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 ...

12月7日，医保、商保"双目录"发布。国家医保局、人力资源社会保障部印发《国家基本医疗保险、生育保险和工伤保险药品目录》以及《商业健康保险 创新药品目录》（2025年）。新版目录将于2026年1月1日在全国范围内正式实施。 2025年国家医保药品目录新增114种药品，其中，50种为1类创新药。同时，首版商保创新药目录共纳入19种药品，既有CAR-T等肿瘤治疗药品，也有神经 母细胞瘤、戈谢病等罕见病治疗药品，还有阿尔茨海默病治疗药品等，涉及北海康成、复星医药、药明巨诺、百济神州等国内多家上市药企。 图片来源：国家医保局网站 支持"真创新" 本次调整后，2025年国家医保药品目录内药品总数增至3253种，其中西药1857种、中成药1396种，肿瘤、慢性病、精神疾病、罕见病、儿童用药等重点领 域的保障水平得到明显提升。 中国证券报记者梳理发现，恒瑞医药、信达生物、众生药业、智翔金泰、康诺亚等多家国内上市公司产品被纳入。 恒瑞医药共有11款抗肿瘤产品被纳入，包括5款首次纳入国家医保目录的创新产品，3款创新药的关键新适应症，以及3款重点产品的医保目录内续约。恒 瑞医药肿瘤领域共16款已上市创新药中，已有14款纳入国家医 ...

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 Insights - Junshi Biosciences announced promising long-term survival results for toripalimab from the JUPITER-02 and JUPITER-06 trials at the ESMO ASIA Congress 2025, highlighting its potential as a leading immunotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC) and advanced esophageal squamous cell carcinoma (ESCC) [1][2] Group 1: JUPITER-02 Trial - JUPITER-02 is the first global multicenter, double-blind, randomized Phase 3 trial in immunotherapy for NPC, demonstrating significant long-term survival benefits with toripalimab plus chemotherapy [3][6] - The trial enrolled 289 chemotherapy-naïve patients with R/M NPC, showing a median overall survival (mOS) of 64.8 months for the toripalimab group compared to 33.7 months for the placebo group, representing a 39% reduction in death risk [5][8] - Toripalimab plus chemotherapy is now approved in over 40 countries and endorsed by major international guidelines, establishing a new standard of care for first-line treatment of R/M NPC [6][8] Group 2: JUPITER-06 Trial - JUPITER-06 is a Phase 3 trial evaluating toripalimab combined with paclitaxel and cisplatin (TP) chemotherapy for advanced or metastatic ESCC, showing a mOS of 17.7 months compared to 12.9 months for the placebo group, with a 28% reduction in death risk [11][12] - The trial included 514 systemic treatment-naïve patients, confirming consistent overall survival benefits across subgroups, regardless of PD-L1 expression status [12][14] - Toripalimab has gained approval for first-line treatment of advanced ESCC in multiple regions, including Europe, marking a significant milestone in immunotherapy [14][19] Group 3: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on developing novel therapies, with a diverse R&D pipeline of over 50 drug candidates across various therapeutic areas [20][21] - The company has successfully developed toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody, which has been approved in over 40 countries [20][21] - Junshi Biosciences aims to provide world-class, affordable, and innovative drugs, with a commitment to global health [21]