香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 自願性公告－ 抗IL-17A單抗治療中重度斑塊狀銀屑病的III期臨床研究 達到主要研究終點 本公告由上海君實生物醫藥科技股份有限公司（「本公司」）自願作出。請亦參見本 公司於2025年9月7日刊發的海外監管公告。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本公司產品重組人源化抗 IL-17A單克隆抗體（代號：JS005）在治療中重度斑塊狀銀屑病的一項多中 心、隨機、雙盲、平行、安慰劑對照的關鍵註冊性III期臨床研究（研究編號： JS005-005-III-PsO）中取得陽性結果，共同主要研究終點和關鍵次要終點均具有統 計學顯著性和臨床意義的改善。本公司計劃將於近期向監管部門遞交該產品的上 市許可申請。 關於JS005-0 ...

Core Viewpoint - Junshi Biosciences (01877.HK) announced positive results from a pivotal Phase III clinical trial of its product, JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, demonstrating statistical significance and clinical relevance in both primary and key secondary endpoints [1] Group 1 - The clinical trial was a multicenter, randomized, double-blind, parallel, placebo-controlled study [1] - The study identifier for the trial is JS005-005-III-PsO [1] - Both primary and key secondary endpoints showed statistically significant and clinically meaningful improvements [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 中國，上海，2025年9月7日 於本公告日期，本公司董事會包括執行董事熊俊先生、李寧博士、鄒建軍博士、 李聰先生、張卓兵先生、姚盛博士、王剛博士及李鑫博士；非執行董事湯毅先 生；以及獨立非執行董事張淳先生、馮曉源博士、楊悅博士、酈仲賢先生及魯琨 女士。 * 僅供識別之用 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於抗IL-17A單抗治療中重度斑塊狀銀 屑病的III期臨床研究達到主要研究終點的公告》，僅供參閱。 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 银 ...

Core Viewpoint - The company has achieved positive results in a pivotal Phase III clinical trial for its humanized anti-IL-17A monoclonal antibody (JS005) for the treatment of moderate to severe plaque psoriasis, with significant statistical and clinical improvements in primary and key secondary endpoints [1][4]. Company Summary - The company plans to submit a marketing authorization application for JS005 to regulatory authorities in the near future [1]. - The company reported a revenue increase of approximately 382 million yuan, a growth rate of 48.64% year-on-year for the first half of 2025, primarily driven by sales of commercialized drugs, with Tuoyi® achieving sales of 954 million yuan, a year-on-year increase of about 42% [1]. Product Summary - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, which effectively alleviates symptoms of autoimmune diseases by blocking the interaction between IL-17A and its receptors [2]. - The Phase III clinical trial for JS005 in treating moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for treating active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [2][4]. Industry Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2%-3%, and approximately 47% in China, affecting around 125 million people worldwide [4]. - Moderate to severe psoriasis significantly impacts patients' physical and mental health, increasing the risk of comorbidities such as metabolic syndrome and cardiovascular diseases, as well as mental health issues like depression and anxiety [4].

智通财经APP讯，君实生物(688180.SH)公告，公司产品重组人源化抗IL-17A单克隆抗体(代号：JS005) 在治疗中重度斑块状银屑病的一项多中心、随机、双盲、平行、安慰剂对照的关键注册性Ⅲ期临床研究 (研究编号：JS005-005-III-PsO)中取得阳性结果，共同主要研究终点和关键次要终点均具有统计学显著 性和临床意义的改善。公司计划将于近期向监管部门递交该产品的上市许可申请。 （原标题：君实生物(688180.SH):抗IL-17A单抗治疗中重度斑块状银屑病的Ⅲ期临床研究达到主要研究 终点） ...

Core Viewpoint - Shanghai Junshi Biosciences has announced positive results from a Phase III clinical trial of its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, achieving both primary and key secondary endpoints with statistical significance and clinical relevance [1][3]. Group 1: Drug Information - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1]. - The drug works by binding with high affinity to IL-17A, selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1]. - The Phase III clinical trial for moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [1][3]. Group 2: Clinical Trial Details - The Phase III clinical trial (study number: JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled study conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital [3]. - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [3]. - The study demonstrated that JS005 significantly improved the psoriasis lesions and severity in participants, with a favorable safety profile, and results are planned to be presented at future international academic conferences [3]. Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory, systemic disease with a global prevalence of 2.0%-3.0%, while in China, the prevalence is 0.47%, affecting approximately 125 million people worldwide, with an increasing trend [2]. - The disease is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, significantly impacting patients' physical and mental well-being [2].

Core Viewpoint - Junshi Biosciences (688180.SH) announced positive results from a pivotal Phase III clinical trial for its product, a humanized anti-IL-17A monoclonal antibody (code: JS005), in treating moderate to severe plaque psoriasis, with both primary and key secondary endpoints showing statistical significance and clinical relevance [1] Group 1 - The clinical study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial (study number: JS005-005-III-PsO) [1] - The company plans to submit a marketing authorization application for the product to regulatory authorities in the near future [1]

人民财讯9月7日电，君实生物(688180)9月7日晚间公告，近日，公司产品重组人源化抗IL-17A单克隆抗 体(代号：JS005)在治疗中重度斑块状银屑病的一项多中心、随机、双盲、平行、安慰剂对照的关键注 册性Ⅲ期临床研究中取得阳性结果，共同主要研究终点和关键次要终点均具有统计学显著性和临床意义 的改善。公司计划将于近期向监管部门递交该产品的上市许可申请。 ...

Core Viewpoint - Junshi Biosciences (688180.SH) announced positive results from a pivotal Phase III clinical trial for its product JS005, a humanized anti-IL-17A monoclonal antibody, in treating moderate to severe plaque psoriasis [1] Group 1 - The clinical study (JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled trial [1] - Both primary and key secondary endpoints showed statistically significant and clinically meaningful improvements [1] - The company plans to submit a marketing authorization application to regulatory authorities in the near future [1]

证券代码：688180 证券简称：君实生物 公告编号：临 2025-050 上海君实生物医药科技股份有限公司 自愿披露关于抗 IL-17A 单抗治疗中重度斑块状银屑 病的Ⅲ期临床研究达到主要研究终点的公告 JS005 是公司自主研发的特异性抗 IL-17A 单克隆抗体。IL（白细胞介素）-17A 是一种具有多效性的细胞因子，其分泌失调与自身免疫性疾病如银屑病、类风湿 关节炎、强直性脊柱炎等疾病的发生发展密切相关。JS005 通过与 IL-17A 高亲 和力结合并选择性地阻断 IL-17A 与其受体 IL-17RA/IL-17RC 的结合，从而阻断 下游信号通路的激活和炎性因子的释放，能有效地缓解自身免疫性疾病的症状。 截至本公告披露日，JS005 用于治疗中重度斑块状银屑病的Ⅲ期临床研究已达到 共同主要研究终点和关键次要终点，JS005 用于治疗活动性强直性脊柱炎的Ⅱ期 临床研究的所有参与者已完成主要终点访视，并进入延伸治疗期。 二、关于 JS005-005-Ⅲ-PsO 研究 银屑病是一种免疫介导的常见慢性、复发性、炎症性、系统性疾病。其患病 率在不同地区之间有较大差别，全球范围内银屑病总体患病率为 2.0% ...