Core Points - The company announced that its subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., has received the clinical trial application acceptance notice for its shingles mRNA vaccine from the National Medical Products Administration [2] Group 1 - The shingles mRNA vaccine is developed by the company's subsidiary, indicating a focus on innovative vaccine technology [2] - The acceptance notice allows the subsidiary to conduct clinical trials within 60 days if no negative or questioning opinions are received from the drug review center [2]

Core Viewpoint - Zhifei Biological (300122) announced that its subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has received the clinical trial application acceptance notice from the National Medical Products Administration for its shingles mRNA vaccine and lyophilized varicella inactivated vaccine [1] Group 1 - The shingles mRNA vaccine and lyophilized varicella inactivated vaccine are developed by Zhifei Longkema [1] - The acceptance notice allows Zhifei Longkema to conduct clinical trials if no negative or questioning opinions are received from the drug review center within 60 days from the date of acceptance [1]

Core Viewpoint - Zhifei Biological has received a clinical trial application acceptance notice for its lyophilized varicella inactivated vaccine from the National Medical Products Administration, allowing it to proceed with clinical trials if no objections are raised within 60 days [1] Company Summary - The vaccine is developed by Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Zhifei Biological [1] - The acceptance number for the clinical trial application is CXSL2500962 [1]

Core Viewpoint - Zhifei Biological (300122.SZ) has received a clinical trial application acceptance notice from the National Medical Products Administration for its shingles mRNA vaccine developed by its wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd [1] Group 1 - The clinical trial acceptance number is CXSL2500961 [1] - The company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center [1]

Core Viewpoint - Zhifei Biological (300122.SZ) announced that its wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has received the clinical trial application acceptance notice for its lyophilized varicella inactivated vaccine from the National Medical Products Administration [1] Group 1 - The clinical trial application acceptance number is CXSL2500962 [1] - The company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center after acceptance [1]

Core Viewpoint - Zhifei Biological (300122.SZ) has received a clinical trial application acceptance notice from the National Medical Products Administration for its lyophilized varicella inactivated vaccine developed by its wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd [1] Group 1 - The clinical trial acceptance number is CXSL2500962, and the company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center [1] - The lyophilized varicella inactivated vaccine utilizes an innovative inactivation technology route, with both the production cell strains and virus strains being independently developed by the company [1] - This product demonstrates significant safety advantages and is suitable for individuals aged 12 months and older to prevent varicella, providing safer vaccination options for healthy individuals as well as those with immune deficiencies or contraindications [1]

Core Viewpoint - The company, Zhifei Biological Products, has received a clinical trial application acceptance notice for its mRNA vaccine for shingles from the National Medical Products Administration, allowing it to proceed with clinical trials if no objections are raised within 60 days [1] Group 1 - Zhifei Biological's wholly-owned subsidiary, Zhifei Longkema, is responsible for the development of the shingles mRNA vaccine [1] - The acceptance notice has the application number CXSL2500961 [1] - The company can initiate clinical trials as long as it does not receive any negative or questioning feedback from the drug review center within 60 days from the acceptance date [1]

证券代码：300122 证券简称：智飞生物 公告编号：2025-68 重庆智飞生物制品股份有限公司 关于冻干水痘灭活疫苗临床试验申请获得受理的公告 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"）研发的冻干水 痘灭活疫苗获得国家药品监督管理局药物临床试验申请受理通知书（受理号： CXSL2500962）。自受理之日起 60 日内，未收到药审中心否定或质疑意见的， 智飞龙科马可以按照提交的方案开展临床试验。 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。 二、获得受理的意义 1 智飞龙科马研发的冻干水痘灭活疫苗采用创新灭活技术路线，生产用细胞株、 毒株均为公司自主研发。本产品安全性具有显著优势，适用于 12 月龄及以上人 群预防水痘，可为正常健康人以及免疫缺陷或者有禁忌的人群接种水痘疫苗提供 更多安全选择。 截至本公告披露日，经查询国家药品监督管理局官网，国内有 8 款水痘减 ...

证券代码：300122 证券简称：智飞生物 公告编号：2025-67 重庆智飞生物制品股份有限公司 关于带状疱疹 mRNA 疫苗临床试验申请获得受理的公告 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。 二、获得受理的意义 截至本公告披露日，经查询国家药品监督管理局官网，国内有 2 款带状疱疹 疫苗获批上市使用，但暂无带状疱疹 mRNA 疫苗正式获批上市。智飞龙科马研 发的带状疱疹 mRNA 疫苗是公司自主知识产权 mRNA 技术产品，其生产效率高、 安全性好，能够有效预防带状疱疹发生。 为加强研发创新效率，降低研发风险，公司采用重组蛋白技术（创新佐剂）、 mRNA 等多条技术路径布局带状疱疹疫苗。公司将综合临床前研究数据等多重 因素，择优、择机开展在研带状疱疹疫苗项目的临床试验，深化公司前沿技术储 备，为公司长远可持续发展奠定坚实基础。 公司的带状疱疹 mRNA 疫苗临床试验申请获得受理，是公司 mRNA 技术平 台应用，聚焦创新技术、增强核心攻关的成果。若本项目进展顺利，将进一步丰 富公司成人疫苗品种，完善公司产品布局，强化公司的市场地位。 三、风险提示 ...

Core Viewpoint - Zhifei Biological experienced a slight increase in stock price, with significant fluctuations in financing and margin trading activities, indicating a mixed sentiment among investors [1][2]. Financing Summary - On November 11, Zhifei Biological had a financing buy-in amount of 109 million yuan, with a net financing buy of -1.06 million yuan, reflecting a cautious approach from investors [1]. - The total financing balance reached 14.32 billion yuan, accounting for 2.75% of the circulating market value, which is below the 30th percentile level over the past year, indicating a low financing level [1]. - Margin trading showed a high level of short selling, with 6,600 shares sold and a remaining short balance of 392.47 million yuan, exceeding the 90th percentile level over the past year [1]. Company Performance Summary - As of September 30, Zhifei Biological reported a total of 131,600 shareholders, a decrease of 3.17% from the previous period, while the average circulating shares per person increased by 3.28% to 10,750 shares [2]. - For the period from January to September 2025, the company achieved a revenue of 7.627 billion yuan, a significant year-on-year decrease of 66.53%, and a net profit attributable to shareholders of -1.206 billion yuan, a decline of 156.10% [2]. - Since its A-share listing, Zhifei Biological has distributed a total of 7.318 billion yuan in dividends, with 3.194 billion yuan distributed in the last three years [2]. Institutional Holdings Summary - As of September 30, 2025, the top ten circulating shareholders of Zhifei Biological included Hong Kong Central Clearing Limited as the third-largest shareholder, holding 33.5608 million shares, a decrease of 2.7888 million shares from the previous period [2]. - Other notable institutional shareholders, such as E Fund's various ETFs, also reported reductions in their holdings, indicating a trend of decreasing institutional interest [2].