CASI Pharmaceuticals Secures FDA Clearance for CID-103 IND Application in Renal Allograft Antibody-Mediated Rejection

Reuters

2025/08/04

CASI Pharmaceuticals Secures FDA Clearance for CID-103 IND Application in Renal Allograft Antibody-Mediated Rejection

CASI Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug $(IND.AU)$ application for CID-103, an anti-CD38 monoclonal antibody intended to treat renal allograft antibody-mediated rejection $(AMR)$. This clearance marks a significant milestone for CASI Pharmaceuticals, a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for organ transplant rejection and autoimmune diseases. The upcoming Phase 1 clinical trial will focus on evaluating the safety, tolerability, and efficacy of CID-103 in adults with active and chronic active renal allograft AMR. The study aims to address the urgent need for new therapeutic options for patients with resistant AMR, a leading cause of kidney transplant loss.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CASI Pharmaceuticals Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1056000) on August 04, 2025, and is solely responsible for the information contained therein.

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ID: 1056000) on August 04, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250804:nNDL9RcsWh:1","article_id":"2556138384","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2556138384","pubTimestamp":1754312436,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"CASI Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration  has cleared its Investigational New Drug  application for CID-103, an anti-CD38 monoclonal antibody intended to treat renal allograft antibody-mediated rejection . 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