, we seek meticulously innovations to improve product quality, and provide products
and services that live up to customer expectations. We want our customers to continue to choose us, and aim at to achieve long-term growth and sustainable
development along with our customers.

To realize a decarbonized society
Since 2012, Sekisui Medical has been working toward decarbonisation by switching boiler fuel from heavy oil to LNG,
introducing high-efficiency boilers and installing a solar power generation system at the Tsukuba Plant as an energy

Diagnostics
Business

The Tsukuba Plant has established a quality management system based on the QMS Ministerial Ordinance on Standards for Manufacturing
Control and Quality Control for Medical Devices and In-Vitro Diagnostics to supply high-quality products worldwide. We continue to holdISO 9001 certification (acquired in March 1997) and ISO 13485 certification (acquired in March 2005). In 2017 the Ami Office was added to the
Tsukuba Plant as a new manufacturing base, and we completed the update to ISO 9001:2015 and ISO 13485:2016. The Tokuyama Plant has
also established a similar quality management system based on ISO 13485 certification (in April 2005).

Pharmaceuticals
Business

Based on ministerial ordinances with regard to GMP for pharmaceuticals and medicated products, the Iwate Plant manufactures high-quality
chemicals, with a particular focus on APIs, pharmaceutical intermediates, and food additives. We are registered with the American FDA and
official bodies in the EU and elsewhere, and we ship APIs not only within Japan but also to the global market.

Drug Development
Solutions Business

The Drug Development Solutions Center has conducted Preclinical drug safety studies in accordance with the Ministerial Ordinance on Good Laboratory
Practice for Nonclinical Safety Studies of Drugs (GLP Ordinance). The Center has received a conformity of assessment/results in the survey on toxicokinetics (TK)
test by the Pharmaceuticals and Medical Devices Agency while assisting pharmaceutical companies in Japan and overseas in the development of new drugs.

creation facility. Additionally, we are actively switching to renewable energy for 100% of purchased electricity used at
the plants.
In addition, the head office and plants are cooperating to achieve zero greenhouse gas (GHG) emissions on a companywide basis. We set GHG emissions reduction target for 2030 of 50% compared with 2019 and will accomplish it byutilizing energy, upgrading to high-efficiency equipment and introducing energy
creation equipment while continuing energy-saving activities for electricity and fuel.
Meanwhile, we have established Environment Legal Leader (ELL) certification
system for enhancing knowledge and skills of the person in charge of environment
and arrange certified personnel for all plants in order to conform environment law
and prevent environment incidents.

Solar power system at Tsukuba Plant

Fuel conversion to LNG at Iwate Plant

Our Commitment to the Environment
Tsukuba Plant

13

The Tsukuba Plant is located in the Tsukuba-no-sato Industrial Park in Ryugasaki, Ibaraki Prefecture, and manufactures in vitro diagnostics alongwith reagents for research use. The Plant implements environmentally friendly measures including the use of renewable energy, the cultivationof native plant species, and the removal of introduced plant species. It acquired ISO 14001 Environmental Management System certification in
September 2011 (assessment and registration) and actively engages in efforts to protect the environment.

Ami Office

The Ami Office is located in the Fukuda Industrial Park in Ami-machi, Inashiki-gun, Ibaraki Prefecture. It manufactures in vitro diagnostics andreagents for research use. The office implements environmentally friendly initiatives, such as the energy-saving operation of its manufacturing
equipment, garbage separation and processing, and clean up campaigns. The Ami Office acquired ISO 14001 Environmental Management
System certification in May 2006 (assessment and registration) and actively engages in efforts to protect the environment.

Tokuyama Plant

The Tokuyama Plant is located in the Shunan Industrial Complex in Yamaguchi Prefecture, and manufactures vacuum blood collection tubes, diabetes
diagnosis columns, and eluents. The Plant has reduced waste and since 2000 has been maintaining a forest leased from Shunan City. In March 2000, theplant obtained the ISO 14001 environmental management system certification (assessment and registration), and is committed to environmental protection.

Iwate Plant

The Iwate Plant manufactures pharmaceutical raw materials and other products in a naturally beautiful enivronment with a view of themountains of Towada-Hachimantai National Park. The Plant strives to coexist with the irreplaceable natural environment by taking environmental
considerations into account through the use of renewable energy, the installation of LNG boilers, and the effective use of methane gas with awastewater treatment system.The Plant acquired ISO 14001 Environmental Management System certification in February 2001 (assessment andregistration) and actively engages in efforts to protect the environment.

