Junshi Biosciences: Ongericimab sNDA Approved in China

Shanghai Junshi Biosciences Co., Ltd, a prominent biopharmaceutical company, has announced that China's National Medical Products Administration (NMPA) has approved two supplemental drug applications for ongericimab injection. This recombinant humanized anti-PCSK9 monoclonal antibody, marketed under the name JUNSHIDA, is designed for two specific patient groups: adults with heterozygous familial hypercholesterolemia (HeFH) and adults with non-familial hypercholesterolemia and mixed dyslipidemia who cannot tolerate statins or for whom statins are contraindicated. This approval marks a significant milestone as ongericimab becomes the first domestic medication in China targeting PCSK9 for patients intolerant to statins.

The Chinese Guidelines for Lipid Management (2023) highlight cardiovascular disease as the top cause of mortality in both urban and rural populations in China, with atherosclerotic cardiovascular disease (ASCVD) being the most common form. High levels of low-density lipoprotein cholesterol (LDL-C) are a primary contributor to ASCVD, and reducing these levels can substantially lower the risk of developing ASCVD and related mortality.

Heterozygous familial hypercholesterolemia is a prevalent form of familial hypercholesterolemia, with an estimated occurrence of 1 in 200 to 1 in 250 people. It is characterized by notably elevated LDL-C levels and a predisposition to early coronary artery disease. Patients with HeFH have higher baseline LDL-C levels and stricter target levels for control compared to non-familial hypercholesterolemia patients. Inadequate control of LDL-C levels, even with treatments like statins, places these patients at high cardiovascular risk.

Statins are usually the primary treatment for lowering lipids, yet around 9.1% of patients struggle with statin intolerance, with Asian populations reporting even higher rates. Stopping statin treatment or using only minimal doses in statin-intolerant patients can result in insufficient reduction of LDL-C levels, failing to minimize ASCVD risk effectively.

Ongericimab, a new lipid-lowering drug, is recommended in both domestic and international lipid management guidelines and is well-regarded by healthcare professionals for its efficacy. Multiple phase 3 clinical studies have confirmed its substantial lipid-lowering effects. In October 2024, NMPA approved ongericimab for treating adult patients with primary hypercholesterolemia and mixed dyslipidemia.

The recent approval of the two supplemental drug applications is primarily based on two registered clinical trials: JS002-005 and JS002-007. The JS002-005 trial, a randomized, double-blind, placebo-controlled Phase 3 study, was conducted on adult patients with HeFH. Led by Professors Changsheng Ma and Jie Lin from Beijing Anzhen Hospital, it involved 135 participants. This trial, the first of its kind to assess an anti-PCSK9 monoclonal antibody in Chinese HeFH patients, demonstrated that ongericimab significantly reduced LDL-C levels by 69.4% to 80.6% over 24 weeks compared to placebo, with consistent reductions during treatment. Additionally, it improved various lipid parameters and maintained a favorable safety profile, with treatment-emergent adverse events comparable to placebo.

The JS002-007 trial was a similar Phase 3 study for patients with primary hypercholesterolemia and mixed dyslipidemia who are statin-intolerant, led by Professor Yida Tang from Peking University Third Hospital. This study represents the first evaluation of an anti-PCSK9 monoclonal antibody in statin-intolerant Chinese patients. The results are expected to be published soon in an international journal.

Dr. Jianjun Zou, CEO of Junshi Biosciences, reflected on the approval, emphasizing the significance of expanding treatment options for Chinese patients with cardiovascular disease. This achievement is seen as a breakthrough in cardiovascular therapy in China. Junshi Biosciences aims to continue advancing in drug discovery to meet the unique needs of local patients and accelerate access to innovative treatments.