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深圳信立泰药业股份有限公司 关于YOLT-101药品临床试验申请获得受理的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 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。 近日,深圳信立泰药业股份有限公司(下称"公司")收到国家药品监督管理局核准签发的受理通知书, 公司引进的创新基因编辑药物YOLT-101注射液(下称"YOLT-101")临床试验申请获得受理。 申请事项:境内生产药品注册临床试验 注册分类:1类 药品类型:治疗用生物制品 自受理之日起60日内,未收到药审中心否定或质疑意见的,申请人可以按照提交的方案开展临床试验。 二、其他相关情况 现就相关信息公告如下: 一、药品基本情况 药品名称:YOLT-101注射液 受理号:CXSL2500313 申请人:尧唐(南京)生物科技有限公司、深圳信立泰药业股份有限公司 受理说明: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。 (相关内容详见2024年8月27日登载于信息披露媒体《中国证券报》、《证券时报》、巨潮资讯网 www.cninfo.com.cn的《关于获得碱基编辑药物YOLT-101独家许可权益的公告》) 该产品临床申请获得受理后,尚需获得临床试验 ...
信立泰(002294) - 关于YOLT-101药品临床试验申请获得受理的公告
2025-04-17 10:46
药品临床试验申请获得受理的公告 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。 证券代码:002294 证券简称:信立泰 编号:2025-024 深圳信立泰药业股份有限公司 关于 YOLT-101 近日,深圳信立泰药业股份有限公司(下称"公司")收到国家药品监督管 理局核准签发的受理通知书,公司引进的创新基因编辑药物 YOLT-101 注射液 (下称"YOLT-101")临床试验申请获得受理。 现就相关信息公告如下: 一、 药品基本情况 药品名称:YOLT-101 注射液 申请事项:境内生产药品注册临床试验 注册分类:1 类 药品类型:治疗用生物制品 受理号:CXSL2500313 申请人:尧唐(南京)生物科技有限公司、深圳信立泰药业股份有限公司 受理说明: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。 自受理之日起 60 日内,未收到药审中心否定或质疑意见的,申请人可以按 照提交的方案开展临床试验。 YOLT-101 是公司从尧唐(上海)生物科技有限公司(下称"尧唐生物") 引进的靶向 PCSK9 碱基编辑药物,拟开发适应症包括家 ...
信立泰20250331
2025-04-15 14:30
Summary of Conference Call Records Company and Industry Overview - The conference call discusses a pharmaceutical company focused on innovative drug development, particularly in the hypertension and metabolic disease sectors. The company is actively involved in clinical trials and product launches. Key Points and Arguments Revenue and Growth Projections - The company anticipates revenue exceeding 1.5 billion, with specific products like Enalapril expected to surpass 300 million. Other products, such as Furosemide and Terlipressin, are projected to reach over 100 million and 200 million, respectively. The medical device segment is expected to grow by 20% to 30% this year, maintaining a revenue of at least 300 million from the previous year [1][2][15]. - For 2025, the company maintains a neutral outlook, expecting better revenue performance based on optimistic internal projections [1]. Profitability Insights - The adjusted profit for the previous year was 570 million, reflecting an 8% increase, which exceeded prior expectations. This profit growth is attributed to strong operational capabilities and significant investments in R&D and sales [1][2]. Product Development and Clinical Trials - The company is focusing on enhancing risk management and adjusting its clinical trial capitalization strategy, moving from Phase I to Phase III before capitalizing on R&D investments [2]. - Several products are in various stages of clinical trials, including SL0951 for anemia and SL0112 for type 2 diabetes, with significant progress reported in patient enrollment [5][6][7]. Market Position and Competitive Strategy - The company emphasizes its competitive edge through innovative products and a strong sales team. The introduction of new hypertension drugs is expected to enhance market penetration and brand differentiation [9][10][12]. - The company plans to leverage its established relationships with healthcare professionals and clinical research to strengthen its market position against competitors [9][10]. Regulatory and Market Access - The company is optimistic about gaining access to national health insurance for its products, which is crucial for market success. The approval process for new drugs is closely monitored, with expectations of timely approvals [3][4][19]. - The company is also preparing for potential challenges from generic competitors and is strategizing on pricing and market entry to maintain its competitive advantage [24][25]. Financial Management and Investment Strategy - The company plans to control sales expenses within 40% of revenue while allowing for flexibility based on market conditions. R&D expenses are projected to remain stable, with a focus on long-term growth [28][29]. - The company is committed to maintaining a balance between cost control and investment in innovative product development [29]. Future Outlook - The company expects a revenue growth of over 10% this year, driven primarily by innovative products, with projections of exceeding 20% growth in the following year [21][22]. - The management expresses confidence in the company's ability to navigate challenges and capitalize on opportunities in the pharmaceutical market, particularly in the hypertension and metabolic disease sectors [37]. Additional Important Content - The company is actively expanding its product pipeline, with plans to submit 4 to 5 new products for R&D applications this year [7][8]. - The management highlights the importance of academic marketing and patient education in promoting new products and enhancing brand recognition [33]. This summary encapsulates the key insights and strategic directions discussed during the conference call, providing a comprehensive overview of the company's current status and future plans in the pharmaceutical industry.
