证券代码：600079 证券简称：人福医药 编号：临 2025-113 人福医药集团股份公司（以下简称"公司"）控股子公司武汉人福利康药业有限公 司（以下简称"人福利康"，公司及全资子公司持有其75.33%的股权，根据增资协议的 远期回购约定，公司持有其100%权益）收到美国食品药品监督管理局（FDA）关于奥 卡西平缓释片的暂定批准文号，现将主要情况公告如下： 药品名称：Oxcarbazepine Extended-Release Tablets （奥卡西平缓释片） 申请事项：ANDA（美国仿制药申请）。由于原研药"OXTELLAR XR"仍处在专 利保护期，此ANDA获得美国FDA暂定批准。 ANDA批件号：219673 剂型：片剂 规格：150 mg、600 mg 药品类型：处方药 人福医药集团股份公司 关于奥卡西平缓释片获得美国 FDA 暂定批准文号的公告 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。 奥卡西平缓释片用于治疗6岁及以上癫痫患者的部分性发作。人福利康于2024年向 FDA递交该ANDA申请并成功受理，截 ...

Core Viewpoint - The company, Renfu Pharmaceutical, announced that its subsidiary, Wuhan Renfu Likang Pharmaceutical Co., Ltd., received a tentative approval number from the U.S. Food and Drug Administration (FDA) for Oxcarbazepine extended-release tablets, which are used to treat partial seizures in patients aged 6 years and older [1]. Group 1 - The FDA's tentative approval indicates a significant milestone for the company in expanding its product offerings in the U.S. market [1]. - Oxcarbazepine extended-release tablets are specifically indicated for the treatment of partial seizures, highlighting the company's focus on addressing neurological conditions [1].

Core Viewpoint - The announcement indicates that Renfu Pharmaceutical's subsidiary, Renfu Likang Pharmaceutical Co., Ltd., has received a tentative approval number from the FDA for Oxcarbazepine extended-release tablets, which are intended for the treatment of partial seizures in patients aged 6 and above [1] Group 1: Product Development - Renfu Likang has invested approximately 15 million RMB in the research and development of Oxcarbazepine extended-release tablets [1] - The total sales revenue for Oxcarbazepine extended-release tablets in the U.S. market is projected to be around 216 million USD in 2024 [1] Group 2: Patent and Market Entry - Supernus currently holds the patent for Oxcarbazepine extended-release tablets, which is set to expire on April 13, 2027 [1] - Renfu Likang can only launch the product in the U.S. market after the patent expiration and the final approval from the FDA [1]

Group 1 - The company, Renfu Pharmaceutical, announced that its subsidiary, Wuhan Renfulikang Pharmaceutical Co., Ltd., received a tentative approval number from the U.S. Food and Drug Administration (FDA) for Oxcarbazepine extended-release tablets [1] - The Oxcarbazepine extended-release tablets are indicated for the treatment of partial seizures in patients aged 6 years and older [1]

Group 1 - The core point of the article is that Renfu Pharmaceutical has received a tentative approval number from the US FDA for its drug Oxycarbazepine extended-release tablets, which are intended for the treatment of partial seizures in patients aged 6 and older [2] - The company has invested approximately 15 million RMB in the research and development of this drug [2] - Several manufacturers, in addition to the original manufacturer Supernus, have received either formal or tentative approval numbers for this product [2] Group 2 - The product can only be marketed in the US after the original drug's patent expires and the FDA grants final approval [2] - The company has issued a reminder to investors to be aware of investment risks associated with this development [2]

Group 1 - The first sublingual nerve stimulation implant surgery in China was successfully completed, marking a significant advancement in the treatment of obstructive sleep apnea (OSA) [1] - The surgery was performed by a multidisciplinary team and resulted in a notable reduction in breathing pauses and improvement in sleep quality for the patient [1] - This procedure represents a new direction in clinical applications of neural interfaces, potentially driving the development of sleep medicine, wearable monitoring, and rehabilitation management industries [1] Group 2 - Haizheng Pharmaceutical signed an exclusive licensing and strategic cooperation agreement with Aixin Dawei to introduce the first-in-class small molecule prodrug AST-3424 in China [2] - The collaboration aims to enhance Haizheng's innovative drug portfolio and leverage Aixin Dawei's promising research pipeline, potentially accelerating the introduction of new cancer treatment options [2] Group 3 - Renfu Pharmaceutical's subsidiary received a drug registration certificate for "Levonorgestrel Tablets" from the National Medical Products Administration [3] - The approval is significant as it addresses the stable demand for emergency contraceptives, enhancing Renfu's product line and competitive position in the women's health medication market [3] Group 4 - Dairui Biotechnology's clinical trial application for RN3161, a GalNAc-siRNA targeting INHBE, has been accepted in Australia [4] - RN3161 aims to provide a long-term weight loss solution for overweight and obese individuals, addressing urgent treatment needs and filling a market gap left by existing GLP-1 drugs [4] Group 5 - New Element Pharmaceuticals submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor [5] - The company focuses on developing therapies for metabolic, inflammatory, and cardiovascular diseases, with a promising product pipeline that includes ABP-671 and ABP-745 [5] - The listing is expected to accelerate research and market expansion, although the industry is highly competitive and poses significant development risks [5]

Core Viewpoint - The approval of Fluorobiphenyl Ester Injection and Levonorgestrel Tablets marks significant advancements for the company in expanding its product pipeline and enhancing its market presence in the pharmaceutical industry [1][4]. Group 1: Fluorobiphenyl Ester Injection - The company’s subsidiary, Yichang Renfu Pharmaceutical, received the drug registration certificate for Fluorobiphenyl Ester Injection from the National Medical Products Administration [1]. - The injection is a non-steroidal analgesic suitable for postoperative and cancer pain management, with a cumulative R&D investment of approximately RMB 35 million [2]. - The projected national sales for Fluorobiphenyl Ester Injection in 2024 are around RMB 980 million, with major competitors including Beijing Tide Pharmaceutical and Wuhan Yanda Medical Nutrition Science [2]. - The approval allows the company to sell the product in the domestic market, which is expected to positively impact its business [2]. Group 2: Levonorgestrel Tablets - The company’s subsidiary, Wuhan Jiulong Renfu Pharmaceutical, received the drug registration certificate for Levonorgestrel Tablets from the National Medical Products Administration [4]. - Levonorgestrel Tablets are indicated for emergency contraception, with a cumulative R&D investment of approximately RMB 13.5 million [5]. - The projected national sales for Levonorgestrel Tablets in 2024 are around RMB 1.14 billion, with key competitors including China Resources Zizhu Pharmaceutical and Gedeon Richter Plc [5]. - The approval signifies the company’s eligibility to market the product domestically, which is anticipated to further enrich its product line and positively influence its financial performance [5].

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： ...