LP-005 / Longbio Pharma - LARVOL DELTA

LP-005, A BIFUNCTIONAL ANTIBODY, DEMONSTRATES SUSTAINED EFFICACY AND A FAVORABLE SAFETY PROFILE IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH): UPDATED RESULTS FROM A PHASE Ⅱ STUDY (EHA 2026) - P2 | "Summary/Conclusion Updated data from this Phase Ⅱ study confirm that LP-005 achieves sustained control of complement-mediated hemolysis in patients with PNH, with durable hemoglobin improvements, maintained transfusion independence, and a favorable safety profile. These findings support LP-005 as a promising novel monotherapy for PNH."

Clinical • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Longbio Pharma (Suzhou) Co., Ltd.

New P2 trial • Dental Disorders • Periodontitis

Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Longbio Pharma

New P2 trial • Nephrology • Renal Disease

Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients. (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Longbio Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Longbio Pharma | Recruiting ➔ Completed

Trial completion • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

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