FXS6837 / Fosun Pharma, Sitala Bio - LARVOL DELTA

FXS6837 for the Treatment for IgAN Patients?Longterm Study? (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

New P2 trial • Glomerulonephritis • IgA Nephropathy

A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH. (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

New P3 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

XH-S003-II-102: A Multicenter, Open-label Study Evaluating the Long-term Safety and Efficacy of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P=N/A | N=26 | Enrolling by invitation | Sponsor: S-INFINITY Pharmaceuticals Co., Ltd

New trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

FXS6837 for the Treatment of IgAN Patients (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

New P2 trial • Glomerulonephritis • IgA Nephropathy

First-in-Human Trial of XH-S003, a Small Molecule Complement Factor B Inhibitor, Shows Favorable Pharmacokinetics and Complete Suppression of Alternative Pathway in Healthy Volunteers in Australia (KIDNEY WEEK 2025) - P1 | "These results support further clinical development of XH-S003. (NCT05946876)"

Clinical • First-in-human • P1 data • PK/PD data • Complement-mediated Rare Disorders • Glomerulonephritis • IgA Nephropathy • Inflammation • Nephrology • Renal Disease • CFB

XH-S003, a Small Molecule Complement Factor B Inhibitor, Shows Favorable Pharmacokinetics and Complete Suppression of an Alternative Pathway at Well-Tolerated Doses in Healthy Volunteers in China (KIDNEY WEEK 2025) - P1 | "XH-S003 showed similar safety and PK/PD profile in healthy volunteers in China and Australia, indicating no significant ethnic differences. (NCT06272747)"

Clinical • PK/PD data • Glomerulonephritis • Renal Disease • CFB

Study of XH-S003 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: S-INFINITY Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Completed

Trial completion

XH-S003-II-101: A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: S-INFINITY Pharmaceuticals Co., Ltd

New P2 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Fosun Pharma's self-developed Class 1 innovative drug XH-S003 capsules for PNH indications approved for clinical trials [Google translation] (Sina Corp) - "On March 13, 2025, Fosun Pharma announced that its holding subsidiary Zhejiang Xinghao Pengbo Pharmaceutical Co., Ltd. (hereinafter referred to as 'Xinghao Pengbo') recently received approval from the National Medical Products Administration to conduct clinical trials of XH-S003 capsules (application registration classification: Class 1 chemical drugs; hereinafter referred to as 'XH-S003') for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Xinghao Pengbo plans to conduct Phase II clinical trials in China (excluding Hong Kong, Macao and Taiwan, the same below) when conditions are met."

New P2 trial • Paroxysmal Nocturnal Hemoglobinuria

A Phase 1 Study of XH-S003 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=77 | Completed | Sponsor: S-Infinity Pharmaceuticals Co., Ltd | Recruiting ➔ Completed

Trial completion