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人福医药集团股份公司关于HW241045片获得药物临床试验批准通知书的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:600079 证券简称:人福医药(维权) 编号:临2025-099 人福医药集团股份公司 关于HW241045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"或"人福医药")全资子公司武汉人福创新药物研发中心有限公 司(以下简称"创新药研发中心")近日收到国家药品监督管理局核准签发的HW241045片《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:HW241045片 特此公告。 人福医药集团股份公司董事会 二〇二五年八月六日 二、剂型:片剂 三、申请事项:境内生产药品注册临床试验 四、注册分类:化学药品1类 五、申请人:武汉人福创新药物研发中心有限公司 六、审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025年5月21日受理的 HW241045片临床试验申请符合药品注册的有关要求,同意本品开展用于特发性肺纤维化适应症的临床 试验。 HW241045片适用于特 ...
人福医药(600079.SH):HW241045片获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-05 08:05
格隆汇8月5日丨人福医药(维权)(600079.SH)公布,全资子公司武汉人福创新药物研发中心有限公司 (简称"创新药研发中心")近日收到国家药品监督管理局核准签发的HW241045片《药物临床试验批准 通知书》。HW241045片适用于特发性肺纤维化的治疗,目前全球范围内尚无同靶点的药物获批上市。 全球范围内仅有尼达尼布和吡非尼酮两种药物批准用于治疗特发性肺纤维化疾病。 ...
“一喷一吸”就能治疗肺纤维化?
Ke Ji Ri Bao· 2025-06-30 23:44
肺组织逐渐纤维化,就像肺部被一层水泥牢牢包裹,让肺纤维化患者每次呼吸都格外艰难。目前,肺纤 维化的临床治疗手段有限,仅能在一定程度上延缓纤维化进程及降低相关并发症的风险。近年来,开发 更安全、有效的新型治疗策略成为研究热点。 近日,清华大学基础医学院科研团队与解放军总医院第一医学中心科研团队联合海南医科大学第一附属 医院呼吸与危重症科、重庆金凤实验室等的科研团队,研究开发了一种"外泌体雾化疗法",为肺纤维化 提供了新型治疗策略。相关研究论文刊登在《自然》子刊《信号转导和靶向治疗》上。 肺纤维化会带来哪些健康问题?外泌体治疗的原理是什么?相对于传统的疗法,其有何优点?科技日报 记者就此采访了相关专家。 肺纤维化被喻为"不死的癌症" 海南医科大学第一附属医院呼吸与危重症医学科主任医师黄华萍介绍,正常的肺像一块富有弹性的海 绵,肺泡就像海绵里的小孔,是气体交换的基本单位。孔与孔之间相连的部分就是肺间质,由结缔组 织、血管、淋巴管等组成,起到联结、支撑、固定、营养和代谢支持的关键作用。正是这种精密的间质 结构赋予了肺组织良好的顺应性和弹性回缩力,使肺泡能在呼吸过程中有效扩张与回缩,保障高效的气 体交换。 而肺组织的纤 ...
IPF稀缺用药叠加ADC联用预期,东阳光药(01558)有望创造BD新奇迹
智通财经网· 2025-05-26 08:15
Core Viewpoint - Dongyangguang Pharmaceutical's stock price has surged since April 9, reaching a high of 15.54 HKD on May 26, marking an 80.70% increase and a five-year high, reflecting market confidence in the company's accelerated innovation and potential blockbuster business development (BD) deals [1] Group 1: Company Overview - Dongyangguang Pharmaceutical is recognized as a leading innovative pharmaceutical company in China, focusing on enhancing its drug research and development capabilities and expanding its competitive edge in key niche markets [1] - The company has over 100 drugs in development, including 49 first-class innovative drugs, with significant potential for blockbuster products, such as the investigational drug Ifenidone for idiopathic pulmonary fibrosis (IPF) [1] Group 2: Market Context - IPF is a chronic, progressive, and irreversible lung disease primarily affecting the elderly, with approximately 3 million patients worldwide, and its incidence and prevalence are on the rise globally [1][2] - Currently, there are only two approved drugs for IPF treatment: Pirfenidone and Nintedanib, due to the high difficulty in developing new drugs for this condition, leading to many clinical trials being terminated or failing [2] - Despite the expiration of patents for existing treatments, the global market for IPF drugs remains over 4 billion USD [2] Group 3: Drug Development and Potential - Ifenidone has shown promising results, with in vitro and in vivo efficacy demonstrating activity 200-500 times greater than Pirfenidone and 40 times in vivo efficacy, along with a higher safety window compared to marketed drugs [2] - The drug has completed Phase I clinical trials in China and the U.S. and has received orphan drug designation from the FDA, with Phase II interim data indicating its potential as a "blockbuster" [2] - Ifenidone is currently advancing to Phase III clinical trials for IPF, indicating a high likelihood of commercialization [2] Group 4: Broader Applications and Collaborations - In addition to IPF, Ifenidone is also being investigated for interstitial lung disease (PF-ILD), which currently has limited treatment options, with lung transplantation being the only curative therapy [3] - Ifenidone has demonstrated significant anti-inflammatory effects and potential therapeutic benefits for interstitial lung diseases [3] - The drug also shows potential for combination therapy with antibody-drug conjugates (ADCs), addressing safety concerns related to interstitial lung disease associated with ADCs, such as DS-8201 [4] - A collaboration with Sanofi has been established, leveraging both companies' strengths, particularly with Sanofi's HER2 ADC product DB-1303, which could enhance the therapeutic potential of both drugs [4]