A Single-center, Randomized, Open-label, Parallel-controlled Study Was Conducted to Compare the Pharmacokinetics of JS002 When Delivered Subcutaneously Via a Prefilled Syringe Versus a Prefilled Autosyringe in Healthy Subjects

This study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B received a single subcutaneous injection of JS002 150 mg via AI. Subjects were followed up to study day 85 for pharmacokinetic equivalence assessment of JS002. A total of 159 subjects were planned to be included in each group. After signing the informed consent form and completing the screening examination, subjects will be randomly assigned to treatment arm A or treatment arm B if eligible for inclusion.
The study period consisted of a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects were admitted to the phase I clinical research unit the day before dose administration (day 1) and were not allowed to leave until all examinations and assessments were completed on day 6 after dose administration and were allowed to return to the clinical research center for follow-up visits on days 8,11,15,22,29,43,57,71, and 85.

开始日期2023-05-30

申办/合作机构

上海君实生物医药科技股份有限公司

CTR20231283

/ Completed临床1期

单中心、随机、开放、平行对照设计在健康受试者中比较使用预充式注射器及预充式自动注射器皮下注射JS002的药代动力学研究

开始日期2023-05-29

申办/合作机构

上海君实生物医药科技股份有限公司

[+2]

NCT05621070

/ Recruiting临床3期

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

开始日期2023-02-03

申办/合作机构

上海君实生物医药科技股份有限公司

100 项与昂戈瑞西单抗相关的临床结果

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100 项与昂戈瑞西单抗相关的专利（医药）

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项与昂戈瑞西单抗相关的文献（医药）

2025-04-01·ATHEROSCLEROSIS

Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial

Article

作者: Zhang, Mengqi ; Lin, Jie ; Xu, Guangma ; Hao, Yu ; Huang, Wei ; Yan, Peishi ; Han, Xuebin ; Tang, Yida ; Yu, Jianjun ; Qiao, Ping ; Chen, Jie ; Yao, Zhuhua ; Chen, Jiyan ; Wang, Minghui ; Ji, Yuan ; Ma, Xueping ; Peng, Daoquan ; He, Yongming ; Wang, Gaopin ; Ma, Changsheng

BACKGROUND AND AIMS:

Heterozygous familial hypercholesterolemia (HeFH) is a prevalent autosomal dominant disorder of lipid metabolism but severely underdiagnosed and undertreated in China. This phase 3 trial aims to evaluate the efficacy and safety of ongericimab, a novel monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), in Chinese patients with HeFH.

METHODS:

Patients who have been diagnosed with definite HeFH according to Dutch Lipid Clinical Network criteria and receiving stable and optimized lipid-lowering therapy were enrolled. A total of 135 patients were randomly assigned in a 2:1:2:1 ratio to receive either ongericimab 150 mg or matching placebo every 2 weeks (Q2W), or ongericimab 450 mg or matching placebo every 4 weeks (Q4W) for 24 weeks. Patients were stratified according to the use of high-intensity statins. The primary endpoint was the percentage change in LDL-C from baseline to week 24.

RESULTS:

Our findings demonstrated that treatment with ongericimab resulted in a significant reduction in LDL-C at week 24. The least-squares mean difference was -69.4 % (95 % confidence interval [CI]: -80.9 %, -57.9 %; p < 0.0001) for the ongericimab 150 mg Q2W group, and -80.6 % (95 % CI: -92.1 %, -69.1 %; p < 0.0001) for ongericimab 450 mg Q4W group compared to respective matching placebo groups. Meanwhile, ongericimab also favorably altered other lipid parameters. A similar incidence of adverse events was observed in the ongericimab and placebo groups.

CONCLUSIONS:

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 TRIAL REGISTRATION:

http://www.

CLINICALTRIALS:

gov; Unique Identifier: NCT05325203.

