证券代码：300122 证券简称：智飞生物 公告编号：2026-18 重庆智飞生物制品股份有限公司 一、研发项目简介 破伤风是由破伤风梭状芽孢杆菌通过皮肤或黏膜的破口侵入人体，引起的以 全身骨骼肌持续强直性收缩和阵发性痉挛为特征的急性、特异性、中毒性疾病。 重症患者可发生喉痉挛、窒息、肺部感染和器官衰竭，在无医疗干预的情况下， 病死率接近 100%，即使经过积极的综合治疗，全球范围病死率仍为 30%-50%。 破伤风由产毒的破伤风梭状芽孢杆菌引起，多散发于我国偏远及医疗卫生条件欠 发达地区和外伤处置不妥当的人群中，是一种极为严重的潜在致命性疾病。 近年来，由于我国免疫规划的推行，新生儿破伤风发病与死亡人数呈逐年下 降趋势，但非新生儿破伤风的问题始终严峻。外伤后接种破伤风疫苗可有效降低 破伤风的发病及死亡率。国家卫生健康委办公厅发布的《非新生儿破伤风诊疗规 范》指出，接种破伤风疫苗是外伤后预防的重要手段。相较于被动免疫制剂，接 种破伤风疫苗保护时间更长、过敏率更低。智飞绿竹研发的吸附破伤风疫苗用于 预防破伤风。 二、同类产品市场情况 1 智飞绿竹研制的吸附破伤风疫苗使用柱层析法纯化有效抗原，相比传统盐析 法纯化 ...

重庆智飞生物制品股份有限公司（以下简称"公司"）于近日获悉，由全资 子公司北京智飞绿竹生物制药有限公司（以下简称"智飞绿竹"）研发的吸附无 细胞百白破（组分）b 型流感嗜血杆菌（结合）联合疫苗（以下简称"组分百白 破-Hib 四联疫苗"）在广西开展Ⅰ期临床试验。 一、研发项目简介 百日咳是由百日咳杆菌引起的一种传染性极强的急性呼吸系统疾病。百日咳 在我国一年四季均可发病，春夏季发病较多，农村发病率高于城市。白喉是由白 喉杆菌所引起的一种急性呼吸道传染病，以发热，气憋，声音嘶哑，咳嗽，咽、 扁桃体及其周围组织出现白色伪膜为特征，发病无明显的季节性。破伤风通常是 致死性的感染性疾病，由产毒的破伤风梭状芽孢杆菌引起，在我国偏远及医疗卫 生条件欠发达地区破伤风的发病及死亡率依然很高。Hib 全称为 b 型流感嗜血杆 菌，是流感嗜血杆菌的一个亚型，易感人群主要是 5 岁以下的儿童，可以引起儿 童脑膜炎、肺炎、会厌炎等多种严重的感染性疾病，甚至可以导致儿童死亡。 智飞绿竹自主研发的组分百白破-Hib 四联疫苗是预防由百日咳、白喉、破 伤风以及 Hib 感染引起疾病的联合疫苗，可减少接种针次，增强预防接种的依从 性。 证券 ...

重庆智飞生物制品股份有限公司（以下简称"公司"）及全资子公司——安 徽智飞龙科马生物制药有限公司（以下简称"智飞龙科马"）、北京智飞绿竹生 物制药有限公司（以下简称"智飞绿竹"）于近日取得中华人民共和国国家知识 产权局颁发的发明专利证书。具体情况如下： | 发明专利名称 | | 专利号 | 专利证书号 | 专利类型 | 专利申请日 | 授权公告日 | 专利权人 | | --- | --- | --- | --- | --- | --- | --- | --- | | 抗 GII.6 | 型诺如 | | | | | | 智飞生物 | | 病毒抗体或其抗 | | ZL202511324531.0 | 第 8786134 | 号 发明专利 | 2025 年 09 月 | 2026 年 03 月 | 智飞绿竹 | | 原结合片段及其 | | | | | 16 日 | 20 日 | | | | | | | | | | 智飞龙科马 | | 制备方法与应用 | | | | | | | | 上述发明专利在公司自主研发过程中取得，未来将应用于相关研发项目。该 专利证书的取得不会对公司近期生产经营产生重大影响，但有利于进一步完善 ...

