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发挥中医药原创优势 我国中药新药上市步伐加快
Xin Hua She· 2025-05-28 03:09
Core Viewpoint - The approval of innovative traditional Chinese medicine (TCM) products, such as the pediatric fever-reducing patch, reflects the accelerated modernization and industrialization of TCM, driven by policy guidance, scientific breakthroughs, and clinical demand [1][2]. Group 1: Recent Developments in TCM - Since 2021, 52 new TCM products have been approved, with a notable increase in the number of innovative drugs, indicating a rapid pace of TCM new drug approvals [1][3]. - The approval of TCM new drugs is supported by the "14th Five-Year Plan for TCM Development," which emphasizes the development of new drugs based on ancient classic formulas and effective components [1][3]. Group 2: Research and Development Trends - A significant characteristic of recent TCM drug approvals is the focus on ancient classic formulas, with 23 out of the 52 new drugs being based on these traditional formulations [3]. - The integration of big data, artificial intelligence, and genomics into TCM research has enhanced precision and efficiency, while collaboration among experts from various fields has provided comprehensive solutions for TCM development [3]. Group 3: Market Demand and Future Outlook - Growing public interest in health and traditional culture has led to increased market demand for TCM, prompting higher investment and research enthusiasm from companies in this sector [2]. - The acceleration of TCM new drug approvals is reshaping treatment models and providing multiple benefits to patients, particularly in challenging diseases like cancer [4]. - The government aims to enhance TCM quality and promote high-quality development in the industry by focusing on significant chronic diseases and optimizing the approval process for innovative TCM drugs [4].
【转|太平洋医药-先声药业深度】创新药密集兑现,未来持续增长可期
远峰电子· 2025-05-27 13:45
以下文章来源于谭谈药市 ,作者谭紫媚 张懿 谭谈药市 . 太平洋证券医药组研究观点分享 文章转自2025年2月13日太平洋医药团队报告 ,分析师: 谭紫媚/ 张懿 投资要点 神经专科制药龙头地位稳固 (1)先必新舌下片获批,成为又一款能够改善卒中预后的重磅药物 先必新注射液于2020年获批上市后销售额快速增长,2020-2023年CAGR达749.9%。 2024年12月,先必新舌下片获批上市,有望与先必新注射液构成涵盖卒中全病程的序贯疗法。结合舌下给药的便捷性,急性脑卒中患者的依从性将有所提高。先 必新有望成为继依达拉奉后又一款能够改善卒中预后的重磅药物。 (2)全球新一代DORA类失眠药快速放量,达利雷生国内上市在即 凭借较好的疗效和安全性,新一代DORA类失眠药上市后销量均出现快速增长:苏沃雷生(默沙东)2020年销售额高达3.3亿美元,莱博雷生(卫材)2023年销售 额已超过苏沃雷生达2.6亿美元,达利雷生(Idorsia)正处于快速放量阶段。 2022年11月,公司与Idorsia订立许可协议,获得科唯可(达利雷生)在中国临床开发及商业化权利。2024年5月,科唯可在香港获批上市, 无精神类药物限制 ...
德源药业(832735) - 投资者关系活动记录表
2025-05-27 12:00
证券代码:832735 证券简称:德源药业 公告编号:2025-040 江苏德源药业股份有限公司 投资者关系活动记录表 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、 误导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带 法律责任。 一、 投资者关系活动类别 二、 投资者关系活动情况 活动时间:2025 年 5 月 26 日 活动地点:江苏省连云港市连云区大浦工业区金桥路 21 号公司三楼会议室 参会单位及人员:华夏基金、信达证券(排名不分先后) 上市公司接待人员:公司董事长、总经理:陈学民先生;公司副总经理、董事 会秘书、财务负责人:王齐兵先生;公司副总经理、研究所所长:杨汉跃先生。 三、 投资者关系活动主要内容 公司组织调研单位实地参观一工厂制剂车间、二工厂研究所、三工厂原料药车 间,了解生产与研发情况。管理层系统介绍经营状况和产品研发,深化调研单位对 1 / 2 公司的认知。此外,本场交流活动就调研单位关心的问题进行沟通与交流,主要问 题及回复情况如下: 问题 1:介绍一下公司创新药 DYX116 的情况。 回复:DYX116 是公司与上海药明康德新药开发有限公 ...
港股创新药50ETF(513780)涨1.89%,君实生物涨超9%!ASCO大会召开在即,中国创新药企惊艳亮相!