2024-11-01·CTS-Clinical and Translational Science

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

Article

作者: Chai, Lin ; Bai, Xuelian ; Zhao, Yi ; Xu, Li ; Li, Lili ; Zhang, Li ; Jiang, Juanjuan ; Yan, Yan ; Liu, Hong ; Guan, Xiaoyuan ; Jia, Youhong ; Tian, Lei

Abstract:

Proprotein convertase subtilisin/kexin type 9 (PCSK9) increases plasma low‐density lipoprotein‐cholesterol (LDL‐C) by decreasing the expression of the LDL‐receptor on hepatic cells. Ongericimab (JS002) is a novel PCSK9 monoclonal antibody that exhibits a long‐acting LDL‐C lowering effect by exclusively inhibiting PCSK9 in pre‐clinical studies. Two randomized, double‐blind, placebo‐controlled trials were conducted to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetic, and pharmacodynamic profiles of ongericimab in healthy subjects and patients with hypercholesterolemia. Eighty‐four healthy subjects in the phase Ia study received a single dose of placebo or ongericimab (15–450 mg). Ninety patients with hypercholesterolemia in the phase Ib/II study received placebo or ongericimab 150 mg Q2W, 300 mg Q4W, or 450 mg Q4W for 12 weeks. Ongericimab exhibited non‐linear kinetics. The apparent clearance decreased as the dosage increased, with terminal elimination half‐life (t1/2) values of 4.5–6.5 days. Overall, ongericimab was well tolerated in both studies. A single dose of ongericimab reduced LDL‐C levels by 30%–73% in healthy subjects, and repeated doses of ongericimab reduced LDL‐C levels by 67%–80% in patients with hypercholesterolemia. 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.

2024-09-01·NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES

Efficacy and safety of ongericimab given by prefilled syringe or autoinjector in primary hypercholesterolemia and mixed hyperlipidemia

Article

作者: Ji, Xianyou ; Wang, Gaopin ; Wu, Yanqing ; Pei, Zhaohui ; Bai, Xuelian ; Cheng, Zhifeng ; Huang, Zhouqing ; Zhao, Yi ; Yang, Keping ; Wang, Minghui ; Zhao, Wang ; Zhao, Shuiping

BACKGROUND AND AIMS:

Limited evidence exist regarding the association between ongericimab, a novel recombinant humanized anti-PCSK9 monoclonal antibody, and primary hypercholesterolemia and mixed dyslipidemia. This study aimed to evaluate the efficacy and safety of ongericimab administered by prefilled syringe (PFS) or autoinjector (AI) in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia on stable optimized lipid-lowering therapy.

METHODS AND RESULTS:

A total of 255 patients on stable optimized lipid-lowering therapy were randomized in a 2:1:2:1 ratio to receive PFS for the subcutaneous injection of ongericimab 150 mg every 2 weeks (Q2W) or a matching placebo, or AI for the subcutaneous injection of ongericimab 150 mg Q2W or a matching placebo. The primary efficacy endpoint was the percent change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Safety was also evaluated. At week 12, the least squares mean percent changes were -72.7% (3.9%) for PFS and -71.1% (3.8%) for AI (all P < 0.001) compared to respective matching placebo groups. Beneficial effects were also seen for all secondary lipid parameters, notably with robust reduction in Lp (a). Treatment-emergent adverse events (TEAEs) and serious AEs with ongericimab were reported in 46.2% and 2.4% of patients, compared to 44.2% and 3.5% with placebo.

CONCLUSION:

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.

CLINICAL TRIAL REGISTRATION:

CTR20220027; January 11, 2022; http://www.chinadrugtrials.org.cn/index.html.

