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治疗的抗PD-1单抗药物；君适达为首次纳入，是新版目录中唯一用于他 汀不耐受人群的国产PCSK9靶点药物。现将相关情况公告如下： 一、药品相关情况 （一）拓益 药品名称：特瑞普利单抗注射液 注册类别：治疗用生物制品 ...

Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. announced the inclusion of its products Tuoyi (Tremelimumab injection) and Junshida (Angrezi monoclonal antibody injection) in the National Medical Insurance Directory, effective January 1, 2026, highlighting the recognition of their clinical value and innovation by the National Healthcare Security Administration [1][6]. Group 1: Product Information - Tuoyi (Tremelimumab injection) has received approval for 12 indications, all of which are now included in the National Medical Insurance Directory, making it the only PD-1 monoclonal antibody drug listed for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1][2]. - Junshida (Angrezi monoclonal antibody injection) is the only domestic PCSK9-targeted drug included in the new insurance directory for patients intolerant to statins, marking its first inclusion [1][5]. Group 2: Market Impact - The inclusion of both drugs in the National Medical Insurance Directory is expected to enhance patient affordability and accessibility, thereby promoting market expansion and increasing sales scale for the company [6]. - The company plans to actively cooperate with the implementation of insurance policies and expand its market coverage to improve patient access to medications [6]. Group 3: Internationalization - Tuoyi has been approved for marketing in multiple countries and regions, including the United States, European Union, and several others, indicating a strong international presence [3].

（原标题：君实生物(01877)：拓益®新增适应症和君适达®纳入国家医保目录） 智通财经APP讯，君实生物(01877)发布公告，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治疗的抗PD-1单抗药物;君适达为首次纳入，是新版目录中唯一用于他汀不耐受 人群的国产PCSK9靶点药物。 ...

格隆汇12月7日丨君实生物(01877.HK)公告，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)》("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。 本次拓益新增适应症和君适达纳入国家医保目录，体现了国家医疗保障局("国家医保局")对上述药物的 临床价值、患者获益、创新程度等方面的认可，凸显了国家对本土创新药企的药物研发和产业化工作的 重视和支持。 公司商业化产品均已纳入国家医保目录，有助于进一步提高在患者中的可负担性和可及性，有利于进一 步推动商业化产品的市场推广、提升销售规模，对公司的长期经营发展具有积极影响。公司将积极配合 推进医保政策落地，持续推进医院准入工作、拓展核心市场及广阔市场的覆盖，以期不断提升患者的用 药可及性。医保报销细则等相关信息，需以国家医保局等相关政府部门公示信息为准。敬请广大投资者 谨慎投资，注意投资风险。 截至本公告日期，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 ...

北京商报讯（记者 丁宁）12月7日晚间，君实生物（688180）发布公告称，公司产品特瑞普利单抗注射 液（商品名：拓益）2项新增适应症、昂戈瑞西单抗注射液（商品名：君适达）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。 君实生物表示，截至公告披露日，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）、 氢溴酸氘瑞米德韦片（商品名：民得维）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治疗的抗PD- 1单抗药物；君适达为首次纳入，是新版目录中唯一用于他汀不耐受人群的国产PCSK9 靶点药物。 ...

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]

