1xbet 로그인 Pharmaceutical Co., Ltd,
Takara Bio Inc.

Pharmaceuticals
February 14, 2019

Designation Description Change 1xbet 로그인 NY-ESO-1・siTCRTM gene therapy product under
"SAKIGAKE Designation System"

Takara Bio Inc. (Takara Bio), announced today that a NY-ESO-1・siTCRTMgene therapy product (Development code: TBI-1301) for synovial sarcoma co-developed by Takara Bio and 1xbet 로그인 Pharmaceutical Co., Ltd, (1xbet 로그인) in Japan has been approved for the description change of product under SAKIGAKE Designation System (hereinafter, "SAKIGAKE") by the Ministry of Health, Labour and Welfare as of February 14, 2019.

Takara Bio is conducting domestic Phase I/II clinical trial of TBI-1301 targeting synovial sarcoma since January 2017, and it has been designated as a SAKIGAKE product in March 2018. This designation change is based on the agreement that Takara Bio has concluded with 1xbet 로그인 for domestic co-development and exclusive sales in April 2018.

Both 1xbet 로그인mpanies will aim 1xbet 로그인operatively for 1xbet 로그인-development of this product.

Description Change

Designation Time Number Designation Date Product Name Designated

Applicant Designated

Efficacy 1xbet 로그인 NY-ESO-1・siTCRTMgene therapy product
Before 3rdtime 1 March 27, 2018 TBI-1301 Takara Bio Anti-tumor therapy for synovial sar1xbet 로그인ma, which a receptor gene re1xbet 로그인gnizing tumor antigen, is transduced ex-vivo to lymphocytes of patients, and the gene-modified lymphocytes are infused back to the patients
After Same as above Same as above Same as above Same as above 1xbet 로그인

Same as above

Reference

Announcement on product designation of NY-ESO-1・siTCR gene therapy product for synovial sar1xbet 로그인ma under "SAKIGAKE Designation System" by the Ministry of Health, Labour and Welfare (Released on March 27, 2018)
http://ir.takara-bio.1xbet 로그인.jp/en/news_all/news_Release/news_Release04062404159330868269856.html

1xbet 로그인 enters agreement with Takara Bio for co-development and sales rights in Japan to NY-ESO-1 siTCRTM and CD19 CAR gene therapies (Released on April 9, 2018)
/en/1xbet 로그인mpany/newsreleases/2018/20180409_1.html