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]

Core Viewpoint - Junshi Biosciences announced the acceptance of the new drug application (NDA) for roconkibart injection, a treatment for moderate to severe plaque psoriasis, by the National Medical Products Administration (NMPA) in China [1][5]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of innovative therapeutics [8]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8]. - Junshi has achieved significant milestones, including the approval of five products in China and international markets, notably toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [8]. Product Details - Roconkibart (JS005) is a recombinant humanized anti-IL-17A monoclonal antibody designed to treat moderate to severe plaque psoriasis by targeting the inflammatory pathway associated with the disease [1][6]. - The NDA submission is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy and a favorable safety profile [3][4]. Clinical Study Insights - The phase 3 clinical study showed that treatment with roconkibart for 12 weeks resulted in significant improvements in the Psoriasis Area and Severity Index (PASI) scores and static Physician Global Assessment (sPGA) scores compared to the placebo group [4]. - The efficacy of roconkibart was maintained throughout a 52-week treatment period, indicating its potential as a long-term treatment option for patients [4]. Market Implications - The acceptance of the NDA is seen as a critical step in transitioning roconkibart from clinical research to real-world application, with expectations for early approval to enhance treatment options for patients in China [5]. - The company aims to collaborate closely with regulatory authorities to expedite the product's market approval process [5].

Core Viewpoint - Junshi Biosciences has received acceptance for the new drug application (NDA) of roconkibart injection, a treatment for moderate to severe plaque psoriasis, by the National Medical Products Administration (NMPA) in China [1][5]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of innovative therapeutics [8]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8]. - Junshi Biosciences has achieved significant milestones, including the approval of five products in China and international markets, notably toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [8]. Product Details - Roconkibart (JS005) is a recombinant humanized anti-IL-17A monoclonal antibody injection designed to treat adult patients with moderate to severe plaque psoriasis [1][6]. - The drug works by selectively blocking IL-17A, a cytokine involved in the inflammatory pathway of psoriasis, thereby alleviating symptoms of autoimmune diseases [6]. Clinical Study Insights - The NDA is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy in improving psoriasis severity scores compared to placebo [3][4]. - Results indicated that treatment with roconkibart for 12 weeks led to substantial improvements in the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA) scores, with a favorable safety profile maintained over 52 weeks [4]. Future Prospects - The acceptance of the NDA is seen as a critical step in transitioning roconkibart from clinical research to real-world application, with expectations for early approval to enhance treatment options for patients in China [5].

Group 1: Major Transactions - Bohai Chemical is planning to sell 100% equity of Tianjin Bohai Petrochemical and acquire control of Anhui Taida New Materials through a combination of share issuance and cash payment, leading to a significant asset restructuring [1] - Zhongneng Electric is set to acquire 65% equity and debt from three companies, which may constitute a major asset restructuring but will not involve share issuance or change in control [4] - Hai Tai Development has decided to terminate the acquisition of controlling interest in Zhixueyun Technology due to disagreements on key terms, ensuring no adverse impact on normal business operations [5] Group 2: Performance Updates - Wen's shares reported a sales revenue of 3.324 billion yuan from meat chickens in November, marking a year-on-year increase of 10.18% [6] - Shuguang shares saw a 71.07% year-on-year increase in vehicle sales, totaling 207 units in November [6] - Muyuan shares experienced a decline in sales revenue from commodity pigs, reporting 9.39 billion yuan, a decrease of 20.43% year-on-year [6] - Pengding Holdings reported a 5.58% year-on-year decrease in consolidated revenue for November [6] Group 3: Industry Developments - Xiangxi Dairy reported a 6.3% month-on-month increase in fresh milk production in November, although it saw a year-on-year decline of 6.47% [7] - Baisheng Intelligent plans to acquire 51% equity in Zhongke Shengu, which focuses on the research and application of core technologies for embodied intelligent robots [7]