BEIJING, May 15, 2024 /PRNewswire/ -- CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.), Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products announced today the following: On April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP).

北京，2024年5月15日/PRNewswire/--专门从事创新治疗和药物产品开发和商业化的生物制药公司CASI制药公司（原名EntreMed，Inc.）（纳斯达克：CASI）今天宣布：2024年4月12日，CASI向FDA提交了CID-103的IND申请，以支持慢性免疫性血小板减少症（ITP）成人CID-103的1/2期研究。

On May 13, 2024 CASI received a letter from FDA indicating that study may proceed..

2024年5月13日，CASI收到FDA的来信，表示研究可能会继续进行。。

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique. Epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.

CID-103是一种完全人IgG1抗CD38单克隆抗体，可识别独特的。与其他抗CD38单克隆抗体相比，表位已显示出令人鼓舞的临床前疗效和安全性。

Dr. Wei-Wu He, CEO of CASI, said 'ITP is a serious autoimmune blood disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, leading to thrombocytopenia and an increased risk of life-threatening bleeding episodes. We are excited to advance this program into clinical development as CID-103 has the potential to represent a new therapeutic option to help alleviate the disease burden in this patient community.'.

CASI首席执行官魏武和博士说，ITP是一种严重的自身免疫性血液疾病，其特征是自身抗体介导的血小板破坏和血小板生成受损，导致血小板减少症和危及生命的出血发作风险增加。我们很高兴将该计划推进临床开发，因为CID-103有可能代表一种新的治疗选择，以帮助减轻该患者社区的疾病负担。”。

About CASI Pharmaceuticals

关于卡西制药

CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need.

卡西制药有限公司是一家生物制药公司，专注于在中国、美国和全世界开发和商业化创新疗法和药品。该公司专注于收购、开发和商业化产品，以增强其血液肿瘤治疗重点以及其他未满足医疗需求的领域。

The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.

该公司打算通过在大中华区市场推出药物，利用该公司在中国的监管和商业能力及其全球药物开发专业知识，实施其成为领导者的计划。该公司在中国的运营是通过其位于中国北京的全资子公司卡西制药（中国）有限公司进行的。