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Social Issues that JSR Group Can Help Resolve / Contributing to a Healthy and Long-Living Society and Better Access to Healthcare and Medical Care

FY :
Fiscal Year means the year starting April 1st.
For example, FY2016 means April 1, 2016 - March 31, 2017

1. Basic Philosophy

One in every three Japanese persons is expected to be over 65 years of age by 2035 (according to the survey conducted by Statistics Bureau, Ministry of Internal Affairs and Communications in September 2014). This super-aging society is already creating issues such as increased medical care expenses and elder-to-elder nursing. Extending healthy life expectancy without daily assistance or care is now an issue that our society faces. Development of personalized medicines which enhance the efficacy of therapies by matching treatment methods more precisely to the condition of the individual patient will increase healthy life expectancy in the future. Healthcare methodologies and techniques will likely change during the coming years. Examples of this shift include the development of diagnostic technologies for early detection of disease as well as advances in highly effective treatments and pharmaceuticals to treat serious diseases at early stages.
JSR Group's Life Sciences Business, which contributes to personalized medical care and other fields, is the Group's third base business, following the Petrochemical Business and Fine Chemicals Business.

2. Structure of initiatives in the Life Sciences Business

While being an active participant in medical fields where diagnoses and treatment are provided and in the manufacture of pharmaceuticals, JSR Group will develop products in the life sciences sector by paying close attention to the technologies and services that society truly needs. To do this, we will build partnerships with institutions and companies possessing knowledge, technologies, and familiarity with approvals and licenses in the medical care field that we traditionally have not had. By taking this approach, we tie JSR Group's strengths in materials to final product quality and precisely meet the expectations of end users including physicians, pharmaceuticals companies and researchers. At the same time, we are setting up systems that will respond quickly to changing needs in medical fields by building strong partnerships with the medical institutions that use final products.

Structure of initiatives in the Life Sciences Business

(as of March 31, 2017)

#1: JSR-mbl VC Life Sciences Investment Business Limited Liability Union JSR =JSR/JSR Life Sciences Corporation/ JSR Micro, Inc./JSR Micro N.V.

#2: KBI Biopharma, Inc. (KBI)
Through a joint acquisition in which JSR was the primary investor, KBI, contract development and manufacturing organization(CDMO) of bio-pharmaceuticals, became a consolidated subsidiary as of FY2015.

#3: Medical & Biological Laboratories Co., Ltd. (MBL)
MBL, previously an equity method affiliated company, became a consolidated subsidiary as of FY2015 through the purchase of a majority of shares.

#4: JSR-Keio University Medical and Chemical Innovation Center (JKiC) where is the cooperative research facility between JSR and Keio University.

#5: SCIVAX Life Science Co., Ltd. changed a company name of it to ORGANOGENIX Co., Ltd. on June 17, 2016.

As part of this, JSR Group will open JSR-Keio University Medical and Chemical Innovation Center (JKiC), a joint-research facility with Keio University, in October 2017.
Located on Keio University’s Shinanomachi Campus, which is home to the university’s School of Medicine and hospital, JKiC has three floors above ground, one basement level, and a total floor area of 3,600 m2. The first floor will have a space for social interaction, an exhibit space, meeting rooms, and an office to support industry-academia-medicine collaboration. The second and third floors will have "free address" rooms and open laboratories where JSR and Keio researchers can work side by side. Plans call for cutting-edge evaluation devices and other equipment to be installed in the basement level.
We will develop new materials and products for health and longevity and other objectives at JKiC through joint research with Keio University. Through our research there, we will aim to contribute to society and education by promoting global innovation in medicine. Specifically, we plan to promote joint research by establishing the following four areas as strategic fields.

1. Precision Medicine

- We will research and develop new diagnostic reagents that will be needed when providing care and administrating drugs tailored to individual patients.

2. Microbiome

- We will strive to clarify the roles that microorganisms present in the intestines, skin, and other parts of the body play in health maintenance and the onset of disease, and establish technologies for disease prevention and treatment.

3. Stem Cell Biology and Cell Based Medicine

- We will aim to develop methods for efficiently culturing iPS cells and other "stem cells" and technologies for controlling their differentiation into tissues and organs. We will also strive to build systems for exploring new drugs and for performance and safety evaluation without using laboratory animals.

4. Designed Medical Devices

- We will develop three-dimensional cell culture substrata, 3D-printing software, and 3D-printed medical devices based on JSR's 3D-printing technologies.

Projected sales by the Life Sciences Business

Projected sales by the Life Sciences Business

3. Fields for Development and Activities in Life Sciences Business

JSR Group's Life Sciences Business is developing operations centered on the bio-pharmaceuticals fields and advanced diagnosis field, both of which are connected with the manufacture of bio-pharmaceuticals.
In the bio-pharmaceuticals field, we are expanding KBI's contract development and manufacturing business for bio-pharmaceuticals and focusing on expanding sales of AmsphereTM A3, a carrier for antibody purification expected to see growing demand in the future.
And in the advanced diagnosis field, we are expanding sales overseas by utilizing the strengths of MBL. We will also develop innovative materials and products through joint research with Keio University's School of Medicine and Hospital at JKiC, which will open in October 2017.

