Core Viewpoint - The company announced that its subsidiary, Wuhan Guanggu Renfu Biopharmaceutical Co., Ltd., has received a notice from the National Medical Products Administration regarding the termination of its drug registration application for the recombinant plasmid-hepatocyte growth factor injection [1] Group 1 - The company holds an 81.30% stake in Wuhan Guanggu Renfu [1] - The withdrawal of the drug registration application will allow Guanggu Renfu to improve research data and reapply for drug registration [1] - The company expects that this matter will not have a significant impact on its current performance [1]

重组质粒-肝细胞生长因子注射液适用于治疗严重下肢缺血性疾病导致的肢体静息痛。此次撤回药品注 册申请后，光谷人福将尽快完善研究资料并重新申报药品注册。此次撤回申请并非终止该项目。 人民财讯12月2日电，人福医药（600079）12月2日公告，公司控股子公司光谷人福(公司持有其81.3%的 股权)近日收到国家药监局签发的《药品注册申请终止通知书》，同意光谷人福撤回重组质粒-肝细胞生 长因子注射液的注册申请。 ...

证券代码：600079 证券简称：人福医药 编号：临 2025-125 人福医药集团股份公司 关于子公司撤回药品注册申请的公告 光谷人福于2024年12月向国家药品监督管理局递交该药品的上市注册申请并予以 受理。截至目前，pUDK-HGF研发项目的累计研发投入约为1.6亿元。此外，公司于2021 年收购光谷人福20.33%股权，将其纳入合并报表范围，收购日pUDK-HGF研发项目可辨 认资产的分摊金额为2.38亿元。根据该项目最新审评情况，经审慎研究，公司决定主动 撤回本次申请。本次注册申请撤回后，公司将根据监管要求和技术要求，对研究资料进 行充分评估完善后重新申报。本次撤回申请并非终止本项目。 三、对公司的影响及风险提示 一、药品信息 药品名称：重组质粒-肝细胞生长因子注射液 剂型：注射剂 申请事项：境内生产药品注册上市许可 注册分类：治疗用生物制品1类 申请人：光谷人福 审查结论：同意本品注册申请的撤回，终止注册程序。 二、药品研究的其他相关情况 重组质粒-肝细胞生长因子注射液（以下简称"pUDK-HGF"）适用于治疗严重下 肢缺血性疾病导致的肢体静息痛。pUDK-HGF为治疗用生物制品1类新药，目前国内 ...

Core Viewpoint - The company announced the withdrawal of its drug registration application for a new biological product aimed at treating severe lower limb ischemic diseases, indicating a proactive approach to meet regulatory and technical requirements [1] Group 1: Company Actions - The company’s subsidiary, Guanggu Renfu, received a termination notice from the National Medical Products Administration regarding its application for the recombinant plasmid-hepatocyte growth factor injection [1] - The company has decided to voluntarily withdraw the application and will improve research materials before reapplying [1] Group 2: Financial and Development Insights - The cumulative research investment for the drug development has reached approximately 160 million yuan [1] - The company expects that this withdrawal will not have a significant impact on its current financial performance [1] Group 3: Industry Context - The development cycle for pharmaceutical products is long and involves multiple stages, which introduces uncertainties [1] - The company commits to timely information disclosure in accordance with regulatory requirements [1]

Core Viewpoint - The company announced that its subsidiary, Wuhan Guanggu Renfu Biopharmaceutical Co., Ltd., has received a termination notice from the National Medical Products Administration regarding the withdrawal of its drug registration application for the recombinant plasmid-hepatocyte growth factor injection [1] Group 1 - The subsidiary has officially withdrawn its application for the recombinant plasmid-hepatocyte growth factor injection [1]

Group 1 - The core point of the announcement is that the company, Renfu Pharmaceutical Group Co., Ltd., is participating in the establishment of a private equity fund, the Ruicheng Venture Capital Fund, with a total initial investment of 250 million yuan, focusing on the high-tech industry in the health sector [2][4][5] - The company will contribute 75 million yuan, accounting for 30% of the total initial capital of the fund, and this investment constitutes a related party transaction due to the company's 32.25% ownership stake in Wuhan Ruicheng [2][4][5] - The investment has been approved by the company's general manager's office and does not require further approval from the board of directors or shareholders, as the transaction amount is below 0.5% of the company's latest audited net assets [3][33] Group 2 - The Ruicheng Venture Capital Fund aims to invest in high-tech industries within the health sector, including biomedicine and medical devices, leveraging industry resources and synergies to accelerate innovation and commercialization [4][5][22] - The fund's management structure includes a decision-making committee composed of five members, with investment decisions requiring a two-thirds majority vote [22] - The fund's management fee is set at 2% of the total capital during the investment period and 1.5% during the exit period, with specific payment schedules outlined [23][24] Group 3 - The company has a history of minimal related party transactions with Wuhan Ruicheng, amounting to 35,900 yuan in the past 12 months, which is negligible compared to its net assets [6][32] - The company emphasizes that this investment will not affect its main business operations or financial performance significantly, and it will not harm the interests of shareholders [31]

