SHANGHAI, Oct. 23, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces the latest clinical progress of 2 novel drugs including Nectin-4 ADC 9MW2821, as well as the clinical study data to be reported on ESMO 2023.

上海，2023年10月23日/PRNewswire/-Mabwell（688062.SH），一家拥有整个行业链的创新型生物制药公司，宣布2种新药包括Nectin-4 ADC 9MW2821的最新临床进展，以及临床研究将在ESMO 2023上报告的数据。

Latest progress & phase I/II study data to report on ESMO 2023 of 9MW2821

报告9MW2821的ESMO 2023的最新进展和I/II期研究数据

Up to now, 195 patients  with advanced solid tumor have been enrolled in the phase I/II study of Nectin-4 ADC 9MW2821. Among 115 patients with solid tumor treated with 9MW2821 at 1.25mg/kg or above and evaluable for tumor assessment, objective response rate (ORR) and disease control rate (DCR) was 43.5% and 81.7%, respectively.

到目前为止，已有195名晚期实体瘤患者参加了Nectin-4 ADC 9MW2821的I/II期研究。在用9MW2821以1.25mg/kg或更高剂量治疗并可评估肿瘤评估的115名实体瘤患者中，客观缓解率（ORR）和疾病控制率（DCR）分别为43.5%和81.7%。

In 37 patients with UC who experienced platinum-based chemotherapy and immune checkpoint inhibitors, dosed at 1.25mg/kg and were evaluable for tumor assessment, ORR and DCR was 62.2% and 91.9%, respectively..

37例UC患者接受铂类化疗和免疫检查点抑制剂治疗，剂量为1.25mg/kg，可评估肿瘤评估，ORR和DCR分别为62.2%和91.9%。。

Core data reported on ESMO from phase I/II study of 9MW2821 showed that among 39 subjects with solid tumor who treated with 9MW2821 at 1.25mg/kg or above and evaluable for tumor assessment, ORR and DCR was 38.5% and 84.6%, respectively. In 18 patients with UC who dosed at 1.25mg/kg and evaluable for tumor assessment, ORR and DCR was 55.6% and 94.4%, respectively.

来自9MW2821的I/II期研究的ESMO报告的核心数据显示，在用9MW2821以1.25mg/kg或更高剂量治疗并且可评估肿瘤评估的39名实体瘤受试者中，ORR和DCR分别为38.5%和84.6%。在18例UC患者中，剂量为1.25mg/kg，可评估肿瘤评估，ORR和DCR分别为55.6%和94.4%。

All UC patients have been treated with platinum-based chemotherapy and immune checkpoint inhibitors before enrollment..

所有UC患者在入组前均接受铂类化疗和免疫检查点抑制剂治疗。。

The results showed that 9MW2821 had manageable safety profile. Treatment related death was not observed. Objective responses were also observed in patients with breast cancer and cervical cancer. Enrollment continues to determine efficacy of 9MW2821 in certain solid tumors.

结果显示9MW2821具有可控的安全性。没有观察到治疗相关的死亡。在乳腺癌和宫颈癌患者中也观察到客观反应。登记继续确定9MW2821在某些实体瘤中的功效。

Proactive communication on pivotal trial of 9MW2821 is ongoing.

关于9MW2821关键试验的积极沟通正在进行中。

Latest progress & phase III study data to report on ESMO 2023 of 8MW0511

最新进展和第三阶段研究数据报告8MW0511的ESMO 2023

Up to now, Mabwell is in the preparation of New Drug Application submission of 8MW0511 within the year.

到目前为止，Mabwell正在准备一年内提交8MW0511的新药申请。

Core data from phase III study of recombinant (yeast-secreted) human granulocyte-colony stimulation factor fusion protein 8MW0511 for injection, reported at ESMO, showed that 8MW0511 was clinically effective, non-inferior to the positive control. It is able to improve the incidence and duration of grade 4 neutropenia, with a significantly lower incidence and duration of grade 4 neutropenia observed at cycle 2-3 than in the positive control group.

来自ESMO报道的用于注射的重组（酵母分泌的）人粒细胞集落刺激因子融合蛋白8MW0511的III期研究的核心数据显示8MW0511在临床上有效，不逊于阳性对照。它能够改善4级中性粒细胞减少症的发生率和持续时间，在2-3周期观察到的4级中性粒细胞减少症的发生率和持续时间显着低于阳性对照组。

The overall safety profile is similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans..

整体安全性与阳性对照组相似，表明可管理的安全性和对人体的良好耐受性。。

About 9MW2821

大约9MW2821

Developed by Mabwell's ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, 9MW2821 is the first clinical stage Nectin-4-targeting ADC developed by Chinese company. Multiple clinical studies of 9MW2821 is ongoing to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with different types of advanced solid tumors..

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，9MW2821是中国公司开发的第一个临床阶段Nectin-4靶向ADC。9MW2821的多项临床研究正在进行中，以评估不同类型晚期实体瘤患者的安全性，耐受性，药代动力学和初步抗肿瘤活性。。

About 8MW0511

大约8MW0511

8MW0511 is a recombinant (yeast-secreted) human granulocyte-colony stimulation factor fusion protein, belonging to Category 1 Therapeutic Biological Products. It is indicated for use in adult patients with non-myeloid malignancies to reduce the incidence of infections manifested by febrile neutropenia when treated with myelosuppressive anticancer drugs that predispose to febrile neutropenia..

8MW0511是重组（酵母分泌的）人粒细胞集落刺激因子融合蛋白，属于1类治疗性生物制品。它适用于成人非髓系恶性肿瘤患者，当用易发生发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，可减少发热性中性粒细胞减少症所表现的感染发生率。。

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。我们提供更有效和易于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基于世界一流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，其中包括10种新型候选药物和4种生物仿制药。我们专注于肿瘤学，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, 1 product has been filed for MA approval, 1 product is in the preparation of filing, 2 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种产品已获得批准和商业化，1种产品已获得MA批准，1种产品正在准备申请，2种产品正在进行关键性试验。我们还开展了1项“重大新药开发”国家重大科技专项，2项国家重点研发项目和几个省市科技创新项目。

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

马Bwell的台州工厂拥有强大的内部制造能力，符合NMPA，FDA和EMA监管的国际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，有益健康”，我们的愿景是“从思想到现实的创新”。

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

欲了解更多信息，请访问www.mabwell.com。。

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，包括但不限于我们产品候选人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相关的潜在安全性，有效性，监管审查或批准以及商业成功。，市场机会，竞争地位，运营，业务策略，潜在增长机会和其他具有预测性的陈述的可能或假设的未来结果。

'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”是非历史事实且涉及若干风险和不确定性的陈述，这可能导致实际结果与前瞻性陈述中表达或暗示的任何未来结果大不相同。这些陈述可以通过使用前瞻性表达来识别，包括但不限于“期望”，“预期”，“意图”，“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否定性。。

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；我们依赖我们的候选产品，其中大部分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；临床试验固有的不确定性；我们有能力为我们的产品候选人完成所需的临床试验，并获得监管部门对我们产品候选人的批准；我们保护知识产权的能力；COVID-19的潜在影响；任何执行官或主要人员的流失。

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.

本公司警告所有人员不要过分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才发表。除法律和适用股权机构的规则明确要求公开更新或修改任何此类声明以反映任何此类声明可能基于的期望或事件，条件或情况的任何变化外，本公司不承担任何义务，或者可能会影响实际结果与前瞻性陈述中提出的结果不同的可能性。

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

来源Mabwell