一、药品名称：HW241045片 二、剂型：片剂 三、申请事项：境内生产药品注册临床试验 证券代码：600079 证券简称：人福医药 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： 根据我国药品注册相关的法律法规要求，创新药研发中心在收到上述药物临床试验 通知书后，需着手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以及产品从研制、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。公司将根据药品研发 的实际进展情况及时履行信息披露 ...

证券日报网讯 8月5日晚间，人福医药发布公告称，公司全资子公司武汉人福创新药物研发中心有限公 司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》。 （文章来源：证券日报） ...

Company Overview - Renfu Pharmaceutical's subsidiary, Wuhan Renfu Innovative Drug Research Center, received approval from the National Medical Products Administration for clinical trials of HW241045 tablets for idiopathic pulmonary fibrosis [1] - HW241045 is a Class 1 chemical drug, with no other drugs targeting the same pathway approved globally [1] - Currently, only two drugs, Nintedanib and Pirfenidone, are approved for treating idiopathic pulmonary fibrosis, with projected sales of 1.2 billion yuan and 670 million yuan in China for 2024, respectively [1] - The company has invested approximately 23 million yuan in the development of this project [1] Industry Context - By the end of 2024, Renfu Pharmaceutical will have established research centers in multiple locations, obtaining 24 clinical approvals across 12 varieties, with 16 approvals for Class 1 and 2 innovative drug projects [2] - The Chinese innovative drug market is entering a golden development period, supported by national health strategies and policies promoting innovation [2] - According to Dongwu Securities, the market size for innovative drugs in China is expected to exceed 2 trillion yuan by 2030, with a compound annual growth rate of 24.1% [2] Corporate Developments - Recently, Renfu Pharmaceutical held a temporary shareholders' meeting to complete a board restructuring, changing its controlling shareholder from Contemporary Technology to China Merchants Life Science Technology [2] - In Q1 2025, the company reported revenue of 6.137 billion yuan, a year-on-year decrease of 3.6%, while net profit attributable to shareholders was 540 million yuan, an increase of 11.09% [2] Strategic Partnerships - On July 28, Renfu Pharmaceutical held discussions with JD Group to deepen cooperation in the pharmaceutical supply chain [3] - The core business units of Renfu Pharmaceutical proposed collaboration directions focusing on e-commerce development [3] - JD's team indicated plans to integrate marketing resources, optimize operational connections, and provide support in logistics technology and channel management [3]

Group 1 - Niuwei Co., Ltd. reported a net profit of 637 million yuan for the first half of 2025, representing a year-on-year increase of 30.47% [1] - The company achieved a total operating revenue of 3.404 billion yuan, up 19.96% year-on-year [1] - Niuwei specializes in the research, manufacturing, and sales of industrial valves [2] Group 2 - Shandong Haohua plans to acquire a 29% stake in Zhongyan Alkali Industry with a total investment of 2.32 billion yuan [2] - The company is involved in the production of soda ash and caustic soda [3] Group 3 - Dongfang Co., Ltd. announced a partnership with Dongfang Import and Export Company to develop overseas marketing business [38] - The company focuses on the research, production, and sales of light commercial vehicles and powertrains [38] Group 4 - Xinyuan Technology reported a net profit of 52.6 million yuan for the first half of 2025, a year-on-year increase of 10.70% [12] - The company achieved an operating revenue of 2.871 billion yuan, up 3.86% year-on-year [12] - Xinyuan provides one-stop custom development and production services for pharmaceutical companies and research institutions [12] Group 5 - Zhuhai Piano announced that its subsidiary won the operating rights project for the Baihuazhai scenic area, with an investment of no less than 400 million yuan over 20 years [21] - The company specializes in the research, manufacturing, and sales of pianos and digital musical instruments [21] Group 6 - Zhenghong Technology reported a sales revenue of 26.02 million yuan from pig sales in July, a year-on-year increase of 288.69% [16] - The company sold 63,000 pigs in total from January to July 2025, with a cumulative sales revenue of 109 million yuan, representing a year-on-year increase of 38.06% [16] - Zhenghong focuses on feed products and pig farming [17] Group 7 - ST Nuotai received the cGMP certification from Brazil's National Health Surveillance Agency for its production facility [15] - The company specializes in the research and development of peptide drugs and small molecule pharmaceuticals [15] Group 8 - Guizhou Moutai has repurchased a total of 3.4517 million shares, accounting for 0.2748% of its total share capital, with a total expenditure of 5.301 billion yuan [48][49] - The company is engaged in the production and sales of Moutai liquor and related products [49]

Core Viewpoint - Renfu Pharmaceutical's subsidiary has received approval for a clinical trial of HW241045, a drug for idiopathic pulmonary fibrosis, marking a significant development in a market with limited treatment options [1] Group 1: Company Developments - Renfu Pharmaceutical's wholly-owned subsidiary, Wuhan Renfu Innovative Drug Research Center, has obtained the clinical trial approval notice for HW241045 from the National Medical Products Administration [1] - HW241045 is specifically indicated for the treatment of idiopathic pulmonary fibrosis, a condition for which there are currently no approved drugs targeting the same mechanism globally [1] Group 2: Market Context - Currently, only two drugs, Nintedanib and Pirfenidone, have been approved for the treatment of idiopathic pulmonary fibrosis worldwide [1]

证券代码：600079 证券简称：人福医药 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董事会 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。根据米内网数据显示，2024 年度尼达尼布和吡非尼酮全国销售额（统计范围包括城 市公立医院、县级公立医院、城市药店、网上药店、城市社区、乡镇卫生）分别约为人 民币 12 亿元和 6.7 亿元。截至目前，创新药研发中心在该项目上的累计研发投入约为人 民币 2,300 万元 ...

人福医药（600079）(600079.SH)公告，公司全资子公司武汉人福创新药物研发中心有限公司近日收到 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。 ...

人民财讯8月5日电，人福医药（600079）8月5日晚间公告，公司全资子公司武汉人福创新药物研发中心 有限公司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》，同意该 药品开展用于特发性肺纤维化适应症的临床试验。 ...

每经AI快讯，8月5日，人福医药（600079）(600079.SH)公告称，公司全资子公司创新药研发中心收到 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》，同意开展用于特发性肺纤 维化适应症的临床试验。HW241045片为化学药品1类，目前全球范围内尚无同靶点的药物获批上市。 ...

智通财经APP讯，人福医药(600079.SH)公告，公司全资子公司武汉人福创新药物研发中心有限公司近 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。 ...