Core Viewpoint - The approval of the drug Fluorobiprophenyl injection by the National Medical Products Administration marks a significant milestone for the company, enabling it to sell the product in the domestic market and enhance its product pipeline [1] Group 1: Product Approval and Market Potential - The company's subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., received the drug registration certificate for Fluorobiprophenyl injection, which is indicated for postoperative and cancer pain relief [1] - The company submitted a marketing authorization application for the drug in December 2023, which has been accepted [1] - The estimated national sales for Fluorobiprophenyl injection in 2024 are approximately 980 million yuan [1] Group 2: Research and Development Investment - The cumulative research and development investment for the drug amounts to around 35 million yuan [1] Group 3: Market and Regulatory Environment - The approval signifies the company's qualification to sell the drug in the domestic market, but future sales may be influenced by industry policies and market conditions, indicating uncertainty [1]

Group 1 - The core point of the article is that Renfu Pharmaceutical has received approval for the drug "Levonorgestrel Tablets" from the National Medical Products Administration [1] - Renfu Pharmaceutical's revenue composition for the year 2024 is as follows: 56.01% from pharmaceuticals, 43.8% from pharmaceutical wholesale and related businesses, and 0.19% from other businesses [1] - As of the report, Renfu Pharmaceutical has a market capitalization of 36.3 billion yuan [1]

证券代码：600079 证券简称：人福医药 编号：临 2025-111 人福医药集团股份公司 关于氟比洛芬酯注射液获得药品注册证书的公告 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"）控股子公司宜昌人福药业有限责任公 司（以下简称"宜昌人福"，公司持有其80%的股权）近日收到国家药品监督管理局核 准签发的氟比洛芬酯注射液的《药品注册证书》。现将批件主要内容公告如下： 一、药品名称：氟比洛芬酯注射液 二、批件号：2025S02800 氟比洛芬酯注射液作为一种以脂微球为药物载体的非甾体类镇痛剂，适用于术后及 癌症的镇痛。宜昌人福于2023年12月向国家药品监督管理局提交氟比洛芬酯注射液的上 市许可申请并获得受理，截至目前该项目累计研发投入约为人民币3,500万元。根据米内 网数据显示，2024年度氟比洛芬酯注射液全国销售额（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9.8亿元，主要厂商包括北京泰德制药股份有限公司、 远大医学营养科学（武汉）有限公司等。 五、注册分类： ...

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 ...