SHANGHAI

上海

,

，

Aug. 19, 2025

2025年8月19日

/PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND

/PRNewswire/ -- 全产业链创新型生物医药企业迈威生物（688062.SH）宣布，其自主研发的 CDH17 靶向 ADC（研发代号：7MW4911）获批 IND

clearance

清除

from the U.S. Food and Drug Administration (FDA). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.

来自美国食品药品监督管理局 (FDA)。该批准使得可以启动 7MW4911 的 I/II 期研究，以评估其在晚期结直肠癌和其他晚期胃肠道肿瘤患者中的安全性、药代动力学和有效性。

7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell's proprietary IDDC™ platform. Its highly optimized structure integrates three key elements:

7MW4911 是一款使用 Mabwell 专有的 IDDC™ 平台开发的在研 CDH17 靶向 ADC。其高度优化的结构整合了三个关键要素：

Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.

Mab0727：一种具有快速内化特性的高特异性CDH17单克隆抗体，跨物种（人/猴）中等亲和力，且几乎没有脱靶结合。

Novel cleavable linker: Ensures precise payload release in tumor tissues.

新型可切割链接子：确保在肿瘤组织中精确释放载荷。

MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.

MF-6有效载荷：一种专有的DNA拓扑异构酶I抑制剂，旨在克服多药耐药性（MDR），具有优异的血浆稳定性、可控的药物释放和强大的旁观者效应。

In

在

July 2025

2025年7月

, 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:.

，迈博威尔在《细胞报告医学》上发表了临床前数据（“使用连接DNA拓扑异构酶抑制剂的CDH17靶向抗体药物偶联物克服胃肠道癌的多药耐药性”），展示了7MW4911通过CDH17介导的内化实现肿瘤选择性细胞毒性。其主要优势包括：。

Opti

优化

mized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.

混合分子设计：均一的药物抗体比（DAR=4，>95%）和稳定的连接子赋予了卓越的血浆稳定性，而可穿透细胞膜的MF-6则驱动强效的旁观者杀伤。

Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS).

广泛的抗肿瘤疗效：在结直肠癌、胃癌和胰腺癌的PDX/CDX模型中显示出显著的肿瘤消退，包括具有RAS/BRAF突变和不同共识分子亚型（CMS）的肿瘤。

MDR resistance: Outperforms MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reverses tumor progression post-ADC treatment.

MDR耐药性：在ABC转运蛋白介导的MDR模型中表现优于基于MMAE/DXd的ADC，并在ADC治疗后逆转肿瘤进展。

Target versatility: Active even in tumors with low-to-moderate CDH17 expression, expanding potential patient eligibility.

靶向多功能性：即使在CDH17表达较低至中等的肿瘤中也具有活性，扩大了潜在患者适用范围。

Favorable safety profile: Limited tissue distribution in mice, controllable pharmacokinetics (moderate half-life, no accumulation), and a wide therapeutic window in cynomolgus monkeys, with no significant toxicity signals.

良好的安全性：在小鼠中组织分布有限，药代动力学可控（半衰期适中，无蓄积），在食蟹猴中具有较宽的治疗窗口，无明显毒性信号。

With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. IND

凭借这一特性，7MW4911 成为治疗晚期胃肠道癌症的有希望的候选药物。IND

application

应用

of 7MW4911 has been accepted by

7MW4911 已被接受

China's

中国的

National Medical Products Administration (NMPA).

国家药品监督管理局（NMPA）。

About CDH17

关于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..

CDH17 是一个在泛癌中验证过的靶点，在正常肠上皮中表达受限，但在胃肠道癌症（如结直肠癌、胃癌、胰腺癌）中显著过表达。其异常表达与肿瘤转移和不良预后相关，因此成为理想的治疗靶点。

About Mabwell

关于迈威生物

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.

迈威生物 (688062.SH) 是一家创新驱动的生物医药公司，拥有医药行业的完整价值链。公司致力于提供更有效且可及的治疗方案和创新药物，以满足全球医疗需求，重点关注肿瘤和与衰老相关的疾病领域。

Mabwell's mission is 'Explore Life, Benefit Health' and its vision is 'Innovation, from ideas to reality'. For more information, please visit .

迈威的使命是“探索生命，造福健康”，其愿景是“创新，从理念到现实”。欲了解更多信息，请访问。

www.mabwell.com/en

www.mabwell.com/zh

.

。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含前瞻性声明，包括但不限于我们候选产品的潜在安全性、有效性、监管审查或批准及商业成功，以及与公司产品开发、临床研究、临床和监管里程碑及时间表、市场机会、竞争地位、可能或假设的运营结果、业务策略、潜在增长机会及其他具有预测性质的声明。

'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..

“前瞻性声明”并非历史事实，而是涉及诸多风险和不确定性，可能导致实际结果与前瞻性声明中明示或暗示的任何未来结果存在重大差异。这些声明可以通过使用前瞻性表述加以识别，包括但不限于“预期”、“预计”、“打算”、“计划”、“相信”、“估计”、“潜在”、“预测”、“展望”、“应该”、“会”以及类似表述和这些术语的否定形式。

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.

前瞻性声明基于公司当前的预期和假设。前瞻性声明受到许多风险、不确定性和其他因素的影响，其中许多因素超出公司的控制范围，包括但不限于：环境；政治；经济；社会；立法；我们对产品候选物的依赖，其中大多数仍处于临床前或不同阶段的临床开发中；我们对第三方供应商的依赖，如合同研究组织和合同制造组织；临床测试固有的不确定性；我们完成产品候选物所需临床试验并获得监管机构批准的能力；我们保护知识产权的能力；新冠疫情的潜在影响；任何高管或关键人员的流失。

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..

如果这些风险或不确定性中的一个或多个恶化，或者任何假设不正确，实际结果可能与所述结果严重不符。

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.

公司告诫所有人士不要过分依赖任何此类前瞻性声明，这些声明仅截至本新闻稿发布之日有效。公司不承担任何义务，除非法律及适用的股票监管机构规则特别要求，公开更新或修改任何此类声明以反映任何预期变化或事件、条件、或情况的变化，或可能影响实际结果与前瞻性声明中所述结果存在差异的可能性。

All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement..

本新闻稿中的所有前瞻性描述、数据和假设均适用于本声明。

SOURCE Mabwell

来源：Mabwell

WANT YOUR COMPANY'S NEWS

想要你公司的新闻吗？

FEATURED ON PRNEWSWIRE.COM?

荣登PRNEWSWIRE.COM？

440k+

44万+

Newsrooms &

新闻编辑室 &

Influencers

影响者

9k+

9k+

Digital Media

数字媒体

Outlets

插座

270k+

27万+

Journalists

记者

Opted In

已选择加入

GET STARTED

开始使用