ebronucimab (AK102) / Akesobio - 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

A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects (clinicaltrials.gov) - P1 | N=204 | Not yet recruiting | Sponsor: Akeso

New P1 trial

A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=246 | Completed | Sponsor: Akeso | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

Ebronucimab Injection Approved for Marketing by China NMPA - "...the Ebronucimab Injection...of Kangrong Dongfang (Guangdong) Pharmaceutical Co., Ltd. is approved for marketing by China NMPA. The indication is: for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia, who cannot achieve the recommended target of low density lipoprotein cholesterol (LDL-C) even after receiving moderate or high doses of statin therapy."

China approval • Dyslipidemia • Heterozygous Familial Hypercholesterolemia

A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=122 | Completed | Sponsor: Akeso | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=464 | Completed | Sponsor: Akeso | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

Ebronucimab: First Approval. (PubMed, Drugs) - "In September 2024, ebronucimab was approved in China, in combination with statins or statins and other lipid-lowering therapies, for adult patients with primary hypercholesterolaemia [including heterozygous familial hypercholesterolaemia (HeFH)] and mixed hyperlipidaemia who are unable to achieve the low-density lipoprotein cholesterol target after receiving moderate or higher doses of statins. This article summarizes the milestones in the development of ebronucimab leading to this first approval for primary hypercholesterolaemia, mixed hyperlipidaemia and HeFH."

Journal • Review • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia • Mixed Hyperlipidemia

A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: Akeso

New P1 trial

Ebronucimab in Chinese Patients with Hypercholesterolemia---A Randomized Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Ebronucimab. (PubMed, Pharmacol Res) - P3 | "In conclusion, Ebronucimab, with either 450mg Q4W or 150mg Q2W doses, demonstrated significant efficacy in lowering serum LDL-C level with a favorable safety and immunogenicity profile among hypercholesterolemic patients. Trial Registration：ClinicalTrials.gov Identifier: NCT05255094."

Clinical • Journal • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Infectious Disease • Metabolic Disorders • Nephrology

Efficacy and Safety of Ebronucimab, a Monoclonal Antibody Against Pcsk9, in Patients With Hyperlipidemia: Result From a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study (AHA 2022) - "ConclusionsEbronucimab was generally safe and well tolerated in Chinese patients with hyperlipidemia. Patients treated with ebronucimab achieved a significant reduction in serum levels of LDL-C and other lipids, especially in 450 mg q4w and 150 mg q2w treatment groups."

Clinical • P2 data • Dyslipidemia • APOB

NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications (PRNewswire) - "Akeso Inc...announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia (HeFH). Ebronucimab is jointly developed by Akeso and AD Pharmaceuticals (a joint venture with Akeso). The new drug marketing application for ebronucimab is based on four pivotal phase 3 studies..."

Non-US regulatory • Cardiovascular • Dyslipidemia • Metabolic Disorders

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Akeso | Unknown status ➔ Completed | N=59 ➔ 10

Enrollment change • Trial completion • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders • APOA1 • APOB

A Long-term Study of AK102 in Patients With Hypercholesterolemia (clinicaltrials.gov) - P2 | N=796 | Completed | Sponsor: Akeso | Unknown status ➔ Completed | N=200 ➔ 796 | Trial completion date: Aug 2022 ➔ Feb 2023 | Trial primary completion date: Jul 2022 ➔ Feb 2023

Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders • APOA1 • APOB

A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia (clinicaltrials.gov) - P2 | N=262 | Completed | Sponsor: Akeso | Unknown status ➔ Completed

Trial completion • Cardiovascular • Dyslipidemia • Metabolic Disorders • APOA1 • APOB

A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) (clinicaltrials.gov) - P2 | N=109 | Completed | Sponsor: Akeso | Unknown status ➔ Completed | N=168 ➔ 109 | Trial completion date: Jul 2021 ➔ Sep 2022 | Trial primary completion date: Dec 2020 ➔ Sep 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • APOA1 • APOB

A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Akeso

New P3 trial • Dyslipidemia • Metabolic Disorders • APOB

A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Akeso

New P3 trial • Dyslipidemia • Metabolic Disorders • APOB

A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia (clinicaltrials.gov) - P3 | N=122 | Recruiting | Sponsor: Akeso

New P3 trial • Dyslipidemia • Metabolic Disorders • APOB

Dawnrays Pharmaceutical (02348): Ebronucimab’s Phase IIb clinical trial for the treatment of hypercholesterolemia in China completed the enrollment of patients ahead of schedule (Eastmoney.com) - "Dawnrays Pharmaceuticals (02348) announced that the company has been informed by Kangrong Dongfang that the Phase IIb clinical trial of Ebronucimab (AK102) in China for the treatment of high-risk or very high-risk hypercholesterolemia has completed 260 patients ahead of schedule. Phase III clinical trials for this indication will be carried out in China. Early clinical data of Ebronucimab showed that Ebronucimab can completely inhibit PCSK9 compared with the target drug Repatha (Eloyuumab). Ebronucimab can significantly reduce the cholesterol of all administered patients."

Enrollment closed • P2b data • Cardiovascular • Dyspepsia

A Phase II Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia (clinicaltrials.gov) - P2; N=260; Not yet recruiting; Sponsor: Akeso

Clinical • New P2 trial • Cardiovascular • Dyslipidemia • Metabolic Disorders • APOA1 • APOB

A Long-term Study of AK102 in Patients With Hypercholesterolemia (clinicaltrials.gov) - P2; N=200; Not yet recruiting; Sponsor: Akeso

Clinical • Combination therapy • New P2 trial

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH (clinicaltrials.gov) - P2; N=59; Recruiting; Sponsor: Akeso; Not yet recruiting ➔ Recruiting

Enrollment open • APOA1

A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) (clinicaltrials.gov) - P2; N=168; Not yet recruiting; Sponsor: Akeso

Clinical • New P2 trial

A Study of PCSK9 Inhibitor AK102 in Healthy Subjects (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Akeso

New P1 trial

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH (clinicaltrials.gov) - P2; N=59; Not yet recruiting; Sponsor: Akeso

Clinical • New P2 trial