证券代码：300122 证券简称：智飞生物 公告编号：2026-15 重庆智飞生物制品股份有限公司 关于公司控股股东部分股份质押的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司（以下简称"公司"）近日接到公司控股股 东、实际控制人蒋仁生先生的通知，获悉蒋仁生先生将其所持有的本公司部分股 份进行了质押，具体事项如下： 一、控股股东股份质押的基本情况 1、本次股份质押基本情况 截至公告披露日，公司控股股东、实际控制人蒋仁生先生及其一致行动人所 持质押股份情况如下： | 股东名称 | 持股数量(股) | 持股 | 本次质押前质 | 本次质押后质 | 占其所 持股份 | 占公司 | | --- | --- | --- | --- | --- | --- | --- | | | | 比例 （%） | 押股份数量 (股) | 押股份数量 (股) | 比例 | 总股本 比例（%） | | | | | | | （%） | | | 蒋仁生 | 1,159,573,500 | 48.44 | 119,250,000 | 139,350,000 ...

获得临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 证券代码：300122 证券简称：智飞生物 公告编号：2026-14 重庆智飞生物制品股份有限公司 关于改良型安卡拉痘苗病毒（MVA）猴痘减毒活疫苗 智飞龙科马研发的改良型安卡拉痘苗病毒（MVA）猴痘减毒活疫苗用于预 防猴痘病毒引起的猴痘疾病。 1 3、该项目后续临床试验进度、结果及产品上市情况存在不确定性，公司将 根据研发进展情况及时履行信息披露义务。 重庆智飞生物制品股份有限公司（以下简称"公司"）于近日收到全资子公司 安徽智飞龙科马生物制药有限公司（以下简称"智飞龙科马"）报告，由智飞龙科 马自主研发的改良型安卡拉痘苗病毒（MVA）猴痘减毒活疫苗获得国家药品监 督管理局药物临床试验批准通知书（通知书编号：2026LP00685），同意本品在 18 周岁及以上人群中开展预防猴痘病毒引起的猴痘疾病的临床试验。 一、研发项目简介 猴痘是由猴痘病毒引起的一种人畜共患病，病程通常分为入侵期和皮疹期。 入侵期持续 0-5 天，特征是发烧、剧烈头痛、淋巴结肿大、背痛、肌肉酸痛和极 度虚弱，淋 ...

证券代码：300122 证券简称：智飞生物 公告编号：2026-13 重庆智飞生物制品股份有限公司 关于德谷胰岛素注射液申请生产注册获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司（以下简称"公司"）于近日获悉，由控 股子公司重庆宸安生物制药有限公司（以下简称"宸安生物"）研发的德谷胰 岛素注射液申请生产注册获得国家药品监督管理局出具的《受理通知书》（受 理号：CXSS2600034）。现将相关情况公告如下： 一、研发项目简介 1 宸安生物处于上市审评中的利拉鲁肽形成协同效应，持续丰富公司产品管线， 为患者提供更加全面的治疗选择，夯实公司"预防&治疗"一体化布局。 三、风险提示 1、药品研制是非常复杂严谨的科学活动，具有投入大，周期长，风险高的 特点，产品的研发和行政审批主要有以下几个阶段：临床前研究；申请临床试 验；进行临床试验；申请生产文号；上市销售。 2、公司德谷胰岛素注射液申请生产注册获得受理对公司近期业绩不会产生 重大影响。若注册工作进展顺利，将对公司未来经营与可持续发展产生一定积 极影响。 3、该项目申请 ...

