证券代码：600079 证券简称：人福医药 编号：临 2025-112 人福医药集团股份公司 关于左炔诺孕酮片获得药品注册证书的公告 十一、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，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。质量标准、说明书、标签及 生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求方可生产销售。 左炔诺孕酮片适用于女性紧急避孕。九珑人福于2024年5月向国家药品监督管理局 提交左炔诺孕酮片的上市许可申请并获得受理，截至目前累计研发投入约为人民币1,350 万元。根据米内网数据显示，2024年度左炔诺孕酮片全国销售额（统计范围包括城市公 立医院、县级公立医院、城市药店）约为人民币11.4亿元，主要厂商为华润紫竹药业有 限公司和Gedeon Richter Plc.等。 二、批件号：2025S02822 三、剂型：片剂 四、规格：1.5mg 五、注册分类：化学药品4类 六、申请事项：药品注册（境内生产） 七、药品批准文号：国药准字H20255422 八、药品批准文号有效期：至2030年09月08日 九、上市许可持有人：武汉九珑人福药业有限责任公司 ...

Core Viewpoint - The approval of the drug registration certificate for Fluorobiphenyl Injection by the National Medical Products Administration marks a significant milestone for the company, enhancing its product pipeline and enabling it to sell the drug in the domestic market [1] Company Summary - The company’s subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., holds 80% of the shares and has received the drug registration certificate for Fluorobiphenyl Injection [1] - Fluorobiphenyl Injection is a non-steroidal analgesic suitable for postoperative and cancer pain management, utilizing lipid microspheres as a drug carrier [1] - The approval is expected to have a positive impact on the company, contributing to its growth and market presence [1]

Core Viewpoint - The approval of Levonorgestrel tablets by the National Medical Products Administration marks a significant milestone for the company, enabling it to sell this emergency contraceptive in the domestic market, which is expected to positively impact its product line and overall business performance [1]. Group 1 - The company’s subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., Ltd., has received the drug registration certificate for Levonorgestrel tablets [1]. - Levonorgestrel tablets are indicated for emergency contraception in women [1]. - The approval enhances the company's product portfolio, which is anticipated to bring positive effects on its sales and market presence [1].

Core Insights - The company announced that its subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., Ltd., received the drug registration certificate for Levonorgestrel Tablets from the National Medical Products Administration [1] - Levonorgestrel Tablets are indicated for emergency contraception in women, with an estimated national sales revenue of approximately 1.14 billion yuan for the year 2024 [1] - The company invested around 13.5 million yuan in the research and development of this product, with the application submitted in May 2024 [1]

Core Viewpoint - The approval of the drug "氟比洛芬酯注射液" by the National Medical Products Administration marks a significant milestone for the company, enabling it to sell the product in the domestic market and enhancing its product pipeline [1] Company Summary - The company’s subsidiary, 宜昌人福药业有限责任公司, received the drug registration certificate for氟比洛芬酯注射液, which is indicated for postoperative and cancer pain relief [1] - The company submitted the application for marketing authorization in December 2023, with a total R&D investment of approximately 35 million yuan [1] - The projected national sales for氟比洛芬酯注射液 in 2024 are estimated to be around 980 million yuan [1] Industry Summary - The approval signifies the company's qualification to market the drug domestically, which will further enrich its product pipeline [1] - Future sales performance may be influenced by industry policies and market conditions, indicating a level of uncertainty [1]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [2] Core Insights - The biotech sector in China is experiencing stable revenue growth, with a significant reduction in net losses. In the first half of 2025, 32 Chinese biotech companies achieved revenue of 46.356 billion yuan, a year-on-year increase of 17.97%. Leading biotech firms have diversified product lines and international expansion, while some smaller companies are rapidly growing due to their core products [6][16] - There is a notable trend of Chinese innovative drug assets entering global markets, with the total amount of business development (BD) transactions reaching new records. The upfront payments and total transaction amounts for Chinese innovative drug assets have surged from 8.7/99.4 billion USD in 2020 to 49.4/561.2 billion USD in 2024. In the first half of 2025, the total transaction amount reached 63.55 billion USD, surpassing the total for 2024 and accounting for approximately 40% of global license-out transactions [7][24] - The report suggests focusing on investment opportunities in seven major innovative drug sectors over the next 6-12 months, including next-generation immuno-oncology, weight loss, and small nucleic acids, which are expected to see significant developments [9] Summary by Sections Biotech Revenue and Profitability - In the first half of 2025, the net loss of Chinese biotech companies narrowed significantly, with a total net loss of 1.755 billion yuan, a 50.34% reduction compared to the first half of 2024. Notably, companies like BeiGene turned a profit with a net income of 450 million yuan, marking its first profitable period [18][20] International Expansion of Chinese Innovative Drugs - The total amount of transactions involving multinational corporations (MNCs) purchasing Chinese assets has approached 100 billion USD from 2020 to the first half of 2025, with approximately 11 billion USD in upfront payments. Major companies like BMS, AZ, Merck, and Novartis have been particularly active in acquiring Chinese assets [8][27] Investment Recommendations - Recommended stocks include major pharmaceutical and biotech companies such as Hengrui Medicine, Innovent Biologics, and others across various sectors including traditional Chinese medicine, raw materials, medical devices, and healthcare services [10]

