Core Viewpoint - Company has received approval for clinical trials of HW241045, a drug aimed at treating idiopathic pulmonary fibrosis, marking a significant step in its research and development efforts [1][2]. Group 1: Drug Approval Details - The drug HW241045 is classified as a Class 1 chemical drug and is intended for domestic production and clinical trials [1]. - The approval was granted by the National Medical Products Administration of China, allowing the company to proceed with clinical trials for the specified indication [1][2]. Group 2: Market Context - Currently, there are no other drugs targeting the same mechanism as HW241045 approved globally, with only two existing treatments, Nintedanib and Pirfenidone, available for idiopathic pulmonary fibrosis [2]. - Sales figures for Nintedanib and Pirfenidone in China for 2024 are projected to be approximately RMB 1.2 billion and RMB 670 million, respectively [2]. Group 3: R&D Investment - The cumulative R&D investment for the HW241045 project by the company's innovation drug research center is approximately RMB 23 million [2]. - The company is required to initiate clinical research activities following the receipt of the clinical trial approval and will submit trial data to the regulatory authority upon completion [2].

Core Viewpoint - Humanwell Healthcare Group has received approval for clinical trials of HW241045 tablets, aimed at treating idiopathic pulmonary fibrosis, a condition for which no other drugs targeting the same pathway have been approved globally [1][2]. Group 1: Drug Approval Details - The drug name is HW241045 tablets, classified as a Class 1 chemical drug, and the application was submitted by Wuhan Humanwell Innovative Drug Research Center [1]. - The approval for clinical trials was granted by the National Medical Products Administration, allowing the drug to proceed with clinical research for idiopathic pulmonary fibrosis [1][2]. Group 2: Market Context - Currently, only two drugs, Nintedanib and Pirfenidone, are approved for treating idiopathic pulmonary fibrosis, with estimated sales in 2024 of approximately RMB 1.2 billion and RMB 670 million, respectively [2]. - The cumulative R&D investment in the HW241045 project by the innovative drug research center is around RMB 23 million [2]. Group 3: Next Steps and Considerations - Following the receipt of the clinical trial approval, the innovative drug research center will initiate the necessary clinical research activities and will submit trial data to the National Medical Products Administration upon completion [2]. - The lengthy and complex process of drug development, from research to market launch, is subject to various uncertainties, which investors should be aware of [2].

Core Viewpoint - The company has received approval for clinical trials of HW241045 tablets, aimed at treating idiopathic pulmonary fibrosis, a condition for which no similar drugs have been approved globally [1][2]. Group 1: Drug Information - Drug Name: HW241045 tablets [1] - Dosage Form: Tablet [1] - Application Matter: Domestic production drug registration clinical trial [1] - Registration Category: Class 1 chemical drug [1] - Applicant: Wuhan Renfu Innovative Drug Research Center Co., Ltd. [1] - Approval Conclusion: Clinical trials for idiopathic pulmonary fibrosis will commence following the approval [1][2]. Group 2: Market Context - Currently, only two drugs, Nintedanib and Pirfenidone, are approved for treating idiopathic pulmonary fibrosis globally [2]. - Sales figures for 2024 indicate that Nintedanib and Pirfenidone are projected to generate approximately RMB 1.2 billion and RMB 670 million, respectively, in China [2]. Group 3: R&D Investment - The cumulative R&D investment for the HW241045 project has reached approximately RMB 23 million [2]. - The company is required to initiate clinical research upon receiving the trial approval and will submit trial data to the regulatory authority for production approval after completion [2].

Group 1 - The core point of the article is that Renfu Pharmaceutical's wholly-owned subsidiary, Wuhan Renfu Innovative Drug Research and Development Center, has received approval from the National Medical Products Administration for the clinical trial of HW241045 tablets [2] Group 2 - The approval signifies a significant step in the development of new drugs by the company, potentially enhancing its product pipeline and market position [2] - This development may attract investor interest and could lead to future financial growth for the company [2] - The clinical trial approval reflects the company's commitment to innovation in the pharmaceutical industry [2]

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]

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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 ...

Core Viewpoint - The company has received approval for clinical trials of HW241045 tablets, which are intended for the treatment of idiopathic pulmonary fibrosis, marking a significant development as there are currently no approved drugs targeting the same pathway globally [1] Group 1 - The company's wholly-owned subsidiary, Wuhan Renfu Innovative Drug Research Center Co., Ltd., has obtained the Drug Clinical Trial Approval Notice from the National Medical Products Administration [1] - HW241045 tablets are specifically designed for the treatment of idiopathic pulmonary fibrosis [1] - There are no other drugs approved globally that target the same pathway as HW241045 [1]

Core Viewpoint - The company, Renfu Pharmaceutical, has received approval from the National Medical Products Administration for clinical trials of its drug HW241045 for the treatment of idiopathic pulmonary fibrosis [1] Group 1 - Renfu Pharmaceutical's wholly-owned subsidiary, Wuhan Renfu Innovative Drug Research and Development Center Co., Ltd., has been granted a clinical trial approval notice for HW241045 [1] - The approved clinical trial is specifically aimed at the indication of idiopathic pulmonary fibrosis [1]