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联环药业:LH-1801项目从临床试验成功到最终上市销售并实现盈利,面临多重关键环节的重大不确定性
news flash· 2025-07-08 09:11
Core Viewpoint - Lianhuan Pharmaceutical (600513) announced an abnormal stock trading fluctuation, indicating significant uncertainty regarding the LH-1801 project, which is currently in the clinical trial phase and employs a non-inferiority design [1] Summary by Relevant Sections - **Project Status** - The LH-1801 project is still in the research and development stage and is not expected to have a significant impact on the company's revenue and operating performance in the foreseeable future [1] - **Clinical Trial Design** - The clinical trial for LH-1801 utilizes a non-inferiority design, which introduces major uncertainties regarding the achievement of its objectives [1] - **Market Implications** - There are multiple critical uncertainties from the success of the clinical trial to the eventual market launch and profitability of the LH-1801 project [1]
开盘4分钟,20cm涨停!
Zhong Guo Ji Jin Bao· 2025-07-08 03:15
Market Overview - On July 8, A-shares opened mixed, with the Shanghai Composite Index up by 0.04%, while the Shenzhen Component and ChiNext indices were in the red. However, by the time of reporting, all three indices turned positive, with the ChiNext index rising over 1% [1][2]. Sector Performance - The morning session saw gains in sectors such as electronics, building materials, telecommunications, and computers, with PCB, CRO, and consumer electronics outsourcing stocks performing well. Conversely, public utilities and banking sectors showed weakness [2][3]. PCB Sector - PCB concept stocks continued to strengthen, with International Composite Materials and Yidong Electronics hitting the 20% daily limit up. Jin'an Guoji achieved a four-day consecutive rise, while Honghe Technology had four limit-up days in six days [8][9]. Pharmaceutical Sector - The pharmaceutical sector was notably strong, with CRO, innovative drugs, and weight-loss drug stocks collectively rising. Lianhuan Pharmaceutical achieved a consecutive limit-up, while companies like Weixin Kang, Hasan Lian, and Xiaofang Pharmaceutical also hit the limit-up. Toxin Pharmaceutical and Ruizhi Pharmaceutical saw increases exceeding 10% [4][5][6]. Notable Stock Movements - Fujilai (301258) surged to a limit-up of 20.01%, reaching a price of 39.28 CNY per share shortly after opening. Other notable stocks included Tuoxin Pharmaceutical and Ruizhi Pharmaceutical, which rose by 13.27% and 12.88%, respectively [5][6]. Regulatory Issues - Ruiskanda faced a trading halt due to a 9.95% drop, attributed to regulatory issues involving its chairman and director, who are under criminal coercive measures for alleged violations related to information disclosure. The company had previously faced administrative penalties from the CSRC [11][13].
开盘4分钟,20cm涨停!
中国基金报· 2025-07-08 03:08
Market Overview - On July 8, A-shares opened mixed, with the Shanghai Composite Index up by 0.04%, while the Shenzhen Component and ChiNext indices were in the red. However, by the time of reporting, all three indices turned positive, with the ChiNext index rising over 1% [1][2]. Sector Performance - The morning session saw gains in sectors such as electronics, building materials, telecommunications, and computers, with circuit board, CRO, and consumer electronics manufacturing stocks performing well. Conversely, public utilities and banking sectors showed weakness [2][3]. Pharmaceutical Sector - The pharmaceutical sector experienced a strong opening, with CRO, innovative drugs, and weight-loss drug stocks collectively rising. Notable stocks included Lianhuan Pharmaceutical, which achieved a two-day limit up, and several others like Weixin Kang and Ha Sanlian hitting the daily limit [7][8]. - Fujilai (301258) surged to a limit up of 20% to reach a price of 39.28 CNY per share shortly after the market opened [8][9]. PCB Sector - PCB (Printed Circuit Board) stocks continued to strengthen, with companies like International Composite Materials and Yidong Electronics hitting the daily limit. Jin'an Guoji achieved a four-day limit up, while Honghe Technology recorded four limit ups in six days [12][13]. - The demand for high-end PCBs is rapidly increasing due to AI computing needs, leading to a significant supply-demand gap in AI PCBs this year. ASIC chip growth is expected to be the main driver of incremental demand for high-end PCBs by 2026 [14][15]. Company-Specific News - Ruisi Kanda faced a trading halt with a limit down of 9.95% due to allegations of information disclosure violations, leading to criminal measures against its executives [17][20]. - ST Huaming also experienced a limit down of 20.03% following administrative penalties for false disclosures in its financial reports [20].
