MHB088C / Minghui Pharma, Qilu Pharma - LARVOL DELTA

Study of MHB088C for Patients With Advanced Solid Malignant Tumors (clinicaltrials.gov) - P1/2 | N=515 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Lung Cancer • Small Cell Lung Cancer • 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

Safety and Efficacy of QLC5508 in Previously Treated Patients with Small Cell Lung Cancer: Updated Data from a Phase 1 Study (IASLC-WCLC 2025) - "Eleven (10.4%) patients had prior treatment of irinotecan. In conclusion, QLC5508 showed prolonged survival as well as manageable and tolerable safety profile in previously treated patients with ES-SCLC. QLC5508 2.0 mg/kg Q2W is being evaluated in an ongoing phase 3 study."

Clinical • P1 data • Cachexia • Interstitial Lung Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase III study of MHB088C comparing physicians' treatment of choice in recurrent small cell lung cancer (ChiCTR) - P3 | N=450 | Not yet recruiting | Sponsor: Shanghai East Hospital; Shanghai East Hospital

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Efficacy and safety of MHB088C, a novel B7-H3-targeted ADC, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC): Subgroup analysis from a phase 1/2 multicenter study. (ASCO 2025) - P1/2 | "MHB088C demonstrated promising anti-tumor activity and favorable safety in previously treated pts with ES-SCLC. A Phase 3 study is planned to compare the efficacy and safety of MHB088C with standard-of-care chemotherapy in relapsed ES-SCLC."

Clinical • P1/2 data • Anemia • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Promising early results of MHB088C (B7-H3 ADC) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) from a phase 1/2 multicenter study. (ASCO 2025) - P1/2 | "These pts were heavily pretreated, with 100% having received novel androgen axis drugs (NAAD) and 80% having received docetaxel... MHB088C demonstrated a manageable safety profile and promising anti-tumor activity in heavily pretreated pts with mCRPC. The preliminary safety and efficacy data are encouraging and warrant further investigation."

Clinical • Metastases • P1/2 data • Anemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • CD276

Minghui Pharmaceutical Announces Strategic Partnership and Licensing Agreement with Qilu Pharmaceutical to Develop B7-H3 ADC in Greater China (PRNewswire) - "Minghui Pharmaceutical...announced an exclusive licensing and collaboration agreement with Qilu Pharmaceutical ('Qilu') for the development, manufacturing, and commercialization of its B7-H3 ADC (MHB088C) in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan). Under the agreement, Qilu will obtain exclusive rights to MHB088C in the region, while Minghui will be eligible for total payments of up to 1.345 billion RMB, including: 280 million RMB upfront and a near-term milestone payment, 1.065 billion RMB in development, regulatory and sales milestone payments, and up to double-digit royalties on net product sales. Minghui will retain global rights to MHB088C outside Greater China and continue advancing its development in these regions....Subgroup analyses in small cell lung cancer (SCLC) and metastatic castration-resistant prostate cancer (mCRPC) will be presented at the ASCO 2025 Annual Meeting as oral and poster presentations, respectively."

Licensing / partnership • P1/2 data • Castration-Resistant Prostate Cancer • Small Cell Lung Cancer

A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Beijing GoBroad Hospital

New P2 trial • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. (ASCO 2024) - "Preclinical studies demonstrated robust binding affinity, superior internalization rates, powerful tumor killing activities (3~10 times more potent than the DS-7300a analog in CDX models) and a favorable safety profile with no unique toxicities observed in the GLP study as compared to other B7H3 ADCs and no occurrences of interstitial lung disease (ILD). MHB088C exhibited a manageable safety profile, with striking efficacy in SCLC pts. The dose optimization and expansion study is continuing to establish the RP2D for MHB088C."

Metastases • P1/2 data • Anemia • Febrile Neutropenia • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CD276

Minghui Pharmaceutical Presents Phase 1/2 Clinical Data of MHB088C (B7-H3 ADC) as Monotherapy for the Treatment of Patients with Recurrent or Metastatic Solid Tumors at the 2024 ASCO Annual Meeting (PRNewswire) - P1/2 | N=48 | NCT05652855 | Sponsor: Minghui Pharmaceutical Pty Ltd | "Minghui Pharmaceutical, Inc...announced today that the preliminary Phase 1/2 clinical data of MHB088C (B7-H3 ADC) was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in an oral presentation...At data cutoff, MHB088C was well tolerated. The most common TRAEs were hematological toxicities. 4 mg/kg Q3W was the DLT dose and 3 mg/kg Q3W was defined as the MTD. 1.6 mg/kg Q2W, 2.0 mg/kg Q3W and 2.4 mg/kg Q3W demonstrated favorable safety profiles with low single-digit Grade ≥3 hematological AEs for the two lower doses....Of 98 efficacy evaluable pts with different tumor types at doses ranging from 0.8 mg/kg to 4.0mg/kg, ORR was 33.7% (33/98) and DCR was 83.7% (82/98), with DoR not reached yet. The majority of pts remain on the treatment....'We look forward to initiating registrational trials of the monotherapy for selected tumor types by the end of 2024...'"

New trial • P1/2 data • Esophageal Squamous Cell Carcinoma • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Minghui Pharmaceutical to Present the Phase I/II Study of MHB088C (B7-H3 ADC) for the Treatment of Patients with Recurrent or Metastatic Solid Tumors in Late-breaking Oral Presentation at the 2024 ASCO Annual Meeting (PRNewswire) - "Minghui Pharmaceutical...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."

P1/2 data • Solid Tumor

Minghui Pharmaceutical Inc. Announces First Patient Dosing in Phase 1 Clinical Studies of Both the Antibody-Drug Conjugate Programs Targeting TROP-2 or B7-H3 Respectively, for Treatment of Advanced or Metastatic Solid Tumors (PRNewswire) - "Minghui Pharmaceutical, Inc...announced today that the first dosing has been completed in two phase 1 clinical studies evaluating MHB036C and MHB088C. The studies aim to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), as well as assess the pharmacokinetics and preliminary efficacy of the ADCs in patients with selected types of advanced or metastatic solid tumors....'MHB036C and MHB088C hold great promise in the fight against various human solid tumors and we look forward to the results from the phase 1 studies, anticipated to conclude in early 2024'."

P1 data • Trial status • Oncology • Solid Tumor

Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: Minghui Pharmaceutical Pty Ltd

New P1/2 trial • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • CD276 • MSI