SHANGHAI, May 8, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a late-stage clinical biopharmaceutical company focused on autoimmune diseases and oncology, will feature Dr. Lin Shen from Beijing Cancer Hospital at the upcoming ASCO Annual Meeting in Chicago. Dr. Shen will present the results from the Phase I/II clinical study of MHB088C, a well-differentiated B7-H3-targeting antibody-drug conjugate (ADC) for recurrent or metastatic solid tumors, in an oral presentation..

上海，2024年5月8日/PRNewswire/--明辉制药有限公司，一家专注于自身免疫性疾病和肿瘤学的晚期临床生物制药公司，将在即将在芝加哥举行的ASCO年会上邀请北京癌症医院的林申博士参加。沈博士将在口服报告中介绍MHB088C（一种用于复发或转移性实体瘤的分化良好的B7-H3靶向抗体-药物偶联物（ADC））的I/II期临床研究结果。。

Oral Presentation

口头陈述

Abstract Title: Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors

摘要标题：MHB088C的1/2期研究结果：一种新型B7-H3抗体-药物偶联物（ADC），在复发或转移性实体瘤中掺入有效的DNA拓扑异构酶I抑制剂

Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

课程名称：发育疗法-分子靶向药物和肿瘤生物学

Session Date and Time: 6/3/2024; 8:00 AM-9:30 AM CDT

会议日期和时间：2024年6月3日；8： CDT上午00:00-9:30

Presentation Time/Duration: 8:00 AM – 8:06 AM CDT

演示时间/持续时间：CDT上午8:00–上午8:06

Presenter: Dr. Lin Shen

主持人：林深博士

Abstract ID: 3012

摘要编号：3012

About MHB088C

关于MHB088C

MHB088C is a novel B7-H3 ADC generated through Minghui's SuperTopoiTM ADC platform. Minghui's proprietary payload is 5 to 10 times more potent than Dxd, retaining key advantages such as bystander effect while eliminating the risk of interstitial lung disease. Conjugated with Minghui's proprietary B7-H3 antibody, which has superior binding and internalization compared to the competitor's antibodies, MHB088C has demonstrated remarkable anti-tumor efficacy across various cancer types.

MHB088C是通过明辉的SuperTopoiTM ADC平台生成的新型B7-H3 ADC。明辉专有的有效载荷比Dxd的效力高5到10倍，保留了旁观者效应等关键优势，同时消除了间质性肺病的风险。MHB088C与明辉专有的B7-H3抗体结合，与竞争对手的抗体相比具有优异的结合和内化作用，已在各种癌症类型中表现出显着的抗肿瘤功效。

It was 3 to 10 times more potent in killing tumor cells than the competitor's compound in xenograft models..

它在异种移植模型中杀死肿瘤细胞的效力是竞争对手化合物的3至10倍。。

Preclinical GLP tox studies revealed an excellent safety profile, with no unique toxicities, particularly no pulmonary toxicities. The highest non-severely toxic dose (HNSTD) was identified at 30 mg/kg, administered once every two weeks (Q2W) for a total of seven doses. The first patient in the Phase I/II study was enrolled on June 20, 2023.

临床前GLP-tox研究显示出良好的安全性，没有独特的毒性，特别是没有肺部毒性。最高的非严重毒性剂量（HNSTD）为30 mg/kg，每两周（Q2W）给药一次，共七剂。I/II期研究的第一名患者于2023年6月20日入选。

Since then, over 150 patients with different tumor types have been enrolled and received at least one dose of MHB088C, showing promising efficacy and a favorable safety profile. Registrational trials for selected tumor types are expected to start by the end of the year..

从那时起，已经招募了150多名不同肿瘤类型的患者，并接受了至少一剂MHB088C，显示出有希望的疗效和良好的安全性。预计年底将开始选定肿瘤类型的注册试验。。

About Minghui Pharmaceutical

明辉药业简介

Minghui Pharmaceutical, Inc. is a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs in oncology and autoimmune diseases. Leveraging the expertise in medical science and the proprietary technology platforms, the company is developing a rich clinical-stage pipeline including a variety of first-in-class or best-in-class product candidates.

明辉制药有限公司是一家晚期临床生物制药公司，致力于开发创新药物，以满足肿瘤学和自身免疫性疾病未满足的医疗需求。利用医学专业知识和专有技术平台，该公司正在开发丰富的临床阶段管道，包括各种一流或一流的候选产品。

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

欲了解更多信息，请访问www.minghuipharma.com。。

Forward-Looking Statements

前瞻性声明

This press release provided by Minghui Pharmaceutical Inc. (the 'Company') contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'potential,' 'possible,' 'predict,' 'should,' 'will,' 'would' or words of similar meaning.

明辉制药股份有限公司（以下简称“公司”）提供的这份新闻稿包含1995年《美国私人证券诉讼改革法案》安全港条款含义范围内的前瞻性声明，其中可能附有“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“打算”、“可能”、“计划”、“潜力”、“可能”、“预测”、“应该”、“将会”、“将会”或类似含义的词语。

These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s).

这些声明基于公司当前的信念和期望，并受到可能导致实际结果与本文声明中所述结果存在重大差异的风险和不确定性的影响。风险和不确定性包括但不限于：一般行业条件和竞争；公司和合作方业务的经济和财务状况发生变化；临床试验因任何原因停止或延迟的风险，包括疗效，安全性，登记或制造；早期临床试验成功的风险可能无法预测后期试验或其他潜在适应症试验的结果；临床试验中阳性结果可能无法在后续或验证性试验中复制的风险；对监管部门批准的期望；为公司产品和候选产品获得、维护和实施专利和其他知识产权保护的挑战。

These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein..

这些前瞻性声明仅在发布到本网站之日起生效，本公司无义务更新此处包含的任何前瞻性声明。。

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SOURCE Minghui Pharmaceutical, Inc.

来源明辉制药有限公司。