SHR-2010 / Jiangsu Hengrui Pharma - LARVOL DELTA

Characterization of a Long-Acting Anti-Human MASP-2 Antibody for the Treatment of Complement-Related Diseases. (PubMed, J Inflamm Res) - "Preclinical studies demonstrated that SHR-2010 exhibited superior pharmacokinetics and sustained lectin pathway inhibition compared to OMS721. When coupled with optimized trial design strategies, SHR-2010 could be a promising therapeutic candidate for lectin pathway-driven diseases, including IgAN."

Journal • Acute Kidney Injury • Bone Marrow Transplantation • Glomerulonephritis • IgA Nephropathy • Inflammation • Nephrology • Rare Diseases • Renal Disease • Transplantation

Safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-2010, a novel anti-MASP-2 antibody, in healthy volunteers: a randomized, double-blind, placebo-controlled phase 1 study. (PubMed, Expert Opin Investig Drugs) - P1 | "SHR-2010 was safe and well tolerated after a single dose and exhibited robust blockade of the lectin pathway, supporting further development. The trial is registered at ClinicalTrials.gov (NCT05398510)."

Clinical • Journal • P1 data • PK/PD data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=53 | Terminated | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=76 ➔ 53 | Trial completion date: Apr 2026 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Jan 2025; Based on the adjustment of the R & D strategy, the sponsor decides to terminate the research.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject (clinicaltrials.gov) - P1 | N=61 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease