MHB088C / Minghui Pharma, Qilu Pharma - LARVOL DELTA

A Phase 2 Trial of QLC5508 (MHB088C) Plus QL1706 or QL2107 as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (IASLC-WCLC 2026) - "This study aimed to evaluate the efficacy and safety of QLC5508 in combination with QL1706 (iparomlimab and tuvonralimab, a bifunctional antibody targeting PD-1 and CTLA-4) or QL2107 (a pembrolizumab biosimilar) as first-line treatment in patients with ES-SCLC. Conclusions : QLC5508 in combination with QL1706 or QL2107 as first-line treatment showed promising anti-tumor activity and a manageable safety profile in patients with ES-SCLC. The combined regimen of B7H3 ADC plus PD-1 or PD-1/CTLA-4 antibody is a potential therapy for ES-SCLC and worthy of further exploration."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Safety and Efficacy of QLC5508 (MHB088C) in patients (pts) with solid tumors: data from a phase 1/2 trial (ESMO 2026) - No abstract available

Clinical • P1/2 data • 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

A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-nave Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=556 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

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

Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

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

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

QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

QLC5508 in Participants With Metastatic Prostate Cancer (clinicaltrials.gov) - P3 | N=700 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=212 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Safety and efficacy of QLC5508 (MHB088C) in heavily-treated patients with metastatic castration-resistant prostate cancer: Updated data from a phase 1/2 trial. (ASCO 2026) - P1/2 | "QLC5508 showed prolonged rPFS as well as manageable safety profile in heavily treated pts with mCRPC. A phase 3 study is currently being planned."

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor

QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=466 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=466 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Efficacy and safety of MHB088C in patients with advanced extrapulmonary neuroendocrine carcinoma after platinum-based therapy failure: An open-label, single-arm, single-center phase II study (ENETS 2026) - P2 | "MHB088C demonstrated promising antitumor acti - vity and manageable safety in patients with advanced EP-NEC after platinum-based therapy failure. These findings support fur - ther evaluation of B7-H3–targeted therapy in this population."

Clinical • Metastases • P2 data • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • TOP1

QLC5508-201: A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=444 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • 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

An open-label, multicenter Phase Ib/II clinical study on the safety, tolerability, pharmacokinetics, and efficacy of QLC5508 injection combined therapy in patients with advanced solid tumors (ChiCTR) - P1/2 | N=414 | Not yet recruiting | Sponsor: Shanghai East Hospital; Qilu Pharmaceutical Co.

New P1/2 trial • Solid Tumor

A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=212 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

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

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