The investigational CD19 CAR-T cell therapy received approval to treat patients with relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.
Inaticabtagene Autoleucel uses CMC manufacturing techniques and has a unique CD19 scFv（HI19a）structure.
The approval by NMPA is based on the data from a multi-centre, single-arm, pivotal trial of 39 adults with r/r B-ALL in China.
The 9.3-month follow up data demonstrated high durable response, overall response rate (ORR) of 82.1%, 66.7% complete response rate (CR) within three months following infusion.
Median duration of response (DoR) was not attained in the trial.
Inaticabtagene Autoleucel is expected to become the first CAR-T therapy option with a positive benefit-risk ratio for adult r/r B-ALL patients given the treatment options that are currently available in China.
CASI Pharmaceuticals chairman and CEO Dr Wei-Wu He said: “The approval of CNCT19 represents a transformative moment not only for CASI and Juventas but for all B-ALL patients in China.
“We are committed to making this groundbreaking therapy accessible to those in need and aspire to extend its reach globally.
“CNCT19 offers new hope to patients battling relapsed B-ALL, and this partnership between CASI and Juventas aims to ensure that this innovative therapy reaches those in need across China and beyond.”