偌考奇拜单抗注射液
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渤海证券研究所晨会纪要(2025.12.15)-20251215
BOHAI SECURITIES· 2025-12-15 00:31
Macro and Strategy Research - The central economic work conference emphasized the importance of "quality improvement" and maintaining domestic demand as a primary task for 2026, highlighting the need for effective quality enhancement alongside reasonable growth [2][3] - The fiscal policy will continue to be proactive, focusing on maintaining necessary fiscal deficits and total debt levels while optimizing expenditure structures and addressing local fiscal difficulties [3][4] - Monetary policy will maintain a moderately loose stance, with a shift towards flexible and efficient use of various policy tools, emphasizing support for key areas such as expanding domestic demand and technological innovation [4][5] - The focus on expanding domestic demand will prioritize supply optimization and service consumption, with plans to implement a "rural and urban resident income increase plan" to boost consumer spending [5][6] - Innovation will be a key area, with plans to establish international technology innovation centers in major regions to enhance the national innovation system and support new momentum cultivation [6][8] - The conference also addressed the need for "anti-involution" measures and emphasized reforms in the capital market to support investment and financing [8] Industry Research - The release of the new basic medical insurance drug list and the first commercial health insurance innovative drug list aims to support the innovative development of the pharmaceutical industry, with 114 new drugs added to the basic insurance list, including 50 innovative drugs [13][14] - The approval of a CDK2/4/6 inhibitor by a Chinese biopharmaceutical company marks a significant advancement in the industry [13] - The stock performance of the pharmaceutical sector showed a mixed trend, with the SW pharmaceutical industry index PE ratio at 50.70 times, indicating a 265% premium over the CSI 300 index [13][14] - The report suggests focusing on the growth potential of pharmaceutical companies' products entering the insurance list and the investment opportunities arising from the optimization of payment structures for innovative drug companies [14]
医药生物行业周报:“医保&商保双目录”正式发布,重视创新药及相关产业链投资机会-20251208
Xinda Securities· 2025-12-08 05:50
Investment Rating - The report maintains an investment rating of "Positive" for the pharmaceutical and biotechnology industry [2]. Core Viewpoints - The recent release of the "Medical Insurance + Commercial Insurance Dual Directory" by the National Medical Insurance Administration is expected to boost investment enthusiasm for innovative drugs. The report suggests focusing on investment opportunities in innovative drugs, CXO, and the upstream life sciences industry chain [3][9]. - The pharmaceutical sector is currently experiencing a lack of clear market direction, with the pharmaceutical commercial sector leading in performance. Notable stocks include Haiwang Biological (up 55.59%), Ruikang Pharmaceutical (up 36.54%), and Yue Wannianqing (up 15.37%) [3][9]. - The report emphasizes the importance of companies with stable dividends and operational improvements, as well as potential turning points in high-end medical devices [3][11]. Summary by Sections 1. Market Performance - The pharmaceutical and biotechnology sector's return was -0.74% last week, underperforming the CSI 300 by 2.02%, ranking 21st among 31 primary sub-industry indices. The pharmaceutical commercial sector had the highest weekly return at 5.19% [3][7]. - Over the past month, the sector's return was -2.35%, also ranking 20th among sub-industry indices, with the pharmaceutical commercial sector leading at 5.78% [3][7]. 2. Innovative Drugs - The report recommends focusing on companies with leading product pipelines and market potential, including Innovent Biologics, 3SBio, Hengrui Medicine, and others [3][9][10]. 3. CXO and Upstream Life Sciences - Key CXO companies to watch include WuXi AppTec, WuXi Biologics, and others. The report also highlights clinical CRO leaders and resource-based CXOs [10]. 4. High-End Medical Devices - The report identifies several companies in the high-end medical device sector that may benefit from market recovery and increased demand, including Mindray Medical and others [11]. 5. Valuation Metrics - The current PE (TTM) for the pharmaceutical and biotechnology industry is 29.27 times, which is below the historical average of 30.88 times over the past five years [12][15].
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
Zheng Quan Ri Bao Zhi Sheng· 2025-12-07 13:07
(编辑 丛可心) 证券日报网讯 12月5日晚间,君实生物发布公告称,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。 ...