深圳信立泰药业股份有限公司 关于参加深圳证券交易所 “成长新启航·民企百舸竞中流” 2024年度集体业绩说明会的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:002294证券简称:信立泰编号:2025-023 深圳信立泰药业股份有限公司 关于参加深圳证券交易所 "成长新启航·民企百舸竞中流" 2024年度集体业绩说明会的公告 二、投资者问题征集方式 为充分尊重投资者、提升交流的针对性,现就本次业绩说明会提前向投资者公开征集问题,广泛听取投 资者的意见和建议。投资者可提前登陆深交所"互动易"平台(http://irm.cninfo.com.cn)"云访谈"栏目进 入本次业绩说明会页面,或扫描二维码(附后)进入问题征集专题页面进行提问。公司将在本次业绩说 明会上对投资者普遍关注的问题进行回答。 ■ 欢迎广大投资者积极参与本次业绩说明会。 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。 深圳信立泰药业股份有限公司(下称"公司")将于2025年4月18日(星期五)15:00-17:00参加由深圳证 券交易所组织召开的以"成长新启航·民企百舸竞中流"为主题的集体业绩说明会活动,现将有关事项公 告如下: 一、本次业绩说明会的安排 1、召开时间:2025年4月18日(星 ...
信立泰(002294) - 关于参加深圳证券交易所“成长新启航·民企百舸竞中流”2024年度集体业绩说明会的公告
2025-04-13 09:00
证券代码:002294 证券简称:信立泰 编号:2025-023 2024 年度集体业绩说明会的公告 深圳信立泰药业股份有限公司 关于参加深圳证券交易所 "成长新启航•民企百舸竞中流" 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。 1、召开时间:2025 年 4 月 18 日(星期五)15:00-17:00 2、召开地点:深圳证券交易所 8 楼上市大厅 3、召开方式:视频直播与图文转播 4、公司出席人员:公司董事、董事会秘书杨健锋先生,财务负责人孔芸女 士。 二、 投资者问题征集方式 为充分尊重投资者、提升交流的针对性,现就本次业绩说明会提前向投资者 公开征集问题,广泛听取投资者的意见和建议。投资者可提前登陆深交所"互动 易"平台(http://irm.cninfo.com.cn)"云访谈"栏目进入本次业绩说明会页面, 或扫描二维码(附后)进入问题征集专题页面进行提问。公司将在本次业绩说明 会上对投资者普遍关注的问题进行回答。 深圳信立泰药业股份有限公司(下称"公司")将于 2025 年 4 月 18 日(星 期五)15:00-17:00 参加由深圳证券交易 ...
信立泰(002294) - 002294信立泰投资者关系活动记录表20250410
2025-04-10 12:02
编号:20250410 | | □特定对象调研 □分析师会议 | | --- | --- | | 投 资 者 关 | □媒体采访 √业绩说明会 | | 系 活 动 类 | □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) | | 活 动 参 与 | 线上参与公司 2024 年年度业绩说明会的全体投资者 | | 人员 | | | 时间 | 2025 年 4 月 10 日 | | 地点 | 线上会议 | | 形式 | 网络远程方式 | | 上 市 公 司 接 待 人 员 | 董事、总经理颜杰,独立董事王学恭,财务负责人孔芸,董事、 | | | 董事会秘书杨健锋 | | 姓名 | | | | 主要交流内容: | | | 1、 请问领导 大概什么时间能获批? 086 | | | 答:您好,S086 技术审评已完成,没有新的发补,等待审批 | | 交 流 内 容 | 阶段。谢谢! | | 及 具 体 问 | | | 答记录 | 2、 1.公司对信立坦+107/108+S086 高血压组合都上市后预 | | | 测最高销售额多少?2.在去年恩那罗上市时,公司计划进医保后 ...