Jin Rong Jie· 2025-05-27 05:19
金融界5月27日消息,港股周二集体低开,盘面上,创新药走高,截至11:30,港股创新药50ETF (513780)涨1.89%,盘中最高涨超3%。 截至5月27日,中证港股通创新药指数前十大成分股累计权重71.6%,包含信达生物、石药集团等A股稀 缺优质标的。指数的50只成分股业务均涉及创新药研发以及为制药企业提供药物研究、开发和生产等服 务。 当前国内创新药板块正站在新的历史起点上:国内企业凭借自身竞争力的提升,出海空间不断拓展;行 业营业收入快速增长,正逐步迈向盈利驱动的新周期;与此同时,政策层面的大力支持,为产业发展保 驾护航。想要把握这一机遇可以关注港股创新药50ETF及其联接基金(A类:023597,C类: 023598)。 本文源自:金融界 作者:E播报 消息面上,2025年ASCO年会将于美国芝加哥当地时间5月30日~6月3日举行。据了解,美国临床肿瘤学 会(ASCO)年会是世界上规模最大、学术水平最高、最具权威的临床肿瘤学会议之一。大会摘要数据于5 月22日正式公布,多家国内创新药企业展示了优异的临床数据,其中中国专家的发言数量再创新高,共 有71项原创性研究成果入选口头发言环节。 光大证券指 ...
医药生物行业跨市场周报:2025年ASCO大会召开在即,中国创新药企惊艳亮相-20250527
EBSCN· 2025-05-27 02:17
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [4]. Core Insights - The upcoming 2025 ASCO conference highlights the impressive presence of Chinese innovative pharmaceutical companies, with over 70 research projects selected, indicating a robust growth in domestic drug development [2][22]. - The report emphasizes the increasing competitiveness of domestic drugs in the global market, particularly in oncology, as several innovative drugs are making significant progress [2][23]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 1.78%, outperforming the CSI 300 index by 1.96 percentage points and the ChiNext index by 2.83 percentage points, ranking first among 31 sub-industries [1][16]. - The Hong Kong Hang Seng Healthcare Index increased by 5.54%, surpassing the Hang Seng Index by 4.18 percentage points [1][16]. Company Research Progress - Recent developments include the IND application for HS-10510 by Haosen Pharmaceutical and ongoing clinical trials for several drugs by companies such as Hengrui Medicine and BeiGene [35]. Key Company Highlights - Hengrui Medicine has 69 research projects selected for the ASCO conference, covering various cancer types, showcasing its leadership in innovative drug development [23][26]. - Innovent Biologics will present clinical data for IBI363 and IBI343 at ASCO, indicating its strong pipeline in oncology [27][28]. - Rongchang Biopharmaceutical has over 20 clinical progress reports accepted for presentation at ASCO, focusing on various cancer treatments [30][31]. Investment Strategy - The report suggests a structural selection of investment opportunities based on payment willingness and ability, focusing on three main areas: hospital payment support, expansion of consumer demand, and overseas market opportunities [3]. Key recommendations include Hengrui Medicine, Mindray Medical, United Imaging Healthcare, and Yuyue Medical [3].
南新制药募投项目延期 上市5年营收缩水七成
Jing Ji Guan Cha Wang· 2025-05-26 15:21
以抗流感药物为核心产品的南新制药(688189),日前公告IPO募投项目延期。当前,南新制药不仅营收 下滑,亏损显著增加,核心产品亦面临激烈市场竞争。 南新制药5月24日公告称,原定2025年6月30日完成的"营销渠道网络升级建设项目",预计延期到2026年 12月31日,比原定计划延后18个月时间。南新制药称,受宏观经济环境和医药行业政策等影响,综合考 虑成本投入、产品管线丰富度等因素,公司及时调整和优化销售策略,对在特定省市建立办事处的实际 需求大幅减少。 位于湖南浏阳的南新制药2020年3月上市,控股股东为湖南省国资委所属湖南医药发展投资集团有限公 司,公司也是湖南省首家登陆科创板的药企。南新制药IPO时,实际募集资金净额为人民币11.3亿元, 募集资金计划投向创新药研发、营销渠道网络升级建设、补充流动资金等项目。 此外,南新制药另有3个创新药、2个改良型新药在研。在仿制药产品线方面,公司在售产品包括辛伐他 汀分散片、头孢克洛胶囊头孢呋辛酯分散片、乳酸环丙沙星氯化钠注射液、复方布洛芬片等较为成熟的 仿制药。 上市首年2020年,尽管受疫情等不利因素影响,南新制药实现营业收入10.29亿元,归属净利润1. ...
创新药突围战:从烧钱到兑现,还需过几道坎?
21世纪经济报道· 2025-05-26 11:55
作 者丨季媛媛 编 辑丨张星 图 源丨摄图网 当创新药行业的领军企业恒瑞医药在港股市场首日上市即收涨25%时,A股和H股市场上的创 新药板块也呈现出显著的上涨趋势。回顾整个创新药板块的市场表现,尽管在5月26日经历了 一定程度的回调,但整体来看, 创新药板块依旧是今年表现最为出色的子板块之一 ,其成绩 令人鼓舞。 根据Wind数据,截至5月26日10时30分, 恒生行业指数中的医疗保健业,年初至今涨幅已超 30% 。其中,三生制药年初至今涨幅高达210.86%、远大医药涨幅达94.17%、科伦博泰生物- B涨幅达87.88%、诺诚健华涨幅达69.28%、乐普生物-B涨幅达64.12%。另外,港股概念板块 中的未盈利生物科技指数年初至今涨幅超39%。其中,德琪医药-B年初至今涨幅达456.92%、 和铂医药-B涨幅达358.60%、加科思-B涨幅达244.88%、康宁杰瑞制药-B涨幅超148%。 面 对 市 场 表 现 , 许 多 行 业 专 家 坦 率 表 示 : 医 药 领 域 , 特 别 是 创 新 药 物 , 已 经 从 " 寒 冬"迈向"暖春",进入了一个新的政策扶持和发展的周期。 长江证券分析认为, ...
