CASI Pharmaceuticals Gets FDA Clearance On The IND Application For CID-103 In Immune Thrombocytopenia
CASI Pharmaceuticals Gets FDA Clearance On The IND Application For CID-103 In Immune Thrombocytopenia
CASI Pharmaceuticals, 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). On May 13, 2024 CASI received a letter from FDA indicating that study may proceed.
专门从事创新治疗和制药产品开发和商业化的生物制药公司CASI Pharmicals, Inc.（纳斯达克股票代码：CASI）今天宣布了以下内容：2024年4月12日，CASI向美国食品药品管理局提交了 CID-103 的IND申请，以支持一项针对慢性免疫血小板减少症（ITP）成人的1/2期研究。CID-1032024年5月13日，CASI收到了美国食品药品管理局的一封信，表明该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 是一种完全人源的 IgG1 抗 CD38 单克隆抗体，可识别一种独特的抗体。与其他抗CD38单克隆抗体相比，该表位已显示出令人鼓舞的临床前疗效和安全性。
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