SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as 'ESCC')..

上海，2024年2月27日/PRNewswire/--Mabwell（688062。SH），一家具有全产业链的创新生物制药公司，宣布其自主开发的靶向Nectin-4的新型ADC药物（研发代码：9MW2821）已被美国食品和药物管理局（FDA）授予快速通道指定（FTD），用于治疗晚期，复发性，或转移性食管鳞状细胞癌（以下简称“ESCC”）。。

As of February 20, 2024, for the indication of esophageal cancer (EC), 9MW2821 has shown an ORR and DCR of 30% and 73.3%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in 30 patients with advanced EC who have received monotherapy and completed at least one tumor assessment. Of those, 28 patients have undergone chemotherapy and immunotherapy.

截至2024年2月20日，对于食管癌（EC）的适应症，9MW2821在一项II期临床研究中显示ORR和DCR分别为30%和73.3%，剂量为1.25 mg/kg，30名接受单一疗法并完成至少一项肿瘤评估的晚期EC患者。其中，28名患者接受了化疗和免疫治疗。

The study is still ongoing with further enrollment and evaluation. 9MW2821 is the world's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC..

该研究仍在进行中，并将进行进一步的注册和评估。9MW2821是世界上第一种针对Nectin-4的药物，可公开EC适应症的临床疗效数据。。

9MW2821 is a site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell's ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first clinical stage Nectin-4-targeting ADC developed by Chinese company.

9MW2821是由Mabwell的ADC平台和自动化高通量杂交瘤抗体分子发现平台开发的位点特异性缀合的新型Nectin-4靶向ADC，是中国公司开发的第一个临床阶段Nectin-4靶向ADC。

The drug achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells..

该药物通过专有的缀合技术接头和优化的ADC缀合过程实现抗体的位点特异性修饰。注射后，9MW2821可与细胞膜表面的Nectin-4特异性结合，内化并释放细胞毒性药物，诱导肿瘤细胞凋亡。。

In addition to EC, Mabwell is conducting clinical studies for multiple indications such as urothelial cancer (UC), Cervical Cancer (CC), with monotherapy for UC entering Phase III clinical study, combination therapy with PD-1 entering Phase I/II clinical study, and monotherapy for CC entering Phase II clinical study.

除EC外，Mabwell正在进行多种适应症的临床研究，如尿路上皮癌（UC），宫颈癌（CC），UC单药治疗进入III期临床研究，PD-1联合治疗进入I/II期临床研究，CC单药治疗进入II期临床研究。

As of now, more than 280 patients have been enrolled. 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world..

截至目前，已有280多名患者入选。9MW2821也是第一个在世界上具有相同目标的药物中披露CC适应症的初步临床疗效数据。。

About EC

关于EC

According to the global cancer burden data released by the International Agency for Research on Cancer (IRAC), there were 604 thousand new cases of EC worldwide in 2020, with 544 thousand deaths. In 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on JNCC, showing that there were 224 thousand new cases of EC in China (167.5 thousand in men, 56.5 thousand in women), with 187.5 thousand deaths (140.4 thousand in men, 47.1 thousand in women), ranking 7th and 5th, respectively, in terms of new cases and deaths.

根据国际癌症研究机构（IRAC）发布的全球癌症负担数据，2020年全球有60.4万例新发EC病例，其中54.4万人死亡。2024年，国家癌症中心在JNCC上发布了2022年中国癌症负担数据，显示中国新增EC病例22.4万例（男性167.5万例，女性56.5万例），死亡18.75万例（男性14.04万例，女性47.1万例），在新增病例和死亡人数方面分别排名第7和第5位。

According to the statistics from the American Cancer Society, it is estimated that there will be 22,370 new cases of EC (17,690 in men, 4,680 in women), and 16,130 deaths (12,880 in men, 3,250 in women) in the United States in 2024. In China, ESCC is the most common histological type, accounting for about 85.79% of EC cases, while esophageal adenocarcinoma (EAC) and other types account for 11.00% and 3.21%, respectively.

根据美国癌症协会的统计数据，预计2024年美国将有22370例新发EC病例（男性17690例，女性4680例），16130例死亡（男性12880例，女性3250例）。在中国，ESCC是最常见的组织学类型，约占EC病例的85.79%，而食管腺癌（EAC）和其他类型分别占11.00%和3.21%。

In the United States, EAC is the most common type of EC among White population, accounting for about 70% of EC cases, with ESCC accounting for about 30%, and ESCC is more common among African Americans..

在美国，EAC是白人中最常见的EC类型，约占EC病例的70%，ESCC约占30%，ESCC在非裔美国人中更为常见。。

Furthermore, according to IQVIA's report, in 2022, the number of prevalent patients with EC in China was 742 thousand, with approximately 70% being cases of advanced metastatic EC, of which about 80% (approximately 416,000 cases) were eligible for systemic treatment. The guidelines of the Chinese Society of Clinical Oncology (CSCO) recommends that PD-1 monoclonal antibody combined with platinum-based chemotherapy is the standard first-line treatment, and PD-1 or monotherapy chemotherapy is an optional second-line treatment.

此外，根据IQVIA的报告，2022年，中国流行的EC患者人数为74.2万，其中约70%为晚期转移性EC病例，其中约80%（约41.6万例）符合全身治疗条件。中国临床肿瘤学会（CSCO）指南建议PD-1单克隆抗体联合铂类化疗是标准的一线治疗，PD-1或单药化疗是可选的二线治疗。

In actual clinical practice, there is a significant unmet clinical need after first-line treatment failure, since no preferred options are available..

在实际的临床实践中，由于没有首选方案，一线治疗失败后临床需求显着未得到满足。。

About MabwellMabwell (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.

关于Mabwell 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 R&D 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，在不同的研发阶段拥有14种管道产品，包括10种新药候选药物和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, 2 products have been approved and commercialized, 2 products have 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 several provincial and municipal science and technological innovation projects.

其中，2种产品已获得批准并商业化，2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，省市科技创新项目数项。

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 located in Shanghai is under construction. Our mission is 'Explore Life, Benefit Health' and our vision is 'Innovation, from ideas to reality'.

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。位于上海的大型制造基地正在建设中。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”。

For more information, please visit www.mabwell.com/en. .

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，可能或假定的未来经营成果、业务战略、潜在增长机会和其他具有预测性的陈述。

'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声明，以反映任何此类声明所依据的预期或事件、条件或情况的任何变化，或者可能影响实际结果与前瞻性声明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