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ST人福:HW221043片获得药物临床试验批准通知书
Core Viewpoint - ST Renfu (600079) has received approval from the National Medical Products Administration for the clinical trial of HW221043 tablets, a new molecular entity aimed at treating advanced solid tumors, with no similar drugs approved in the market to date [1]. Group 1: Company Developments - The wholly-owned subsidiary of ST Renfu, Hubei Biopharmaceutical Industry Technology Research Institute Co., Ltd., has been granted the clinical trial approval for HW221043 tablets [1]. - HW221043 tablets represent a self-developed new molecular entity by the company [1]. - The total research and development investment for HW221043 tablets has reached approximately 24 million yuan [1]. Group 2: Market Context - There are currently no similar drugs approved for market use, indicating a potential unique position for HW221043 in the treatment of advanced solid tumors [1].
ST人福(600079) - 关于HW221043片获得药物临床试验批准通知书的公告
2026-01-05 08:15
关于 HW221043 片获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、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法律责任。 人福医药集团股份公司(以下简称"公司")全资子公司湖北生物医药产业技术研 究院有限公司(以下简称"研究院有限公司")近日收到国家药品监督管理局核准签发 的HW221043片的《药物临床试验批准通知书》,现将相关情况公告如下: 一、药品名称:HW221043片 二、剂型:片剂 证券代码:600079 证券简称:ST 人福 编号:临 2026-001 人福医药集团股份公司 四、注册分类:化学药品1类 五、申请人:湖北生物医药产业技术研究院有限公司 六、审批结论:经审查,2025年10月29日受理的HW221043片符合药品注册的有关 要求,同意本品单药在晚期实体瘤患者中开展临床试验。 HW221043 片拟用于晚期实体瘤的治疗,是由公司自主研发的新分子实体化合物, 目前国内外暂无同类药物获批上市。截至目前,HW221043 片累计研发投入约为 2,400 万元人民币。 根据我国药品注册相关的法律法规要求,研究院有限公司在收到 ...
ST人福:HW221043片临床试验获批
Xin Lang Cai Jing· 2026-01-05 08:13
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of HW221043 tablets in patients with advanced solid tumors, marking a significant step in its drug development efforts [1] Group 1: Drug Development - HW221043 tablets are intended for the treatment of advanced solid tumors and are a new molecular entity developed by the company [1] - Currently, there are no similar drugs approved for market in both domestic and international markets [1] - The total research and development investment for HW221043 tablets has reached approximately 24 million RMB [1]
ST人福(600079.SH):HW221043片获得药物临床试验批准通知书
Ge Long Hui A P P· 2026-01-05 08:13
Core Viewpoint - ST Renfu (600079.SH) has received approval from the National Medical Products Administration for its drug HW221043, which is intended for the treatment of advanced solid tumors and is a new molecular entity developed by the company [1] Group 1: Drug Development - HW221043 is a new molecular compound developed independently by the company [1] - There are currently no similar drugs approved for market use domestically or internationally [1] - The total research and development investment for HW221043 has reached approximately 24 million RMB [1]
ST人福:HW221043片获药物临床试验批准通知书
Xin Lang Cai Jing· 2026-01-05 08:13
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of HW221043 tablets, which are intended for the treatment of advanced solid tumors and represent a new molecular entity with no similar drugs approved in the market to date [1] Group 1 - The full subsidiary of the company, Hubei Biopharmaceutical Industry Technology Research Institute Co., Ltd., has been granted the clinical trial approval notice for HW221043 tablets [1] - HW221043 tablets are developed independently by the company and are aimed at treating advanced solid tumors [1] - The total research and development investment for HW221043 tablets has reached approximately 24 million RMB [1]
ST人福:子公司HW221043片获得药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2026-01-05 08:09
每经AI快讯,1月5日,ST人福(600079)(600079.SH)公告称,全资子公司湖北生物医药产业技术研究 院有限公司近日收到国家药品监督管理局核准签发的HW221043片的《药物临床试验批准通知书》,同 意本品单药在晚期实体瘤患者中开展临床试验。HW221043片拟用于晚期实体瘤的治疗,目前国内外暂 无同类药物获批上市。截至目前,该药物累计研发投入约为2400万元人民币。根据相关法律法规要求, 研究院有限公司需启动药物的临床研究相关工作,待完成临床研究后,将向国家药品监督管理局递交临 床试验数据及相关资料,申报生产上市。医药产品的前期研发及产品从研制、临床试验报批到投产的周 期长、环节多,容易受到一些不确定性因素的影响,敬请广大投资者注意投资风险。 ...
