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君实生物:上半年民得维®实现全渠道覆盖,探索社区和县域市场医疗合作模式
Cai Jing Wang· 2025-09-08 04:14
民得维®于2023年1月获得国家药品监督管理局附条件批准上市后,公司积极组建商业化团队,不断探 索销售模式。2025年上半年,民得维®实现全渠道覆盖,完成在美团、京东、阿里健康等药品零售电商 平台上线,与全国级医药公司及连锁药店达成战略合作,积极探索社区和县域市场医疗合作模式,帮助 患者更便捷的接受诊疗。 君迈康®目前共有8项适应症获批上市,并已全部纳入国家医保目录。根据公司与迈威生物的合作协 议,迈威生物或其控股子公司负责对君迈康®进行推广。 君适达®于2024年10月获批,目前共有三项适应症获批上市。公司合作伙伴博创医药正积极推进君适达 ®在中国大陆的后续商业化工作。 9月8日,君实生物举办2025半年度业绩说明会。会上有投资者提问,特瑞普利单抗之外,公司其他3款 款已实现商业化上市的产品如何为公司持续造血。公司现阶段在 BD 策略上是否有明确的规划或预期。 对此,管理层回应,特瑞普利单抗以外,公司及合作伙伴亦积极拓宽其他商业化产品的销售渠道。民得 维®(氢溴酸氘瑞米德韦片)、阿达木单抗( 商品名: 君迈康®)、昂戈瑞西单抗( 商品名: 君适达 ®)现阶段商业化进展如下: (上证路演) (编辑:林辰) 管 ...
君实生物跌2.00%,成交额5.81亿元,主力资金净流出1140.50万元
Xin Lang Cai Jing· 2025-09-08 03:32
9月8日,君实生物盘中下跌2.00%,截至10:54,报47.04元/股,成交5.81亿元,换手率1.58%,总市值 482.95亿元。 君实生物所属申万行业为:医药生物-生物制品-其他生物制品。所属概念板块包括:中盘、融资融券、 增持回购、H股、猴痘概念等。 截至6月30日,君实生物股东户数3.12万,较上期增加5.88%;人均流通股24543股,较上期减少5.56%。 2025年1月-6月,君实生物实现营业收入11.68亿元,同比增长48.64%;归母净利润-4.13亿元,同比增长 36.01%。 机构持仓方面,截止2025年6月30日,君实生物十大流通股东中,华夏上证科创板50成份ETF (588000)位居第六大流通股东,持股2971.67万股,相比上期减少53.67万股。易方达上证科创板 50ETF(588080)位居第七大流通股东,持股2221.32万股,相比上期增加63.00万股。香港中央结算有 限公司位居第十大流通股东,持股1312.91万股,相比上期减少186.65万股。 资金流向方面,主力资金净流出1140.50万元,特大单买入5998.46万元,占比10.32%,卖出5474.26万 元 ...
科创生物医药ETF(588250)涨近1%,国内创新药研发加速
Xin Lang Cai Jing· 2025-09-08 02:53
Core Viewpoint - The biopharmaceutical sector in China is experiencing a positive trend in innovation and investment, with significant growth in the approval of innovative drugs and a recovery in market conditions [1][2] Industry Summary - As of September 8, 2025, the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index (000683) increased by 0.89%, with notable gains from companies such as United Imaging Healthcare (688271) up 11.48% and BGI Genomics (688114) up 9.35% [1] - The "National Drug Safety Publicity Week" launched on September 1 highlights the positive development of the pharmaceutical industry, with 210 innovative drugs approved in the past five years, indicating a sustained growth trend [1] - Currently, approximately 30% of the world's innovative drugs under research are from China, showcasing the country's significant role in global pharmaceutical innovation [1] Company Summary - The top ten weighted stocks in the Sci-Tech Innovation Board Biopharmaceutical Index as of August 29, 2025, include United Imaging Healthcare (688271), BeiGene (688235), and others, collectively accounting for 50.27% of the index [2] - The Sci-Tech Biopharmaceutical ETF (588250) closely tracks the performance of the Sci-Tech Innovation Board Biopharmaceutical Index, reflecting the overall performance of representative biopharmaceutical companies listed on the Sci-Tech Board [2]
上海君实生物医药科技股份有限公司 自愿披露关于抗IL-17A单抗治疗中重度斑块状银屑病的Ⅲ期临床研究达到 主要研究终点的公告
Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has achieved positive results in a pivotal Phase III clinical trial for its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, with plans to submit a marketing authorization application soon [1][3]. Group 1: Product Information - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1][2]. - The drug works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1][2]. Group 2: Clinical Trial Details - The Phase III clinical trial (JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled study conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital [3]. - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [3]. Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2.0%-3.0%, while in China, it is approximately 0.47%, affecting around 125 million people worldwide [2]. - The disease is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, highlighting the urgent need for effective treatments [2].
华纳药厂控股子公司拟引入战略投资者;礼来又一减重新药首次启动临床丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-09-07 23:20
Group 1 - Junshi Biosciences' anti-IL-17A monoclonal antibody (JS005) achieved positive results in a Phase III clinical trial for moderate to severe plaque psoriasis, with both primary and key secondary endpoints showing statistical significance and clinical relevance. The company plans to submit a marketing authorization application soon [1] - Warner Pharmaceuticals announced that its subsidiary, Shanghai Zhigen Pharmaceutical Technology Co., Ltd., will introduce strategic investors for a capital increase not exceeding 70 million yuan, which will support the clinical trials of its innovative drugs, including ZG-001 and ZG-002 [2] - Sunflower is planning a major asset restructuring to acquire controlling stakes in Zhangzhou Xipu Material Technology Co., Ltd. and 40% of Zhejiang Beid Pharmaceutical Co., Ltd., aiming to enhance its competitiveness in the pharmaceutical sector and enter the new materials field [3] Group 2 - Huaxi Biological's controlling shareholder, Huaxi Xinyu Investment Co., Ltd., plans to increase its stake in the company with an investment of no less than 200 million yuan and no more than 300 million yuan, having already exceeded the lower limit of the planned increase. This move reflects confidence in the company's long-term development [4] - Eli Lilly has initiated a Phase I clinical trial for its weight loss drug LY4064912, which has no disclosed mechanism target yet. This step underscores the company's commitment to the metabolic field and aims to solidify its leading position in the obesity treatment market [5]
股市必读:9月5日君实生物发生1笔大宗交易 成交金额4766万元
Sou Hu Cai Jing· 2025-09-07 18:48
Group 1 - On September 5, 2025, Junshi Biosciences (688180) closed at 48.0 yuan, up 7.38%, with a turnover rate of 3.3% and a trading volume of 252,900 shares, amounting to a transaction value of 1.173 billion yuan [1] - On the same day, there was a net inflow of 12.36 million yuan from institutional investors, accounting for 1.05% of the total transaction value, while retail investors saw a net inflow of 13.08 million yuan, also representing 1.11% of the total [1][4] - A block trade occurred on September 5, with a transaction amount of 47.66 million yuan [2][4] Group 2 - Junshi Biosciences will hold its first extraordinary general meeting of shareholders on September 26, 2025, to review several proposals, including the election of Yang Jin as an independent non-executive director and the introduction of a stock option incentive plan for 2025 [3][4] - The company plans to issue 41 million H-shares, increasing its registered capital from 985,689,871 yuan to 1,026,689,871 yuan, and will abolish the supervisory board, transferring its duties to the audit committee of the board [2][4] - The company announced that its anti-IL-17A monoclonal antibody JS005 has achieved the primary endpoint in a Phase III clinical trial for moderate to severe plaque psoriasis, with plans to submit a marketing authorization application soon [4][7]
Junshi Biosciences Announces the Phase 3 Study of JS005 (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis Met Primary Endpoints
GlobeNewswire News Room· 2025-09-07 12:30
Core Insights - Junshi Biosciences announced positive results from the Phase 3 clinical study of JS005, an anti-IL-17A monoclonal antibody for treating moderate to severe plaque psoriasis, meeting both co-primary and key secondary endpoints [1][3][4] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [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 received approvals for five products in China and international markets, including toripalimab, the first domestically produced anti-PD-1 monoclonal antibody in China, approved in 40 countries [8] Clinical Study Details - The Phase 3 study of JS005 was conducted at 60 clinical sites across China, led by Professor Jianzhong Zhang, with the primary objective to assess the efficacy of JS005 compared to placebo [3][4] - Results indicated that JS005 significantly improved psoriasis lesions and achieved a higher proportion of participants with a sPGA score of 0 or 1 compared to placebo, demonstrating good safety [4][5] Disease Context - Psoriasis is a chronic inflammatory disease with a global prevalence of 2.0% to 3.0%, and 0.47% in China, affecting approximately 125 million patients worldwide [2] - Patients with moderate to severe psoriasis face increased risks of metabolic syndrome, cardiovascular disease, and mental health issues, highlighting the urgent need for effective treatments [2]
Junshi Biosciences Announces the Phase 3 Study of JS005 (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis Met Primary Endpoints
Globenewswire· 2025-09-07 12:30
Company Overview - Junshi Biosciences is a leading innovation-driven biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies [1][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 received approvals for five products in China and international markets, including toripalimab, the first domestically produced anti-PD-1 monoclonal antibody in China [8] Product Development - The recombinant humanized anti-IL-17A monoclonal antibody, JS005, has shown positive results in a Phase 3 clinical study for treating moderate to severe plaque psoriasis [1][3] - The study met both co-primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements compared to the placebo group [1][4] - JS005 is designed to block IL-17A, a cytokine involved in autoimmune diseases, thereby alleviating symptoms of conditions like psoriasis [6] Clinical Study Insights - The Phase 3 study was conducted at 60 clinical sites across China, led by Professor Jianzhong ZHANG from Peking University People's Hospital [3] - Results indicated that a higher proportion of participants achieved a sPGA score of 0 or 1 with JS005 compared to the placebo, along with good safety profiles [4][5] - The study results will be presented at future international academic conferences, highlighting the significance of JS005 in psoriasis treatment [4] Market Context - Psoriasis affects approximately 125 million people globally, with a prevalence of 2.0% to 3.0% worldwide and 0.47% in China [2] - Patients with moderate to severe psoriasis face increased risks of metabolic syndrome, cardiovascular disease, and mental health issues, underscoring the need for effective treatments [2] - The successful Phase 3 study of JS005 represents a significant milestone in addressing the treatment gap for patients suffering from this chronic condition [5]
公告精选:向日葵筹划收购兮璞材料控股权及贝得药业40%股权;天际股份等提示风险
Group 1 - Company Xiangrikui is planning to acquire controlling stakes in Xipu Materials and 40% of Beid Pharmaceutical, leading to a stock suspension [3] - Company Nanchin Technology intends to issue convertible bonds to raise no more than 1.933 billion yuan for research and industrialization of power management chips in the smart computing sector [2] - Company ST Pawa has received a notice of investigation from the China Securities Regulatory Commission [4] Group 2 - Company Junshi Biosciences has achieved the primary research endpoint in a Phase III clinical study for its anti-IL-17A monoclonal antibody treatment for moderate to severe plaque psoriasis [4] - Company Gansu Energy's Changle Company has officially put into commercial operation the 5th unit of its 2×1000 MW coal-fired unit expansion project [4] - Company Jidian has received 913 million yuan in renewable energy subsidy funds from the state for August [4]
君实生物(01877):抗IL-17A单抗治疗中重度斑块状银屑病的Ⅲ期临床研究达到主要研究终点
智通财经网· 2025-09-07 10:34
Core Viewpoint - Junshi Biosciences (01877) announced positive results from a pivotal Phase III clinical trial of its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, achieving statistically significant and clinically meaningful improvements in primary and key secondary endpoints [1][2][3] Group 1: Clinical Trial Results - The Phase III clinical trial (study number: JS005-005-III-PsO) successfully met its primary and key secondary endpoints, demonstrating significant improvement in psoriasis severity compared to placebo [1][2] - The study was conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital, with the main objective being to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI90) and a static Physician Global Assessment (sPGA) score of 0 or 1 by week 12 [2] Group 2: Product Information - JS005 is a proprietary monoclonal antibody developed by the company that selectively blocks IL-17A, a cytokine involved in autoimmune diseases, thereby alleviating symptoms of conditions like psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] - The safety profile of JS005 in moderate to severe plaque psoriasis participants was reported to be good, with plans to present the study results at future international academic conferences [3] Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2.0%-3.0%, while in China, the prevalence is 0.47%, affecting approximately 125 million people worldwide [2] - Moderate to severe psoriasis is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, highlighting the urgent need for effective treatments [2]