Innovent Biologics Inc. (IVBXF,1801.HK) announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody, IBI3003, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration.
The designation applies to the treatment of relapsed or refractory multiple myeloma (R/R MM) in patients who have previously undergone four or more lines of anti-myeloma therapies. These prior treatments must include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.
This milestone underscores the potential of IBI3003 to address significant unmet medical needs in patients with advanced multiple myeloma.
IBI3003 was discovered and developed using Innovent's proprietary Sanbody platform and its development is being advanced globally. IBI3003 is currently undergoing a Phase 1/2 clinical trial in patients with relapsed or refractory multiple myeloma in China and Australia, and there are plans to initiate a Phase 1/2 clinical trial in the United States imminently.
Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Programs granted FTD benefit from more frequent interactions with the FDA, which may accelerate clinical development and regulatory review.
1801.HK closed at HKD 81.65, down HKD 2.05 or 2.45% at the end of trading. The closing time was 4:08:10 PM GMT+8 on the Hong Kong Stock Exchange (HKSE).
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