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-07 06:48
申请事项:境内生产药品注册上市许可 受理号:CXSS2500129、CXSS2500130 申请人:上海君实生物医药科技股份有限公司 规格:150mg(1ml)/支(预充式注射器)、150mg(1ml)/支(预充式自动注射器) 登录新浪财经APP 搜索【信披】查看更多考评等级 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 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 ...
渤海化学筹划重大资产重组 下周一起停牌;海泰发展终止收购丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-05 15:11
Group 1: Major Transactions - Bohai Chemical is planning to sell 100% equity of Tianjin Bohai Petrochemical and acquire control of Anhui Taida New Materials through a combination of share issuance and cash payment, leading to a significant asset restructuring [1] - Zhongneng Electric is set to acquire 65% equity and debt from three companies, which may constitute a major asset restructuring but will not involve share issuance or change in control [4] - Hai Tai Development has decided to terminate the acquisition of controlling interest in Zhixueyun Technology due to disagreements on key terms, ensuring no adverse impact on normal business operations [5] Group 2: Performance Updates - Wen's shares reported a sales revenue of 3.324 billion yuan from meat chickens in November, marking a year-on-year increase of 10.18% [6] - Shuguang shares saw a 71.07% year-on-year increase in vehicle sales, totaling 207 units in November [6] - Muyuan shares experienced a decline in sales revenue from commodity pigs, reporting 9.39 billion yuan, a decrease of 20.43% year-on-year [6] - Pengding Holdings reported a 5.58% year-on-year decrease in consolidated revenue for November [6] Group 3: Industry Developments - Xiangxi Dairy reported a 6.3% month-on-month increase in fresh milk production in November, although it saw a year-on-year decline of 6.47% [7] - Baisheng Intelligent plans to acquire 51% equity in Zhongke Shengu, which focuses on the research and application of core technologies for embodied intelligent robots [7]
君实生物偌考奇拜单抗注射液新药上市申请获得受理
Bei Jing Shang Bao· 2025-12-05 12:35
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。 北京商报讯(记者 丁宁)12月5日晚间,君实生物(688180)发布公告称,公司收到国家药品监督管理 局核准签发的《受理通知书》,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)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。 ...
君实生物(01877):偌考奇拜单抗注射液新药上市申请获得受理
Zhi Tong Cai Jing· 2025-12-05 12:02
(原标题:君实生物(01877):偌考奇拜单抗注射液新药上市申请获得受理) 智通财经APP讯,君实生物(01877)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。 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。截至本公告披露日,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(01877.HK):”偌考奇拜单抗注射液“上市申请获受理
Ge Long Hui· 2025-12-05 11:41
药品基本情况 药品名称:偌考奇拜单抗注射液 格隆汇12月5日丨君实生物(01877.HK)公告,近日,上海君实生物医药科技股份有限公司收到国家药品 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: 申请事项:境内生产药品注册上市许可 申请人:上海君实生物医药科技股份有限公司 规格:150mg(1ml)/支(预充式注射器)、150mg(1ml)/支(预 充式自 动注射器) 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。 受理号:CXSS2500129、CXSS2500130 ...
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
公告显示,偌考奇拜单抗是特异性抗IL-17A单克隆抗体,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。 北京商报讯(记者 王寅浩 宋雨盈)12月5日,君实生物发布公告称,公司收到国家药品监督管理局核准 签发的《受理通知书》,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。 ...
12月5日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-05 10:24
民生银行:成功发行60亿元3年期浮动利率金融债券 12月5日晚,民生银行(600016)发布公告称,公司于12月4日在全国银行间债券市场成功发行"2025年金融债券(第二期)",发行规模60亿元,期限3年。 募集资金将用于优化负债结构、充实资金来源。 百胜智能:拟1亿元收购中科深谷51%股权 12月5日晚,百胜智能(301083)发布公告称,公司已与合肥中科深谷科技发展有限公司及其股东签署《股权收购框架协议》,拟以现金方式收购中科深谷 51%股权,初步估值不超过2亿元,收购价暂定1亿元。标的公司为工信部"专精特新"小巨人企业,专注具身智能机器人底层技术研发。 君实生物:偌考奇拜单抗注射液新药上市申请获受理 12月5日晚,君实生物(688180)发布公告称,公司近日收到国家药监局核准签发的《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)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。 希荻微:股东拟减持不超过3%公司股份 12月5日晚,希荻微(688173)发布公告称,公司股东重庆唯纯企业管理咨询有限公司计划通过集中竞价和大宗交易方式减 ...