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科伦药业(002422) - 关于子公司SKB103新药临床试验申请获国家药品监督管理局批准的公告
2026-03-24 09:30
证券代码:002422 证券简称:科伦药业 公告编号:2026-017 四川科伦药业股份有限公司 关于子公司 SKB103 新药临床试验申请 获国家药品监督管理局批准的公告 作为 ADC 领域的行业领军者之一,科伦博泰已建立起坚实的领先优势。目 前,科伦博泰自主研发的靶向人滋养细胞表面抗原 2(TROP2) ADC、靶向人类表 皮生长因子受体 2(HER2) ADC 均已获批上市,并展现出显著的临床疗效及差异 化的竞争优势。与此同时,科伦博泰着眼于肿瘤治疗的迭代升级,持续拓展创新 布局,构建了涵盖放射性核素偶联药物(RDC)、bsADC 等前沿疗法的多元化管线 矩阵,全力推动肿瘤现有治疗模式的突破与革新。 一、关于 SKB103 SKB103 是科伦博泰基于专有的 OptiDC™平台研发的一款潜在同类最佳新 型 TAA-PD-L1 bsADC。作为单一分子,SKB103 在设计上有望同时实现肿瘤靶 向递送细胞毒载荷及肿瘤免疫微环境调节。在临床前研究中,SKB103 展现出优 异的抗肿瘤活性和安全性,其突出的肿瘤治疗潜力为后续临床开发提供了有力支 撑。 二、风险提示 创新药物研发过程周期长、环节多、能否开发成功 ...
社保基金最新持仓出炉
财联社· 2026-03-20 16:07
Core Viewpoint - The article discusses the recent adjustments in stock holdings by social security funds and institutional investors, highlighting the sectors and companies that have seen increased or decreased investments due to changing market dynamics and demand for AI-related technologies. Group 1: Institutional Investment Trends - Social security funds have recently increased their holdings in companies benefiting from rising demand for AI computing power, such as Nanya New Materials and Jiemai Technology [2][5] - A total of 13 new stocks have been added to the top ten shareholders by social security funds, with significant investments in Kelong Pharmaceutical, Puxin Technology, and Tianhua New Energy, each exceeding 300 million yuan in market value [2][8] - The funds have also shown a mixed approach, with some stocks like New Industry in the medical device sector being reduced, while others like Jiemai Technology have seen increased holdings [7][9] Group 2: Specific Stock Movements - Nanya New Materials, a key player in the PCB industry, has seen social security funds become its ninth-largest shareholder with 1.93 million shares [5] - Jiemai Technology, involved in MLCC packaging materials, has been increased by social security funds to 4.77 million shares, reflecting a 30% increase in stock price recently [5] - Southeast Network Framework and Qingniao Fire Protection have also attracted new investments from social security funds, indicating a broader interest in sectors like construction and safety [6] Group 3: Sector Performance and Adjustments - The medical device sector, represented by New Industry, has experienced a reduction in holdings by social security funds, continuing a trend from the previous quarter [7] - The consumer electronics sector, particularly Electric Connection Technology, has also seen a slight reduction in holdings, attributed to anticipated profit declines due to external pressures [7] - The article notes that social security funds have diversified their investments across various sectors, including cyclical resources, chemicals, pharmaceuticals, and real estate, with a total of 23 stocks involved in these adjustments [8][9]
科伦药业(002422) - 关于公司注射用阿立哌唑获得药品注册批准的公告
2026-03-20 08:15
证券代码:002422 证券简称:科伦药业 公告编号:2026-015 四川科伦药业股份有限公司 关于公司注射用阿立哌唑获得药品注册批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司(以下简称"公司"或"我公司")子公司湖南 科伦制药有限公司的化学药品"注射用阿立哌唑"于近日获得国家药品监督管 理局的药品注册批准,现将相关情况公告如下: 一、药品基本情况 1. 药品名称:注射用阿立哌唑 药品批准文号:国药准字 H20263611、国药准字 H20263610 上市许可持有人:湖南科伦制药有限公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 2. 药品的其他相关情况 注射用阿立哌唑由大冢制药研发,2013 年美国首获批,2023 年中国批准进 口,用于成人精神分裂症。 阿立哌唑为第二代非典型抗精神病药,是全球首个获批的多巴胺 D2 受体部 分激动剂及多巴胺系统稳定剂,能同时缓解阳性和阴性症状,且锥体外系和体重 剂型:注射剂 规格:按 C23H27Cl2 ...
