Gelonghui, April 9, 丨 Xiansheng Pharmaceutical (02096.HK) announced that on April 9, 2024, Beijing time, the group's self-developed new anti-tumor drug, SIM0500, a humanized GPRC5D-BCMA-CD3 tri-specific antibody injection, was granted a fast-track qualification by the US Food and Drug Administration (“FDA”) to be used for previous treatment with ≥3 lines of treatment (including a proteasome inhibitor (PI), an immunomodulator (IMID), and an anti-CD38 monoclonal antibody), and is known to provide clinical benefits standards Treat patients with drug-resistant or intolerable multiple myeloma.
FDA fast-track eligibility is a way to speed up the development and approval of potential drugs. Fast Track eligible drugs are designed to treat serious diseases and address unmet medical needs. They may be the first treatment for a specific disease, or have significant clinical advantages over existing treatments, or may benefit patients who are less effective or intolerant to existing treatments.
SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody. Based on preclinical data, it is a potential best-in-class (BIC) drug for the treatment of multiple myeloma. Through the Group's own T-cell connector multi-specific antibody drug development platform, the SIM0500 series combines CD3 antibodies with low affinity and high target activation and antibodies with anti-tumor related antigens developed by the Group to form a tumor-targeted T-cell activating drug, which has the advantages of excellent tumor killing effect and good tolerability. SIM0500 can potentially overcome drug resistance caused by existing treatments. It has shown excellent anti-tumor activity in BCMA or GPRC5D animal efficacy models with various pre-clinical expression levels, and has multiple advantages such as low effective dose and no recurrence of tumors after drug discontinuation.