Huadong Medicine's IM19 Chimeric Antigen Receptor T-cell Injection Receives NDA Acceptance from NMPA

Huadong Medicine (000963.SZ) announced that on November 27, 2024, the marketing authorization application for IM19 Chimeric Antigen Receptor T-Cell Injection, a CD19-targeted autologous CAR-T candidate product exclusively commercialized by its wholly-owned subsidiary Huadong Medicine (Hangzhou) Co., Ltd. ["Huadong Medicine (Hangzhou)" hereinafter], was accepted by the National Medical Products Administration.

It is reported that IM19 Chimeric Antigen Receptor T-Cell Injection (IM19 CAR-T Cell Injection) is the first CAR-T cell therapy product independently developed by Beijing Yimiao Shenzhou Medical Technology Co., Ltd. ("Yimiao Shenzhou"), and Huadong Medicine (Hangzhou) holds the exclusive commercial rights to the product in mainland China.

IM19 CAR-T Cell Injection is an autologous CD19 (a leukocyte differentiation antigen on the surface of B cells) targeted CAR-T cell (chimeric antigen receptor T cell) product, which is generated through lentiviral transduction of T cells.

IM19 The CAR-T cell injection has successively received clinical trial approval notices for three indications from the National Medical Products Administration, namely, relapsed/refractory diffuse large B-cell lymphoma (r/r-DLBCL), acute B-cell lymphoblastic leukemia (B-ALL), and mantle-cell lymphoma (MCL).

The acceptance of the marketing authorization application for IM19 CAR-T cell injection is based on an open-label, single-arm, multi-center Phase I/II clinical trial conducted in China. The study results show that IM19 CAR-T cell injection has good efficacy and safety for relapsed or refractory CD19-positive non-Hodgkin lymphoma.