科伦药业(002422) - 关于公司布瑞哌唑口溶膜获得药品注册批准的公告
2026-03-20 08:15
证券代码:002422 证券简称:科伦药业 公告编号:2026-016 四川科伦药业股份有限公司 关于公司布瑞哌唑口溶膜获得药品注册批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司(以下简称"公司"或"我公司")的化学药品 "布瑞哌唑口溶膜"于近日获得国家药品监督管理局的药品注册批准,现将相关 情况公告如下: 一、药品基本情况 1. 药品名称:布瑞哌唑口溶膜 剂型:膜剂 规格:(1)1mg (2)2mg 受理号:CXHS2400050、CXHS2400051 药品批准文号:国药准字 H20260013、国药准字 H20260014 上市许可持有人:四川科伦药业股份有限公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 2. 药品的其他相关情况 布瑞哌唑由大冢和灵北制药共同研发,2015 年美国首获批片剂,用于抑郁、 精神分裂症和阿尔茨海默病痴呆症引起的躁动,2024 年中国批准进口。 布瑞哌唑为第二代非典型抗精神病药,因对多巴胺和 5-羟色胺系统的平 ...
科伦药业(002422) - 关于子公司核心产品芦康沙妥珠单抗(sac-TMT)于2025年欧洲肺癌大会上公布的研究成果的公告
2026-03-18 12:45
证券代码:002422 证券简称:科伦药业 公告编号:2026-014 四川科伦药业股份有限公司 关于子公司核心产品芦康沙妥珠单抗(sac-TMT) 于 2025 年欧洲肺癌大会上公布的研究成果的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司(以下简称"公司")近日获悉,公司控股子公 司四川科伦博泰生物医药股份有限公司(以下简称"科伦博泰")靶向人滋养细 胞表面抗原 2 (TROP2)抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT)(佳泰莱®) 关键临床研究(OptiTROP-Lung03)的总生存期(OS)最终分析结果将于当地时间 3 月 25 日至 28 日在丹麦哥本哈根举行的 2026 年欧洲肺癌大会(ELCC)的小型口头 报告专场公布。该研究成果成功入选突破性摘要 (报告编号:LBA4),相关摘要 发布于 ESMO OPEN 期刊。 一、关于 OptiTROP-Lung03 研究 OptiTROP-Lung03 研究旨在评估芦康沙妥珠单抗(sac-TMT)单一疗法(5 mg/kg 每 2 周一次)对比多西他赛,在既 ...
