HRS-5965 / Jiangsu Hengrui Pharma - LARVOL DELTA

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

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) - No abstract available

Clinical • P2 data • 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

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 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Hematological Disorders

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

HRS-5965-103: Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • 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=35 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P3 trial • 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=70 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P1 trial • Hepatology • Renal Disease

A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P1 trial • Anemia • Hematological Disorders

Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency (clinicaltrials.gov) - P1 | N=83 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Nov 2023 | Trial primary completion date: Apr 2023 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Glomerulonephritis • Lupus Nephritis • Nephrology • Renal Disease

HRS-5965-105: A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Renal Disease

Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=26 | Completed | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Mar 2024 | Trial primary completion date: Oct 2024 ➔ Mar 2024

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

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=70 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

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

A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

New P1 trial • Renal Disease

Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Dec 2024

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

Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=18 | 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

HRS-5965-203: Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

HRS-5965-203: Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

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

Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=26 | 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

A Trial of HRS-5965 Tablets in Primary IgA Nephropathy (clinicaltrials.gov) - P2 | N=105 | Not yet recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Trial completion date • Trial initiation date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Chengdu Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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