119

项与昂戈瑞西单抗相关的新闻（医药）

2025-04-25

·健识局

君实生物，2025没有退路

PCSK9抑制剂算是医保谈判的常客，这几年经常参与国谈，至今有三款药谈判成功，而且医保降价幅度都很大。去年，信达的托莱西单抗谈判成功，价格从一针1388元降到不超300元。唯一硬抗的是诺华的英克司兰钠，那当然没有谈成，依旧卖9988元一针。到了今年，市场格局就发生了变化。国内企业对降血脂这一慢病领域十分热衷，没有赶上去年谈判的康方生物、君实生物、恒瑞产品在过去大半年里密集获批相关产品。今年，“进医保，拓宽渠道”已经成了PCSK9药物的一场开卷应试。康方生物的伊努西单抗、君实生物的昂戈瑞西单抗、恒瑞医药的瑞卡西单抗，这三款PCSK9药物应该都在紧张筹备2025国谈了。4月23日，君实昂戈瑞西单抗的商业化合作方植恩生物向健识局确认：“我们已经在做了。”2025年医保谈判，将非常考验这三款产品的谈判技巧。不进医保，没有“活路”按照弗若斯特沙利文数据，近年的中国PCSK9市场增量明显，年均复合增长率在36.9%左右，2028年市场将超10亿美元。2017年8月，君实拿到了国内第一个PCSK9抑制剂的临床批件。当时业内预测它可能成为国内首个问世的PCSK9单抗，没想到临床进度偏慢。等到昂戈瑞西单抗上市时，四周竞争对手已然林立：比它稍早一点获批的是康方生物的伊努西单抗注射液；今年1月，恒瑞医药的注射用瑞卡西单抗也官宣获批。至此，市面上该靶点药品已有7款，包括6款单抗和1款诺华的siRNA。早上市的安进、赛诺菲等PCSK9药物早就进了医保：安进的依洛尤单抗目前只要300多元一支，赛诺菲的阿利西尤单抗价格也相近。降价让PCSK9降脂药快速普及。米内网数据显示，进医保的首年，依洛尤单抗在重点省市公立医院终端年销售额同比增长258.52%，突破了4亿元，并且成功跻身国内院内销售排名前10的产品。大外企都降价了，后来者也必须看齐。2023年8月，信达的托莱西单抗上市，恰好赶上同期上市的诺华英克司兰钠降价相逼。信达只能死保2025年的医保资格，才能有实力和安进、赛诺菲一战。还好，托莱西单抗进医保后销量还不错，有机构预计2027年收入可达约5000万元。慢病领域医保的以量换价反馈机制一直十分明显。在PCSK9这个靶点上，近几年入局的玩家只会更多。国内还有齐鲁制药、石药集团、大睿生物等7家药企有同类靶点单抗在研，不乏口服、多肽、小核酸等多种路线。据国信证券数据，瑞博生物、悦康药业、恒瑞医药等都加入了PCSK9降脂siRNA的升级战局。还有的企业已经跳出PCSK9的框框，开始研发同样能实现降脂的新型靶点Lp(a)，首款药物有望在2026-2027年间上市，届时，降脂市场格局又将会重新洗牌。热闹意味着：今年，昂戈瑞西单抗要是不进医保，真的会一点活路都没有。2024年君实业绩依然是亏损的，昂戈瑞西单抗是能回血的主力产品之一，君实不能再多等一年了。一场价格战，是躲不过了当下君实生物最应该想清楚的，是如何从竞争中突围。三家企业要打一场硬仗。目前，本土产品在适应症上都处于同一条水平线，都是针对成人原发性高胆固醇血症（非家族性）和混合型血脂异常，而安进和赛诺菲的两款进口产品还获批了用于降低成人患者心梗、卒中、心绞痛及冠脉血运重建的风险等。几家单抗类PCSK9抑制剂都要面对同一个强大的对手：诺华的siRNA药物英克司兰钠。这款药只需要半年一针，依从性上就秒杀了其他竞品。还好，诺华去年没有选择降价进医保，以年治疗费2万元的价格自行组织市场。不过，英克司兰钠真的有优势，去年上半年中国市场就大卖24.22亿元。就跟二人搏斗一样，“一力降十会”，诺华就靠着半年一针的优势轻松碾压。上市的国产PCSK9大多是低剂量150mg、每半月给药一次。几款产品的主要差异在高剂量能实现多久的用药周期。像信达托莱西单抗就有很多选择：有两周一次、四周一次、六周一次三种剂量的给药方案；康方的伊努西单抗复刻了以上方案；恒瑞的瑞卡西单抗则是发现了更长效的方案：可实现最高450mg、每三个月给药一次。君实的昂戈瑞西单抗没有那么多花样，只有基础的半月一次的用法，它的最大优势在于疗效。临床中，降脂药物降低“坏蛋白”水平是衡量产品硬实力的金标准。康方生物、君实生物、恒瑞产品基本在50-70%之间，而此前3款进口、1款国产产品的数字大多在50-60%。而且昂戈瑞西单抗的数据最好：当剂量为150mg，每半月给药一次时，“坏蛋白”水平能显著降低70%以上，是已上市同品类药物中数据最好的。但是酒香也怕巷子深，想要突围，价格战还是得打。2025年有机会进医保的三款PCSK9中，市场定价最便宜的是恒瑞，瑞卡西单抗价格为每支1660元；最高的是康方的伊努西单抗，每支2362.4元；昂戈瑞西单抗每支定价为1860元，处于中段。而已经进医保的不管国产进口，统统都在300元左右一针。价格底线，会是君实非常重要的谈判筹码。撰稿丨苗苗编辑丨江芸贾亭运营｜廿十三插图｜视觉中国声明：健识局原创内容，未经许可请勿转载康方生物为什么盯上百济神州？又一个惨痛案例：创新药不进医保，就没有活路！新事 | 市医保局局长被查