大象起舞,恒瑞医药的大航海时代来临
Ge Long Hui· 2025-05-26 11:54
Core Viewpoint - Hengrui Medicine has successfully listed on the Hong Kong Stock Exchange, marking the largest pharmaceutical IPO in Hong Kong in nearly five years, with significant international investor interest and a total subscription amount of approximately HKD 41.31 billion, representing 41.77% of the total issuance scale [1][5][21]. Group 1: Company Overview - Hengrui Medicine, a leader in China's innovative pharmaceutical sector, has transformed from a small local manufacturer to a global player, now ranked among the top 50 pharmaceutical companies worldwide [4][10]. - The company has a rich history of over 55 years, witnessing significant growth and development in the pharmaceutical industry [4][22]. Group 2: Historical Development - From 1970 to 2003, Hengrui Medicine began as a small pharmaceutical factory, focusing on basic medicines, and achieved its first major success with the launch of the cancer drug Ifosfamide in 1995, leading to its status as a billion-yuan sales enterprise [5][6]. - Between 2004 and 2017, the company accelerated its transformation by establishing a research center in Shanghai and entering the high-value innovative drug development sector, achieving FDA certification for its products [6][7]. - From 2018 to 2022, Hengrui increased its R&D investment significantly, reaching CNY 6.346 billion in 2022, which accounted for 29.83% of its sales revenue, marking a historical high for the company [7][8]. Group 3: Recent Developments - Since 2023, Hengrui has shifted its focus from generic drugs to innovative drug development, with projected sales revenue from innovative drugs reaching CNY 13.892 billion in 2024, a year-on-year increase of 30.60% [9][12]. - The company has also engaged in 14 innovative drug licensing transactions since 2018, leading the domestic pharmaceutical industry in this area [9][12]. Group 4: Global Expansion Strategy - Hengrui is actively pursuing international markets, having initiated over 20 overseas clinical trials in regions such as the US, Europe, and Japan, and has completed 9 business development transactions in the past three years, with a cumulative transaction value of approximately USD 14 billion [18][21]. - The recent listing on the Hong Kong Stock Exchange is a strategic move to enhance its global brand influence and attract international investors, facilitating further international collaborations and business expansion [21][22].
九芝堂:YB211项目启动II期临床试验
news flash· 2025-05-26 08:51
Core Viewpoint - The announcement indicates that Jiuzhitang's subsidiary Youbo Pharmaceutical has initiated a Phase II clinical trial for the new drug YB211, which targets acute bacterial skin and skin structure infections caused by Gram-positive pathogens [1] Group 1: Clinical Trial Details - The clinical trial kickoff meeting was held on May 24, 2025, with 26 clinical trial centers, including Fudan University Huashan Hospital [1] - YB211 is a novel cyclic lipopeptide with a new chemical structure, and the trial will compare its efficacy against the control drug Daptomycin in adult patients [1] - The trial consists of two parts: dose exploration and pharmacokinetic studies [1] Group 2: Regulatory Approvals - Youbo Pharmaceutical received the clinical trial approval notice from the National Medical Products Administration on February 6, 2025 [1] - The company obtained the ethics review committee's approval by the end of April [1] Group 3: Impact on Company Performance - The initiation of the clinical trial is expected to advance the research and evaluation progress of the new drug YB211 [1] - However, it is noted that there will be no significant impact on the company's operating performance in the short term [1]
信立泰(002294):创新产品持续落地,管线优势凸显成长潜力
Tianfeng Securities· 2025-05-26 02:15
公司报告 | 季报点评 信立泰(002294) 证券研究报告 创新产品持续落地,管线优势凸显成长潜力 事件 公司发布2024 年年报和2025 年第一季度报告,2024 年实现营业收入 40.12 亿元,同比增长 19.22%,归母净利润 6.02 亿元,同比增长 3.71%,盈利水 平稳健提升;2025 年第一季度的营业收入为 10.62 亿元,同比下降 2.64%, 归母净利润为 2 亿元,同比增长 0.03%。 加大销售推广力度,开拓市场 2024 年,销售费用率为 36.71%,同比增加 6.53pct,主要因为新上市产品 推广费用增加以及产品销售量增加;管理费用率为 6.78%,同比下降 1.74pct;研发费用率为 10.50%,同比下降 1.66pct。2025Q1,销售费用率 为 38.11%,同比增长 3.55pct;管理费用率为 6.62%,同比增长 0.05pct; 研发费用率为 10.18%,同比增加 0.32pct。 制剂驱动营收结构优化,创新产品板块比重提升 2025Q1 营业收入同比略有下降,造成收入同比下降的原因主要是受到仿制 药政策影响,相关产品收入占营收比重进一步降低。从产 ...