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.
專門從事創新治療和製藥產品開發和商業化的生物製藥公司CASI Pharmicals, Inc.（納斯達克股票代碼：CASI）今天宣佈了以下內容：2024年4月12日，CASI向美國食品藥品管理局提交了 CID-103 的IND申請，以支持一項針對慢性免疫血小板減少症（ITP）成人的1/2期研究。CID-1032024年5月13日，CASI收到了美國食品藥品管理局的一封信，表明該研究可能會繼續進行。
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 是一種完全人源的 IgG1 抗 CD38 單克隆抗體，可識別一種獨特的抗體。與其他抗CD38單克隆抗體相比，該表位已顯示出令人鼓舞的臨床前療效和安全性。
譯文內容由第三人軟體翻譯。