上市批准siRNA

2025-04-03

·米内网

【火热】4个品种新增挂网，2款1类新药成功突围

精彩内容日前，河南省医药集采平台发布《关于公示2025年3月通过绿色通道增补挂网药品的通知》，4个产品位列其中，包括2款1类新药——用于晚期或转移性非小细胞肺癌的EGFR抑制剂利厄替尼片、以及治疗原发性高胆固醇血症的PCSK9抑制剂昂戈瑞西单抗注射液。米内网数据显示，2023年中国公立医疗机构终端抗肿瘤药、血脂调节剂销售额分别超1100亿元和160亿元。利厄替尼片为全新分子结构的口服第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），用于治疗EGFR突变非小细胞肺癌（NSCLC），是奥赛康首款获批上市的1类创新药。该药一线治疗NSCLC上市申请已于2024年8月获CDE承办。2024年10月，奥赛康与信达生物就利厄替尼片在中国大陆地区达成独家商业化合作。米内网数据显示，除利厄替尼片外，奥赛康至少还有7款1类新药处于获批临床及以上阶段。其中，ASKB589注射液正开展用于胃及食管胃交界处腺癌的Ⅲ期临床试验，ASKG712注射液已进入Ⅱa期临床，ASKC202片、注射用ASKG315、注射用ASKG915、注射用ASK0912等新品已进入Ⅰ期临床。奥赛康在研1类创新药来源：米内网中国申报进度（MED）数据库昂戈瑞西单抗注射液是一种重组人源化抗PCSK9单抗，用于治疗原发性高胆固醇血症（非家族性）和混合型血脂异常的成人患者，为君实生物自主研发的1类创新药。资料显示，该新药另有2项新适应症上市申请已获CDE受理，分别为：①杂合子型家族性高胆固醇血症；②他汀类药物不耐受或禁忌使用的原发性高胆固醇血症和混合型血脂异常（单药）。在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端，血脂调节剂（化+生）2022-2023年销售额均在160亿元以上，2024上半年收获超85亿元，市场潜力值得期待。近年来中国公立医疗机构终端血脂调节剂（化+生）销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局此外，还有诺泰生物制药的依折麦布阿托伐他汀钙片(Ⅱ)拟通过绿色通道增补挂网，通过审核理由为：申报价格低于支付标准的国谈仿制药。米内网数据显示，目前国内有8家企业以仿制4类提交了依折麦布阿托伐他汀钙片(Ⅱ)上市申请，其中诺泰生物制药拿下首仿+首家过评，福元医药为国产第2家冲线，倍特药业、乐普制药、重庆圣华曦药业等6家均在审评审批中。拟通过绿色通道增补挂网的药品（单位：元）来源：米内网数据库、河南省医药集采平台注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至4月3日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

