证券代码：300194 证券简称：福安药业 公告编号：2025-043 福安药业（集团）股份有限公司 关于公司产品纳入《国家医保药品目录》的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，不存在虚假 记载、误导性陈述或者重大遗漏。 特此公告。 福安药业（集团）股份有限公司 董事会 二〇二五年十二月八日 一、新纳入《医保目录》药品基本情况 | 药品名称 | 药品分类 | 药品分类代码 | 编号 | 适应症 | | --- | --- | --- | --- | --- | | 帕拉米韦注射液 | 神经氨酶抑制剂（乙） | XJ05AH | 805 | 用于治疗甲型或乙 | | | | | | 型流行性感冒。 | 二、对公司的影响 新版《国家医保药品目录》将于 2026 年 1 月 1 日起正式执行，药品纳入《医 保目录》将对相关产品销售有积极作用，但对公司未来业绩的影响暂无法准确估 计，药品未来销售情况受医药行业政策变动、市场环境变化等影响，具有不确定 性。敬请广大投资者谨慎决策，注意投资风险。 2025 年 12 月 7 日，国家医保局、人力资源社会保障部发布了《关于印发< 国家基本医疗保险、 ...

Group 1 - The core viewpoint of the news highlights the financial performance and trading activity of Fu'an Pharmaceutical, indicating a decrease in revenue and profit for the year 2025 [1][2] - As of December 4, Fu'an Pharmaceutical's stock price increased by 0.87%, with a trading volume of 204 million yuan, and a net financing buy of -792,800 yuan [1] - The company's financing balance reached 378 million yuan, accounting for 6.81% of its market capitalization, which is above the 60th percentile of the past year [1] Group 2 - For the period from January to September 2025, Fu'an Pharmaceutical reported a revenue of 1.315 billion yuan, a year-on-year decrease of 34.08%, and a net profit of 166 million yuan, down 44.87% year-on-year [2] - The number of shareholders for Fu'an Pharmaceutical decreased by 0.49% to 39,100, while the average circulating shares per person increased by 0.49% to 24,753 shares [2] - The company has distributed a total of 688 million yuan in dividends since its A-share listing, with 202 million yuan distributed over the past three years [2]

Core Insights - The approval of 51 drug varieties (70 specifications) through consistency evaluation reflects the growing strength of domestic pharmaceutical companies in research and development [1][23] - The first generic approvals for non-naloxone tablets and cefotolan piperazine granules indicate a competitive landscape in the pharmaceutical market, with significant sales potential for these drugs [6][13] Group 1: Non-naloxone Tablets - Non-naloxone tablets, developed by Bayer, are the first breakthrough drug for chronic kidney disease related to type 2 diabetes, with a projected global sales exceeding $500 million in 2024, marking a year-on-year growth of 89.21% [3][6] - Hunan Mingrui Pharmaceutical has secured the first generic approval for non-naloxone tablets, amidst over 30 companies that have submitted applications for generic versions [6][12] - The original patent for non-naloxone will not expire until 2028, limiting the market entry of generics unless patents are challenged [9][22] Group 2: Cefotolan Piperazine Granules - Cefotolan piperazine granules, originally developed by Meiji Seika Pharma, have been approved for domestic production, marking the first generic approval in this category [13][14] - The drug is a third-generation cephalosporin antibiotic with a strong efficacy against beta-lactamase-producing strains, and it has been in the Chinese market for nearly 10 years [13][14] - Currently, 14 companies have submitted applications for cefotolan piperazine granules, indicating a competitive market environment as more generics are expected to enter [19][21] Group 3: Market Dynamics - The rapid progress in domestic generic drug approvals is driven by early completion of consistency evaluations, allowing companies to gain market advantages [22] - The potential inclusion of non-naloxone tablets in centralized procurement by 2028 could significantly reduce treatment costs, from approximately 6 yuan to around 1 yuan [12][22] - The approval of these generics not only enhances patient access to affordable medications but also propels the domestic pharmaceutical industry towards innovation-driven, high-quality development [23]

Group 1 - The core point of the article is that Fu'an Pharmaceutical reported its number of shareholders as of November 28, totaling 39,120 households [2]

Group 1 - The core point of the article is that Fengyu Pharmaceutical has been identified as the first domestic generic manufacturer of Cefotolan Pivoxil Granules in China, apart from the original imported manufacturers [2] Group 2 - Investors inquired about the approval status of Cefotolan Pivoxil Granules on the investor interaction platform [2] - Fengyu Pharmaceutical confirmed its position as the first domestic generic manufacturer of the product [2]

Group 1 - The core point of the article is that Fujian Pharmaceutical Industry (300194.SZ) has announced that, apart from original research import manufacturers, Qingyutang is the first generic manufacturer of Cefotetan Granules in China [1]

