Wuhan YZY Biopharma Receives FDA IND Approval for M701 Clinical Trials

Reuters

Feb 03

Wuhan YZY Biopharma Receives FDA IND Approval for M701 Clinical Trials

Wuhan YZY Biopharma Co., Ltd. announced that its Investigational New Drug $(IND)$ application for M701, a recombinant anti-epithelial cell adhesion molecule (EpCAM) and anti-cluster of differentiation 3 (CD3) human-mouse chimeric bispecific antibody, has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials. The approved study is an open-label, multicenter, phase Ib/II trial to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of intrapleurally administered M701 in patients with malignant pleural effusion (MPE) caused by advanced epithelial tumors. The company noted that there is no guarantee M701 will ultimately be successfully developed and marketed.

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. Wuhan Yzy Biopharma Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260203-12011974), on February 03, 2026, and is solely responsible for the information contained therein.

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The approved study is an open-label, multicenter, phase Ib/II trial to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of intrapleurally administered M701 in patients with malignant pleural effusion (MPE) caused by advanced epithelial tumors. The company noted that there is no guarantee M701 will ultimately be successfully developed and marketed.\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. Wuhan Yzy Biopharma Co. 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The approved study is an open-label, multicenter, phase Ib/II trial to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of intrapleurally administered M701 in patients with malignant pleural effusion (MPE) caused by advanced epithelial tumors. The company noted that there is no guarantee M701 will ultimately be successfully developed and marketed.\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. Wuhan Yzy Biopharma Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260203-12011974), on February 03, 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":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260203:nNDL89WnXG:1","article_id":"2608954824","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2608954824","pubTimestamp":1770113209,"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":"Wuhan YZY Biopharma Co., Ltd. announced that its Investigational New Drug  application for M701, a recombinant anti-epithelial cell adhesion molecule  and anti-cluster of differentiation 3  human-mouse chimeric bispecific antibody, has been approved by the U.S. Food and Drug Administration  for clinical trials. The approved study is an open-label, multicenter, phase Ib/II trial to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of intrapleurally administered M701 in patients with malignant pleural effusion  caused by advanced epithelial tumors. The company noted that there is no guarantee M701 will ultimately be successfully developed and marketed.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. Wuh","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1161":"生物科技","02496":"友芝友生物-B"},"translate_title":"武汉亿智生物制药M701临床试验获得FDA IND批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02496":0.9},"content_text":"Wuhan YZY Biopharma Receives FDA IND Approval for M701 Clinical Trials\n    \n\n        Wuhan YZY Biopharma Co., Ltd. announced that its Investigational New Drug $(IND)$ application for M701, a recombinant anti-epithelial cell adhesion molecule (EpCAM) and anti-cluster of differentiation 3 (CD3) human-mouse chimeric bispecific antibody, has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials. The approved study is an open-label, multicenter, phase Ib/II trial to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of intrapleurally administered M701 in patients with malignant pleural effusion (MPE) caused by advanced epithelial tumors. The company noted that there is no guarantee M701 will ultimately be successfully developed and marketed.\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. Wuhan Yzy Biopharma Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. 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