Mabwell Announces IND Application Acceptance for CDH17-Targeting ADC 7MW4911 from Both NMPA and FDA
Mabwell Announces IND Application Acceptance for CDH17-Targeting ADC 7MW4911 from Both NMPA and FDA |
| [01-August-2025] |
SHANGHAI, Aug. 1, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its proprietary CDH17-targeting antibody-drug conjugate (ADC), 7MW4911, has received Investigational New Drug (IND) application acceptance from China's National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the U.S. Food and Drug Administration (FDA). 7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell's proprietary IDDC™ platform. Its highly optimized structure integrates three key elements:
In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911's tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:
With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. About CDH17 CDH17 is a pan-cancer validated target with restricted expression in normal intestinal epithelium but marked overexpression in gastrointestinal cancers (e.g., colorectal, gastric, pancreatic). Its aberrant expression correlates with tumor metastasis and poor prognosis, positioning it as an ideal therapeutic target. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. The company provides more effective and accessible therapy and innovative medicines to fulfill global medical needs, focusing on oncology and aging-related disease indications. Mabwell's mission is "Explore Life, Benefit Health" and its vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com/en. Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.
SOURCE Mabwell | ||
Company Codes: Shanghai:688062,Shanghai:688062.SS |
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