Junshida (ongericimab) / Shanghai Junshi Biosci, Chongqing Bochuang Pharmaceuticals - LARVOL DELTA

Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial. (PubMed, Atherosclerosis) - P3 | "Ongericimab significantly reduced LDL-C as well as other atherogenic lipid levels and was well tolerated in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia."

Journal • P3 data • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia • APOB

Junshi Biosciences Announces Ongericimab’s sNDA Approval in China (GlobeNewswire) - "Shanghai Junshi Biosciences...announced that the National Medical Products Administration (the “NMPA”) has approved two supplemental new drug applications for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA...for: 1) adult patients with heterozygous familial hypercholesterolemia ('HeFH'); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated. Ongericimab has become China’s first domestic PCSK9-targeted drug approved for statin-intolerant patients....The approval of the two supplemental new drug applications are mainly based on two registered clinical trials—JS002-005 (NCT05325203) and JS002-007 (NCT05621070)."

China approval • Heterozygous Familial Hypercholesterolemia

Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial. (PubMed, Atherosclerosis) - P3 | "Ongericimab administered at either 150 mg Q2W or 450 mg Q4W for 24 weeks, significantly reduced LDL-C levels and was well-tolerated in Chinese patients with HeFH."

Clinical • Journal • P3 data • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

Clinical pharmacokinetics and pharmacodynamics of ongericimab: A potential long-acting PCSK9 monoclonal antibody in healthy subjects and patients with hypercholesterolemia: Randomized, double-blind, placebo-controlled phase Ia and Ib/II studies. (PubMed, Clin Transl Sci) - "At the end of the dosing interval in the phase Ib/II study, over 70% of patients' LDL-C levels decreased by more than 50% from baseline. The results showed that ongericimab had a significant long-acting LDL-C lowering effect with good safety and potential for clinical application."

Clinical • Journal • P1 data • PK/PD data • Dyslipidemia • Metabolic Disorders

Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia (clinicaltrials.gov) - P3 | N=582 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2023 ➔ Sep 2024

Enrollment open • Monotherapy • Trial primary completion date • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

A Pharmacokinetic Study of JS002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=318 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Sep 2023

Trial completion • Trial completion date

Efficacy and safety of ongericimab in Chinese statin intolerant patients with primary hypercholesterolemia or mixed dyslipidemia (ESC 2024) - No abstract available

Clinical • Cardiovascular • Dyslipidemia

To Evaluate the Efficacy and Safety of JS002 in HoFH Patients (clinicaltrials.gov) - P2 | N=31 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

Efficacy and safety of ongericimab given by prefilled syringe or autoinjector in primary hypercholesterolemia and mixed hyperlipidemia. (PubMed, Nutr Metab Cardiovasc Dis) - "In Chinese patients with primary hypercholesterolemia and mixed dyslipidemia, a 12-week treatment regimen with ongericimab administered by PFS or AI significantly reduced LDL-C and other lipid parameters, proving to be safe and well tolerated. Patients experienced consistent effects from PFS or AI devices."

Journal • Dyslipidemia • Metabolic Disorders

Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia. (PubMed, J Am Heart Assoc) - P3 | "Ongericimab, as an add-on treatment to optimized lipid-lowering therapy, significantly reduced LDL-C and was well-tolerated in Chinese patients with primary hyperlipidemia and mixed dyslipidemia who did not achieve their LDL-C targets."

Journal • Dyslipidemia • Metabolic Disorders

A Study Explore JS001+JS002 in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=114 ➔ 9 | Trial completion date: Apr 2024 ➔ Nov 2023 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2024 ➔ Nov 2023; The regimen of JS002 75~300mg Q3W has been completed, and the combination therapy is well tolerated and safe. However, considering that the efficacy did not reach the preset, it is recommended to terminate the trial in advance.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Cancer • Lung Cancer • Oncology • MSI • PD-1 • PD-L1 • TMB

A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). (clinicaltrials.gov) - P3 | N=135 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia (AHA 2023) - P3 | "Eligible patients receiving stable statin (±ezetimibe) therapy but not achieving LDL-C goals were enrolled. Ongericimab on stable background LLT significantly reduced LDL-C and was well tolerated in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia."

Clinical • Dyslipidemia • Metabolic Disorders

A Pharmacokinetic Study of JS002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=318 | Active, not recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

A Pharmacokinetic Study of JS002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=318 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1 trial

The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia (clinicaltrials.gov) - P3 | N=806 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders

The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=255 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders

Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia (clinicaltrials.gov) - P3 | N=582 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Monotherapy • New P3 trial • Dyslipidemia • Metabolic Disorders • APOB

Efficacy and Safety of Ongericimab in Chinese Patients With Homozygous Familial Hypercholesterolemia (AHA 2022) - "Ongericimab was well tolerated and significantly reduced LDL-C levels in Chinese patients with HoFH. Patients with defective LDLR demonstrated better response than those with negative LDLR."

Clinical • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P3 trial • Dyslipidemia • Metabolic Disorders

A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P3 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • APOA1

To Evaluate the Efficacy and Safety of JS002 in HoFH Patients (clinicaltrials.gov) - P2; N=30; Active, not recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders

A Study Explore JS001+JS002 in Patients With Advanced Cancer (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Lung Cancer • Oncology • PD-L1

A Study Explore JS001+JS002 in Patients With Advanced Cancer (clinicaltrials.gov) - P1; N=114; Not yet recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Clinical • New P1 trial • Gastrointestinal Cancer • Lung Cancer • Oncology • PD-L1

To Evaluate the Efficacy and Safety of JS002 in HoFH Patients (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders