Junshi Biosciences Proves Efficacy of Ongericimab: Phase 3 Clinical Studies Show Promising Results

Junshi Biosciences is celebrating a major milestone, having successfully completed two randomized, double-blind, placebo-controlled, multi-center phase III clinical studies (Study nos.: JS002-003 and JS002-006) of ongericimab (JS002, a recombinant humanized anti-PCSK9 monoclonal antibody) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, with both studies meeting their primary endpoints. This is a momentous occasion for the innovation-driven biopharmaceutical company, as it marks a major step forward in the development of novel therapies.

The increasing prevalence of dyslipidemia in the Chinese population is a major cause for concern, as it is a major risk factor for atherosclerotic cardiovascular diseases (ASCVDs). With up to 40.4% of adults affected, the importance of effective treatments to lower low-density lipoprotein cholesterol (LDL-C) levels cannot be overlooked. Lowering LDL-C levels can significantly reduce the risk of death from ASCVDs, making it an urgent need for the population.

Dyslipidemia remains a concern in China, with low awareness, treatment, and control rates among adults. Despite the clinical demand for effective lipid-lowering treatments, only two imported anti-PCSK9 monoclonal antibodies have been approved for use in China. Fortunately, these drugs can effectively reduce LDL-C levels and have been recommended in both Chinese and overseas dyslipidemia management guidelines. Unfortunately, there is still a need for a domestic anti-PCSK9 monoclonal antibody to be approved for marketing.

Junshi Biosciences’ breakthrough anti-PCSK9 monoclonal antibody, ongericimab, has achieved remarkable success in two pivotal registered clinical studies (Study nos.: JS002-003 and JS002-006). Outstanding results were seen in patients with primary hypercholesterolemia and mixed dyslipidemia, who experienced significant lipid-lowering efficacy with the subcutaneous injection of ongericimab, delivered via two drug delivery systems (pre-filled syringes and pre-filled automatic syringes). The treatment was found to be safe and well-tolerated, making ongericimab a promising therapeutic solution for those with lipid-related health issues.

The arrival of PCSK9 inhibitors has opened the door to better treatment for dyslipidemia patients, particularly those at high or extreme risk of ASCVD. Ongericimab’s phase III clinical trial results are heartening, displaying comparable efficacy and safety to similar PCSK9 inhibitors from overseas. We eagerly anticipate ongericimab’s launch to address unmet medical needs, and we hope it will help reduce the incidence and mortality of cardiovascular disease in China.

We are delighted to witness the groundbreaking results of the Chinese-developed anti-PCSK9 monoclonal antibody, which is delivering exceptional lipid-lowering outcomes. This will provide Chinese clinicians with more options to treat high blood lipid levels and benefit countless patients in China. Professor Shuiping ZHAO from the Second Xiangya Hospital of Central South University notes that the management of Chinese population’s blood lipid levels requires continuous improvement, and ongericimab is set to make a significant contribution to this progress.

Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences, is thrilled to witness the results of two phase III studies on ongericimab. This remarkable success is a result of the collaborative efforts of researchers, patients, and R&D teams. As China continues to experience an aging population, ongericimab offers a promising solution to address the unmet medical needs of hyperlipidemia patients.

About Ongericimab (JS002)

Junshi Biosciences has made history by becoming the first Chinese company to gain clinical trial approval for their independently developed drug, a recombinant humanized anti-PCSK9 monoclonal antibody called Ongericimab. This drug is designed to treat primary hypercholesterolemia and mixed hyperlipidemia. To date, Junshi Biosciences has completed Phase III clinical studies in patients with primary hypercholesterolemia and mixed hyperlipidemia, and Phase II clinical studies in patients with homozygous familial hypercholesterolemia. The enrollment of patients for Phase III clinical studies of heterozygous familial hypercholesterolemia has also been successfully concluded. With Ongericimab, Junshi Biosciences has made a remarkable breakthrough in the treatment of cholesterol-related conditions.

About Junshi Biosciences

Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovative biopharmaceutical company that is taking the healthcare industry by storm. Since its foundation in 2012, Junshi has developed over 50 drug candidates, focusing on treating cancer, autoimmune, metabolic, neurological and infectious diseases. The company made history when it became the first Chinese pharmaceutical company to receive marketing approval for its anti-PD-1 monoclonal antibody. Furthermore, Junshi was the first in the world to be approved by the FDA and NMPA for its first-in-human anti-BTLA monoclonal antibody, which is currently undergoing Phase Ib/II trials in both China and the US. Junshi is also the first in China to receive approval for its anti-PCSK9 monoclonal antibody clinical trial. This company is revolutionizing the medical industry and changing the way we approach healthcare.

In the face of the global pandemic, Junshi Biosciences has taken the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Their response was immediate and strong, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat SARS-CoV-2. In 2021, JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against the virus, was granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Additionally, VV116 (deuremidevir hydrobromide), a novel oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, has been approved for marketing in China and Uzbekistan. Junshi Biosciences is dedicated to innovating disease control and prevention measures to combat this pandemic.

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