Core Insights - The article highlights the significant impact of domestic PD-1 inhibitors on reducing cancer treatment costs, leading to a release of previously constrained consumer demand [1] - It emphasizes the evolution of Chinese innovative pharmaceutical companies from imitation to original innovation, particularly in the field of cancer treatment [1][2] Company Development - Junshi Biosciences, as a representative of the thriving domestic innovative pharmaceutical sector, has made notable strides since its establishment in 2012, culminating in the launch of its PD-1 monoclonal antibody, Tuoyi, in 2018 [2][3] - Tuoyi has received approval for 12 indications, with 10 included in the national medical insurance catalog, significantly alleviating patient financial burdens [7] Market Dynamics - The competitive landscape has evolved with the emergence of "PD-1 Four Dragons," including Junshi Biosciences, Innovent Biologics, Hengrui Medicine, and BeiGene, marking PD-1 as a hot innovation track [3][4] - The industry is actively pursuing the development of next-generation immunotherapy drugs to address unmet clinical needs, with Junshi Biosciences allocating a significant portion of its recent financing for this purpose [4][5] Pricing and Accessibility - Junshi's Tuoyi was initially priced at less than one-third of similar imported products, making it one of the lowest-priced PD-1 drugs globally [6] - The company is focused on balancing accessibility and commercialization, as the Chinese innovative drug payment environment undergoes systemic reforms [7][8] International Expansion - Junshi Biosciences is exploring various international market entry strategies, including licensing, joint ventures, and independent commercialization, with a global network covering over 80 countries [10][11] - The company is actively pursuing partnerships to enhance its drug pipeline and expedite the approval process for its products in international markets [10][11] Future Outlook - The innovative drug industry is transitioning from a focus on "life-saving necessities" to "long-term health management services," driven by an aging population and increased health awareness [13] - Junshi Biosciences aims to contribute to the establishment of a globally competitive biopharmaceutical innovation system, emphasizing the importance of clinical efficacy, affordability, and user convenience in redefining the consumption value of innovative drugs [12][13][16]

Core Viewpoint - The article highlights the significant advancements and competitive landscape of China's innovative drug industry, particularly focusing on the development and commercialization of PD-1 inhibitors, with Junshi Biosciences as a key player in this transformation [3][4][5]. Group 1: Industry Development - The Chinese innovative drug sector is experiencing a pivotal decade, with local companies transitioning from imitation to original innovation, particularly in the field of cancer treatment [3]. - The approval of the first domestic PD-1 monoclonal antibody, Tuoyi (Tremelimumab), marked a significant milestone, leading to the emergence of a competitive landscape known as the "PD-1 Four Dragons" [7][8]. - As of now, Tuoyi has received approval for 12 indications, with 10 included in the national medical insurance catalog, significantly reducing treatment costs for patients [7][11]. Group 2: R&D and Innovation - Junshi Biosciences is focusing on the development of next-generation immunotherapy drugs to address unmet clinical needs, including PD-1/VEGF dual antibodies and other innovative targets [9][10]. - The company has raised over 1 billion HKD through equity financing, with a significant portion allocated to R&D for innovative drugs [9]. - The competitive landscape is becoming increasingly crowded, necessitating a focus on original innovation and differentiated product development strategies [10]. Group 3: Market Accessibility and Policy - Junshi's pricing strategy for Tuoyi was significantly lower than imported counterparts, making it one of the most affordable PD-1 drugs globally, which has been crucial for patient access [11]. - The Chinese government is reforming the medical insurance system to balance commercial viability with the need to reflect the value of innovation, aiming for a sustainable ecosystem for innovative drugs [11][12]. - Recent policy changes, including a dual-track payment system for innovative drugs, are expected to enhance market flexibility and accessibility [12]. Group 4: Global Expansion - The global market is becoming a new battleground for innovative drugs, with Junshi exploring various international strategies, including licensing and joint ventures [14][15]. - The company has established a global commercialization network covering over 80 countries and regions, actively pursuing international clinical trials for its pipeline products [16]. - The trend of licensing out has become a primary funding source for unprofitable innovative drug companies, with significant growth in transaction volumes reported [17]. Group 5: Future Outlook - The innovative drug industry is transitioning from a focus on urgent medical needs to long-term health management services, driven by an aging population and increased health awareness [19]. - Junshi aims to redefine the consumer value of innovative drugs by enhancing clinical efficacy, affordability, and patient adherence [19]. - The industry is expected to see increased interest from multinational pharmaceutical companies, providing opportunities for domestic firms to secure funding and expand internationally [21].