湖北山河律师事务所 Hubei S&H Law Firm 为出具本法律意见书，本所律师出席了本次股东会，审查了公司提 供的有关本次股东会的相关文件，听取了公司董事会就有关事项所作的 说明。本所已得到人福医药的如下保证：人福医药已向本所提供了出具 法律意见书所必需的、真实的原始书面材料、副本材料或口头证言。其 所提供的书面材料、副本材料或口头证言均是真实、准确和完整的，无 任何虚假陈述、误导或重大遗漏；所提供的所有文件、资料的签字盖章 均为真实，其副本文件或复印件与正本或原件一致。 本所对本法律意见书的出具特做如下声明： 人福医药集团股份公司 2025 年第四次临时股东会 法律意见书 （2025）山河非章第 3725 号 时间（Date）：2025 年 9 月 12 日 致：人福医药集团股份公司 根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中 华人民共和国证券法》（以下简称"《证券法》"）、《上市公司股东 会规则》（以下简称"《股东会规则》"）以及《人福医药集团股份公 司章程》（以下简称"《公司章程》"）《人福医药集团股份公司股东 会议事规则》（以下简称"《股东会议事规则》"）等内部规章制度的 有 ...

证券代码：600079 证券简称：人福医药 公告编号：2025-110 人福医药集团股份公司 2025年第四次临时股东会决议公告 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： 本次会议是否有否决议案：无 一、 会议召开和出席情况 (一) 股东会召开的时间：2025 年 9 月 12 日 (二) 股东会召开的地点：武汉市东湖高新区高新大道 666 号人福医药集团会议室 (三) 出席会议的普通股股东和恢复表决权的优先股股东及其持有股份情况： | 1、出席会议的股东和代理人人数 | 897 | | --- | --- | | 2、出席会议的股东所持有表决权的股份总数（股） | 683,863,459 | | 3、出席会议的股东所持有表决权股份数占公司有表决权股份总 | 41.898 | | 数的比例（%） | | (四) 表决方式是否符合《公司法》及《公司章程》的规定，股东会主持情况等。 本次会议由公司董事会召集，公司董事长邓伟栋先生由于工作原因未能出席本次 会议，经过半数董事推举，由董事黄晓华先生主持。本次会议采 ...

Group 1 - The core transaction of Renfu Pharmaceutical on September 11 involved a volume of 116,000 shares and a transaction amount of 2.5555 million yuan, with a transaction price of 22.03 yuan per share [2] - The closing price of Renfu Pharmaceutical on the same day was 22.03 yuan, reflecting a decrease of 2.09%, with a daily turnover rate of 3.23% and a total transaction amount of 1.092 billion yuan [2] - The net outflow of main funds for the stock was 51.1954 million yuan, and over the past five days, the stock has accumulated a rise of 1.15% with a total net outflow of 278 million yuan [2] Group 2 - The latest margin financing balance for Renfu Pharmaceutical is 765 million yuan, which has decreased by 25.6334 million yuan over the past five days, representing a decline of 3.24% [2] - The buyer's brokerage for the large transaction was Dongxing Securities Co., Ltd. Beijing Jinbao Street Securities Business Department, while the seller's brokerage was Bohai Securities Co., Ltd. Tianjin Zhongshan Road Branch [2]

Group 1 - On September 11, Renfu Pharmaceutical conducted a block trade of 116,000 shares, with a transaction amount of 2.5555 million yuan, accounting for 0.23% of the total transaction amount for the day [1] - The transaction price was 22.03 yuan, which was flat compared to the market closing price of 22.03 yuan [1][2] - The buying brokerage was Dongxing Securities, while the selling brokerage was Bohai Securities [2]