临床3期申请上市

2025-03-29

·GlobeNewswire-Health Care

Junshi Biosciences Announces 2024 Full Year Financial Results and Provides Corporate Updates

SHANGHAI, March 28, 2025 (GLOBE NEWSWIRE) -- 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 its financial results for the full year of 2024 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue of Junshi Biosciences was approximately RMB1,948 million in 2024, representing an increase of approximately 30% compared to 2023, which was mainly due to the increase in revenue from pharmaceutical products, in particular: the domestic sales revenue of our core product, toripalimab, was approximately RMB1,501 million, representing an increase of approximately 66% compared to 2023.Total research and development (“R&D”) expenses of the company were approximately RMB1,275 million in 2024, representing a decrease of approximately 34% compared to 2023. The decrease in R&D expenses was mainly due to the company’s cost control policy and efforts to optimize resource allocation and focus on R&D pipelines with greater potential. In addition, a number of clinical trials of our core product, toripalimab, successively met the primary endpoints, which also contributed to the natural decline of R&D expenditure.Loss attributable to owners of the company decreased to RMB1,282 million in 2024, representing a decrease of approximately RMB999 million or approximately 44% compared to 2023.As of the end of 2024, the company’s aggregate balance of bank balances and cash and financial products was approximately RMB2,917 million, ensuring a relatively sufficient cash position to support the company’s development. BUSINESS HIGHLIGHTS During 2024, our commitment to addressing “unmet medical needs” has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. Here are the notable achievements and milestones: Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecule drugs, polypeptide drugs, antibody drug conjugates (ADCs), bi-specific or multi-specific antibodies, bispecific antibody drug conjugates, fusion protein and nucleic acid drugs, as well as the exploration of next-generation innovative therapies, including cancer and autoimmune diseases. Our product pipelines cover five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. A total of four drugs have been commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the preclinical drug development stage. In January 2024, Coherus BioSciences, a partner of Junshi Biosciences, announced that toripalimab was available for access and administration in the United States. Prior to this, toripalimab (US trade name: LOQTORZI®) was approved for marketing by the US Food and Drug Administration (the “FDA”) in October 2023, and is the first drug for the treatment of nasopharyngeal carcinoma (“NPC”) in the United States. At present, it is also the only preferred drug recommended in the National Comprehensive Cancer Network (“NCCN”) Clinical Practice Guidelines in Oncology for Head and Neck Cancers 2025.V1 for the treatment of recurrent/ metastatic NPC across all lines.In January 2024, the new drug application (the “NDA”) for toripalimab for the treatment of NPC was accepted by the Singapore Health Sciences Authority (the “HSA”). In March 2025, the NDA for toripalimab (Singapore trade name: LOQTORZI®) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC has been approved by the HSA. Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore.In April 2024, the Japanese Pharmaceuticals and Medical Devices Agency (the “PMDA”) agreed that the company may proceed with a randomized, double-blind, placebo-controlled, international multi-regional phase 3 clinical study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination with toripalimab as consolidation therapy for patients with limited-stage small cell lung cancer (“LS-SCLC”) without disease progression following chemo-radiotherapy.In April 2024, the supplemental new drug application (the “sNDA”) for toripalimab in combination with axitinib for the first-line treatment for patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”) was approved by the National Medical Products Administration of China (the “NMPA”). This is the first approved immunotherapy for renal carcinoma in China.In April 2024, the NDA for toripalimab in combination with cisplatin and gemcitabine for 1) the first-line treatment of adults with metastatic or recurrent locally advanced NPC and 2) toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy was accepted by the Drug Office of the Department of Health, Hong Kong Special Administration Region Government (the “DO”), and was approved by the Pharmacy and Poisons Board of Hong Kong (the “PPB”) in October 2024, making toripalimab the first and only immunotherapy drug for NPC in Hong Kong SAR, China.In June 2024, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of a multinational multi-center, randomized, open-label, active