Review Reports: Regenerative Medical Products

The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.

The review reports were selected for translation among those of new regenerative medical products that recently received marketing approval, in consideration of relevant factors including the novelty and priority.
 

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Alofisel	darvadstrocel	September 2021
Breyanzi	lisocabtagene maraleucel	March 2021
Collategene	beperminogene perplasmid	March 2019
Delytact	teserpaturev	June 2021
HeartSheet	human (autologous) skeletal myoblast-derived cell sheet	September 2015
JACC	human autologous tissue for transplantation	July 2012
JACE* Initial Approval	human (autologous) epidermal cell sheet	October 2007
JACE Partial Change Approval	human (autologous) epidermal cell sheet	September 2016
JACE Partial Change Approval	human (autologous) epidermal cell sheet	December 2018
Kymriah	tisagenlecleucel	March 2019		1. 2.
Nepic	human (autologous) corneal limbus-derived corneal epithelial cell sheet	March 2020
Ocural	human (autologous) oral mucosa-derived epithelial cell sheet	June 2021
Sakracy	human (autologous) oral mucosa-derived epithelial cell sheet using human amniotic membrane substrate	January 2022
Stemirac	human (autologous) bone marrow-derived mesenchymal stem cells	December 2018
Temcell	human (allogeneic) bone marrow-derived mesenchymal stem cells	September 2015
YESCARTA	axicabtagene ciloleucel	January 2021
ZOLGENSMA	onasemnogene abeparvovec	March 2020

* This product was approved as a medical device under the previous regulatory framework.