Drug Development
Solutions Center

The Drug Development Solutions Center is located in Tokai-mura, Ibaraki Prefecture, and conduct safety studies of pharmaceuticals. The Center is involved ina number of environmental initiatives, including the installation of LNG boilers , the use of renewable energy, waste separation, the reduction of copier paper
usage, and the implementation of a clean up campaign. The center has been EA21 certified since 2011 and is currently pursuing ISO 14001 certification.

Our approach to Human Resource Development
Our approach to Human Resource Development
Based on our belief that employees are precious assets bestowed on us by society, we, SEKISUI CHEMICAL Group, are committed to developing an environment
where employees can work enthusiastically. We also offer various opportunities through which we help individual employees enhance their specialties and growpersonally through embracing challenges.
Sekisui Medical has established "Customer Focus" as one of its values to achieve the Group vision of "Creating a Healthy, Sustainable World." We launched theCustomer Focus Project in 2021, which includes activities such as discussions between sales and other sites, hands-on training at sales and production sites,
and temporary assignments to other departments. Through the project, we make the value of customer focus take root among our employees, while also allowing
them to experience firsthand helping to solve social challenges.

Deepening Engagement
SEKISUI CHEMICAL Group periodically conducts an engagement survey targeting all employees every three years. We assert that continued empathy with, andundertaking of, the Vision, as well as the feelings of individual employees that they are always the key players and that they have the determination to do theirbest and not give up until the results surpass expectations, in other words engagement, is crucial for achieving the SEKISUI CHEMICAL Group Long-term Vision,
Vision 2030.

14

Business domain

Data

Sekisui Chemical Group Business Domain

Sekisui Medical in Numbers

SEKISUI Medical Group

LIFE SCIENCER ESIDENTIAL

Support global health and longevity
with products, systems,

Providing more people with peace of mind, safety, andand services which contributecomfort, through high performance housing andto healthcare advancements.

housing-related services andTown and Community Development

Consolidated
Net Sales

Consolidated Operating Income

Sales ratio by business segment(FY2023)(FY2023)(FY2023)

92.6

11.0

billion yen

Pharmbillion yen

17.9
billion yen

Diag.JP

92.6

32.2
billion yen

billion yen

Number of Sekisui Medical
Group companies

Number of Sekisui Medical
Group Employees

Providing high-value added materials

Solving infrastructural issues and

2,276

8

1,551 (Nonconsolidated)for equipment which contributes

improving social infrastructure on a global scale(Group total)

Diag.Int

42.5
billion yen

companies

to both sustainable society and lifestyles.

with advanced materials and methods.

A D VA N C E D L I F E L I N E

I N N O VAT I V E M O B I L I T Y
Medium-term Plan
(FY2023-2025)

History

112,5

Net Sales

Operatingincomebillion yen

18billion yen

Newproducts

50

items or more

Corporate History

1947

Foundation of Daiichi Pure Chemical Co., Ltd.
Start of domestic production of in vitro diagnostic reagents.

2010 Establishment of SEKISUI Medical Technology (China)

1955

Established the first private sector radioisotope laboratory

2011

1958

Started production and sales of amino acids

2015 Established SEKISUI Medical Technology (Suzhou)

1963

Released the first ever domestically-produced
radiopharmaceuticals

1968

Started contract safety research business

Male

63

%

FemaleRatio of male and female employees taking
childcare leave

37

%

Male

62

%

Female100%

Acquired Eisai in-vitro diagnostics subsidiary EIDIA

2017

Merged SEKISUI Medical and EIDIA

a wholly owned subsidiary of SEKISUI Chemical
2006 Became
through transfer of shares owned by Daiichi Pharmaceutical2018 SEKISUI Chemical acquired Veredus Laboratories

Medical established by merging the Medical
2008 SEKISUI
Business Division of SEKISUI Chemical with Daiichi Pure

medical business from Tokuyama Sekisui Industry
2023 AcquiredCo., Ltd. and newly established Sekisui Medical Co., Ltd.

Chemicals

15

Acquired the Diagnostic Pharmaceuticals Division of Genzyme
Corporation and established SEKISUI Diagnostics

Ratio of male and female employees of
Sekisui Medical Co., Ltd.

Usage rate for annual
paid leave

74%

Ratio of remote working(head office)46%

Ratio of female managers

15%

Tokuyama Plant.

