FDA Clears CASI's IND Application for CID-103 in ITP

BEIJING, May 15, 2024 — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a company dedicated to the development and commercialization of innovative therapeutic and pharmaceutical products, announced a significant milestone today. On April 12, 2024, the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CID-103. This application aims to support a phase 1/2 clinical trial of CID-103 in adults suffering from chronic Immune Thrombocytopenia (ITP). The FDA responded on May 13, 2024, indicating that the study could proceed.

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that targets a unique epitope. This antibody has shown promising preclinical results in terms of both efficacy and safety when compared to other anti-CD38 monoclonal antibodies available.

Dr. Wei-Wu He, the CEO of CASI Pharmaceuticals, highlighted the significance of this development, stating, "Immune Thrombocytopenia (ITP) is a severe autoimmune disorder that leads to the destruction of platelets and impairs platelet production. This condition increases the risk of life-threatening bleeding episodes. We are thrilled to move CID-103 into clinical development, as it has the potential to provide a new therapeutic option to reduce the disease burden for patients suffering from ITP."

CASI Pharmaceuticals, Inc. is a biopharmaceutical firm that focuses on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and other global markets. The company's strategy includes acquiring, developing, and commercializing products particularly in the field of hematology oncology, as well as addressing other areas of unmet medical needs. The company aims to become a leader by launching medicines in Greater China, leveraging its local regulatory and commercial capabilities alongside its global drug development expertise. CASI’s operations in China are managed through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., based in Beijing.

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