recaticimab (SHR-1209) / Jiangsu Hengrui Pharma - LARVOL DELTA

Comparative Efficacy of Ongericimab Versus Six PCSK9 Inhibitors in Treating Hypercholesterolemia or Mixed Dyslipidemia: A Network Meta-Analysis (ISPOR-EU 2025) - "This study aimed to assess the relative lipid-lowering efficacy of ongericimab compared with other PCSK9 inhibitors through a network meta-analysis (NMA). We conducted a systematic literature review (SLR) to identify phase 3 randomized controlled trials (RCTs) of ongericimab and six other PCSK9 inhibitors (evolocumab, alirocumab, tafolecimab, recaticimab, ebronucimab, and inclisiran) assessing efficacy in adult patients with hypercholesterolemia or mixed dyslipidemia, compared with background lipid-lowering therapies. Ongericimab demonstrated superior efficacy in reducing LDL-C and Lp(a) levels compared with most existing PCSK9 inhibitors. These findings may inform clinical decisions and support formulary positioning in lipid-lowering treatment strategies."

Retrospective data • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

Impact of PCSK9 Inhibitor Recaticimab on Hyperlipidemia and Plasma Glucose: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study. (PubMed, Biomed Environ Sci) - "For participants with normal and abnormal glucose metabolism, no significant group × time interaction effects on FPG or HbA1c levels were identified. Recaticimab showed no adverse glycemic effects in participants with normal or abnormal glucose metabolism, indicating its safety in patients with or without diabetes."

Clinical • Journal • P1/2 data • Diabetes • Dyslipidemia • Metabolic Disorders

Immunogenicity of Recaticimab Does Not Impact Its Efficacy in Patients with Dyslipidemia: A Pooled Analysis of Three Phase III and One Phase Ib/II Studies (AHA 2025) - P1/2 | "The incidence of ADAs (14.1%) and Nabs (3.2%) following recaticimab treatment did not impact efficacy. ADA+ and Nab+ patients had a higher incidence of self-resolving injection site reactions compared to ADA- patients. These findings support the clinical use of recaticimab for lipid-lowering therapy, regardless of immunogenicity status."

P1/2 data • P3 data • Retrospective data • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

A phase II clinical study of adebrelimab in combination with chemotherapy and recaticimab for the treatment of immune checkpoint inhibitors pretreated NSCLC patients (ChiCTR) - P2 | N=43 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

Checkpoint inhibition • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Recaticimab in adult heterozygous familial hypercholesterolemia (REMAIN-3): A multicentre, randomised, double-blind, placebo-controlled phase 3 study. (PubMed, Cardiovasc Res) - P3 | "Recaticimab significantly lowered the LDL-C level compared with placebo, with an acceptable safety profile, providing a new effective treatment option for patients with inadequately controlled HeFH."

Journal • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • APOB

PICASSO: PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (clinicaltrials.gov) - P3 | N=5276 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P3 trial • Atherosclerosis

PISTIAS-2: PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Peking Union Medical College Hospital | Not yet recruiting ➔ Recruiting | Initiation date: May 2025 ➔ Sep 2025

Enrollment open • Trial initiation date • Atherosclerosis • Cardiovascular • Plasma NfL

An Exploration of the Clinical Efficacy of PCSK9 Inhibitors in Combination With Neoadjuvant Chemotherapy in the Treatment of Breast Malignancies: A Prospective Multicenter Randomized Controlled Clinical Trial (ChiCTR) - P1 | N=60 | Not yet recruiting | Sponsor: The First Hospital of Lanzhou University; The First Hospital of Lanzhou University

New P1 trial • Breast Cancer • Cardiovascular • Oncology

HP-BTC-002: A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. (PubMed, Clin Pharmacokinet) - P1, P1/2, P2, P3 | "No adjustment of clinical dosage is required based on the PopPK and PopPK/PD covariates. Estimated glomerular filtration rate and anti-drug antibodies are not significant covariates for any PopPK parameter. After achieving a steady state, switching the dosing regimen and prolonging the dosing interval should not cause concerns about drug efficacy."

