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君实生物盘中涨超3% 拓益®2项新增适应症和君适达®纳入国家医保目录
Xin Lang Cai Jing· 2025-12-08 01:48
Core Viewpoint - Junshi Biosciences (01877) has seen a stock price increase of 1.87% to 24 HKD following the announcement of new indications for its products being included in the National Medical Insurance Directory [2][5]. Group 1: Product Developments - Junshi Biosciences 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 Directory (2025) under the Class B category [2][5]. - The new version of the National Medical Insurance Directory will be officially implemented on January 1, 2026 [2][5]. Group 2: Product Portfolio - As of the announcement date, four commercialized products from the company, including Tuoyi®, Adalimumab injection (brand name: Junmaikang®, product code: UBP1211), Dexamethasone Hydrochloride Tablets (brand name: Mindewi®, product code: VV116/JT001), and Junshida®, have all been included in the National Medical Insurance Directory [2][5]. - Tuoyi® is the only anti-PD-1 monoclonal antibody in the directory that is approved for treating renal cancer, triple-negative breast cancer, and melanoma, with all 12 approved indications included [2][5]. - Junshida® is newly included and is the only domestic PCSK9-targeted drug in the new directory for patients intolerant to statins [2][5].
盘前公告淘金:恒瑞医药多款药品纳入医保,千方科技为“星算计划”首批合作伙伴,佳华科技拟购数盾科技90%股份复牌
Sou Hu Cai Jing· 2025-12-08 00:56
Group 1: National Medical Insurance Directory Inclusion - Heng Rui Medicine has multiple drugs included in the 2025 National Medical Insurance Directory [1] - Xing Qi Eye Medicine has 39 products continuing to be included in the National Medical Insurance Drug Directory [1] - Bei Da Pharmaceutical has four products included in the National Medical Insurance Drug Directory [1] - Junshi Biosciences has added indications for Tuoyi® and included Junshida® in the National Medical Insurance Directory [1] - Zhongsheng Pharmaceutical's innovative drug Angladiwei tablets have been included in the National Medical Insurance Directory through negotiation [1] - Yiling Pharmaceutical's subsidiary has its exclusive product Qifang Nasal Tablets included in the National Medical Insurance Directory, totaling 12 exclusive patented traditional Chinese medicine products [1] - Aosaikang's product Liratinib tablets (Aoyi Xin®) has been included in the 2025 National Medical Insurance Directory [1] - Kanghong Pharmaceutical's product Kangbai Xip eye injection (Langmu) has been included in the 2025 National Medical Insurance Directory [1] - Dongcheng Pharmaceutical's Technetium-99m injection has been included in the medical insurance directory; its subsidiary has received clinical trial approval for 177Lu-LNC1009 injection [1] - Micron Biomedical's Sidabena tablets have been included in the National Medical Insurance Directory for regular Class B management [1] - Haichuang Pharmaceutical's Deuteroenzalutamide soft capsules have been included in the National Medical Insurance Directory for the first time [1] - Huadong Medicine's subsidiary products and cooperative products have been included in the National Medical Insurance and commercial insurance innovative drug directory [1] - Aidi Pharmaceutical's two anti-HIV innovative drugs continue to be included in the National Medical Insurance Directory through a simplified renewal process [1] Group 2: Corporate Developments - Hengyin Technology has signed a cooperation agreement with Muxi Co., focusing on the domestic GPU scenario [1] - Jia Jian Co. is planning a change in control, with stock resuming trading on December 8 [2] - Gu Ao Technology's actual controller is planning a change in control, leading to stock suspension [2] Group 3: Financial Performance - Tianbang Food reported a commodity pig sales revenue of 654 million yuan in November, a month-on-month increase of 7.66% [3] - Tian Ci Materials' controlling shareholder has committed not to reduce company shares [3]
港股公告掘金 协合新能源11月权益发电量为697.23GWh,同比增长7.77%
Jin Rong Jie· 2025-12-07 13:34
Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]
港股公告掘金 | 协合新能源11月权益发电量为697.23GWh,同比增长7.77%
Zhi Tong Cai Jing· 2025-12-07 12:19
Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy in first-line treatment of gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of the III phase clinical study of Nilotinib in first-line treatment of Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharma-B (02595) initiated a registration clinical trial for GFH375 in metastatic pancreatic cancer, marking the first global oral KRAS G12D inhibitor monotherapy controlled chemotherapy III phase study [1] - Xixiangfeng Group (02473) subsidiary signed a business cooperation agreement with Hello Car Rental to develop car rental business in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for GLP-1/GIP receptor dual agonist peptide injection [1] - MIRXES-B (02629) plans to collaborate with Jingtai Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automotive (01728) plans to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) intends to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) announced that seven innovative products, including new indications, were successfully included in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biopharma-B (09887) clinical data for LBL-034 was presented at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Aurantium Extract Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) had five new products successfully included in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) core products were included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported contract sales of approximately 47.7 billion yuan in the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported November equity power generation of 697.23 GWh, a year-on-year increase of 7.77% [2]
君实生物(688180.SH):拓益新增适应症和君适达纳入国家医保目录
智通财经网· 2025-12-07 08:47
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]
君实生物(688180.SH):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 07:44
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]
