创新药研发

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前次募投有项目“烂尾”,广生堂又要再募近10亿
IPO日报· 2025-05-28 13:27
星标 ★ IPO日报 精彩文章第一时间推送 近期,福建广生堂药业股份有限公司(300436.SZ,下称"广生堂")发布定增预案,拟向不超过35名特定对象发行股票不超过4778.01万股,募集 资金总额不超过9.77亿元,扣除发行费用后全部用于创新药研发项目、中药传统名方产业化项目及补充流动资金。 目前,本次定增已获深交所受理。 AI制图 持续亏损 据悉,广生堂成立于2001年,2015年登陆创业板,是国内抗乙肝病毒药物领域的头部企业,核心产品包括恩替卡韦、拉米夫定等仿制药。 然而,受药品集采降价冲击,其仿制药业务收入持续下滑。 2021年至2024年,公司抗乙肝药物带来的营业收入分别为1.68亿元、1.55亿元、1.22亿元、1.06亿元, 毛利率从2021年的51.06%降至2023年 的42.29%。 另外,叠加创新药研发高投入等因素,公司经营业绩已经连续四年亏损。 2021年至2024年,公司归母净利润分别为-0.35亿元,-1.27亿元、-3.49亿元、-1.56亿元,累计亏损超6亿元。 制图:李昕 本次定增募资项目中,创新药研发项目总投资额为6.31亿元,用于创新药物临床研发,拟使用募集资金投资额为 ...
76亿并购折戟,新诺威深陷资金困局:创新药豪赌如何破局?
Xin Lang Zheng Quan· 2025-05-28 10:31
Core Viewpoint - The termination of the 7.6 billion yuan acquisition of Shiyao Baike Biotech by XinNuoWei highlights significant operational challenges, including declining performance, cash flow issues, and excessive R&D expenditures, pushing the company towards a critical transformation juncture [1][5]. Group 1: Acquisition and Market Challenges - The acquisition of Shiyao Baike Biotech was officially halted by the Shenzhen Stock Exchange after 15 months of planning, marking a significant setback for XinNuoWei [1]. - The core product of Shiyao Baike, the long-acting G-CSF drug "Jin You Li®," saw revenues plummet over 40% year-on-year to 922 million yuan in the first half of 2024, following aggressive price reductions due to provincial alliance procurement [2]. - The competitive landscape for long-acting G-CSF has intensified, evolving from a "six-strong competition" to a "nine-hero melee," with new entrants like Maiwei Biotech posing additional threats [2]. Group 2: Financial Performance and Cash Flow - The company reported a staggering 87.63% drop in net profit attributable to shareholders, falling to 53.72 million yuan in 2024, with a further loss of 26.9 million yuan in the first quarter of 2025 [3]. - R&D expenses surged to 240 million yuan in the first quarter of 2024, a 117.68% increase year-on-year, contributing to the company's financial strain [3]. - For the first time, the company experienced negative cash flow, with a net outflow of 1.235 billion yuan from operating activities in 2024, and a continued outflow of 86.79 million yuan in the first quarter of 2025 [3]. Group 3: Transformation and Strategic Pressures - Despite the controlling shareholder, Shiyao Group, increasing its stake by 103 million yuan to bolster market confidence, XinNuoWei continues to face three major pressures: high R&D costs, low cash flow, and weakening traditional business performance [4]. - R&D investments have consumed over 50% of the company's total revenue, raising concerns about the sustainability of this model without rapid commercialization of new products [4]. - The termination of the 7.6 billion yuan acquisition underscores the broader challenges XinNuoWei faces in balancing innovative drug development with declining traditional business segments [5].
华森制药(002907) - 2024年度暨2025年一季度业绩网上说明会投资者关系活动记录表
2025-05-28 08:50
重庆华森制药股份有限公司 投资者关系活动记录表 证券代码:002907 证券简称:华森制药 编号:2025-006 | 投资者关系活动类别 | 特定对象调研 分析师会议 | | --- | --- | | | 媒体采访 业绩说明会 | | | □新闻发布会 □路演活动 | | | □现场参观 | | | □其他 | | 参与单位名称及 | 通过"路演中"网络平台参与公司 2024 年度暨 2025 年一季度 | | 人员姓名 | 业绩网上说明会的投资者 | | 时间 | 2025 年 5 月 28 日 | | 地点 | 公司 2 楼会议室 | | 上市公司接待人姓名 | 游洪涛(董事长、总经理) | | | 游雪丹(副总经理、董事、董事会秘书) | | | 李嘉明(独立董事) | | | 彭晓燕(财务总监) | | | 周智如(证券事务代表) | | | 徐 君(证券事务专员) | | | 一、公司在遵守信息披露制度的前提下,介绍公司经营业 绩、产品布局、市场开发和生产管理等情况,沟通内容与公司 | | | 公告内容一致。 | | 投资者关系活动 | 二、采取问答方式,由游雪丹女士、李嘉明先生 ...
【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].