Journal • PK/PD data • Dyslipidemia • Metabolic Disorders

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

Recaticimab: First Approval. (PubMed, Drugs) - "Recaticimab received its first approval on 8 January 2025 in China, as an adjunct to diet, in combination with statins (with or without other lipid-lowering therapies) in adults with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have not achieved their low-density lipoprotein cholesterol (LDL-C) target despite receiving moderate or higher doses of statins, and for use as monotherapy in adults with non-familial hypercholesterolemia and mixed dyslipidemia to reduce LDL-C, total cholesterol, and apolipoprotein B levels. This article summarizes the milestones in the development of recaticimab leading to this first approval for hypercholesterolemia and mixed dyslipidemia."

Journal • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia • APOB

PCSK9 Inhibitor with Statin Therapy for Asymptomatic Intracranial Atherosclerosis (PISTIAS-2): A Multicenter, Open-label, Blinded-endpoint, Randomized Controlled Trial (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New trial • Atherosclerosis • Cardiovascular

EAST-LDL: Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion (clinicaltrials.gov) - P3 | N=652 | Not yet recruiting | Sponsor: Shanghai East Hospital

New P3 trial • Cardiovascular • Ischemic stroke

An evaluation of recaticimab for the treatment of hypercholesterolemia. (PubMed, Expert Opin Biol Ther) - "Recaticimab may offer advantages over current mAbs in clinical use in terms of its long half-life, dosing interval of up to 12 weeks, and potentially a lower cost, however, long-term concerns regarding immunogenicity remain. Longer-term studies in a variety of more diverse patient cohorts will be needed to further evaluate the efficacy, safety, and durability of recaticimab and to ascertain the best dosing schedule for cardiovascular outcome studies."

Journal • Review • Cardiovascular • Dyslipidemia • Metabolic Disorders • APOB

A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. (PubMed, Eur J Drug Metab Pharmacokinet) - P1 | "A single subcutaneous injection of 450 mg recaticimab into the abdomen, upper-arm, or thigh was well-tolerated and presented similar PK and PD profiles, which supported the interchangeable use of the three injection sites for patients."

Journal • P1 data • PK/PD data • Dyslipidemia

Prospective, exploratory clinical study of Camrelizumab combined with Recaticimab for first-line maintenance in advanced NSCLC (ChiCTR) - P=N/A | N=37 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhengzhou University; First Affiliated Hospital of Zhengzhou University

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Long-term efficacy and safety of Recaticimab in patients with ASCVD or at high risk of ASCVD not achieving lipid targets (ChiCTR) - P4 | N=140 | Recruiting | Sponsor: Second Xiangya Hospital of CSU; Second Xiangya Hospital of CSU

New P4 trial • APOB

PISTIAS-2: PCSK9 Inhibitor with Statin Therapy for Asymptomatic Intracranial Atherosclerosis (clinicaltrials.gov) - P4 | N=300 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P4 trial • Atherosclerosis • Cardiovascular • Plasma Aβ40

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Dyslipidemia • Metabolic Disorders

Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Beijing Chest Hospital, Capital Medical University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Mar 2027 | Trial primary completion date: Dec 2025 ➔ Aug 2026

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial. (PubMed, J Am Coll Cardiol) - "Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia."

Clinical • Journal • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Genetic Disorders • Metabolic Disorders • APOB

Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia: The Phase 3 REMAIN-1 Randomized Trial. (PubMed, J Am Coll Cardiol) - "Recaticimab monotherapy yielded significant LDL-C reductions and showed comparable safety vs placebo in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate ASCVD risk, even with an infrequent dosing interval up to Q12W."

Clinical • Journal • Monotherapy • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

A Step Forward for Long-Acting PCSK9 Inhibition: Improvements Without a Breakthrough. (PubMed, J Am Coll Cardiol) - No abstract available

Journal • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

Adebrelimab Plus Chemo and Recaticimab Perioperative Treatment for Resectable NSCLC (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Beijing Chest Hospital, Capital Medical University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor