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君实生物偌考奇拜单抗注射液新药上市申请获受理
Bei Jing Shang Bao· 2025-12-05 10:30
Core Viewpoint - Junshi Biosciences has received the acceptance notice from the National Medical Products Administration for the new drug application of Rocabotamab injection for the treatment of moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The drug Rocabotamab is a specific anti-IL-17A monoclonal antibody that binds with high affinity to IL-17A and selectively blocks its interaction with receptors IL-17RA/IL-17RC [1] - By inhibiting the activation of downstream signaling pathways and the release of inflammatory factors, Rocabotamab can effectively alleviate symptoms of autoimmune diseases [1]
12月5日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-05 10:24
Group 1 - Shareholder of Xidiwei plans to reduce holdings by up to 3% of total shares, amounting to 12.37 million shares [2] - Minsheng Bank successfully issued 6 billion yuan of 3-year floating rate financial bonds to optimize its liability structure [3] - Baisheng Intelligent intends to acquire 51% stake in Zhongke Shengu for 100 million yuan, with a preliminary valuation of up to 200 million yuan [4] Group 2 - Junshi Biosciences received acceptance for the new drug application of Rocaqi monoclonal antibody injection for treating moderate to severe plaque psoriasis [5] - Ganneng Co. announced the successful commissioning of its clean coal power project, achieving national performance standards [6] - Yuekang Pharmaceutical plans to issue H-shares and list on the Hong Kong Stock Exchange [7][8] Group 3 - Qingtang City received notice of expropriation for Huaneng Mall, which will be shut down pending approval processes [9] - Meilixin's controlling shareholder plans to increase holdings by 50 million to 100 million yuan, with a maximum price of 52 yuan per share [10] - Zhenghong Technology reported a 20.43% year-on-year decline in November pig sales revenue [11][12] Group 4 - GAC Group reported a 9.72% year-on-year decline in November automobile sales, totaling 179,700 units [16] - Oupokangshi received approval for clinical trials of a new eye drop for treating presbyopia [17] - Kang En Bei announced the resignation of its chairman and legal representative due to work adjustments [18] Group 5 - Jiangxi Changyun is set to receive 15.7 million yuan in compensation for the expropriation of part of its properties [28] - Tianrun Dairy reported a 2.99% month-on-month increase in November pig sales revenue [29] - New Point Software won a 54 million yuan contract for a digital smart community construction project [31]
君实生物(688180) - 君实生物自愿披露关于偌考奇拜单抗注射液新药上市申请获得受理的公告
2025-12-05 09:46
证券代码:688180 证券简称:君实生物 公告编号:临 2025-071 上海君实生物医药科技股份有限公司 自愿披露关于偌考奇拜单抗注射液 新药上市申请获得受理的公告 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")收到国家 药品监督管理局核准签发的《受理通知书》,公司产品偌考奇拜单抗注射液(重 组人源化抗 IL-17A 单克隆抗体注射液,产品代号:JS005)用于治疗适合系统治 疗或光疗的中度至重度斑块状银屑病的成人患者的新药上市申请获得受理。由于 药品的研发周期长、审批环节多,容易受到一些不确定性因素的影响,本次新药 上市申请能否获得批准存在不确定性,敬请广大投资者谨慎决策,注意防范投资 风险。现将相关情况公告如下: 一、药品基本情况 药品名称:偌考奇拜单抗注射液 审批结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审查, 决定予以受理。 二、药品的其他相关情况 偌考奇拜单抗是公司自主研发的特异性抗 IL-17A 单克隆抗体。IL(白细胞 介素)-1 ...
君实生物:偌考奇拜单抗注射液新药上市申请获得受理
Ge Long Hui· 2025-12-05 09:38
Group 1 - The core point of the article is that Junshi Biosciences has received acceptance for its new drug application for JS005, a monoclonal antibody targeting IL-17A, for the treatment of moderate to severe plaque psoriasis in adults [1] - JS005 is a recombinant humanized monoclonal antibody that specifically targets IL-17A, which is associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] - 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] Group 2 - Psoriasis is a common chronic, relapsing, inflammatory, and systemic immune-mediated disease, with a prevalence rate in China reaching 0.47% in 2008, significantly higher than 0.12% in 1984 [2] - Moderate to severe psoriasis patients have an increased risk of metabolic syndrome and atherosclerotic cardiovascular diseases, as well as mental health issues such as depression, anxiety, and suicidal tendencies [2] - Psoriasis severely impacts the physical and mental health of patients, highlighting the need for effective treatment options [2]
君实生物:产品偌考奇拜单抗注射液新药上市申请获得受理
Mei Ri Jing Ji Xin Wen· 2025-12-05 09:35
每经AI快讯,12月5日,君实生物(688180.SH)公告称,公司收到国家药品监督管理局核准签发的《受理 通知书》,产品偌考奇拜单抗注射液用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患 者的新药上市申请获得受理。由于药品研发周期长、审批环节多,本次新药上市申请能否获得批准存在 不确定性。截至公告披露日,除本次新药上市申请外,偌考奇拜单抗用于治疗活动性强直性脊柱炎的Ⅱ 期临床研究的所有参与者已完成治疗,进入安全随访期。 ...
君实生物(688180.SH):偌考奇拜单抗注射液新药上市申请获得受理
智通财经网· 2025-12-05 09:33
偌考奇拜单抗是公司自主研发的特异性抗IL-17A单克隆抗体。IL(白细胞介素)-17A是一种具有多效性的 细胞因子,其分泌失调与自身免疫性疾病如银屑病、类风湿关节炎、强直性脊柱炎等疾病的发生发展密 切相关。偌考奇拜单抗通过与IL-17A高亲和力结合并选择性地阻断IL-17A与其受体IL-17RA/IL-17RC的 结合,从而阻断下游信号通路的激活和炎性因子的释放,能有效地缓解自身免疫性疾病的症状。截至公 告披露日,除本次新药上市申请外,偌考奇拜单抗用于治疗活动性强直性脊柱炎的Ⅱ期临床研究的所有 参与者已完成治疗,进入安全随访期。 智通财经APP讯,君实生物(688180.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的 《受理通知书》,公司产品偌考奇拜单抗注射液(重组人源化抗IL-17A单克隆抗体注射液,产品代号: JS005)用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病的成人患者的新药上市申请获得受理。 ...
ETF日报 | “牛市旗手”卷土重来!反弹行情中的板块轮动怎么把握?
Sou Hu Cai Jing· 2025-12-05 07:47
Non-Bank Financials - The Guangdong provincial government has issued a plan to support the integration and merger of industrial chains, allowing insurance funds to increase equity investment in M&A projects, which will enhance the role of non-bank financials as "patient capital" [2] - Morgan Stanley has included China Ping An in its focus list, expressing optimism about its long-term performance [2] - Donghai Securities is optimistic about the sector's configuration opportunities driven by year-end style switching and the "New Year Red" initiative, highlighting the importance of M&A restructuring, wealth management transformation, and ROE improvement [2] Nonferrous Metals - Three rare earth permanent magnet companies have obtained general export licenses, with the Chinese government facilitating compliant trade to maintain global supply chain stability [3] - Changjiang Futures believes that nonferrous metals like copper and aluminum will benefit from the optimization of traditional industries and the growth of emerging sectors during the 14th Five-Year Plan period [3] - The focus on rare metals such as rare earths and lithium is increasing, with the rare metal ETF (159608) gaining attention [3] Machinery Equipment - The "Machinery Industry Stable Growth Work Plan (2025-2026)" sets a revenue target of 10 trillion yuan by 2026, emphasizing innovation in key areas like industrial mother machines and smart equipment [4] - Excavator sales increased by 17% year-on-year from January to October, with engineering machinery exports reaching $48.57 billion, up 12% [4] - Bohai Securities notes a continued recovery in the engineering machinery sector, driven by domestic demand and significant infrastructure projects [4] Market Performance - As of December 5, 2025, the A-share market saw non-bank financials, nonferrous metals, and machinery equipment leading with gains of 3.50%, 2.84%, and 2.34% respectively [1][5] - The banking sector experienced a decline of 0.58%, with Chongqing Bank and Qilu Bank showing the largest drops [5][8] Pharmaceutical Sector - The upcoming release of the new basic medical insurance drug list and the first version of the commercial insurance innovative drug list is expected to create investment opportunities in related pharmaceutical companies [6] - The ongoing flu season is increasing interest in sectors such as in vitro diagnostics, vaccines, and pharmacies, presenting short-term investment opportunities [6] - The largest Hong Kong innovative drug ETF (513120) has seen continuous net inflows over the past six days, indicating strong investor interest [6]
君实生物涨0.70%,成交额1.55亿元,今日主力净流入-739.09万
Xin Lang Cai Jing· 2025-12-05 07:29
Core Viewpoint - Junshi Biosciences aims to establish itself as a global innovative pharmaceutical company with a complete industry chain capability from drug discovery to commercialization, focusing on quality and innovation [2] Company Overview - Junshi Biosciences, founded on December 27, 2012, and listed on July 15, 2020, specializes in the research and commercialization of monoclonal antibodies and therapeutic proteins [7] - The company's main revenue sources include 90.67% from drug sales, 8.74% from technology licensing, and 0.59% from technical services [7] Product Development - The company has developed a promising drug portfolio, including its core product, Toripalimab, which is the first domestically approved PD-1 monoclonal antibody in China, with 11 approved indications and one supplemental NDA under review [2] - Toripalimab is also the first innovative biologic drug developed and produced in China to receive FDA approval, with approvals in multiple regions including the EU, the US, and Australia [2] - Junshi's Tifcemalimab is the first anti-tumor anti-BTLA monoclonal antibody to enter clinical development, with ongoing Phase III trials and several combination studies with Toripalimab [2] Collaborations and Vaccine Development - On October 27, 2023, Junshi announced collaborations with several institutions, including Peking University and the Chinese Academy of Sciences, to develop a monkeypox recombinant protein vaccine [3] - The company's subsidiary, JunTuo Biotech, is also involved in the development of vaccines for monkeypox and Zika, currently in the preclinical stage [3] Financial Performance - For the period from January to September 2025, Junshi reported revenues of 1.806 billion yuan, a year-on-year increase of 42.06%, while the net profit attributable to shareholders was -596 million yuan, a 35.72% increase year-on-year [8] - As of September 30, 2025, the number of shareholders increased by 15.17% to 35,900, with an average of 21,361 shares per shareholder, a decrease of 12.96% [8] Market Position - Junshi Biosciences operates within the pharmaceutical and biotechnology sector, focusing on innovative drugs, monkeypox concepts, and precision medicine [8] - The stock has seen a recent trading volume of 155 million yuan with a market capitalization of 36.961 billion yuan [1]
12月5日A股投资避雷针︱德艺文创:董事长吴体芳拟减持不超过2%股份;航天机电:主营业务不涉及商业航天
Sou Hu Cai Jing· 2025-12-04 14:15
| | | 12月5日A股投资避雷针 | | --- | --- | --- | | 类别 | 公司 | 主要内容 | | 股东减持 | 海森药业 | 董事、高级管理人员拟合计减持12.43万股 | | | 海科新源 | 海科新源资管计划拟减持不超过2.5%股份 | | | 德艺文创 | 董事长吴体芳拟减持不超过2%股份 | | | 飞鹿股份 | 刘雄鹰拟减持不超过0.63%股份 | | | 太阳电缆 | 象屿集团及其一致行动人拟减持不超过3%股份 | | | 东望时代 | 新岭科技拟合计减持不超过1.20%公司股份 | | | 联德股份 | 控股股东之一致行动人合计减持2.37%股份 | | | 龙江交通 | 股东穗甬控股减持1570.4万股公司股份 | | | 盟科药业 | 盟科香港合计减持73.56万股公司股份 | | | 君实生物 | 上海檀英合计减持1.1688%公司A股股份 | | | 安德利 | 控股股东BVI东华完成减持341.2万股公司股份 | | | 草源钙业 | 章源控股合计减持1.1530%公司股份 | | | 保木股份 | 股东方培教减持1026. 46万股公司股份 | | 其他 | ...
君实生物:关于持股5%以上股东减持股份结果公告
(编辑 袁冠琳) 证券日报网讯 12月4日晚间,君实生物发布公告称,上海檀英投资合伙企业(有限合伙)于2025年9月5 日至9月22日通过大宗交易方式合计减持公司A股股份12,000,000股,减持比例占公司总股本的 1.1688%,减持总金额557,940,000.00元,减持后持股59,459,326股,占比5.7914%。 ...