SHR-2004 / Jiangsu Hengrui Pharma - LARVOL DELTA

SHR-2004, a Humanized Monoclonal Antibody Targeting Factor XI, for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active-Controlled Phase 2 Study. (PubMed, Am J Hematol) - P2 | "Patients with newly diagnosed Stage III-IV or recurrent ovarian cancer scheduled for surgery were randomly assigned (1:1) to receive subcutaneous SHR-2004 (180 mg on Day 1 and 120 mg on Day 15) or enoxaparin-rivaroxaban (subcutaneous enoxaparin 40 mg once daily during hospitalization, followed by oral rivaroxaban 10 mg once daily after discharge until Day 28). The twice-monthly dosing schedule offers a potential advantage over daily anticoagulation, supporting further investigation in adequately powered Phase 3 trials. Trial Registration: ClinicalTrials.gov identifier: NCT06220123."

Journal • P2 data • Cardiovascular • Oncology • Ovarian Cancer • Solid Tumor • Venous Thromboembolism

Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Completed | N=48 ➔ 10

Enrollment change • Trial completion • Atrial Fibrillation • Cardiovascular

Efficacy and safety of SHR-2004 for venous thromboembolism prevention after elective total knee arthroplasty: results from a randomized, double-blind, active-controlled phase 3 study (ISTH 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Orthopedics • Venous Thromboembolism

A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P3 | N=1166 | Completed | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Trial completion date: Dec 2026 ➔ Apr 2026 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P3 | N=1166 | Active, not recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Factor XI Monoclonal Antibody SHR-2004 in Healthy Subjects (ASH 2023) - P1 | "Single intravenous infusion (0.1-1.0 mg/kg) and subcutaneous injection (0.5-4.5 mg/kg) of SHR-2004 are safe and well tolerated. SHR-2004 showed predictable PK with a relatively slowly elimination, which supports administration once a month in the future clinical and market. The encouraging PD data demonstrated a fast and sustained anticoagulant effect."

Clinical • First-in-human • P1 data • PK/PD data • Cardiovascular • Thrombosis

Pharmacokinetics and pharmacodynamics of SHR-2004, a novel humanized monoclonal antibody targeting factor XI, in patients with atrial fibrillation (ESC-WCC 2025) - "Multiple subcutaneous doses of SHR-2004 were safe and well tolerated in patients with AF, particularly regarding the low risk of bleeding. The safety, PK, and PD data from this trial support further exploration of SHR-2004 in patients with AF."

Clinical • PK/PD data • Atrial Fibrillation • Cardiovascular • Venous Thromboembolism

A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery (clinicaltrials.gov) - P2 | N=225 | Completed | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Completed | N=350 ➔ 225 | Trial completion date: Jul 2025 ➔ Dec 2024 | Trial primary completion date: Jun 2025 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Oncology • Ovarian Cancer • Solid Tumor • Venous Thromboembolism

Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P3 | N=1167 | Recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

2025 ESGO︱Hengrui Medicine's Phase II study results of its innovative anticoagulant drug SHR-2004 injection were presented in an oral presentation [Google translation] (Jiangsu Hengrui Press Release) - P2 | N=350 | NCT06220123 | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | "The results of this study showed that subcutaneous injection of SHR-2004 in patients with ovarian cancer after surgery showed encouraging efficacy in preventing VTE, with good safety....Based on the modified intention-to-treat (mITT) set, 11 of 87 subjects (12.6%) in the SHR-2004 group developed VTE, and 19 of 94 subjects (20.2%) in the positive control group developed VTE, with a rate difference of -8.4% (95% CI, -19.9 to 3.1; p value for non-inferiority was 0.0110). No subject in the SHR-2004 group developed major VTE (including non-fatal PE and proximal DVT) or VTE-related death, while 4 subjects (4.3%) in the positive control group developed major VTE or VTE-related death, with a rate difference of -4.4% (95% CI, -8.7 to -0.1; p=0.0428)."

P2 data • Ovarian Cancer • Venous Thromboembolism

Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P3 | N=1167 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P3 trial • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P2 | N=353 | Completed | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Jun 2024

Trial completion • Trial completion date • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. (PubMed, Expert Opin Investig Drugs) - P1 | "SHR-2004 is a promising candidate for further development as an anticoagulant drug that exerts effective anticoagulation with minimal risk of bleeding. www.clinicaltrials.gov identifier is NCT05369767."

Clinical • Journal • P1 data • PK/PD data • Cardiovascular

Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P1 trial • Atrial Fibrillation • Cardiovascular

A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery (clinicaltrials.gov) - P2 | N=350 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P2 trial • Surgery • Cardiovascular • Oncology • Ovarian Cancer • Solid Tumor • Venous Thromboembolism

SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P2 | N=316 | Recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P2 | N=316 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P2 trial • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hematological Disorders • Thrombosis • Venous Thromboembolism

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hematological Disorders • Thrombosis • Venous Thromboembolism

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

New P1 trial • Cardiovascular • Hematological Disorders • Thrombosis • Venous Thromboembolism