MHB039A / Minghui Pharma - LARVOL DELTA

A Study of MHB039A for Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=196 | Active, not recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Solid Tumor

A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=116 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P1/2 trial • Solid Tumor

A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P1/2 trial • Lung Cancer • Oncology • Solid Tumor

A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Minghui raises $131M 'pre-IPO' round to bankroll JAK inhibitor launch, ADC trials (FierceBiotech) - "Minghui Pharmaceutical has secured $131 million in what the company describes as a “pre-IPO” round to fuel the potential launch of its dermatitis cream in China as well as various clinical-stage oncology and immunology assets...The Shanghai-based biotech said part of the funds will be used to support a hoped-for commercial launch in China of MH004, a phase 3-stage pan-JAK inhibitor topical cream...Some of the fresh funds will also be used to push forward with Minghui’s various clinical programs, including a PD-1/VEGF bispecific antibody called MHB039A and a TROP-2-directed antibody-drug conjugate dubbed MHB036C....There’s also a B7-H3-targeted ADC called MHB088C."

Financing • Atopic Dermatitis • Castration-Resistant Prostate Cancer • Dermatitis • Non Small Cell Lung Cancer

Minghui Pharmaceutical Announces First Patient Dosed in the Phase Ⅱ Combination Study of PD-1xVEGF Bispecific and TROP-2 ADC in Advanced NSCLC (The Manila Times) - P1/2 | N=196 | NCT06345482 | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | "Minghui Pharmaceutical...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)....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."

P1 data • Trial status • Non Small Cell Lung Cancer

Minghui Pharmaceutical Announces Promising Initial Results from Phase I Clinical Trial of MHB039A, a Novel PD-1 x VEGF Bispecific Antibody, in Patients with Relapsed/Refractory Solid Tumors (PRNewswire) - P1/2 | N=196 | NCT06345482 | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | "The study included a heavily pretreated patient population, with a median of three prior lines of therapy. Robust PD-1 receptor occupancy and circulating VEGF biomarker responses were observed across all dose levels. The 20 mg/kg Q3W regimen demonstrated substantial and sustained inhibition of both PD-1 and VEGF. Tumor volume reduction was noted in patients with sqNSCLC and non-sq NSCLC without actionable genomic alterations (AGA) who had previously received PD-1 inhibitors and chemotherapy, as well as in NSCLC patients with EGFR mutations who had relapsed following third-generation TKI therapy. MHB039A was well tolerated at doses up to 20 mg/kg."

P1 data • Lung Non-Squamous Non-Small Cell Cancer • Solid Tumor

A Study of MHB039A for Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=196 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P1/2 trial • Oncology • Solid Tumor