CASI PHARMACEUTICALS AND CLEAVE THERAPEUTICS ANNOUNCE CLINICAL TRIAL APPLICATION APPROVAL FOR CB-5339 IN PATIENTS WITH MULTIPLE MYELOMA IN CHINA

~ NMPA approved CB-5339 CTA for Multiple Myeloma indication ~

~ Expected enrollment to begin in 2023 ~

ROCKVILLE, Md. and BEIJING, Jan. 6, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces that the China National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) for CB-5339, a first-in-class VCP/p97 inhibitor from Cleave Therapeutics. CASI is planning a Phase 1 development program in China of CB-5339 as a single agent to evaluate the PK/safety profile, select the Recommended Phase 2 Dose, and assess early signs of clinical efficacy. The Phase 1 development program is expected to start in 2023.