Group 1 - Hehe Information achieved operating revenue of 1.81 billion yuan in 2025, a year-on-year increase of 25.83%, and net profit of 454 million yuan, a year-on-year increase of 13.39% [1] - Shengyi Technology announced that Guangxin Group and Chen Renxi have completed their share reduction plan, with Guangxin Group reducing its shares by 24.29 million, accounting for 1% of the total share capital [2] - Huaci Co., Ltd. received approval from the China Securities Regulatory Commission for its stock issuance to specific targets [3] Group 2 - New Nuo Wei plans to transfer 30.07% of its shares in Guoxin Huijin to Shiyao Holdings for 230 million yuan, with a valuation increase of 94.85% [4] - Tianli Lithium Energy has completed the scheduled maintenance of its lithium iron phosphate production line and resumed production [5] - Jinchuan Electric reported a net profit of 81.218 million yuan in 2025, a year-on-year decrease of 10.87% [6] Group 3 - Shenzhou Taiyue reported a net profit of 798 million yuan in 2025, a year-on-year decrease of 44.09% [7] - Jingwei Hengrun achieved a net profit of 99.5375 million yuan in 2025, reversing a loss from the previous year [8] - Keheng Technology signed a maximum pledge contract worth 450 million yuan to support its supply chain procurement [9] Group 4 - Zhongchu Media reported a net loss of 20.2858 million yuan in 2025, with operating revenue of 157 million yuan, a year-on-year decrease of 18.99% [10] - Tongde Chemical's subsidiary is involved in a lawsuit with a claim amount of approximately 49.1824 million yuan [12] - Jichuan Pharmaceutical signed an exclusive commercialization rights agreement for a new eczema treatment, with payments not exceeding 190 million yuan [13] Group 5 - Tianli Lithium Energy reported a net loss of 211 million yuan in 2025, with operating revenue of 408 million yuan, a year-on-year decrease of 20.20% [14] - Fortune Trend achieved a net profit of 315 million yuan in 2025, a year-on-year increase of 3.62% [15] - CITIC Securities received approval to publicly issue corporate bonds totaling no more than 80 billion yuan [16] Group 6 - Yongshan Lithium Industry reported a reduction of 23 million shares by Ningbo Jutai, decreasing its total shareholding from 13.24% to 4.52% [17] - Taifu Pump Industry achieved a net profit of 17.5631 million yuan in 2025, a year-on-year increase of 38.78% [18] - Longxun Co., Ltd. reported a net profit of 172 million yuan in 2025, a year-on-year increase of 19.05% [19] Group 7 - Duori Pharmaceutical's acquisition offer period has expired, and the company's stock will resume trading [20] - Tianhao Energy obtained a loan commitment letter for stock repurchase from a financial institution, with a loan amount not exceeding 90 million yuan [21] - Lijun Co., Ltd. reported a net profit of 57.545 million yuan in 2025, a year-on-year decrease of 52.09% [22] Group 8 - Zhongchumai reported a net profit of 212 million yuan in 2025, a year-on-year increase of 45.55% [23] - Kangxino reported a net profit of 27.8727 million yuan in 2025, reversing a loss from the previous year [24] - Baiao Saitu achieved a net profit of 173 million yuan in 2025, a year-on-year increase of 416.37% [25] Group 9 - Guangxun Technology's private placement application was approved by the Shenzhen Stock Exchange [26] - Sandam Membrane reported a net profit of 378 million yuan in 2025, a year-on-year increase of 19.95% [27] - Shangsheng Electronics reported a net profit of 184 million yuan in 2025, a year-on-year decrease of 21.71% [28] Group 10 - Xin'an Century reported a net profit of 79.2904 million yuan in 2025, reversing a loss from the previous year [29] - Zhenlei Technology achieved a net profit of 133 million yuan in 2025, a year-on-year increase of 582.01% [30] - Fuan Pharmaceutical's subsidiary received approval for a new drug application [32] Group 11 - Baotai reported a net loss of 336 million yuan in 2025, with operating revenue of 934 million yuan [33] - Aohua Endoscope reported a net profit of 11.4619 million yuan in 2025, a year-on-year decrease of 45.45% [34] - Maide Medical reported a net profit of 65.2599 million yuan in 2025, reversing a loss from the previous year [35] Group 12 - Chip Original Co. reported a net loss of 528 million yuan in 2025, with operating revenue of 3.152 billion yuan [36] - Zhongwei Semiconductor set a preliminary transfer price of 43.35 yuan per share for its inquiry [37] - Tieke Railway reported a net profit of 171 million yuan in 2025, a year-on-year decrease of 20.09% [38] Group 13 - Changjiang Electric announced a cash dividend distribution plan of 2.1 yuan per 10 shares for the 2025 fiscal year [39] - Kunheng Shunwei reported a net profit of 46.7676 million yuan in 2025, a year-on-year increase of 26.28% [40] - Ailis reported a net profit of 2.181 billion yuan in 2025, a year-on-year increase of 52.55% [41] Group 14 - Aerospace Software reported a net loss of 11.3126 million yuan in 2025, with operating revenue of 1.216 billion yuan [42] - Qizhong Technology reported a net profit of 266 million yuan in 2025, a year-on-year decrease of 15.16% [43] - Guotou Zhonglu plans to acquire 70% of Luochuan Lingxian Company for 74.8745 million yuan [44] Group 15 - Aokema plans to acquire 45% of its subsidiary for 253 million yuan [45] - ST Dali signed a procurement framework agreement worth 88.8794 million yuan with a leading new energy company [46] - Zhifei Biological received clinical trial approval for a new mRNA vaccine [47]

