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特瑞普利单抗注射液(拓益)
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君实生物:2025年归母净利润亏损8.74亿元
Di Yi Cai Jing· 2026-02-27 08:31
君实生物晚间公告,2025年度营业总收入24.98亿元,同比增长28.23%。2025年公司核心产品特瑞普利 单抗注射液(商品名:拓益 )于国内市场销售收入同比大幅增长约37.72%。报告期内,公司营业收入 较上年同期增长,主要系公司核心产品特瑞普利单抗注射液(商品名:拓益 )于国内市场销售收入同 比大幅增长。归属于母公司所有者的净利润-8.74亿元,上年同期为-12.81亿元。 ...
君实生物涨超5% 预期2025年度归母净亏损同比收窄31.85%左右
Zhi Tong Cai Jing· 2026-02-09 02:21
公告称,公司2025年年度归属于母公司所有者的净利润仍出现亏损,但亏损金额与上年同期相比显著缩 窄,主要系公司持续落实"提质增效重回报"行动方案,商业化能力显著提升的同时不断加强费用管控与 资源聚焦。 报告期内,公司营业收入增长,主要系商业化药品的销售收入与上年同期相比有所增长。报告期内,公 司核心产品特瑞普利单抗注射液(商品名:拓益)于国内市场销售收入同比大幅增长。截至本公告披露 日,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。 消息面上,近日,君实生物发布公告,预计2025年年度实现营业收入25亿元左右,同比增长28.32%左 右。预计2025年年度研发费用为13.53亿元,同比增长6.10%左右。预计2025年年度实现归属于母公司所 有者的净亏损为8.73亿左右,同比亏损减少31.85%左右。预计2025年年度扣除股份支付影响后实现归属 于母公司所有者的净亏损为7.99亿元左右,同比亏损减少37.62%左右。预计2025年年度实现归属于母公 司所有者扣除非经常性损益后的净亏损为9.85亿元左右,同比亏损减少23.64 ...
君实生物发盈警 预期2025年归母净亏损为8.73亿左右 同比亏损减少 31.85%左右
Zhi Tong Cai Jing· 2026-01-30 11:16
君实生物(01877)公布,预计2025年年度实现营业收入25亿元左右,同比增长28.32%左右。预计2025年 年度研发费用为13.53亿元,同比增长6.10%左右。预计2025年年度实现归属于母公司所有者的净亏损为 8.73亿左右,同比亏损减少31.85%左右。预计2025年年度扣除股份支付影响后实现归属于母公司所有者 的净亏损为7.99亿元左右,同比亏损减少37.62%左右。预计2025年年度实现归属于母公司所有者扣除非 经常性损益后的净亏损为9.85亿元左右,同比亏损减少23.64%左右。预计2025年年度扣除股份支付影响 后实现归属于母公司所有者扣除非经常性损益后的净亏损为9.11亿元左右,同比亏损减少29.37%左右。 公司亦持续拓展全球商业化网络,截至本公告披露日,特瑞普利单抗已在中国内地、中国香港、美国、 欧盟、印度、英国、约旦、澳大利亚、新加坡、阿联酋、科威特、巴基斯坦、加拿大和巴林等40多个国 家和地区获批上市,并在全球多个国家和地区接受上市审评。 公司2025年年度归属于母公司所有者的净利润仍出现亏损,但亏损金额与上年同期相比显著缩窄,主要 系公司持续落实"提质增效重回报"行动方案,商业 ...
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
Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has successfully included two of its products, Toripalimab Injection (brand name: Tuoyi) and Engrelistat Injection (brand name: Junshida), in the National Medical Insurance Catalog (2025) under Category B, effective from January 1, 2026 [1][2]. Group 1: Product Information - Toripalimab Injection is the first domestically approved PD-1 monoclonal antibody in China, with 12 indications approved for listing in the National Medical Insurance Catalog, including treatments for renal cancer, triple-negative breast cancer, and melanoma [2][4]. - Engrelistat Injection is a domestically developed PCSK9-targeting drug, newly included in the National Medical Insurance Catalog, specifically for patients intolerant to statins [5][6]. Group 2: Market Impact - The inclusion of these products in the National Medical Insurance Catalog reflects the recognition of their clinical value and innovation by the National Healthcare Security Administration, which supports local innovative pharmaceutical companies [6]. - The listing of all commercialized products in the National Medical Insurance Catalog is expected to enhance affordability and accessibility for patients, thereby promoting market expansion and increasing sales scale for the company [6].
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
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].
君实生物(01877):拓益®新增适应症和君适达®纳入国家医保目录
Zhi Tong Cai Jing· 2025-12-07 10:49
Core Viewpoint - Junshi Biosciences (01877) announced the addition of two new indications for its product Toripalimab (brand name: Tuoyi) and the inclusion of its product Engrezt (brand name: Junshida) in the National Medical Insurance Directory, effective January 1, 2026 [1] Group 1 - The product Toripalimab has received approval for 12 indications in mainland China, all of which are included in the National Medical Insurance Directory, making it the only anti-PD-1 monoclonal antibody in the directory for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1] - Engrezt is newly included in the directory and is the only domestic PCSK9-targeted drug for patients intolerant to statins in the updated list [1]
君实生物(01877.HK)拓益®新增适应症和君适达®纳入国家医保目录
Ge Long Hui· 2025-12-07 10:36
Core Viewpoint - Junshi Biosciences (01877.HK) announced that its products, Toripalimab Injection (brand name: Tuoyi, product code: JS001) and Engreitzumab Injection (brand name: Junshida, product code: JS002), have been included in the National Medical Insurance Catalog (2025) under Category B, effective January 1, 2026 [1] Group 1 - The inclusion of Toripalimab's two new indications and Junshida in the National Medical Insurance Catalog reflects the National Healthcare Security Administration's recognition of the clinical value, patient benefits, and innovation of these drugs [1] - Toripalimab is the only anti-PD-1 monoclonal antibody in the catalog approved for treating renal cancer, triple-negative breast cancer, and melanoma, with all 12 approved indications included [1] - Junshida is the first domestic PCSK9-targeted drug included in the new catalog for patients intolerant to statins [1] Group 2 - All four commercialized products of the company, including Tuoyi, Adalimumab Injection (brand name: Junmaikang, product code: UBP1211), Dexamethasone Hydrochloride Tablets (brand name: Mindewi, product code: VV116/JT001), and Junshida, are now part of the National Medical Insurance Catalog [2] - The inclusion in the catalog is expected to enhance affordability and accessibility for patients, promoting market expansion and increasing sales scale, positively impacting the company's long-term operational development [2] - The company will actively cooperate to implement the medical insurance policy, continue to advance hospital access, and expand coverage in core and broader markets to improve patient access to medications [2]
君实生物拓益新增适应症和君适达纳入国家医保目录
Bei Jing Shang Bao· 2025-12-07 08:05
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]
君实生物:拓益 新增适应症和君适达 纳入国家医保目录
Mei Ri Jing Ji Xin Wen· 2025-12-07 07:51
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]
君实生物: 开启免疫治疗2.0时代
Bei Jing Shang Bao· 2025-08-05 10:36
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]