March 17, 2023
Japan Tissue Engineering Co., Ltd.

Notice of Marketing Approval for Autologous Cultured Epidermis “JACEMIN”
for the Treatment of Vitiligo
This is to inform you that Japan Tissue Engineering Co., Ltd. (“J-TEC”, headquarters in Gamagori,Aichi, Japan; President & CEO, Ken-ichiro Hata) obtained marketing approval for Autologous
Cultured Epidermis Maintaining Melanocytes “JACEMIN”, a regenerative medical product for thetreatment of vitiligo*, on March 17.
JACEMIN is the fifth regenerative medical product launched by our company in Japan. Through
JACEMIN, J-TEC will contribute to the improvement of quality of life (QOL) in a greater number ofpatients while providing them with a new treatment method.
1. Overview of marketing approval

Details

Approval number

30500FZX00001000

Date of approval

March 17, 2023

Generic nameMelanocyte-maintaining human (autologous) epidermis-derived cell sheet

Proprietary name

JACEMIN

Effects or functions

Vitiligo for which nonsurgical therapy is ineffective or not indicated<Precautions for use related to effects or functions> This product is for use in the treatment of the following: vitiligo vulgaris inwhich symptoms have been stable for about 12 months, Vogt-KoyanagiHarada disease, complete depigmentation by chemical substance, andcomplete depigmentation due to congenital abnormality such aspiebaldism.
 Selection of patients for whom this product is indicated should be madewith a thorough knowledge of the content of the section entitled “ClinicalResults” as it pertains to the background of the patients who have been
included in clinical trials (vitiligo status, etc.) and results after thetransplantation of this product, as well as a thorough understanding of theaction mechanism, efficacy, and safety of this product.

Approval conditions

1. Because clinical cases are extremely limited, all-cases post-marketingsurveillance must be conducted until the end of the re-examination period
in principle, in order to grasp background information on the patients whouse this product. At the same time, data on the safety and efficacy of thisproduct should be collected early on, and the necessary measures for properuse of this product should be taken.
2. In light of the risks that accompany heterologous transplantation of the 3T3J2 cells derived from murine fetuses that are used as feeder cells in themanufacturing process for this product, the necessary measures should betaken to ensure proper handling, such as retaining samples of the final
product and records regarding use for 30 years.

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

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2. Product overview
 Autologous Cultured Epidermis Maintaining Melanocytes
JACEMIN is autologous cultured epidermis in which the patient’sown cutaneous tissue is harvested, and isolated cells cultured tomaintain melanocytes are produced in sheet form for use in thepatient.
Melanocyte-maintaining human Curing vitiligo with pigment regeneration(autologous) epidermis-derived cell sheet
JACEMIN is transplanted into areas affected by vitiligo* whereJACEMIN
nonsurgical therapy is ineffective or not indicated, after theepidermal layer has been shaved thin. Melanocytes are supplied through transplantation ofthis product, and its purpose is to regenerate pigment.

 Low invasiveness and improvement of quality of life (QOL)
Because JACEMIN grafts are manufactured using a smaller area of cutaneous tissue than inexisting surgical therapies, the procedure is low in invasiveness for the patient, and it makes it
possible to treat a large area at one time. Moreover, regenerating pigment with thistreatment method can be expected to reduce the patient’s psychological burden regarding
aesthetics and improve patient quality of life (QOL).
* Vitiligo is a disease in which the skin loses color and turns white because of the loss or decreaseof pigment cells called melanocytes that are normally present in the skin. This product is for thetreatment of vitiligo for which nonsurgical therapies such as topical preparations, oralmedications, or phototherapy are ineffective or not indicated, such as acquired vitiligo vulgaris inwhich there has been destruction of melanocytes and symptoms have been stable for about 12months, or piebaldism caused by a congenital genetic abnormality. The number of patients withvitiligo vulgaris is estimated at about 150,000 in Japan. Moreover, the incidence of piebaldism isthought to be one in 20,000 to 100,000 people.
(Reference: Transplantation of Autologous Cultured Epidermis Maintaining Melanocytes JACEMIN)

PatientHarvesting

Normal cutaneous
tissueCell separation

Affected part

Transplantation

Epidermis cultured
maintaining
melanocytes

Formation into sheet

Cell seeding

3T3-J2 cells

3. Future outlook
J-TEC made its business plan for JACEMIN public in “Medium-Term Management Plan (Matters
Related to Business Plans and Growth Potential) ” dated March 10, 2022. Because things have beenproceeding according to plan, this product approval will not have any effect on our full-year
earnings forecast for the term ending in March 2023. We will promptly apprise you of any newfacts that would have a major impact on our business performance.

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

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(Reference: About J-TEC)
J-TEC is a maker of regenerative medical products. Our vision is “Creating a Future forRegenerative Medicine”, and we have been a member of the Teijin Group since March 2021.
As the top runner in Japan’s regenerative medicine industry, we provide a stable supply ofregenerative medical products, and of the regenerative medical products that have been
approved in Japan, the following five are J-TEC products.
 Approved Oct. 2007:

Autologous Cultured Epidermis JACE® – Japan’s first regenerative
medical product Approved July 2012: Autologous Cultured Cartilage JACC® – Japan’s first regenerative
medical product in the plastic surgery field Approved March 2020: Autologous Cultured Corneal Epithelium NEPIC® – Japan’s firstregenerative medical product in the ophthalmology field Approved June 2021: Autologous Cultured Oral Mucosal Epithelium OCURAL®
 Approved March 2023: Autologous Cultured Epidermis Maintaining Melanocytes JACEMIN

Contact information for inquiries about this announcement:
Japan Tissue Engineering Co., Ltd.
Corporate Communication Office
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

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