流感疫情持续,防控系统工程再受考验
Guan Cha Zhe Wang· 2025-12-31 09:13
Group 1 - The flu epidemic in China is at a high level, primarily driven by the H3N2 strain, with increased transmission risk due to upcoming population movements during the New Year holiday [1] - Demand for antiviral and symptomatic medications has surged, with a reported over 500% increase in flu-related drug purchases on Alibaba Health and over 100% increase in orders for traditional Chinese medicine on Meituan [1] - The pharmaceutical industry is responding effectively across the supply chain, from vaccine production to drug distribution, indicating a well-coordinated effort to manage the public health challenge [1][2] Group 2 - Vaccine companies are ramping up production, with Hualan Vaccine reporting 55 batches of flu vaccine issued since November, reflecting increased public willingness to get vaccinated [2] - Diagnostic companies like Dian Diagnostics and Kingmed Diagnostics are seeing increased business, supporting the trend of testing before treatment, which enhances rational drug use [2] - The treatment landscape is diversifying, with both chemical and traditional Chinese medicines being utilized, indicating a shift in market dynamics [3][5] Group 3 - Traditional Chinese medicine is gaining traction, with companies like China Resources Sanjiu and Kangyuan Pharmaceutical seeing strong growth in their antiviral product lines [5] - The distribution sector is crucial, with companies like Yiyigou ensuring rapid delivery of essential medications during peak demand periods [5] - The clinical relevance of traditional Chinese medicine is increasing, supported by government policies that endorse its use in flu treatment, leading to a rise in evidence-based research [6][9] Group 4 - Companies are focusing on clinical research to validate the efficacy of traditional Chinese medicines, with Kangyuan Pharmaceutical conducting head-to-head trials against conventional drugs [7][9] - The competitive landscape in the respiratory system traditional Chinese medicine market is diverse, with companies like China Resources Sanjiu and Yiling Pharmaceutical leveraging brand strength and market recognition [9] - As the industry moves towards evidence-based medicine, companies with strong research capabilities and clinical data are likely to capture more market opportunities [9]
人福医药集团股份公司 关于收到中国证券监督管理委员会湖北监管局《行政处罚决定书》的公告
公司于2025年12月12日收到中国证监会湖北监管局下发的《行政处罚事先告知书》(鄂处罚字〔2025〕 8号),具体内容详见公司于2025年12月13日披露的《人福医药集团股份公司关于收到中国证券监督管 理委员会湖北监管局〈行政处罚事先告知书〉的公告》(公告编号:临2025-128号)。 公司及相关责任人于2025年12月29日收到中国证监会湖北监管局出具的《行政处罚决定书》(〔2025〕 10号),现将相关情况公告如下: 一、《行政处罚决定书》主要内容 当事人:人福医药集团股份公司(以下简称人福医药),住所:湖北省武汉市东湖高新区。 武汉当代科技产业集团股份有限公司(以下简称当代集团),住所:湖北省武汉市东湖新技术开发区。 艾路明,男,195×年5月出生,时任当代集团董事,住址:湖北省武汉市洪山区。 登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、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法律责任。 人福医药集团股份公司(以下简称"公司")及原控股股东武汉当代科技产业集团股份有限公司(以下简 称"当代科技")于2024年10月2 ...
人福医药正式处罚落地,投资者索赔已递交立案
Xin Lang Cai Jing· 2025-12-30 07:08
登录新浪财经APP 搜索【信披】查看更多考评等级 一、正式处罚落地 12月29日,ST人福(维权)公告,公司及控股股东收到湖北监管局的《行政处罚事先告知书》,公司 及相关主体涉嫌多项信息披露违法违规行为,涉及非经营性资金占用、关联交易未披露、年报虚假记载 等多方面问题。 监管对人福医药公司处以850万元罚款;对原控股股东当代集团处以900万元罚款;相关责任人同步领 罚。 因此引发的投资者索赔事宜,上海沪紫律师事务所刘鹏律师团队代理的案件已按顺序陆续递交立案,还 在征集受损投资者中。 二、存在巨额资金占用 湖北证监局调查认定的违法事实,揭示了人福医药及其原控股股东"当代集团"在数年间的一系列违规操 作。 2020年至2022年期间,ST人福及当代集团存在多项违法事实:一是非经营性资金占用累计127.85亿元未 及时披露,且2020年年度报告遗漏该信息;二是2022年3月下属子公司与关联方16.45亿元物业资产交易 未及时披露,且未载入当年年报;三是2020年至2022年半年度多份财报存在虚假记载,累计虚增归母净 利润超3亿元;四是当代集团隐瞒关联关系,导致公司1亿元股权收购交易未按规定披露关联信息。 监管部门的 ...
人福医药:因信息披露违法违规,公司及原控股股东当代集团等12名相关责任人被罚超2900万元
Cai Jing Wang· 2025-12-30 06:05
根据处罚决定,ST人福被给予警告并罚款850万元,当代集团合计罚款900万元;艾路明因组织领导相 关违法行为,被罚款390万元且7年不得从事证券相关业务;时任ST人福董事长李杰、财务总监吴亚君 分别被罚390万元、340万元,另有8名时任董监高分别被处以50万至250万元不等罚款。 经监管查明,2020年至2022年期间,ST人福(600079)及当代集团存在多项违法事实:一是非经营性 资金占用累计127.85亿元未及时披露,且2020年年度报告遗漏该信息;二是2022年3月下属子公司与关 联方16.45亿元物业资产交易未及时披露,且未载入当年年报;三是2020年至2022年半年度多份财报存 在虚假记载,累计虚增归母净利润超3亿元;四是当代集团隐瞒关联关系,导致公司1亿元股权收购交易 未按规定披露关联信息。 近日,人福医药发布公告称,公司及原控股股东武汉当代科技产业集团股份有限公司(下称"当代集 团")等12名相关责任人,因信息披露违法违规收到湖北证监局《行政处罚决定书》,合计罚款超2900 万元,时任当代集团实际负责人艾路明被采取7年市场禁入措施。 公告显示,ST人福目前已触及其他风险警示,但未触及重大违法 ...