HS-10542 / Jiangsu Hansoh Pharma - LARVOL DELTA

HS-10542, A ONCE-DAILY NOVEL SMALL-MOLECULE FACTOR B INHIBITOR, IN HEALTHY PARTICIPANTS: A FIRST-IN-HUMAN PHASE 1 TRIAL (ISN-WCN 2026) - P1 | "Throughout all time points up to 24 hours after last dosing of MAD, mean inhibition of AP exceeded 90% (92-100%) across doses, with >95% inhibition at 24 hours after last dosing of MAD across doses.Conclusion HS-10542 demonstrated favorable tolerability, safety, PK and robust inhibition of AP activity, supporting once daily dosing in clinical trials of complement-mediated diseases.I have potential conflict of interest to disclose.• Yusong Zhu, Jian Yang, Ran Liu, Wei Liu and Xiaoqing Zhang are the employees of Shanghai Hansoh Biomedical Co., Ltd. • Other authors disclaimed no related conflict of interest.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • First-in-human • P1 data • Complement-mediated Rare Disorders • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • CFB

Efficacy and Safety Study of HS-10542 for IgA Nephropathy (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P2 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1/2 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • HP

HS-10542 Study in Healthy Participants (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial

THE CLINICAL TRIAL APPROVAL FOR HS-10542 CAPSULES ISSUED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (Hansoh Pharma Press Release) - "The board of directors...of Hansoh Pharmaceutical Group Company Limited...is pleased to announce that, HS-10542 capsules, a Category 1 innovative drug self-developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration (NMPA) of China, which is intended to be investigated in clinical trials for paroxysmal nocturnal hemoglobinuria (PNH), and immunoglobulin A nephropathy (IgAN)."

New trial • IgA Nephropathy • Paroxysmal Nocturnal Hemoglobinuria