controlled phase III clinical study (the HEPATORCH study, NCT04723004) of TUOYI® in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (“HCC”) met the pre-defined efficacy boundary. The sNDA was accepted by the NMPA in July 2024 and was approved by the NMPA in March 2025.In June 2024, the sNDA for TUOYI® in combination with etoposidein plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) was approved by the NMPA.In June 2024, the sNDA for TUOYI® in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (“TNBC”) with a well-validated test to evaluate PD-L1 positive (CPS ≥ 1) was approved by the NMPA.In July 2024, the investigational new drug (“IND”) application for JS125 (a targeted histone deacetylases (“HDACs”) inhibitor) was accepted by the NMPA and approved in September 2024.In July 2024, a positive opinion was obtained from the Committee for Medicinal Products for Human Use (the “CHMP”) of the European Medicines Agency (the “EMA”) for the marketing authorization application (the “MAA”) of toripalimab (European trade name: LOQTORZI®), which recommended approval for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (“ESCC”). In September 2024, this MAA was approved by the European Commission (the “EC”). The approval is applicable to all 27 member states of the European Union (the “EU”), Iceland, Norway and Liechtenstein, making toripalimab the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC regardless of PD-L1 status in Europe.In August 2024, the sNDA for toripalimab as the first-line treatment for unresectable or metastatic melanoma was accepted by the NMPA.In September 2024 and November 2024, toripalimab was approved for marketing in India and Jordan, respectively, for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Toripalimab officially commenced commercial sales in India in 2024.In October 2024, the NDA for ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) as the treatment for adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia was approved for marketing by the NMPA.In November 2024, toripalimab (UK trade name: LOQTORZI®) obtained the marketing authorisation from the United Kingdom’s (the “UK”) Medicines and Healthcare products Regulatory Agency (the “MHRA”) for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC. Toripalimab has become the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC regardless of PD-L1 status in the UK.In November 2024, four new indications of toripalimab were successfully included in Category B of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2024) (the “NRDL”). The ten approved indications of toripalimab in the Chinese mainland were all included in the NRDL, and TUOYI® is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of non-small cell lung cancer (“NSCLC”), treatment of renal carcinoma and treatment of TNBC. Update on business operations In June 2024, Junshi Biosciences convened the 2023 annual general meeting, the 2024 first class meeting of A shareholders and the 2024 first class meeting of H shareholders, and completed the election of the fourth session of the Board of Directors and the board of supervisors of the company and other matters.In July 2024, Suzhou Union Biopharm Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, received the CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER issued by The Ireland Health Products Regulatory Authority (the “HPRA”) in accordance with the relevant regulations of the EMA. This is the first time that the relevant production facilities of toripalimab obtained the GMP certificate of a member state of the EU. According to the GMP mutual recognition system among the EU member states, obtaining the GMP certificate indicates that the production facilities with the certificate have met the GMP standards of the EU.In August 2024, the A shares of Junshi Biosciences (“A Shares”) were included in the SSE STAR Brand Name Drug Index. The index selects 30 securities of companies listed on the STAR Market with the largest market capitalization and engaged in innovative drugs as constituents, reflecting the overall performance of the securities of the companies listed on the STAR Market and engaged in innovative drugs.As of September 2024, the company completed the implementation of the A-Share repurchase plan, with a total of 815,871 A Shares repurchased, accounting for 0.0828% of the total share capital of the company, which will be used for the purpose of share incentives and/or employee stock ownership plan(s) at an appropriate time in the future.In December 2024, the company’s A Shares were included in the CSI A500 Index. The index selects 500 securities with the largest market capitalization and strong liquidity from various sectors as constituents, reflecting the overall performance of the most representative listed companies across different sectors. About Junshi BiosciencesFounded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

