SHANGHAI

上海

,

，

April 2, 2025

2025年4月2日

/PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors..

/PRNewswire/ -- 全产业链创新型生物制药企业迈威生物（688062.SH）宣布，其新型 B7-H3 靶向 ADC（研发代号：7MW3711）已获国家药品监督管理局 (NMPA) 批准，与 PD-1 抑制剂联合使用，伴或不伴其他抗肿瘤疗法，针对晚期实体瘤开展 Ib/II 期临床试验。

7MW3711 is developed by Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform and is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor, with or without antitumor therapies, in patients with advanced solid tumors.

7MW3711是由迈威生物的链间二硫键药物偶联（IDDC™）平台开发，其药物特性表现为结构稳定、成分均一、纯度高，且适合工业放大。已获批的 Ib/II 期临床试验旨在评估 7MW3711 联合 PD-1 抑制剂，伴或不伴其他抗肿瘤疗法，用于治疗晚期实体瘤患者时的安全性、耐受性、初步疗效及药代动力学特征。

Previously, 7MW3711 has been approved for clinical studies in advanced solid tumors by the NMPA and the FDA, respectively, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer..

此前，7MW3711已分别获得NMPA和FDA批准开展针对晚期实体瘤的临床研究，并被FDA授予治疗小细胞肺癌的孤儿药资格（ODD）。

About Mabwell

关于迈威

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established.

迈威生物 (688062.SH) 是一家全产业链布局的创新型生物医药公司，致力于提供更有效、可及的治疗和创新药物以满足全球医疗需求。自 2017 年起，建立了覆盖靶点发现、早期发现、成药性研究、临床前研究、临床研究和生产转化的先进研发体系。

Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials.

基于世界级、最先进的研发引擎，迈博拥有16个处于不同阶段的管线产品，包括12个创新药候选药物和4个生物类似药。我们专注于肿瘤、免疫、骨骼疾病、眼科、血液学和传染病等治疗领域。其中3款产品已获批并商业化，1款产品已提交上市申请，3款产品处于关键试验阶段。

We have also undertaken 1 national major scientific and technological special project for 'Significant New Drugs Development', 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit.

我们还承担了1项“重大新药创制”国家科技重大专项，2项国家重点研发计划项目，以及多个省市科技创新项目。迈威生物的泰州工厂具备符合中国国家药品监督管理局（NMPA）、美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）国际GMP标准的自主生产能力，并已通过欧盟QP审计。

The large-scale manufacturing base in .

大型制造基地在 。

Shanghai

上海

and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is 'Explore Life, Benefit Health' and our vision is 'Innovation, from ideas to reality'. For more information, please visit

泰州的ADC商业化生产基地正在建设中。我们的使命是“探索生命，造福健康”，我们的愿景是“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、业务战略、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的声明，这些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来识别，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。前瞻性声明受多种风险、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；我们对公司产品候选物的依赖，其中大部分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，除非法律及适用的证券管理机构的规定特别要求，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出现差异的可能性。

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

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