November 25, 2021
Japan Tissue Engineering Co., Ltd.

Announcement of Start of Clinical Trial for Allogeneic Cultured Epidermis “Allo-JaCE03”— J-TEC’s first allogeneic cell therapy product:
Submitted notification of clinical trial plan to realize ready-made productthat can be swiftly provided to patients —Japan Tissue Engineering Co., Ltd. (“J-TEC”, headquarters in Gamagori,Aichi, Japan; President & CEO Ken-ichiro Hata) is pleased to announce
that it submitted notification of the clinical trial plan for Allogeneic Cultured
Epidermis (development name: “Allo-JaCE03”) to the Pharmaceuticals andMedical Devices Agency today.
J-TEC will acquire knowledge and know-how about medical devices
through the development of “Allo-JaCE03” and develop new business infields that use allogeneic cells (cells from other people). With the vision of“creating a future for regenerative medicine”, J-TEC is promoting thecreation of a regenerative medicine industry and contributing to theimprovement of patient quality of life (QOL) by continuously developing
and marketing new regenerative medical products and medical devices, inaddition to promoting the spread of J-TEC’s existing products.

Beforereconstitution

Afterreconstitution
Allogeneic Cultured Epidermis

Details[Product Description]“ Allo-JaCE03” is dried epidermal cell sheet derived from healthy human skin. Throughreconstitution, it returns to the resilient physical properties it had before drying. Its high degree ofbiocompatibility makes it suitable for use in the promotion of early wound healing.
[Clinical Trial Summary]
The purpose of this clinical trial is to verify the efficacy and confirm the safety of “Allo-JaCE03” inpatients with deep dermal burn (DDB), which is a typical skin defect disorder. J-TEC plans toconduct the clinical trial at a total of 5 facilities, including Kyoto University Hospital.
[Product Features](1) Because the raw material is allogeneic cells, systematic mass-production of a product thatmeets certain quality standards is possible.
(2) The dried form of this cultured product means that it can be stored at room temperature for long
periods of time. Medical institutions can stock it as a ready-made product (one that is
manufactured and stored in advance so that it can be used without delay when needed).
(3) This product is a medical device that does not contain living cells. J-TEC is taking advantage ofthe product features of allogeneic origin and dried form to accelerate deployment not only within
Japan but also to overseas markets.
[Background/History]
J-TEC obtained marketing approval for Japan’s first regenerative medical product, autologous
cultured epidermis “JACE”, in 2007, for the indication of severe thermal burns. When “JACE” wasmarketed in 2009, the percentage of burn victims whose lives were saved improved. However, withsevere thermal burns and other skin defects, it is necessary to close the wound swiftly after the burnis sustained in order to stabilize the patient’s general condition. The existing treatment methods had
Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan. URL: https://www.jpte.co.jp

1/2

the following challenges. Development of “Allo-JaCE03” is being promoted to solve these challenges.
(1) “JACE” is a made-to-order product which uses the patient’s own skin as the raw material. It
takes 3 weeks to manufacture, and in severe burn cases, it is not uncommon for the patient todie before the skin grafting can be performed.
(2) There are limits to the therapeutic effects of the existing wound covering materials. Autologous
skin grafting is highly invasive for the patient.
(3) Because the medical costs associated with the treatment of severe thermal burns are extremely
high, it is desirable to shorten the treatment period from the standpoint of social welfare
spending.
At the same time, development of allogeneic products involves raw material supply issues.
Construction of a system for the productization of J-TEC’s “Allo-JaCE03” and the stable supply ofhuman allogeneic cells was adopted as a subsidized project by the Japan Agency for Medical
Research and Development (AMED), and J-TEC is striving to resolve raw material supply issues
with funding from the national government.
August 25, 2021: “Announcement: Acceptance of Development Project in FY2021 AMED Program for the Promotion of
Innovation through Industrial-Academic Collaboration”
June 15, 2021: Acceptance of Development Project in FY2021 AMED Program for the Development of Basic Technology
for the Industrialization of Regenerative Medicine and Gene Therapies (Project for the Promotion of Stable Supply of
Human (Allogeneic) Somatic Cell Material for Regenerative Medical Products).

[Earnings Estimate]
J-TEC announced this business plan as part of its “Medium-Term Management Plan (BusinessPlan and Projects with Growth Potential)”, dated May 11, 2021. The project is proceeding according
to plan and will have no effect on the earnings outlook for the term ending in March 2022. J-TEC willpromptly announce any new facts that could have a major impact on its business performance.

(Reference: About J-TEC)
J-TEC is a maker of regenerative medical products whose corporate vision is “creating a future forregenerative medicine,” and has been a member of the Teijin Group since March 2021. As Japan’s
top runner in regenerative medicine, J-TEC obtained marketing approval for autologous cultured
epidermis “JACE”, Japan’s first regenerative medical product, in October of 2007, and beganmarketing the product in January of 2009. J-TEC then went on to obtain marketing approval for
Autologous Cultured Cartilage “JACC” in July of 2021, for Autologous Cultured Corneal Epithelium“Nepic” in March of 2020, and for Autologous Cultured Oral Mucosal Epithelium “Ocural” in June
2021. “JACC” was Japan’s first regenerative medical product for use in orthopedic surgery, and“Nepic” was the first for use in ophthalmology. Of the 14 regenerative medical products that havebeen approved in Japan, four are J-TEC products.

Contact information for inquiries about this announcement:
Japan Tissue Engineering Co., Ltd.
Corporate Planning Department, Corporate Management HQ
TEL: 0533-66-2020 Email: jtec-info@jpte.co.jp

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan. URL: https://www.jpte.co.jp

2/2