SHANGHAI, July 16, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its self-developed novel B7-H3-targeting ADC (R&D code: 7MW3711) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of small cell lung cancer..

上海，2024年7月16日/PRNewswire/--Mabwell（688062。SH），一家具有全产业链的创新驱动生物制药公司，宣布其自行开发的新型B7-H3靶向ADC（研发代码：7MW3711）已被美国食品和药物管理局（FDA）授予孤儿药名称（ODD），用于治疗小细胞肺癌。。

The FDA grants Orphan Drug Designation to treatments for rare diseases in the United States that affect fewer than 200,000 patients. Orphan Drug Designation offers policy benefits to drug developers, including as aid with medication development, tax credits for a part of clinical trial expenditures, and seven years of market exclusivity upon approval..

美国食品和药物管理局（FDA）将孤儿药指定为美国罕见疾病的治疗药物，这些疾病影响的患者不到20万。孤儿药指定为药物开发人员提供政策优惠，包括药物开发援助、部分临床试验支出的税收抵免以及批准后七年的市场排他性。。

7MW3711 is a novel B7-H3-targeting ADC developed by Mabwell's IDDC™ platform. It is composed of innovative antibody molecule, novel linker, and novel payload Mtoxin™ (TOP1i). When 7MW3711 enters human body, it specifically binds to antigens on the tumor cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells..

7MW3711是由Mabwell的IDDC™平台开发的新型B7-H3靶向ADC。它由创新的抗体分子，新型接头和新型有效载荷Mtoxin™（TOP1i）组成。当7MW3711进入人体时，它与肿瘤细胞膜表面的抗原特异性结合，被内化并转运至溶酶体，释放细胞毒性药物，并诱导肿瘤细胞凋亡。。

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good safety profile and pharmacokinetic properties.

7MW3711是一种结构稳定、组成均匀、纯度高的药物，适用于工业放大。与国内外同类ADC相比，7MW3711在多种动物肿瘤模型中显示出更好的肿瘤杀伤效果。在包括食蟹猴在内的动物安全性评估模型中，有效控制了7MW3711的靶向和非靶向毒性，显示出其良好的安全性和药代动力学特性。

The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development..

上述研究结果表明，7MW3711具有临床分化特征，临床开发前景广阔。。

About the next generation ADC platform - IDDC™

关于下一代ADC平台-IDDC™

IDDC™ is a next generation ADC site-specific conjugation technology platform independently developed by Mabwell, consisting of multiple systematic core patented technologies including the site-specific conjugation process DARfinity™, the site-specific linker IDconnect™, the novel payload Mtoxin™, and the conditional release structure LysOnly™.

IDDC™是由Mabwell独立开发的下一代ADC位点特异性缀合技术平台，由多种系统核心专利技术组成，包括位点特异性缀合过程DARfinity™、位点特异性接头IDconnect™、新型有效载荷Mtoxin™和条件性释放结构LysOnly™。

The next generation ADCs developed based on the above systematic patented technologies have better structural uniformity, quality stability, efficacy, and tolerability. The novel payload Mtoxin™ (MF6) demonstrates good pharmacodynamics, bystander killing efficacy, and anti-multidrug resistance..

基于上述系统专利技术开发的下一代ADC具有更好的结构均匀性，质量稳定性，功效和耐受性。新型有效载荷Mtoxin™（MF6）表现出良好的药效学，旁观者杀伤功效和抗多药耐药性。。

The IDDC™ platform has been validated in multiple drug candidates under development. Mabwell currently has several ADCs in clinical development stages. Among them, the novel Nectin-4-targeting ADC, 9MW2821, is in Phase III clinical trial for the indication of urothelial carcinoma. The novel B7-H3-targeting ADC, 7MW3711, and Trop-2-targeting ADC, 9MW2921, are both in clinical trial stages..

IDDC™平台已在正在开发的多种候选药物中得到验证。Mabwell目前在临床开发阶段有几个ADC。其中，新型靶向Nectin-4的ADC 9MW2821正在进行III期临床试验，用于指示尿路上皮癌。新型靶向B7-H3的ADC 7MW3711和靶向Trop-2的ADC 9MW2921均处于临床试验阶段。。

About Mabwell

关于Mabwell

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.

Mabwell（688062。SH）是一家创新驱动的生物制药公司，拥有制药行业的整个价值链。我们提供更有效和更易获得的治疗和创新药物，以满足全球医疗需求。自2017年以来，建立了涵盖目标发现，早期发现，可药用性，临床前，临床研究和制造转型的先进研发体系。

Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc.

Mabwell基于世界级和最先进的研发引擎，在不同阶段拥有14种管道产品，包括10种新型候选药物和4种生物仿制药。我们专注于肿瘤、自身免疫疾病、代谢紊乱、眼科疾病和传染病等治疗领域。

Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. 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.

其中，3种产品已获得批准并商业化，1种产品已提交MA批准，3种产品正在进行关键试验。承担“重大新药开发”国家重大科技专项1项、国家重点研发项目2项、省市级多项科技创新项目。

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. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction.

Mabwell的台州工厂拥有强大的内部生产能力，符合NMPA、FDA和EMA规定的国际GMP标准，并已通过欧盟QP审核。上海大型制造基地和台州ADC商业化制造基地正在建设中。

Our mission is 'Explore Life, Benefit Health' and our vision is 'Innovation, from ideas to reality'. For more information, please visit www.mabwell.com/en..

我们的使命是“探索生活，造福健康”，我们的愿景是“创新，从理念到现实”。有关更多信息，请访问www.mabwell.com/en。。

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、监管审查或批准以及商业成功，以及与公司产品开发、临床研究、临床和监管里程碑和时间表、市场机会、竞争地位、可能或假定的未来运营结果、业务战略、潜在增长机会和其他具有预测性质的声明有关的声明。

'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..

“前瞻性陈述”是指非历史事实的陈述，涉及许多风险和不确定性，可能导致实际结果与前瞻性陈述中明示或暗示的任何未来结果存在重大差异。这些陈述可以通过使用前瞻性表达来识别，包括但不限于“预期”，“预期”，“打算”，“计划”，“相信”，“估计”，“潜力”，“预测”，“项目”，“应该”，“将会”，以及类似的表达和这些术语的负面影响。。

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.

前瞻性陈述基于公司当前的预期和假设。前瞻性陈述受到许多风险、不确定性和其他因素的影响，其中许多因素超出了公司的控制范围，包括但不限于：环境；政治；经济；社会；立法；我们对候选产品的依赖，其中大多数仍处于临床前或临床开发的各个阶段；我们依赖第三方供应商，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；我们能够完成候选产品所需的临床试验，并获得监管机构对候选产品的批准；我们保护知识产权的能力；新型冠状病毒肺炎的潜在影响；任何高管或关键人员的损失。

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..

如果一个或多个风险或不确定性恶化，或任何假设不正确，实际结果可能与所述结果严重不一致。。

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.

公司提醒所有人士不要过度依赖任何此类前瞻性声明，这些声明仅在本新闻稿发布之日起生效。公司不承担任何义务，除非法律和适用股票管理局的规则明确要求公开更新或修订任何此类报表，以反映任何此类报表所依据的预期或事件、条件或情况的任何变化，或可能影响实际结果与前瞻性报表中所述结果不同的可能性。

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、数字和假设均适用于本声明。。

SOURCE Mabwell

源Mabwell