Yuanchi Biologics Receives NMPA Approval for IND of OriCAR-017, China’s First and World’s Second GPRC5D-Targeting CAR-T Therapy for R/R Multiple Myeloma

On August 10, the official website of the National Medical Products Administration (NMPA) announced that the Investigational New Drug (IND) application for OriCAR-017 injection, a CAR-T product targeting GPRC5D for the treatment of R/RMM (relapsed/refractory multiple myeloma) developed by Oricell Therapeutics Holdings Limited (hereinafter referred to as "Oricell Therapeutics"), has been officially approved. Public information shows that this is the first CAR-T cell therapy product targeting GPRC5D to be approved for clinical trials in China and the second globally. The product has demonstrated significant differentiation advantages in terms of development speed, efficacy, and safety, thus drawing considerable attention.

GPRC5D is a G protein-coupled receptor that is highly expressed on multiple myeloma cells but has low expression in normal tissues, making it a promising therapeutic target for multiple myeloma. Studies have found that GPRC5D and BCMA are expressed independently. Therefore, GPRC5D-targeted drugs hold the potential to become a new treatment option, offering significant clinical value, whether for end-stage patients with relapsed or refractory disease or for relapsed cases with low or negative BCMA expression after receiving CAR-T, bispecific antibodies, or ADC drugs targeting BCMA.

Previously, the exploratory clinical research phase data of OriCAR-017 had already been presented at the 2022 ASCO (American Society of Clinical Oncology Annual Meeting) and the 2022 EHA (European Hematology Association Annual Meeting), where its efficacy and safety advantages gained widespread attention from global experts. In this study, which enrolled 10 patients, including 5 cases previously treated with BCMA CAR-T cell therapy and 4 cases with extramedullary disease (EMD). According to the latest data, the median follow-up time was 280 days (217~459 days), with an ORR (Overall Response Rate) reaching 100% and sCR (stringent Complete Response) reaching 80%. Additionally, compared with other therapies targeting the same antigen, OriCAR-017 demonstrated significant safety advantages. After treatment, only one case of Grade 2 CRS (Cytokine Release Syndrome) occurred, with the rest being Grade 1. No ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) was observed, and there were no Grade 3 or higher skin toxicities or nail changes. Notably, no infection events were observed during long-term follow-up post-treatment. These safety features make it possible for patients to potentially receive treatment in an outpatient setting without requiring hospitalization to manage common CAR-T toxic side effects, thereby reducing the burden on both patients and healthcare providers.

Editor: Mu Mian

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