16

Domestic Network
Drug Development
Solutions Center
Sekisui Medical Creative
Laboratory Center

Pharmaceuticals & Fine
Chemicals Sales OfficeDrug Development
Solutions Sales Office

Head Office

Hokkaido Sales Office

Ami Office
Ami Office

Tsukuba Plant
Tsukuba Research Institute
Drug Synthesis R&D Center
Supply Chain Management Center

Iwate Plant

Tohoku Sales Office

East Japan Sales Office
Metropolitan Sales Office I
Metropolitan Sales Office II
Metropolitan Sales Office III

Head
OfficeUrban Net Nihonbashi 2-chome Building, Nihonbashi 2-1-3, Chuo-ku, Tokyo
103-0027 Japan

Distribution
depot

Supply Chain Management Center

Sales
Offices

Hokkaido Sales Office

Manufacturing
base

Tsukuba Plant

Sapporo Center Building 7F, Kita 5 Jonishi 6-2-2, Chuo-ku, Sapporo
060-0005 Japan

Tohoku Sales OfficeTokuyama Plant

Tokuyama Plant

TOC Ariake East Tower 8F, Ariake 3-5-7, Koto-ku, Tokyo
135-0063 Japan

Kaiseicho 4560, Shunan-shi, Yamaguchi
746-0006 Japan

Chubu Sales Office

Iwate Plant

Nagoya Itochu Building 3F, Nishiki 1-5-11, Naka-ku, Nagoya
460-0003 Japan

Matsuo 4-115, Hachimantai, Iwate
028-7305 JapanWest Japan Sales Office I‐II

Drug Development Solutions Center

Uemura Nissei Building 16F, Miyahara 3-3-31, Yodogawa-ku, Osaka
532-0003 Japan

Muramatsu 2117, Tokai-mura, Naka-gun, Ibaraki
319-1182 Japan

R&D
centerTsukuba Research Institute
Koyodai 3-3-1, Ryugasaki, Ibaraki
301-0852 Japan

Kyushu Sales Office

Ami Office

Head Office

Kyu-kan Hakata Building 2F, Hakataekimae 3-26-29, Hakata-ku, Fukuoka
812-0011 Japan

Yoshiwara 3262-12, Ami-machi, Inashiki-gun, Ibaraki
300-1155 Japan

Sales Offices

Pharmaceuticals & Fine Chemicals Sales OfficeDrug Synthesis R&D Center

Distribution depot

Urban Net Nihonbashi 2-chome Building, Nihonbashi 2-1-3, Chuo-ku, Tokyo
103-0027 Japan

Koyodai 3-3-1, Ryugasaki, Ibaraki
301-0852 Japan

Manufacturing base
R&D centerWest Japan Sales Office I
West Japan Sales Office II

Yoshiwara 3262-12, Ami-machi, Inashiki-gun, Ibaraki
300-1155 Japan

East Japan Sales Office/Metropolitan Sales Office I‐III

GRANODE Hiroshima 6F, Hutabanosato 3-5-7, Higashi-ku, Hiroshima732-0057 Japan

Kyushu Sales Office

Koyodai 3-3-1, Ryugasaki, Ibaraki
301-0852 Japan

Ami Office

Taiju Seimei Sendai Honcho Building 18F, Honcho 1-1-1, Aoba-ku, Sendai
980-0014 Japan

Chugoku & Shikoku Sales Office

Chubu Sales Office

Koyodai 3-3-1, Ryugasaki, Ibaraki
301-0852 Japan

Clinical Laboratory

Chugoku & Shikoku Sales OfficeDrug Development Solutions Sales OfficeUrban Net Nihonbashi 2-chome Building, Nihonbashi 2-1-3, Chuo-ku, Tokyo
103-0027 Japan

ClinicalLaboratory

Sekisui Medical Creative Laboratory Center
Muramatsu 2117, Tokai-mura, Naka-gun, Ibaraki
319-1182 Japan

Overseas Network
EuropeSEKISUI DIAGNOSTICS (UK) LIMITEDSEKISUI MEDICAL TECHNOLOGY (CHINA) LTD.
SEKISUI MEDICAL TECHNOLOGY (CHINA) LTD.
Beijing BranchNorth America
SEKISUI DIAGNOSTICS P.E.I. INC.

Asia
SEKISUI DIAGNOSTICS GmbHSEKISUI DIAGNOSTICS, LLC, San Diego

SEKISUI DIAGNOSTICS, LLC.
SEKISUI MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.
SEKISUI DIAGNOSTICS, LLC, Exton
SEKISUI MEDICAL TECHNOLOGY (CHINA) LTD., Shanghai BRANCHVEREDUS LABORATORIES PTE. LTD.

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