HRS-5965 / Jiangsu Hengrui Pharma - LARVOL DELTA

HRS-5965-103: Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Jan 2026 | Trial primary completion date: Mar 2025 ➔ Jan 2026

Trial completion • Trial completion date • Trial primary completion date • Hepatology • Renal Disease

Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment (clinicaltrials.gov) - P3 | N=39 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

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

Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Complement-mediated Rare Disorders • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Renal Disease

HRS-5965-203: Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

Multicenter, Randomized Phase 2 Study Evaluating the Efficacy and Safety of HRS-5965 in Patients with Primary IgAN (KIDNEY WEEK 2025) - "Most common TEAEs (＞ 10%) in HRS-5965 groups were upper respiratory tract infection and hyperuricemia. Conclusion HRS-5965 showed proteinuria reduction in IgAN patients with acceptable safety and tolerability, which will further support the evaluation of HRS-5965 in phase 3 clinical trials."

Clinical • Late-breaking abstract • P2 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Inflammation • Respiratory Diseases • CFB

Efficacy and Safety of HRS-5965 Monotherapy in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Not Received Complement Inhibitors: A Proof-of-Concept, Multicenter, Randomized, Open-Label Study (ASH 2024) - P2 | "Both dosages were well-tolerated. This study provides evidence that HRS-5965 might represent a novel treatment option for this patient population."

Clinical • Monotherapy • Anemia • Aplastic Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • CFB

Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment (clinicaltrials.gov) - P3 | N=39 | Active, not recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

HRS-5965-301: A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy (clinicaltrials.gov) - P3 | N=76 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

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

A Trial of HRS-5965 Capsule in Primary IgA Nephropathy (clinicaltrials.gov) - P3 | N=378 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Anemia • Hematological Disorders • Renal Disease

Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Anemia • Hematological Disorders • Renal Disease

A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Complement-mediated Rare Disorders • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Renal Disease

HRS-5965-106: A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Completed

Trial completion • Anemia • Hematological Disorders

Efficacy and safety of HRS-5965 monotherapy in complement inhibitor-naïve patients with paroxysmal nocturnal haemoglobinuria. (PubMed, Br J Haematol) - "The most common treatment-related adverse events were mild lab abnormalities, including increased alkaline phosphatase and alanine aminotransferase. In conclusion, HRS-5965 monotherapy at either 50 or 75 mg BID resulted in substantial Hb improvements and reduced haemolysis with an acceptable safety profile, suggesting its potential as a promising oral therapy for complement inhibitor-naïve PNH patients."

Journal • Monotherapy • Cardiovascular • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Thrombosis • CFB

Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P1 trial • Anemia • Hematological Disorders • Renal Disease

A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P1 trial • Complement-mediated Rare Disorders • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Renal Disease

Efficacy And Safety Of Hrs-5965 In Patients With Primary Immunoglobulin A Nephropathy (Igan): A Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Trial (ERA 2025) - P1, P2 | "Consistent with its mechanism of action, HRS-5965 results in clinically meaningful proteinuria reduction with in IgAN patients at 12 weeks compared with placebo. This suggests that HRS- 5965 may reduce the risk of chronic kidney disease progression. These results reinforce the therapeutic rationale for selective AP inhibitors and further support the evaluation of HRS-5965 in phase 3 clinical trials for treating IgAN."

Clinical • P2 data • Anemia • Chronic Kidney Disease • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Infectious Disease • Inflammation • Renal Disease • Respiratory Diseases • CFB

A Trial of HRS-5965 Capsule in Primary IgA Nephropathy (clinicaltrials.gov) - P3 | N=378 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

HRS-5965-203: Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | N=24 ➔ 120

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

HRS-5965, a small-molecule factor B inhibitor, in healthy participants and participants with renal insufficiency: A first-in-human, phase 1 trial. (PubMed, Med) - P1 | "HRS-5965 demonstrated favorable safety and robust inhibition of alternative pathway activity, supporting further clinical development."

Clinical • Journal • P1 data • Nephrology • Renal Disease • CFB

A Trial of HRS-5965 Tablets in Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=123 | Active, not recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • IgA Nephropathy • Renal Disease

Must-read for the stock market on March 31: Hengrui Medicine (600276) had a net outflow of 57.4687 million yuan of main funds on that day, accounting for 1.49% of the total transaction volume [Google translation] (Stockstar) - "HRS-5965 capsules of Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, have been included in the public list of proposed breakthrough therapies, with the proposed indication being primary IgA nephropathy."

Breakthrough therapy • IgA Nephropathy

A Trial of HRS-5965 Tablets in Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=115 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2025 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

HRS-5965-301: A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy (clinicaltrials.gov) - P3 | N=76 | Active, not recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

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

Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment (clinicaltrials.gov) - P3 | N=35 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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