君实生物(01877.HK):“JS001sc” 一线治疗非鳞状非小细胞肺癌的Ⅲ期临床研究达到主要研究终点
Ge Long Hui· 2025-11-24 11:57
Core Viewpoint - The company announced that its product, JS001sc (subcutaneous injection of Tislelizumab), has achieved the primary endpoint in a Phase III clinical trial for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer, and plans to submit a marketing authorization application soon [1] Group 1: Clinical Trial Results - The Phase III clinical study (JS001sc-002-III-NSCLC) comparing JS001sc with Tislelizumab injection (brand name: Tuoyi®) in combination with chemotherapy has reached its primary endpoint [1] - JS001sc is the first domestically developed subcutaneous PD-1 monoclonal antibody to enter Phase III clinical trials, potentially offering convenience for patients [1] Group 2: Regulatory Plans - The company intends to submit a marketing authorization application to regulatory authorities in the near future [1] Group 3: Product Development - JS001sc is developed based on the already marketed Tislelizumab injection, indicating a strategic expansion of the company's product line [1]
君实生物披露抗IL-17A单抗治疗研究进展 近期将递交产品上市许可申请
Core Viewpoint - The company has achieved positive results in a pivotal Phase III clinical trial for its humanized anti-IL-17A monoclonal antibody (JS005) for the treatment of moderate to severe plaque psoriasis, with significant statistical and clinical improvements in primary and key secondary endpoints [1][4]. Company Summary - The company plans to submit a marketing authorization application for JS005 to regulatory authorities in the near future [1]. - The company reported a revenue increase of approximately 382 million yuan, a growth rate of 48.64% year-on-year for the first half of 2025, primarily driven by sales of commercialized drugs, with Tuoyi® achieving sales of 954 million yuan, a year-on-year increase of about 42% [1]. Product Summary - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, which effectively alleviates symptoms of autoimmune diseases by blocking the interaction between IL-17A and its receptors [2]. - The Phase III clinical trial for JS005 in treating moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for treating active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [2][4]. Industry Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2%-3%, and approximately 47% in China, affecting around 125 million people worldwide [4]. - Moderate to severe psoriasis significantly impacts patients' physical and mental health, increasing the risk of comorbidities such as metabolic syndrome and cardiovascular diseases, as well as mental health issues like depression and anxiety [4].
尚未盈利的君实生物:上半年亏损收窄,药品销售收入超10亿元
Xin Jing Bao· 2025-08-28 05:17
Core Viewpoint - Junshi Biosciences reported a significant increase in revenue for the first half of 2025, but the company has not yet achieved profitability, highlighting the challenges of the biopharmaceutical industry, which is characterized by long R&D cycles, high investment, and substantial risks [1][2]. Financial Performance - In the first half of 2025, Junshi Biosciences achieved approximately 1.168 billion yuan in revenue, a year-on-year increase of 48.64%, with drug sales revenue reaching 1.059 billion yuan, up 49.41% [1][2]. - The net loss attributable to shareholders was approximately 413 million yuan, which represents a narrowing of losses compared to the previous year [1][2]. - The company's R&D expenses were about 706 million yuan, reflecting a year-on-year increase of 29.14%, driven by a focus on competitive and innovative R&D projects [3]. Product Pipeline and Innovation - Junshi Biosciences has expanded its innovation scope beyond monoclonal antibodies to include small molecule drugs, antibody-drug conjugates (ADC), bispecific or multispecific antibodies, fusion proteins, nucleic acid drugs, and vaccines [2]. - The company has a product pipeline covering five major therapeutic areas: malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases [2]. - As of the report date, Junshi Biosciences has four commercialized drugs and nearly 30 drug candidates in clinical trials, with over 20 in preclinical development [2]. Cash Flow and Funding - The net cash flow from operating activities showed a reduction in net outflow compared to the previous year, primarily due to increased sales revenue from commercialized drugs and significant technical licensing fees received during the period [2]. - In June 2025, Junshi Biosciences successfully completed a new H-share placement, raising approximately 1.026 billion HKD, with total cash and financial assets amounting to about 3.507 billion yuan at the end of the reporting period [3].
君实生物发布半年度业绩,归母净亏损4.13亿元
智通财经网· 2025-08-26 18:00
Core Viewpoint - Junshi Biosciences (688180.SH) reported a significant revenue increase of 48.64% year-on-year for the first half of 2025, driven by the sales of commercialized drugs, despite a net loss attributable to shareholders of 413 million yuan [1] Financial Performance - The company achieved a revenue of 1.168 billion yuan, an increase of approximately 382 million yuan compared to the same period last year, reflecting a growth rate of 48.64% [1] - The net loss attributable to shareholders was 413 million yuan, with a basic earnings per share of -0.42 yuan [1] - The diluted earnings per share also reflected a loss, indicating ongoing financial challenges despite revenue growth [1] Sales Performance - The sales revenue of Tuoyi® in the domestic market reached 954 million yuan, representing a year-on-year growth of approximately 42% [1] - The increase in sales revenue from commercialized drugs contributed significantly to the reduction in net loss compared to the previous year [1] Strategic Focus - The company is implementing a "quality improvement and efficiency enhancement" action plan, focusing on R&D projects with competitive advantages and innovation [1] - Efforts are being made to accelerate clinical development, reduce production costs, and improve sales efficiency to further decrease losses [1]