医药生物行业跟踪周报:“十五五”聚焦脑机接口、首款产品获批,关注:微创脑科学、翔宇医疗、爱朋医疗等
Soochow Securities· 2026-03-15 10:45
Investment Rating - The report maintains a "Buy" rating for the industry, focusing on companies involved in brain-computer interfaces and innovative pharmaceuticals [1]. Core Insights - The report highlights significant advancements in the brain-computer interface sector, particularly the approval of the world's first invasive brain-computer interface by BoRuiKang, marking a pivotal moment for commercialization in this field [18][24]. - The report emphasizes a favorable outlook for innovative drugs, particularly in the small nucleic acid segment, and suggests a diversified investment strategy across various sub-sectors within the pharmaceutical industry [3][11]. Summary by Sections Industry Performance - The A-share pharmaceutical index has shown a slight decline of -0.22% this week and -0.13% year-to-date, underperforming the CSI 300 index by -0.41% and -0.97% respectively [11]. - The report notes that the medical device sector has seen a positive performance, with raw materials and medical devices increasing by 1.32% and 0.60% respectively [11]. Brain-Computer Interface Developments - BoRuiKang's invasive brain-computer interface, NEO, has received approval from the National Medical Products Administration, representing a breakthrough in the commercialization of brain-computer interfaces [18][20]. - The product is designed for patients with cervical spinal cord injuries, utilizing a minimally invasive implantation technique that reduces risks associated with traditional methods [20][24]. Investment Recommendations - The report ranks sub-sectors in the following order of attractiveness: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [3][11]. - Specific companies to watch include: - PD1 PLUS: Sanofi Biopharma, Kangfang Biopharma, and others [14]. - ADC: YingEn Biopharma, Kelun Biotech, and others [14]. - Small nucleic acids: Frontier Biopharma, Fuyuan Biopharma, and others [14]. - CXO and research services: WuXi AppTec, Haoyuan Biopharma, and others [14]. - Medical devices: United Imaging Healthcare, Yuyue Medical, and others [14]. Regulatory and Market Insights - The report discusses the supportive regulatory environment for brain-computer interfaces, with policies aimed at facilitating research and commercialization [24]. - It also highlights the importance of technological breakthroughs in driving the industry forward, with BoRuiKang setting a benchmark for future product approvals [24].
科伦药业(002422) - 关于子公司SKB575新药临床试验申请获国家药品监督管理局批准的公告
2026-03-09 09:00
证券代码:002422 证券简称:科伦药业 公告编号:2026-013 四川科伦药业股份有限公司 关于子公司 SKB575 新药临床试验申请 获国家药品监督管理局批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司(以下简称"公司")近日获悉,公司控股子公 司四川科伦博泰生物医药股份有限公司(以下简称"科伦博泰")与和铂医药控 股有限公司(以下简称"和铂医药")合作研发的靶向胸腺基质淋巴细胞生成素 (TSLP)及一个未公开靶点的长效双特异性抗体(bsAb)SKB575(亦称 HBM7575)的 新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)批准,用于治疗特 应性皮炎。 一、关于 SKB575(亦称 HBM7575) SKB575/HBM7575 是一款靶向 TSLP 及一个未公开靶点的长效 bsAb,具有 双重作用机制:一方面通过阻断 TSLP 与其受体的相互作用,可抑制 TSLP 介导 的信号通路以及 Th2 免疫细胞的激活;另一方面,其针对另一未公开靶点的结 合与阻断可产生协同效应,克服TSLP单靶点抗体的 ...
医药生物行业跟踪周报:两会将创新药列为新兴支柱产业,26年BD出海再提速-20260308
Soochow Securities· 2026-03-08 12:39
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The National People's Congress has designated innovative drugs as a "new emerging pillar industry," indicating a strategic shift for the biopharmaceutical sector from a nurturing phase to a key driver of economic growth [16][17]. - As of March 6, 2026, the total contract value for Chinese innovative drug outbound business development (BD) has reached USD 56.8 billion, with an upfront payment of USD 3.3 billion, representing 41% of the total for 2025 and exceeding the total for 2024 [17][21]. - Despite significant stock price corrections from 2025 highs, the fundamental outlook for quality companies remains strong, with ongoing clinical development and internationalization efforts [21]. Summary by Sections Industry Trends - The A-share pharmaceutical index has seen a year-to-date decline of 2.42%, underperforming the CSI 300 by 1.02% [9]. - The Hang Seng Healthcare Index has outperformed the Hang Seng Technology Index by 0.97% year-to-date [9]. R&D Progress and Company Dynamics - Recent approvals include HSK31679 for non-alcoholic fatty liver disease and the GLP-1 receptor agonist Enogratide, marking significant advancements in innovative drug development [17]. - The report highlights specific companies to watch, including: - PD1 PLUS: Sangamo Therapeutics, CanSino Biologics, Innovent Biologics, and Zai Lab [12]. - ADC: I-Mab Biopharma, Kelun-Biotech, and Baillie Gifford [12]. - Small nucleic acids: Frontier Biotechnologies, Fuyuan Pharmaceutical, and Yuyuan Pharmaceutical [12]. Market Performance - The report notes that the pharmaceutical index's price-to-earnings ratio is currently at 36.18, which is 2.24 times lower than the historical average [9]. - The report identifies high-performing stocks such as Yahu Pharmaceutical (+40.65%) and Duoyi Pharmaceutical (+30.81%) for the week, while stocks like Haixiang Pharmaceutical (-15.06%) and Furu Medical (-13.07%) faced significant declines [9].
