SHANGHAI, China, May 27, 2025 — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (the \u201cNMPA\u201d) has approved two supplemental new drug applications for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA (\u541b\u9002\u8fbe\u00ae)) for: 1) adult patients with heterozygous familial hypercholesterolemia (\u201cHeFH\u201d); 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\u2019s first domestic PCSK9-targeted drug approved for statin-intolerant patients.<\/p>\n\n\n\n
According to the Chinese Guidelines for Lipid Management (2023), cardiovascular disease is the leading cause of death among both urban and rural residents in China, with atherosclerotic cardiovascular disease (\u201cASCVD\u201d) being the predominant subtype. The rise of low-density lipoprotein cholesterol (\u201cLDL-C\u201d) levels is a major cause of ASCVD. Lowering LDL-C levels can significantly decrease the incidence of ASCVD and risk of death.<\/p>\n\n\n\n
HeFH is a common type of familial hypercholesterolemia with an estimated prevalence of 1:250 ~ 1:200, and its main clinical features are significantly elevated LDL-C and early onset of coronary artery disease. Compared to patients with non-familial hypercholesterolemia, patients with HeFH exhibit higher baseline LDL-C levels and lower target levels for control recommended by the guidelines. Failure to achieve target LDL-C levels after treatments such as statins will result in patients being at high cardiovascular risk.<\/p>\n\n\n\n
In addition, despite statins currently being the cornerstone of lipid-lowering treatment, approximately 9.1% of patients clinically exhibit statin intolerance, with a higher proportion observed in Asian populations. Discontinuation of statins or the use of only tolerable doses in patients with statin intolerance may lead to suboptimal LDL-C levels, thereby failing to effectively reduce the patient\u2019s ASCVD risk.<\/p>\n\n\n\n
As a new lipid-lowering drug that effectively reduces LDL-C levels, PCSK9 inhibitor has been recommended in the guidelines for the management of lipids both in China and overseas and is widely recognized by clinicians. The significant lipid-lowering effects of ongericimab have been demonstrated in multiple phase 3 clinical studies, and ongericimab was approved by the NMPA for the treatment of adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia in October 2024.<\/p>\n\n\n\n
The approval of the two supplemental new drug applications are mainly based on two registered clinical trials\u2014JS002-005 (NCT05325203) and JS002-007 (NCT05621070).<\/p>\n\n\n\n
JS002-005 is a randomized, double-blind, placebo-controlled Phase 3 clinical study in adult patients with HeFH. JS002-005 was led by Professor Changsheng MA and Professor Jie LIN from Beijing Anzhen Hospital affiliated to Capital Medical University as the principal investigators. A total of 135 patients with HeFH were enrolled. This study is the first Phase 3 clinical study evaluating an anti-PCSK9 monoclonal antibody in Chinese patients diagnosed with HeFH (DLCN>8).<\/p>\n\n\n\n
The latest data on JS002-005 has been published in full in Atherosclerosis. The results showed that, compared with placebo, the ongericimab subcutaneous injection (150 mg every 2 weeks (Q2W) or 450 mg every 4 weeks (Q4W)) significantly reduced LDL-C levels by 69.4% and 80.6% (p<0.0001), respectively, for a 24-week treatment, with steady reduction during the treatment. At the same time, ongericimab also demonstrated significant improvements in other lipid parameters. Non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC), and lipoprotein (a) (\u201cLp(a)\u201d) levels all markedly decreased from baseline. Notably, Lp(a) levels decreased by 50% from baseline. The overall safety profile was favorable, with the incidence of treatment-emergent adverse events (TEAEs) being comparable to that of the placebo group.<\/p>\n\n\n\n
JS002-007 is a randomized, double-blind, placebo-controlled Phase 3 clinical study conducted in adult patients with primary hypercholesterolemia and mixed hyperlipidemia who are statin-intolerant. JS002-007 was led by Professor Yida TANG from Peking University Third Hospital as the principal investigator. This is the first Phase 3 clinical study of anti-PCSK9 monoclonal antibody in Chinese patients with primary hypercholesterolemia or mixed dyslipidemia who are statin-intolerant. The results will be published in an international academic journal shortly.<\/p>\n\n\n\n
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences<\/strong>, said, \u201cAs of now, ongericimab has received approval for three key indications, including heterozygous familial hypercholesterolemia, non-familial hypercholesterolemia or mixed dyslipidemia who are statin-intolerant or statins contraindicated. This achievement not only represents a remarkable breakthrough in cardiovascular therapy, it also means that Chinese patients with cardiovascular disease will have more treatment options. Moving forward, our focus will continue \u2018In China\u2019 as we address more unique needs of local patients. Through innovative drug discovery, we aim to tackle more therapeutic areas while accelerating the development of and access to novel treatments.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":" The NMPA has recently approved ongericimab’s two sNDA, becoming China\u2019s first domestic PCSK9-targeted drug approved for statin-intolerant patients<\/p>\n","protected":false},"author":6,"featured_media":1854,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[91,90],"class_list":["post-3566","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-ongericimab","tag-pcsk9-en"],"yoast_head":"\n