Innovent Biologics Inc. announced that its anti-GPRC5D/BCMA/CD3 trispecific antibody, IBI3003, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory multiple myeloma in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. The designation is intended to facilitate the development and expedite the review of IBI3003, which is currently undergoing Phase 1⁄2 clinical trials in China and Australia, with plans to initiate similar trials in the United States. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Innovent Biologics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN70624) on January 27, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

Innovent Biologics Inc. has received Fast Track Designation from the FDA for its trispecific antibody IBI3003, aimed at treating relapsed or refractory multiple myeloma in patients with extensive prior therapy. This designation will expedite the development and review process for IBI3003, which is currently in Phase 1/2 clinical trials in China and Australia, with plans for trials in the U.S.

Reuters

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FDA Grants Fast Track Designation to Innovent's IBI3003 for Relapsed or Refractory Multiple Myeloma