医药生物行业跟踪周报:两会将创新药列为新兴支柱产业,26年BD出海再提速
Soochow Securities· 2026-03-08 12:34
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The National People's Congress has designated innovative drugs as a "new emerging pillar industry," indicating a strategic shift for the biopharmaceutical sector from a nurturing phase to a core engine of economic growth [16][17]. - As of March 6, 2026, the total value of business development (BD) contracts for Chinese innovative drugs has reached $56.8 billion, with an upfront payment of $3.3 billion, representing 41% of the total for 2025 and exceeding the total for 2024 [17][21]. - Despite significant stock price corrections from 2025 highs, the fundamentals of quality companies remain solid, and the long-term growth logic for innovative drug exports is still intact [21]. Summary by Sections Industry Trends - The A-share pharmaceutical index has seen a year-to-date decline of 2.42%, underperforming the CSI 300 by 1.02% [9]. - The Hang Seng Healthcare Index has outperformed the Hang Seng Technology Index by 0.97% year-to-date [9]. R&D Progress and Company Dynamics - Recent approvals include HSK31679 for non-alcoholic fatty liver disease and the GLP-1 receptor agonist Enogratide, marking significant advancements in innovative drug development [17]. - The report highlights specific companies to watch, including: - PD1 PLUS: Sangamo Therapeutics, CanSino Biologics, Innovent Biologics, and Zai Lab [12]. - ADC: I-Mab Biopharma, Kelun-Biotech, and Baiyue Tianheng [12]. - Small nucleic acids: Frontier Biotechnologies, Fuyuan Pharmaceutical, and Yuyuan Pharmaceutical [12]. Market Performance - The report notes that the pharmaceutical index's price-to-earnings ratio is currently at 36.18, which is 2.24 times lower than the historical average [9]. - The report identifies top-performing stocks for the week, including Yahu Pharmaceutical (+40.65%) and Duoyi Pharmaceutical (+30.81%), while highlighting significant declines in stocks like Haixiang Pharmaceutical (-15.06%) and Furu Medical (-13.07%) [9].
科伦药业(002422) - 2026年度第二期科技创新债券发行结果的公告
2026-03-04 08:15
公司于2025年11月12日收到中国银行间市场交易商协会(以下简称"交易 商协会")于2025年11月11日下发的《接受注册通知书》(以下简称"《通知 书》")(中市协注〔2025〕SCP332号),交易商协会同意接受公司超短期融 资券注册,超短期融资券注册额度为人民币40亿元,注册额度自《通知书》落 款之日起2年内有效。 公司于近日获悉,公司2026年度第二期科技创新债券于2026年3月2日发行, 募集资金已于2026年3月3日全额到账。 四川科伦药业股份有限公司 2026年度第二期科技创新债券发行结果的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性 陈述或重大遗漏。 四川科伦药业股份有限公司(以下简称"公司")《关于公司发行非金融 企业债务融资工具的议案》已于2025年4月22日经公司第八届董事会第六次会议 审议通过,并于2025年5月19日经公司2024年年度股东大会审议批准。相关董事 会和股东大会决议公告详见2025年4月24日和2025年5月20日的《证券时报》、 《上海证券报》、《证券日报》和《中国证券报》以及公司指定信息披露网站 巨潮资讯网(http://www ...