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－ 拓益®新增適應症和君適達®納入國家醫保目錄 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，本公司產品特瑞普利單抗注射液 （商品名：拓益®，產品代號：JS001）2項新增適應症、昂戈瑞西單抗注射液（商 品名：君適達®，產品代號：JS002）成功納入《國家基本醫療保險、生育保險和工 傷保險藥品目錄（2025年）》（「國家醫保目錄」）乙類範圍。新版國家醫保目錄將於 2026年1月1日起正式實施。 截至本公告日期，本公司4款商業化產品拓益®、阿達木單抗注射液（商品名：君 邁康®，產品代號：UBP1 ...

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 （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拓益®新增適應症和君適達®納入國 家醫保目錄的公告》，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、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 ...

Core Insights - Junshi Biosciences (688180.SH) announced that its product Toripalimab injection (brand name: Tuoyi®, product code: JS001) has received two new indications, and its product Engreztinib injection (brand name: Junshida®, product code: JS002) has been successfully included in the National Medical Insurance Catalog (2025) under Category B, effective January 1, 2026 [1] Group 1 - As of the announcement date, the company has four commercialized products, including Tuoyi®, Adalimumab injection (brand name: Junmaikang®, product code: UBP1211), Dihydrocodeine Bromide tablets (brand name: Mindewi®, product code: VV116/JT001), and Junshida®, all of which have been included in the National Medical Insurance Catalog [1] - Tuoyi® is the only anti-PD-1 monoclonal antibody in the catalog that is approved for treating renal cancer, triple-negative breast cancer, and melanoma, with all 12 approved indications in mainland China included in the National Medical Insurance Catalog [1] - Junshida® is newly included in the catalog and is the only domestic PCSK9-targeted drug for patients intolerant to statins in the new version of the catalog [1]

Core Insights - Junshi Biosciences (君实生物) announced the inclusion of two new indications for its product Toripalimab injection (brand name: Tuoyi) and the successful addition of its product Engreztinib injection (brand name: Junshida) to the National Medical Insurance Catalog for 2025 [1] Group 1: Product Developments - Toripalimab has now been approved for all 12 indications in mainland China and is the only anti-PD-1 monoclonal antibody in the catalog for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1] - Junshida is newly included in the catalog and is the only domestic PCSK9-targeted drug for patients intolerant to statins in the updated list [1] Group 2: Market Position - As of the announcement date, four commercialized products from Junshi Biosciences, including Tuoyi, Adalimumab injection (brand name: Junmaikang), Dexamethasone Hydrochloride tablets (brand name: Mindewi), and Junshida, have been included in the National Medical Insurance Catalog [1]

Core Viewpoint - Junshi Biosciences (688180.SH) announced that its products, Toripalimab injection (brand name: Tuoyi) and Engreztinib injection (brand name: Junshida), have been included in the Category B of the National Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List (2025) [1] Group 1 - Toripalimab has been approved for 12 indications in mainland China and is the only anti-PD-1 monoclonal antibody included in the national medical insurance directory for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1] - Engreztinib is newly included in the directory and is the only domestic PCSK9-targeted drug for patients intolerant to statins [1] - The inclusion of these drugs reflects the recognition by the National Healthcare Security Administration, which will enhance patient affordability and accessibility of medications, thereby promoting the commercialization and sales growth of these products [1]

证券代码：688180 证券简称：君实生物 公告编号：临 2025-072 上海君实生物医药科技股份有限公司 自愿披露关于拓益®新增适应症 和君适达®纳入国家医保目录的公告 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"）产品特瑞 普利单抗注射液（商品名：拓益®，产品代号：JS001）2 项新增适应症、昂戈瑞 西单抗注射液（商品名：君适达®，产品代号：JS002）成功纳入《国家基本医疗 保险、生育保险和工伤保险药品目录（2025 年）》（以下简称"国家医保目录"） 乙类范围。新版国家医保目录将于 2026 年 1 月 1 日起正式实施。 截至本公告披露日，公司 4 款商业化产品拓益®、阿达木单抗注射液（商品 名：君迈康®，产品代号：UBP1211）、氢溴酸氘瑞米德韦片（商品名：民得维®， 产品代号：VV116/JT001）和君适达®均已纳入国家医保目录。拓益®已在中国内 地获批上市的 12 项适应症全部纳入国家医保目录，是目录中唯一用于肾癌、三 阴性乳腺癌和黑色素瘤 ...

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].

Core Viewpoint - Junshi Biosciences has received the acceptance notice from the National Medical Products Administration for its new drug application of Rocabotamab injection, aimed at treating moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The product Rocabotamab is a recombinant humanized anti-IL-17A monoclonal antibody injection [1] - The acceptance of the new drug application marks a significant step for Junshi Biosciences in expanding its product portfolio in the dermatology sector [1] - As of the announcement date, all participants in the Phase II clinical study of Rocabotamab for treating active ankylosing spondylitis have completed treatment and entered the safety follow-up period [1]