NTQ5082 / Sino Biopharm - LARVOL DELTA

Efficacy and safety of NTQ5082 monotherapy in complement-inhibitor-Naïve patients with paroxysmal nocturnal hemoglobinuria: A proof-of-concept, multicenter, randomized, open-label phase 2 study [WITHDRAWN] (ASH 2025) - P2 | "NTQ5082 monotherapy at 100 mg or 200 mg once daily led to rapid and durable hemolysiscontrol and transfusion-free improvement in Hb levels in complement inhibitor-naïve PNH patients. Bothdosages of NTQ5082 were well tolerated. With its once-daily dosing regimen, robust improvement in Hb,and a favorable safety profile, NTQ5082 is positioned as a highly competitive CFB inhibitor for thetreatment of PNH."

Clinical • Monotherapy • P2 data • Anemia • Aplastic Anemia • Cardiovascular • Complement-mediated Rare Disorders • Hematological Disorders • Infectious Disease • Meningococcal Infections • Paroxysmal Nocturnal Hemoglobinuria • Pneumococcal Infections • Pneumonia • Rare Diseases • Respiratory Diseases • Thrombosis • CFB

NTQ5082-201: A Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Jul 2027

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

A Long-term Efficacy and Safety of NTQ5082 Capsules (clinicaltrials.gov) - P3 | N=78 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

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

A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients (clinicaltrials.gov) - P3 | N=78 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

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

Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

New P2 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

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

Effect of Food of NTQ5082 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

New P1 trial

A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

New P1 trial