CASI Pharmaceuticals Receives China NMPA Approval for Phase 1/2 Clinical Trial of CID-103 in Renal Allograft AMR

Reuters

01/15

CASI Pharmaceuticals Receives China NMPA Approval for Phase 1/2 Clinical Trial of CID-103 in Renal Allograft AMR

CASI Pharmaceuticals Inc. announced that it has received regulatory approval from the China National Medical Products Administration (NMPA) for a Phase 1/2 clinical trial application $(CTA)$ to study CID-103 for the treatment of renal allograft antibody-mediated rejection $(AMR)$. Additionally, the U.S. Food and Drug Administration (FDA) has previously approved an Investigational New Drug $(IND)$ application for a Phase 1 study of CID-103 in adults with chronic active renal allograft AMR. These approvals allow CASI Pharmaceuticals to proceed with clinical studies of CID-103, a potential anti-CD38 monoclonal antibody, in both China and the United States.

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: 1127439) on January 15, 2026, and is solely responsible for the information contained therein.

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Additionally, the U.S. Food and Drug Administration (FDA) has previously approved an Investigational New Drug <a href=\"https://laohu8.com/S/IND\">$(IND)$</a> application for a Phase 1 study of CID-103 in adults with chronic active renal allograft AMR. These approvals allow CASI Pharmaceuticals to proceed with clinical studies of CID-103, a potential anti-CD38 monoclonal antibody, in both China and the United States.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>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: 1127439) on January 15, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>CASI Pharmaceuticals Receives China NMPA Approval for Phase 1/2 Clinical Trial of CID-103 in Renal Allograft AMR</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCASI Pharmaceuticals Receives China NMPA Approval for Phase 1/2 Clinical Trial of CID-103 in Renal Allograft AMR\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2026-01-15 22:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      CASI Pharmaceuticals Receives China NMPA Approval for Phase 1/2 Clinical Trial of CID-103 in Renal Allograft AMR\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        CASI Pharmaceuticals Inc. announced that it has received regulatory approval from the <a href=\"https://laohu8.com/S/688128\">China National</a> Medical Products Administration (NMPA) for a Phase 1/2 clinical trial application <a href=\"https://laohu8.com/S/CTA\">$(CTA)$</a> to study CID-103 for the treatment of renal allograft antibody-mediated rejection <a href=\"https://laohu8.com/S/AMR\">$(AMR)$</a>. Additionally, the U.S. Food and Drug Administration (FDA) has previously approved an Investigational New Drug <a href=\"https://laohu8.com/S/IND\">$(IND)$</a> application for a Phase 1 study of CID-103 in adults with chronic active renal allograft AMR. These approvals allow CASI Pharmaceuticals to proceed with clinical studies of CID-103, a potential anti-CD38 monoclonal antibody, in both China and the United States.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>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: 1127439) on January 15, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\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:20260115:nNDL2YgQp9:1","article_id":"2603983264","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2603983264","pubTimestamp":1768485634,"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. announced that it has received regulatory approval from the China National Medical Products Administration  for a Phase 1/2 clinical trial application  to study CID-103 for the treatment of renal allograft antibody-mediated rejection . Additionally, the U.S. Food and Drug Administration  has previously approved an Investigational New Drug  application for a Phase 1 study of CID-103 in adults with chronic active renal allograft AMR. These approvals allow CASI Pharmaceuticals to proceed with clinical studies of CID-103, a potential anti-CD38 monoclonal antibody, in both China and the United States.Disclaimer: This news brief was created by Public Technologies  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 gen","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技"},"translate_title":"CASI Pharmaceuticals获得中国NMPA批准CID-103治疗同种异体肾AMR的1/2期临床试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CASI":0.9},"content_text":"CASI Pharmaceuticals Receives China NMPA Approval for Phase 1/2 Clinical Trial of CID-103 in Renal Allograft AMR\n    \n\n        CASI Pharmaceuticals Inc. announced that it has received regulatory approval from the China National Medical Products Administration (NMPA) for a Phase 1/2 clinical trial application $(CTA)$ to study CID-103 for the treatment of renal allograft antibody-mediated rejection $(AMR)$. Additionally, the U.S. Food and Drug Administration (FDA) has previously approved an Investigational New Drug $(IND)$ application for a Phase 1 study of CID-103 in adults with chronic active renal allograft AMR. These approvals allow CASI Pharmaceuticals to proceed with clinical studies of CID-103, a potential anti-CD38 monoclonal antibody, in both China and the United States.\n      \n\n\nDisclaimer: 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: 1127439) on January 15, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}