Register of Class 2 Cell, Tissue or Gene Therapy Products

Find information on currently registered cell, tissue or gene therapy products (CTGTP) in Singapore.

Product NameActive Ingredient(s)Product Registration Number RegistrantApproval DateApproved Package Insert (PI)/ Patient Information Leaflet (PIL)
KYMRIAH® cells dispersion for infusionTisagenlecleucel CTGT0001P

Novartis (Singapore) Pte Ltd

2021/03/03
Kymriah PI approved 4 January 2023
LUXTURNA® 5x1012 vector genomes/ml Concentrate and Solvent for Solution for InjectionVoretigene neparvovec CTGT0002PNovartis (Singapore) Pte Ltd2022/01/20

Luxturna PI approved 19 April 2023

Luxturna PIL approved 20 January 2022

YESCARTA® suspension for intravenous infusion Axicabtagene ciloleucel CTGT0003P Gilead Sciences Singapore Pte Ltd 2023/03/01 

Yescarta PI approved 13 Sep 2024

Yescarta PIL approved 13 Sep 2024

ZOLGENSMA® Suspension for intravenous infusionOnasemnogene abeparvovecCTGT0004PNovartis (Singapore) Pte Ltd2023/04/21Zolgensma PI approved 22 February 2024
SpheChon 10-70 spheroids/cm2 implantation suspension Spheroids of human autologous matrix-associated chondrocytes

CTGT0005P CTGT0006P

Relive Biotechnologies Pte Ltd2023/12/15SpheChon PI approved 15 December 2023
TECARTUS® suspension for intravenous infusionBrexucabtagene autoleucel CTGT0007PGilead Sciences Singapore Pte Ltd 2024/08/20Tecartus PI approved 20 Aug 2024

Tecartus PIL approved 20 Aug 2024