Fields for Development and Activities in Life Sciences Business

(1) Companion diagnostics for personalized medical care

- JSR and MBL engaged in collaborative research to develop products for the early detection of disease -

Companion diagnostics refers to the predetermination of the effectiveness of pharmaceuticals and treatment in patients so that future diagnoses can be performed with existing knowledge of potential side effects in individual patients. This diagnostic process is a necessary part of personalized medical care that will be utilized for various purposes. For example response monitoring to optimize treatment schedules, dosages, and the timing of treatment cancellation. A typical method of performing companion diagnostics is to detect antigens (disease-related substances) that have bound themselves to antibodies*1 attached to particles.
By combining our particle manufacturing technologies (magnetic, coloring, grain size control, and high-selectivity via surface characteristics control) with MBL's various antibodies, we can develop diagnostic medicines for specific antigens. We are also conducting research with MBL to enable the early detection of disease through the isolating and detection of exosomes*2 and proteins by combining our internally developed MagnosphereTM magnetic particles for medical diagnosis*3 with MBL's antibodies. The ExoCapTM Streptavidin Kit developed by the joint JSR/MBL research team was released in June 2016. We are expanding our product lineup and supplying it to researchers throughout the world.

*1 Antibodies: Biomolecules produced by the immune system as a defensive response to eliminate foreign substances in the body. They consist of bio-derived proteins.

*2 Exosome: Vesicle released from cells and reflects the status of the derived cell. Recent research efforts have let to the detection of diseases, including cancer, by examining exosomes.

*3 MagnosphereTM: High-performance magnetic particles used to separate and obtain specific bio-derived substances. The particle surface is coated with a proprietary polymer material. This coating prevents bonding with non-specific proteins and the movement of antibodies that have attached themselves to the particle surface. These characteristics result in a product suitable for use as a carrier in diagnostic medicines.

ExoCap Streptavidin Kit Usage Concept

ExoCap Streptavidin Kit Usage Concept

(2) Bioprocess materials used for bio-pharmaceuticals

- JSR products used in manufacturing processes of bio-pharmaceuticals in therapies for cancer and other diseases -

Bio-pharmaceuticals are therapeutic drugs developed and manufactured using biotechnologies. Bio-pharmaceuticals include antibodies,* vaccines, cells and nucleic acids. Specifically, antibodies for treatment of cancer and other serious diseases are being rapidly developed and utilized as pharmaceuticals because of their high degree of effectiveness and few side effects.
Antibody drugs are manufactured by first cultured microorganisms or cells in which large amounts of antibodies are biologically synthesized. Antibodies are then collected from the culture and purified. JSR Group Life Sciences Business provides materials fluid used in the purification process. The purification of antibodies is both a technological and financial challenge. Advancement of purification technologies will reduce the cost of manufacturing, which will lead to widespread use of antibodies. This will enable the manufacturing of antibodies with new functionality.

Bioprocess materials used for bio-pharmaceuticals

JSR Life Sciences' AmsphereTM A3 is a chromatography resin used in the initial purifying process to extract necessary antibody components from culture. AmsphereTM A3 can extract and purify a larger amount of antibody efficiently than other conventional products in the marketplace can. It can also be reused with minimal degradation of performance. With a high level of mechanical strength, it can be used in higher-flow rate purification processes, which also increases efficiency. AmsphereTM A3 has been commercially available since January of 2016.
JSR Group will continue its efforts to provide solutions for antibody manufacturing processes through the expansion of our base of strategic partners. We also provide materials and devices used in the manufacturing processes for next-generation antibodies and other bio-pharmaceuticals.

Regarding use of genetic modification technologies:

As a matter of policy, JSR Group formulates internal safety management standards based on national laws, ordinances, and regulations that correspond to the Cartagena Protocol (Cartagena Protocol on Biosafety to the Convention on Biological Diversity) and continually adheres to them.

* Antibodies: Biomolecules produced by the immune system as a defensive response to eliminate foreign substances in the body.
They consist of bio-derived proteins.

(3) Contributing to a healthy and long-living society even outside the life sciences sector

- A collaborative research project with Keio University to develop and demonstrate prosthetic limbs produced with 3D printing -

Collaborative research project with Keio University to develop and demonstrate prosthetic limbs produced with 3D printingJSR and the Keio University SFC Research Institute collaborated to develop the FABRIALTM R Series, which is an elastomer-based biocompatible material for 3D printer. With support from JSR and the Frontier Makers Project, promoted by the Ministry of Economy, Trade and Industry, researchers from the Keio University SFC Research Institute held a demonstration in the Philippines showcasing prosthetic legs created with 3D printing technology in FY2015.
There are approximately 1,200,000 amputees in the Philippines. Unfortunately, the country is only capable of manufacturing 470 prosthetic legs per year, which results in many amputees being unable to leave their homes. Many amputees are also unable to afford the high cost of prosthetic legs. However, designs for prosthetic legs created using 3D printers are easily customizable, have replaceable parts, and are relatively inexpensive. The flexibility provided by JSR FABRIALTM 3D printer resin can be used for the sections that make contact with the amputated leg to reduce stress at these sections.
The JSR Group will continue to explore ways in which it can apply FabrialTM to other areas health care.

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