上市批准临床3期免疫疗法财报生物类似药

100 项与昂戈瑞西单抗相关的药物交易

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适应症	国家/地区	公司	日期
复杂性血脂异常	中国	上海君实生物医药科技股份有限公司	2024-10-09
原发性高胆固醇血症	中国	上海君实生物医药科技股份有限公司	2024-10-09

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适应症	最高研发状态	国家/地区	公司	日期
杂合子家族性高胆固醇血症	申请上市	中国	上海君实生物医药科技股份有限公司	2024-04-02
纯合子家族性高胆固醇血症	申请上市	中国	上海君实生物医药科技股份有限公司	2023-04-26
家族性混合型高脂血症	临床3期	中国	上海君实生物医药科技股份有限公司	2020-12-23
II型高脂蛋白血症	临床2期	中国	上海君实生物医药科技股份有限公司	2020-08-19
动脉粥样硬化	临床2期	中国	上海君实生物医药科技股份有限公司	2019-05-23
合并高脂血症	临床2期	中国	上海君实生物医药科技股份有限公司	2019-05-23
高脂血症	临床2期	中国	上海君实生物医药科技股份有限公司	2019-05-23
晚期癌症	临床1期	中国	上海君实生物医药科技股份有限公司	2022-02-10
高胆固醇血症	临床1期	中国	上海君实生物医药科技股份有限公司	2017-12-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05325203 (Pubmed \| Atherosclerosis)	临床3期	杂合子家族性高胆固醇血症 LDL-C	135	Ongericimab 150 mg Q2W	鬱繭獵選醖齋網衊窪齋(衊製築淵鹹獵淵簾醖齋) = 蓋醖觸繭觸選鹹衊窪鹽餘鑰獵鹽鏇壓積壓範觸 (餘糧鹽範窪鑰築簾構襯, -80.9% ~ -57.9%)	积极	2025-04-01
				Placebo Q2W	-
NCT04781114 (JS002-003, Pubmed) 人工标引	临床3期	血脂障碍 \| 原发性高胆固醇血症追加	806	Ongericimab 150 mg every 2 weeks	鹹鏇膚繭廠窪壓築醖廠(鏇獵鹹鏇鹹壓廠積醖廠) = 網膚鹹積鹹獵顧衊觸顧夢顧鹽獵夢夢膚網廠築 (鬱網遞窪襯鹹遞蓋鹹膚, −70.3 ~ −64.4) 更多	积极	2024-06-04
				Placebo every 2 weeks	鹹鏇膚繭廠窪壓築醖廠(鏇獵鹹鏇鹹壓廠積醖廠) = 艱顧衊壓淵憲壓範膚衊夢顧鹽獵夢夢膚網廠築 (鬱網遞窪襯鹹遞蓋鹹膚, −3.7 ~ 4.5) 更多
CTR20220027 (Literature) 人工标引	临床3期	原发性高胆固醇血症 \| 家族性混合型高脂血症	255	Ongericimab 150 mg Q2W by prefilled syringe	餘窪顧遞艱顧齋憲鹽製(網鑰鹽艱膚網壓淵齋夢) = 鹽窪遞糧鹹淵鹽壓願襯窪窪積遞築願鏇願積蓋 (鑰襯願築廠繭繭製遞夢 ) 更多	积极	2024-04-23
				Ongericimab 150 mg Q2W by autoinjector	餘窪顧遞艱顧齋憲鹽製(網鑰鹽艱膚網壓淵齋夢) = 夢觸範窪築窪膚膚衊繭窪窪積遞築願鏇願積蓋 (鑰襯願築廠繭繭製遞夢 )
NCT04781114 (NEWS) 人工标引	临床3期	血脂障碍 \| 原发性高胆固醇血症	802	昂戈瑞西单抗 150 mg Q2W	糧夢積構構憲顧襯鹽夢(範憲齋艱簾餘鬱鏇遞廠): Difference(%) = -67.74 (95% CI, -72.5 ~ -63.0), P-Value = 0.0001 更多	积极	2023-11-14
				Placebo 150 mg Q2W