Core Points - The company, Renfu Pharmaceutical, announced that its wholly-owned subsidiary, Hubei Biopharmaceutical Industry Technology Research Institute, has received the clinical trial approval notice for HWS117 injection from the National Medical Products Administration [2] Group 1 - The approval signifies a significant step in the development of HWS117 injection, indicating potential advancements in the company's product pipeline [2] - This development may enhance the company's position in the biopharmaceutical industry, potentially leading to increased market opportunities [2]

Core Viewpoint - The company, Renfu Pharmaceutical, is establishing a new investment fund focused on the health sector, collaborating with various investment institutions to leverage their expertise and resources while ensuring stable development of its main business [1] Group 1: Investment Fund Details - Renfu Pharmaceutical, along with partners including Wuhan Ruicheng and several funds, is setting up the Wuhan Ruicheng New Drug Technology Achievement Transformation Venture Capital Fund Center (Limited Partnership) [1] - The initial capital contribution for the Ruicheng Venture Capital Fund is set at 250 million yuan, primarily targeting high-tech industries in the health sector [1] - The company will act as a limited partner, committing 75 million yuan, which represents 30% of the total initial capital contribution [1] Group 2: Ownership and Related Party Transactions - The company holds a 32.25% equity stake in Wuhan Ruicheng, which is classified as an associated party under the Shanghai Stock Exchange listing rules [1] - The joint investment constitutes a related party transaction due to the ownership structure [1]

证券代码：600079 证券简称：人福医药 公告编号：2025-124 人福医药集团股份公司 关于参与投资设立私募基金暨关联交易的公告 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。 重要内容提示： 参与投资设立私募基金的基本情况：为更好地借助专业投资机构的经验优势 及资源优势，拓宽投资渠道，在保障主营业务稳健发展的前提下，人福医药集团股份 公司（以下简称"人福医药"或"公司"）与武汉睿成创业投资管理有限公司（以下 简称"武汉睿成"）、湖北省楚天凤鸣科创天使投资基金合伙企业（有限合伙）（以下 简称"科创天使基金"）、武汉产业发展基金有限公司（以下简称"武汉产业基金"）、 武汉长江新区创新产业发展基金有限公司（以下简称"新区产业基金"）、武汉光创新 兴技术一期创业投资基金合伙企业（有限合伙）（以下简称"光创基金"）、殷弘韬、 田水共同投资设立武汉睿成新药科技成果转化创业投资基金中心（有限合伙）（以下 简称"睿成创投基金"）。睿成创投基金首期出资额为 2.5 亿元，主要投向大健康领域 的高新技术产业。 投资金额在投资基金中的占比及 ...

证券代码：600079 证券简称：人福医药 编号：临 2025-123 三、申请事项：境内生产药品注册临床试验 四、注册分类：治疗用生物制品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09月05日受理的HWS117注射液临床试验申请符合 药品注册的有关要求，同意本品开展临床试验。适应症：用于辅助生殖中的控制性卵巢 刺激，促进多卵泡发育。 辅助生殖技术（ART）是女性不孕症的有效治疗手段，促卵泡激素（FSH）在ART 中卵泡的发育和成熟过程中起着重要作用。长期以来，国内辅助生殖市场由短效FSH药 物主导，根据米内网数据统计，2024年中国短效促卵泡激素类药物销售额约为30亿元。 然而短效FSH在人体内半衰期短，为了达到临床刺激阈值需要在生殖周期连续8-12天皮 下注射给药，患者身体负担较重。 HWS117注射液作为一款新型长效FSH药物，拟通过延长FSH在体内的半衰期，满 足减少注射频率、提高治疗依从性的临床需求，截至目前该项目累计研发投入约为3,600 万元人民币。目前国内已有2个长效FSH药物（治疗用生物制品3.2类）获批上市，3个长 效FSH药物（治疗用生物制品1 ...