Core Viewpoint - Zhifei Biological (300122.SZ) announced that its wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its self-developed HK.3-JN.1 mRNA vaccine for the prevention of diseases caused by novel coronavirus infection [1] Group 1 - The HK.3-JN.1 mRNA vaccine is designed to prevent diseases caused by novel coronavirus infection [1] - The approval allows the company to initiate clinical trials for the vaccine [1]

Core Insights - The A-share biopharmaceutical sector in 2025 is characterized by extreme polarization, with some companies experiencing profit surges while others face significant losses, indicating a harsh competitive landscape [1][4]. Group 1: Profitability and Losses - Among 275 listed pharmaceutical companies that released performance forecasts, 138 are expected to be profitable while 137 are projected to incur losses, reflecting a near-even split [1]. - WuXi AppTec is anticipated to achieve a net profit of 19.151 billion yuan, leading the profitability rankings, followed by companies like 3SBio, Jilin Aodong, and Jiuzan Medical, each expected to exceed 2 billion yuan in net profit [2]. - In stark contrast, Zhifei Biological is projected to report a staggering loss of 10.698 billion to 13.726 billion yuan, marking its first annual loss since going public [3]. Group 2: Sector Performance Variability - The biopharmaceutical industry is witnessing a divide where companies in the pharmaceutical outsourcing sector, such as WuXi AppTec, are thriving, while those in the vaccine sector, like Zhifei Biological, are struggling significantly [5][6]. - The pharmaceutical outsourcing sector is highlighted as a major growth area, with WuXi AppTec expected to achieve a revenue of 45.456 billion yuan, a year-on-year increase of 15.84% [5]. - The vaccine sector is facing severe challenges, with multiple companies, including Wantai Biological and Baike Biological, transitioning from profit to loss, indicating the end of the vaccine industry's golden era [6]. Group 3: Growth Strategies of Profitable Companies - Successful companies are leveraging core products that meet clinical needs, with Shanghai Yizhong expecting a net profit growth of 819.42% due to a key product's inclusion in the national medical insurance [8]. - International expansion is becoming essential, with companies like Nanwei Technology and Kexing Pharmaceutical reporting significant increases in international revenue [8]. - Cost control measures are also critical, as seen with Guoyao Yizhi and Yixin Hall, which have closed underperforming stores to improve profitability [8]. Group 4: Challenges for Loss-Making Companies - The loss-making companies are primarily affected by declining product prices, with at least 30 companies citing this as a reason for their losses, exacerbated by intensified competition and the implementation of national drug procurement policies [9]. - Many small and medium-sized innovative pharmaceutical companies are struggling due to a lack of differentiated innovation, leading to a failure to secure financing and maintain operations [11]. - The current environment is not a failure of innovation but rather a failure of blind innovation, emphasizing the need for companies to focus on genuine clinical needs rather than following trends [11][12]. Group 5: Industry Dynamics and Future Outlook - The biopharmaceutical industry's polarization is seen as a necessary outcome of evolving market dynamics, where quality and differentiation in innovation are prioritized over quantity [12][13]. - The approval process for new drugs has become more stringent, with a significant drop in the approval rate for drugs that lack differentiation, indicating a shift towards valuing clinical innovation [12]. - The industry is undergoing a "purification" phase, eliminating companies that do not provide real value and supporting those that deliver true innovation [14].

Group 1 - The core point of the article is that Zhifei Biological has received approval for clinical trials of its new mRNA vaccine for COVID-19, developed by its subsidiary Anhui Zhifei Longcom Biopharmaceutical [1] Group 2 - The vaccine, named HK.3-JN.1, is aimed at preventing diseases caused by new coronavirus infections [1] - The approval was granted by the National Medical Products Administration, with the notification number 2026LP00481 [1]