March 31, 2025
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Multiple Myeloma

China NMPA approves IND for KPG-818 in relapsed or refractory MM

By Phillip Mcleod

The Center for Drug Evaluation of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for KPG-818, a novel oral molecular glue modulator of CRL4-CRBN, for the treatment of relapsed or refractory multiple myeloma (MM) in patients who have received prior therapies. This approval was announced on February 25, 2025.

The phase I clinical trial of KPG-818 in the United States for various hematological tumors has been completed. Preliminary results indicate that in relapsed or refractory MM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects, according to the press release from Kangpu Biopharmaceuticals, the manufacturer of the therapy.

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