Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

HEFEI,China,Feb. 25,2025 -- Kangpu Biopharmaceuticals,Ltd. ("Kangpu") today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM).

IND approval record on CDE official website

KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1),two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory,anti-angiogenic,and anti-tumor effects.

The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM 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.

About Kangpu Biopharmaceuticals

Kangpu Biopharmaceuticals,Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors,hematologic malignancies,autoimmune diseases,and inflammatory disorders through novel solutions,including targeted protein degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms,including NeoMIDES®,gDACs®,and X-SYNERGY®.

For more information,please visit www.KangpuGroup.com.