创新药概念反复走强 联环药业2连板
news flash· 2025-07-08 01:39
创新药概念反复走强 联环药业2连板 智通财经7月8日电,创新药概念反复走强,联环药业走出2连板,睿智医药、广生堂涨超10%,前沿生 物、赛升药业、北陆药业、亿帆医药、美迪西等多股涨超5%。中金公司研报称,长期看,中国创新药 在经历跟随创新沉淀后,已经进入渐进式创新时代,开始具备国际竞争力。同时,一二级融资的便利, 国际形势趋缓带来产业链CXO/科研上游等领域的衍生投资机会。 ...
医药生物行业今日净流出资金34.30亿元,广生堂等8股净流出资金超亿元
Zheng Quan Shi Bao Wang· 2025-07-07 10:27
资金面上看,两市主力资金全天净流出143.37亿元,今日有10个行业主力资金净流入,轻工制造行业主 力资金净流入规模居首,该行业今日上涨1.52%,全天净流入资金9.30亿元,其次是房地产行业,日涨 幅为1.68%,净流入资金为9.17亿元。 主力资金净流出的行业有21个,电子行业主力资金净流出规模居首,全天净流出资金44.75亿元,其次 是医药生物行业,净流出资金为34.30亿元,净流出资金较多的还有通信、计算机、机械设备等行业。 医药生物行业今日下跌0.97%,全天主力资金净流出34.30亿元,该行业所属的个股共474只,今日上涨 的有176只,涨停的有6只;下跌的有277只。以资金流向数据进行统计,该行业资金净流入的个股有171 只,其中,净流入资金超5000万元的有5只,净流入资金居首的是联环药业,今日净流入资金1.15亿 元,紧随其后的是宝莱特、联影医疗,净流入资金分别为8373.92万元、7667.30万元。医药生物行业资 金净流出个股中,资金净流出超亿元的有8只,净流出资金居前的有广生堂、长春高新、京新药业,净 流出资金分别为2.28亿元、1.51亿元、1.37亿元。(数据宝) 医药生物行业资金 ...
联环药业(600513) - 联环药业投资者关系活动记录表
2025-07-04 09:15
投资者关系活动记录表 | | 特定对象调研 □分析师会议 | | --- | --- | | 投资者关系活动类 | □媒体采访 □业绩说明会 | | | □新闻发布会 路演活动 | | 别 | □现场参观 | | | □其他 (请文字说明其他活动内容) | | 参与单位名称 | 华创自营、华夏未来、华安证券、风炎投资、偕沣资产、 | | | 本见投资、浩友投资、首创证券、金友投资、财达证券 | | 时间 | 2025 年 7 月 3 日 | | 地点 | 北京 | | 上市公司接待人员 | 董事兼总经理:牛犇先生 | | 姓名 | 董事会办公室主任兼证券事务代表:葛楷先生 | | | 1、问:公司未来在创新药研发投入方面有何规划? | | | 如何保障创新药研发质量与效率? | | | 答:公司未来将持续加大创新药研发投入,根据 2025 | | | 年度财务预算报告,2025 年研发费用预算超 2 亿元,后 | | | 续根据项目进展动态调整。公司聚焦临床需求大、市场 | | | 规模广的领域如慢性病,发挥自身治疗领域优势,拓展 | | 投资者关系活动主 | 产品管线并强化技术壁垒。为保障研发质量与效率 ...
联环药业(600513) - 联环药业投资者关系活动记录表
2025-07-03 09:30
证券代码:600513 证券简称:联环药业 公告编号:2025-039 江苏联环药业股份有限公司 投资者关系活动记录表 | 的商业化前景充满信心。 | | --- | | 5、问:请介绍一下公司的财务状况,尤其是研发投入情 | | 况? | | 答:2024 年公司营收 21.60 亿,尽管受到一些政策 | | 影响利润有小幅下滑,但公司依然加大研发投入,2024 | | 年公司累计研发投入 2.77 亿,主要用于创新药研发,目 | | 前仿制药和创新药研发投入的约为 5/5。2025 年根据公 | | 司财务预算研发费用为 2.29 亿元。公司作为地方国企, 资金实力雄厚,能够持续投入研发,支撑企业长期发展。 | 合作开发背景、临床试验进展及数据预期? 答:LH-1801 项目是公司与中科院上海药物所合作 开发的治疗糖尿病的 SGLT2 抑制剂。该项目凭借创新的 分子结构、完善的临床前研究与充足的 I 期临床数据, 经与国家药监局药品审评中心(CDE)充分沟通,免除Ⅱ 期临床试验直接进入Ⅲ期临床试验。目前,两个试验组 分别于今年 1 月和 3 月按计划完成受试者入组工作,各 项试验正有序开展,目前处于临床数 ...
