Minghui Pharmaceutical Announces First Patient Dosed in the Phase Ⅱ Combination Study of PD-1xVEGF Bispecific and TROP-2 ADC in Advanced NSCLC

SHANGHAI, May 20, 2025 /PRNewswire/ -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative therapies in immunology and oncology, today announced that the first patient has been successfully dosed in a Phase Ⅱ clinical trial evaluating the safety and efficacy of an investigational combination therapy with MHB039A, a PD-1xVEGF bispecific antibody, and MHB036C, a TROP-2-directed antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC).

MHB039A is a novel bispecific antibody targeting PD-1 and VEGF. It demonstrated full blocking activities against both PD-1 and VEGF with superior PD-1 activity compared to competitor antibodies. In a completed Phase Ⅰ dose-escalation study, MHB039A was well-tolerated at doses up to 30 mg/kg, with no DLTs observed and the MTD not reached. The safety profile was consistent with that of previously reported PD-1xVEGF bispecifics. Robust PD-1 receptor occupancy and VEGF biomarker responses were observed across all dose levels. Encouraging anti-tumor activity was noted in NSCLC patients who had progressed after prior PD-1 inhibitor and chemotherapy treatment.

MHB036C is a novel antibody-drug conjugate targeting TROP-2, developed using Minghui's proprietary SuperTopoi™ ADC platform. In ongoing Phase 1/2 studies, MHB036C has been evaluated in 138 patients with advanced or metastatic solid tumors. The ADC has demonstrated a favorable safety profile, with no major hematologic adverse events and ILD. Promising anti-tumor activity has been observed in heavily pre-treated NSCLC and breast cancer patients.

"We are excited to initiate this Phase Ⅱ trial investigating the combination therapy with MHB039A and MHB036C in advanced NSCLC," said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "Emerging clinical data increasingly support the potential of combining ADCs with immuno-oncology (I/O) agents to achieve more robust and durable anti-tumor responses across multiple solid tumors. We believe these combinations will play a pivotal role in reshaping the standard-of-care treatment paradigms. Our PD-1xVEGF bispecific antibody offers a promising new backbone for I/O-based combination therapies."

Dr. Cao added, "This trial underscores our strategic focus on developing ADCs and PD-1xVEGF bispecific combination therapies and establishes a strong foundation for extending this approach to other solid tumors, including breast cancer."

About Minghui Pharmaceutical

Minghui Pharmaceutical is a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address unmet medical needs in oncology and autoimmune diseases. With expertise in medical science and proprietary technology platforms, the company has built a diverse clinical-stage pipeline, including novel ADC programs and a PD-1xVEGF bispecific antibody. Minghui is committed to advancing breakthrough therapies that improve patient outcomes worldwide. For more information, please visit www.minghuipharma.com.

Forward-Looking Statements

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. 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). 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.

View original content:https://www.prnewswire.com/news-releases/minghui-pharmaceutical-announces-first-patient-dosed-in-the-phase--combination-study-of-pd-1xvegf-bispecific-and-trop-2-adc-in-advanced-nsclc-302460254.html

SOURCE Minghui Pharmaceutical