CASI Begins Dosing in CID-103 Phase 1/2 Trial for Immune Thrombocytopenia

BEIJING, CHINA - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical firm known for its development and commercialization of innovative therapeutic solutions, has announced a significant milestone in the treatment of chronic Immune Thrombocytopenia (ITP). The company has commenced a Phase 1/2 clinical trial in China, with the first patient already dosed. This trial will assess the safety and tolerability of CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, in adult patients suffering from chronic ITP.

Dr. Wei-Wu He, the Chairman and CEO of CASI, emphasized the importance of this milestone, noting that it highlights the company's dedication to advancing clinical research at an accelerated pace. Dr. He pointed out the limited treatment options available for chronic ITP patients, underscoring the potential impact of the CID-103 program. The clinical study is structured to gather critical safety information and examine dose-response relationships, which will inform the future development strategies for CID-103. This could extend to other autoimmune diseases that presently have unmet medical needs.

CID-103 has shown promising results in preclinical trials, demonstrating both safety and efficacy when compared to other anti-CD38 monoclonal antibodies. This makes it a promising candidate for further exploration and development, particularly for conditions that lack effective treatments.

CASI Pharmaceuticals is headquartered in the United States but operates globally, with a strong focus on the Chinese market. The company aims to become a leader by launching innovative medicines in Greater China, capitalizing on its regulatory expertise and commercial capabilities in the region. CASI’s operational strategies are supported by its subsidiary, CASI Pharmaceuticals (China) Co., Ltd., based in Beijing. This subsidiary plays a crucial role in the company’s efforts to enhance its presence and impact in the Chinese healthcare market.

The company’s broader focus is on acquiring, developing, and commercializing products, particularly in the fields of hematology oncology and autoimmune diseases, as well as in addressing other areas where there are significant unmet medical needs. CASI Pharmaceuticals leverages its global drug development expertise to strategically position itself as a leader in these specialized therapeutic areas.

The initiation of the CID-103 trial represents a pivotal step in CASI's strategic plan to expand its product offerings and address critical gaps in existing treatment paradigms for autoimmune disorders. The data from the Phase 1/2 trial will be crucial for determining the subsequent phases of clinical development and possibly broadening the scope of CID-103’s applications to benefit a wider patient population.

Through its innovative approaches and strategic market positioning, CASI Pharmaceuticals aims to significantly impact the therapeutic landscape, particularly in regions like China, where there is a high demand for advanced medical treatments. The company's commitment to addressing unmet medical needs and improving patient outcomes remains at the core of its operations and future endeavors.