Core Viewpoint - Junshi Biosciences has announced that two of its products, Toripalimab Injection (brand name: Tuoyi®) and Engreztinib Injection (brand name: Junshida®), have been included in the National Medical Insurance Catalog (2025) under the Class B category, effective January 1, 2026 [1] Group 1: Product Developments - Toripalimab has received approval for all 12 indications in mainland China and is the only anti-PD-1 monoclonal antibody in the catalog for treating renal cancer, triple-negative breast cancer, and melanoma [1] - Engreztinib is newly included in the catalog and is the only domestic PCSK9-targeted drug for patients intolerant to statins [1] Group 2: Market Implications - The inclusion of these products in the National Medical Insurance Catalog is expected to enhance their market accessibility and potentially increase sales [1] - With four commercialized products now listed in the National Medical Insurance Catalog, the company is positioned to benefit from broader patient access and reimbursement support [1]

Core Viewpoint - Junshi Biosciences announced that its products, Toripalimab Injection (Tuoyi®) has received two new indications, and the drug Oncorine Injection (Junsida®) has been successfully included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) under Category B, effective from January 1, 2026 [1] Group 1 - The inclusion of Toripalimab's 12 approved indications in the insurance catalog enhances the affordability and accessibility of the product [1] - Oncorine Injection is being included in the insurance catalog for the first time, which is expected to boost its market penetration [1] - All four commercialized products of the company are now covered by medical insurance, facilitating market promotion [1]

Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has received a notice of acceptance from the National Medical Products Administration for its new drug application for JS005, a monoclonal antibody injection for treating moderate to severe plaque psoriasis in adults [1][2]. Drug Basic Information - Drug Name: JS005 (Rocacitinib Injection) - Application: Domestic production drug registration and marketing license - Acceptance Number: CXSS2500129, CXSS2500130 - Applicant: Shanghai Junshi Biosciences Co., Ltd. - Specifications: 150mg (1ml) per pre-filled syringe and 150mg (1ml) per pre-filled auto-injector - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Drug Development and Clinical Research - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases like psoriasis [2]. - The drug works by binding to IL-17A and blocking its interaction with receptors, thereby alleviating symptoms of autoimmune diseases [2]. - A pivotal Phase III clinical study (JS005-005-III-PsO) involving 747 moderate to severe plaque psoriasis patients showed significant improvement in psoriasis area and severity index (PASI) scores after 12 weeks of treatment, with sustained efficacy over 52 weeks [3].

截至公告披露日，除本次新药上市申请外，偌考奇拜单抗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治疗，进入安全随访期。 北京商报讯（记者 丁宁）12月5日晚间，君实生物（688180）发布公告称，公司收到国家药品监督管理 局核准签发的《受理通知书》，公司产品偌考奇拜单抗注射液（重组人源化抗IL-17A单克隆抗体注射 液）用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患者的新药上市申请获得受理。 ...

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。 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12月5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，近日，本公司收到國家藥品監督 管理局核准簽發的《受理通知書》，本公司產品偌考奇拜單抗注射液（重組人源化 抗IL-17A單克隆抗體注射液，產品代號：JS005）用於治療適合系統治療或光療的 中度至重度斑塊狀銀屑病的成人患者的新藥上市申請獲得受理。 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－ 偌考奇拜單抗注射液新藥上市申請獲得受理 研究結果顯示，偌考奇拜單抗治療12周顯著改善了銀屑病面積與嚴重程度指數 (PASI)75/90/100和靜態醫師全面評估(sPGA)評分0或1，療效顯著優於安慰劑 ...

Core Viewpoint - Junshi Biosciences (01877) has received acceptance for its new drug application for the injection of Rocabotilumab, a recombinant humanized anti-IL-17A monoclonal antibody, aimed at treating moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The National Medical Products Administration has issued an acceptance notice for the new drug application of Rocabotilumab [1] - Rocabotilumab is a specific anti-IL-17A monoclonal antibody developed by the company [1] - IL-17A is a multifunctional cytokine closely related to the development of autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] Group 2 - Rocabotilumab works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting the activation of downstream signaling pathways and the release of inflammatory factors [1] - As of the date of the announcement, all participants in the Phase II clinical study of Rocabotilumab for the treatment of active ankylosing spondylitis have completed treatment and entered the safety follow-up period [1]

Core Viewpoint - Junshi Biosciences has received a notice of acceptance from the National Medical Products Administration for its new drug application for JS005, a monoclonal antibody injection for treating moderate to severe plaque psoriasis in adults [1] Drug Information - Drug Name: JS005 (Rocacitinib Injection) - Application Type: Domestic production drug registration and marketing license - Acceptance Numbers: CXSS2500129, CXSS2500130 - Applicant: Junshi Biosciences - Specifications: 150mg (1ml) per pre-filled syringe and 150mg (1ml) per pre-filled autoinjector [1] - Approval Conclusion: The application has been accepted following the review under Article 32 of the Administrative Licensing Law of the People's Republic of China [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 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偌考奇拜單抗注射液新藥上市申請 獲得受理的公告》，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 中國，上海，2025年12月5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、酈仲賢先生、魯琨女士及楊勁 博士。 * 僅供識別之用 证券代码：688180 证券简称：君实生物 公告编号：临 2025-071 （於中華人民共和國註冊成立的股份有限公司） ...

公告显示，偌考奇拜单抗是特异性抗IL-17A单克隆抗体，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。 北京商报讯（记者 王寅浩 宋雨盈）12月5日，君实生物发布公告称，公司收到国家药品监督管理局核准 签发的《受理通知书》，偌考奇拜单抗注射液用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病 的成人患者的新药上市申请获得受理。 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2025-071 上海君实生物医药科技股份有限公司 自愿披露关于偌考奇拜单抗注射液 新药上市申请获得受理的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 近日，上海君实生物医药科技股份有限公司（以下简称"公司"）收到国家 药品监督管理局核准签发的《受理通知书》，公司产品偌考奇拜单抗注射液（重 组人源化抗 IL-17A 单克隆抗体注射液，产品代号：JS005）用于治疗适合系统治 疗或光疗的中度至重度斑块状银屑病的成人患者的新药上市申请获得受理。由于 药品的研发周期长、审批环节多，容易受到一些不确定性因素的影响，本次新药 上市申请能否获得批准存在不确定性，敬请广大投资者谨慎决策，注意防范投资 风险。现将相关情况公告如下： 一、药品基本情况 药品名称：偌考奇拜单抗注射液 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二、药品的其他相关情况 偌考奇拜单抗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）-1 ...