联环药业加速美阿沙坦钾片商业化 创新转型步入收获期
Zheng Quan Shi Bao Wang· 2025-07-03 00:31
Core Viewpoint - The ARB market is experiencing significant developments, particularly with the commercialization of the drug Benazepril by Lianhuan Pharmaceutical, which is expected to drive substantial revenue growth for the company [1][2]. Group 1: Market Position and Commercialization - Lianhuan Pharmaceutical has accelerated its market presence, with its Benazepril product already listed in 13 provinces as of June 30, indicating a rapid commercialization process [2]. - The drug is recognized as a first-line antihypertensive medication, with a strong clinical position and promising market prospects, potentially generating hundreds of millions in revenue for the company [2][3]. - The drug's core advantages include a breakthrough in receptor binding affinity, significant blood pressure reduction, and improved stability in blood pressure control, which enhance its market competitiveness [2]. Group 2: Research and Development Investments - Lianhuan Pharmaceutical has increased its R&D investment for three consecutive years, with a projected R&D expenditure of 277 million yuan in 2024, reflecting a year-on-year growth of 95.93% and surpassing 10% of its revenue for the first time [4]. - The company is advancing its core new drug LH-1801, which targets diabetes and hypertension, with clinical trials expected to conclude in early 2026, potentially opening a market worth 2 billion yuan [4]. Group 3: Product Portfolio and Strategic Positioning - Lianhuan Pharmaceutical has established a multi-layered product portfolio, including basic, combined, and innovative drugs, which strengthens its market position against competitors in the ARB market [6][7]. - The company is pursuing a "generic-innovative" strategy, which is crucial for its transformation into an innovative pharmaceutical enterprise, as it balances innovation with commercial viability [7].
联环药业(600513) - 联环药业投资者关系活动记录表
2025-07-01 09:30
在投资者关系管理上,公司始终秉持真诚沟通、开 放透明的原则,既把投资者请进上市公司,同时上市公 司也积极走出去。今年通过组织投资者调研活动,搭建 更直接的交流平台,增进投资者对公司的了解与信任; 同时持续创新沟通形式,如组织公司董监高、研发部负 责人、临床实验负责人等在北京、上海、广州、深圳等 一线城市,就公司创新药研发进展、管线布局及市场前 景等内容举办专题投资者现场沟通活动,加强与投资者 的互动交流。同时,公司重视回馈股东,已持续多年每 年分红比例达 30%,以实际行动回馈投资者,分享企业 发展成果。通过多维度协同推进,公司将不断提升企业 内在价值,实现市值与内在价值的良性互动与协同增长。 4、问:请问公司在提升研发人才稳定性、核心骨干 建设方面有哪些机制?是否设有研发激励制度,如项目 收益分享、股权激励等? 资领域持续发力。通过投资并购整合行业优质资源,完 善产业链布局,增强协同效应;积极探索多元化融资渠 道,合理规划融资方案,为企业发展提供充足资金支持。 答:公司高度重视研发人才的引进、培养和激励, 建立了较为完善的机制。在人才引进方面,公司积极从 国内外引进高端研发人才,充实研发团队力量。在人才 培 ...
联环药业创新药LH-1801片有望于2026年申报上市
Zheng Quan Ri Bao Wang· 2025-06-23 01:50
本报记者 袁传玺 6月20日,江苏联环药业股份有限公司(以下简称:联环药业)针对投资者提问公司一类创新药LH-1801片研发进展一事进 行了回复。公司披露的信息显示,LH-1801片联合二甲双胍用药治疗项目(以下简称"联合用药治疗项目")三期临床试验的已 于2025年1月份完成615例患者入组(60家中心)。 全球范围内的SGLT2抑制剂上市产品包括阿斯利康的达格列净、强生的卡格列净等。若LH-1801片成功上市,将有望满足 国内巨大的未满足临床需求。 (编辑 张伟) 上海九水投资管理合伙企业(有限合伙)执行事务合伙人黄建忠向《证券日报》记者表示,联环药业的一类新药LH-1801 跳过Ⅱ期临床试验直接进入Ⅲ期临床,可见药物在Ⅰ期临床试验中表现出非常理想的药代动力学特性和安全性,如药物的吸 收、分布、代谢和排泄过程符合预期,且在人体内的耐受性良好,没有出现严重的不良反应,同时初步的药效学指标也显示出 潜在的治疗作用。 本次全国多中心Ⅲ期临床研究由北京大学人民医院纪立农教授担任主要研究者(LeadingPI),联合全国70多家顶尖医院的 内分泌领域权威专家共同开展,确保了研究的科学性和严谨性。 当前,继肿瘤、心脑 ...