信立泰2024年报点评:成长动能切换,创新主线渐明
Orient Securities· 2025-04-03 00:23
Investment Rating - The report maintains a "Buy" rating for the company, with a target price of 34.80 CNY based on a 58 times price-to-earnings ratio for 2025 [5][8]. Core Views - The company has shown a return to growth with significant improvements in gross margin and cash flow, achieving a revenue of 4.012 billion CNY in 2024, a year-on-year increase of 19.22%, and a net profit of 602 million CNY, up 3.71% [11]. - The growth in the formulation and medical device segments is accelerating, driven by channel expansion and new product launches, with the formulation revenue reaching 3.192 billion CNY, a 20.43% increase [11]. - The company is advancing its R&D pipeline, with several projects nearing completion, including four in the NDA stage and three in Phase III clinical trials, indicating a strong innovation trajectory [11]. Financial Summary - Revenue for 2023 was 3.365 billion CNY, with a projected increase to 4.012 billion CNY in 2024, reflecting a 19.2% growth [7]. - The gross margin improved to 72.64% in 2024, up 4.06 percentage points from the previous year [11]. - The net profit margin for 2024 is projected to be 15.0%, with net profit expected to reach 666 million CNY by 2025, a 10.7% increase from 2024 [7][11].
信立泰(002294):成长动能切换 创新主线渐明
Xin Lang Cai Jing· 2025-04-02 12:41
Core Insights - The company reported a revenue of 4.012 billion yuan (+19.22%) and a net profit of 602 million yuan (+3.71%) for the 2024 fiscal year, indicating a return to growth with significant improvements in gross margin and cash flow [1] - The gross margin increased to 72.64% (+4.06 percentage points), and net cash flow from operating activities rose to 1.186 billion yuan (+41.32%) [1] Segment Performance - The formulation segment generated revenue of 3.192 billion yuan (+20.43%), while the medical device segment saw revenue of 305 million yuan (+41.68%). The raw materials and intermediates segment reported revenue of 412 million yuan (-0.37%) [2] - Growth in the formulation segment was driven by enhanced channel expansion and brand strength, particularly in grassroots and community markets, as well as the rapid rollout of new products [2] - The medical device segment experienced high growth, with over 50,000 Maurora implants [2] R&D and Innovation - The company is progressing well with its key pipeline, with four projects in the NDA stage and three in Phase III clinical trials [2] - The company is also expanding its innovative drug development into new areas such as peptides, small nucleic acids, and gene editing [2] Earnings Forecast and Investment Recommendation - Based on the 2024 annual report, the company adjusted its revenue forecasts for raw materials and intermediates while increasing sales expenses and medical device gross margins [3] - Projected earnings per share for 2025-2027 are 0.60, 0.70, and 0.82 yuan respectively, with a target price of 34.80 yuan based on a 58 times price-to-earnings ratio for 2025 [3]
深圳信立泰药业股份有限公司 关于举行2024年年度业绩说明会 的公告
Core Viewpoint - Shenzhen Xinlitai Pharmaceutical Co., Ltd. is holding an annual performance briefing for the year 2024 to enhance communication with investors and gather their opinions and suggestions [1]. Group 1: Meeting Details - The annual performance briefing will take place on April 10, 2025, from 15:00 to 17:00 via "Value Online" [1]. - Investors can participate in the online briefing through a specific URL or by scanning a QR code [2]. - Key personnel attending the meeting include the General Manager Mr. Yan Jie, Independent Director Mr. Wang Xuegong, Financial Officer Ms. Kong Yun, and Secretary of the Board Mr. Yang Jianfeng [3]. Group 2: Investor Engagement - The company is collecting questions from investors prior to the meeting to enhance the relevance of the discussion [4]. - Investors can submit their questions through the provided URL or by scanning the QR code before April 10, 2025 [4]. - The company aims to address commonly asked questions during the performance briefing within the limits of information disclosure [4].
信立泰(002294) - 关于举行2024年年度业绩说明会的公告
2025-04-01 09:01
证券代码:002294 证券简称:信立泰 编号:2025-022 深圳信立泰药业股份有限公司 关于举行 2024 年年度业绩说明会的公告 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。 出席本次说明会的人员有:董事、总经理颜杰先生,独立董事王学恭先生, 财务负责人孔芸女士,董事、董事会秘书杨健锋先生。 深圳信立泰药业股份有限公司(下称"公司")《2024 年年度报告》、《2024 年年度报告摘要》已于 2025 年 3 月 29 日披露。 为便于广大投资者进一步了解公司 2024 年度经营情况,公司将于 2025 年 4 月 10 日(星期四)15:00-17:00 在"价值在线"(www.ir-online.cn)举办 2024 年年度业绩说明会,与投资者进行沟通和交流,广泛听取投资者的意见和建议。 一、 参会方式 本次网上业绩说明会将采用网络文字互动的方式举行,投资者可于 2025 年 4 月 10 日(星期四)15:00-17:00 通过网址 https://eseb.cn/1n5Tgp84pws 或使用微 信扫描下方小程序码即可进入参与互动交流。 二、 ...