LP-005 / Longbio Pharma - LARVOL DELTA

LP-005, a bifunctional C5 antibody fusion protein, efficacy and safety in PNH patients with active hemolysis: Updated results from a Phase 2 study at 12/24 weeks (ASH 2025) - "The current standard-of-care for PNH consists of anti-C5 blockade with eculizumab to control intravascular hemolysis (IVH). Updated Phase 2 results show LP-005, a bifunctional complement inhibitor, providessustained clinical benefits and favorable safety in PNH patients with active hemolysis, demonstratingpotential superiority over single-pathway inhibitors with best-in-class efficacy and improved treatmentconvenience."

Clinical • P2 data • Anemia • Aplastic Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombosis

Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Longbio Pharma

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

Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients. (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Longbio Pharma

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

BI-FUNCTIONAL C5 ANTIBODY-FUSION PROTEIN (LP-005) WITH POTENTIAL BEST-IN-CLASS BIOACTIVITY FOR COMPLEMENT INHIBITION (ISN-WCN 2024) - " The sequence of Eculizumab, Ravulizumab, Crovalimab, Pozelimab, Narsoplimab, were obtained from INN. In summary, LP-005 is a novel bifunctional anti-C5 monoclonal antibody fusion protein, with highest bioactivity in CP, AP, LP. LP-005 is also engineered to change it surface charge (PI) and FcRn binding, which together has the potential to be a bestin-class drug candidate with improved pharmacokinetic properties and strongest in-vitro and in-vivo bioactivity."

CNS Disorders • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Inflammatory Arthritis • Lupus • Nephrology • Renal Disease

A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Longbio Pharma

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