Group 1 - The core point of the article is that Fuan Pharmaceutical (300194.SZ) has announced that, apart from original research import manufacturers, Qingyutang is the first generic manufacturer of cefotetan granules in China [1] Group 2 - Fuan Pharmaceutical made this announcement on its investor interaction platform [1] - The mention of Qingyutang as the first generic manufacturer indicates a competitive landscape in the pharmaceutical industry, particularly in the area of cefotetan granules [1] - This development may have implications for market dynamics and pricing strategies within the pharmaceutical sector in China [1]

Core Viewpoint - Fuan Pharmaceutical announced the receipt of drug registration certificates for its product, Cefotolan Pivoxil Granules, from the National Medical Products Administration, indicating compliance with registration requirements [2] Group 1 - Fuan Pharmaceutical's wholly-owned subsidiary, Fuan Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd., received registration certificates for Cefotolan Pivoxil Granules in two dosages: 50mg and 30mg [2] - The product registration numbers are National Drug Standard H20256029 and H20256028 [2] - The approval signifies that the product meets the necessary requirements for drug registration [2]

Group 1: SAIC Motor Corporation - In November, SAIC Motor's total vehicle sales reached 460,800 units, a year-on-year decrease of 3.75% [1] - New energy vehicle sales were 209,400 units, showing a year-on-year increase of 19.75% [1] - Cumulative vehicle sales from January to November reached 4,108,100 units, a year-on-year increase of 16.38% [1] - SAIC's subsidiary plans to establish a private equity fund focused on the smart electric vehicle industry with an initial subscription size of 1.09 billion yuan [1] Group 2: Top Group - Top Group is planning to issue H-shares and list on the Hong Kong Stock Exchange [2] - The company is in discussions with relevant intermediaries regarding the specifics of the H-share listing [2] Group 3: Ningbo Fuda - Ningbo Fuda's subsidiary intends to publicly sell 100% equity of its subsidiary, Hekou Yingzhou Cement Company, with an assessed value of 1.5752 million yuan [4] Group 4: Fuguang Co., Ltd. - Fuguang Co., Ltd. plans to sell a 25% stake in its associate company, Xiaotunpai, for 67.2636 million yuan [5] Group 5: Puluo Pharmaceutical - Puluo Pharmaceutical's subsidiary received a drug registration certificate for Amoxicillin and Clavulanate Potassium Tablets, used for various infections [6][7] Group 6: Fosun Pharma - Fosun Pharma's subsidiary received approval to conduct Phase I clinical trials for a dual-specific antibody injection for treating advanced solid tumors [8] Group 7: Far East Group - Far East Group's subsidiaries won contracts totaling 2.383 billion yuan in November [9] Group 8: Samsung Medical - Samsung Medical's subsidiary is expected to win a procurement project from the State Grid worth approximately 124 million yuan [10] Group 9: Changhua Group - Changhua Group received a development notification from a domestic automaker, with an expected total sales amount of approximately 732 million yuan over five years [12] Group 10: Xinbang Intelligent - Xinbang Intelligent's application for issuing shares to acquire Wuxi Yindichip Microelectronics has been accepted by the Shenzhen Stock Exchange [14] Group 11: Jinjing Development - Jinjing Development's subsidiary won a residential and commercial land bid in Tianjin for 474 million yuan [16] Group 12: Guohong Holdings - Guohong Holdings signed an investment framework agreement to develop a strategic emerging industry park in Tanzhou Town [17] Group 13: Hanma Technology - Hanma Technology reported a 149.94% year-on-year increase in truck sales in November, totaling 2,002 units [22] Group 14: Yufeng Group - Yufeng Group decided to terminate its plan to issue A-shares due to the expiration of authorization and market conditions [24] Group 15: Zhenhua Electric - Zhenhua Electric's subsidiary plans to invest up to 201 million yuan in a private equity fund focused on specific industries, including new energy [28] Group 16: Fuao Co., Ltd. - Fuao Co., Ltd. completed the transfer of 40% equity in Fuao Wan'an for 26.222 million yuan [29] Group 17: Baotailong - Baotailong plans to acquire an additional 2.83% stake in its subsidiary, totaling 15 million yuan [31] Group 18: Zhongchao Holdings - Zhongchao Holdings' subsidiaries won projects totaling 1.318 billion yuan [32] Group 19: Annie Co., Ltd. - Annie Co., Ltd. announced a potential change in control, leading to a temporary suspension of its stock [34] Group 20: Ganfeng Lithium - Ganfeng Lithium's subsidiary plans to issue $100 million in exchangeable notes [38]

Core Viewpoint - The company Fu'an Pharmaceutical (300194) has obtained invention patents related to the crystal forms and preparation methods of its psychiatric drugs Butorphanol and Midazolam, but has not yet secured patents for the related compositions [1] Group 1 - The company has responded to investor inquiries on an interactive platform regarding its patent status [1] - The patents obtained are specifically for the crystal forms and preparation methods of Butorphanol and Midazolam [1] - There is currently no patent for the related compositions of these drugs [1]