Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its chimeric antigen receptor T cell (CAR-T) product, IM19. The therapy is being sought for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
IM19’s Clinical Trial Progress and Indications
IM19 has previously received clinical trial approvals in China for the treatment of r/r-DLBCL, acute B-cell leukemia (B-ALL), and mantle cell lymphoma (MCL), with all indications currently in late-stage clinical trials. The NDA submission is supported by results from an open-label, single-arm, multi-center, confirmatory clinical study conducted in China, which demonstrated the therapy’s good efficacy and safety profile.
Commercialization Rights and Licensing Deal
Huadong Medicine Co., Ltd (SHE: 000963) secured the commercialization rights to IM19 in mainland China through a significant RMB 1 billion licensing deal in August. This deal underscores the potential market impact and therapeutic value of Immunochina’s CAR-T therapy as it moves through the regulatory review process.-Fineline Info & Tech
