ZHIFEI-BIOL(300122)
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智飞生物(300122.SZ):带状疱疹mRNA疫苗临床试验申请获得受理
Ge Long Hui A P P· 2025-11-12 09:32
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]
智飞生物(300122.SZ):冻干水痘灭活疫苗临床试验申请获得受理
Ge Long Hui A P P· 2025-11-12 09:32
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]
智飞生物:冻干水痘灭活疫苗临床试验申请获得受理
Zhi Tong Cai Jing· 2025-11-12 09:31
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]
智飞生物:带状疱疹mRNA疫苗临床试验申请获受理
Xin Lang Cai Jing· 2025-11-12 09:24
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]
智飞生物(300122) - 关于冻干水痘灭活疫苗临床试验申请获得受理的公告
2025-11-12 09:16
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 ...
智飞生物(300122) - 关于带状疱疹mRNA疫苗临床试验申请获得受理的公告
2025-11-12 09:16
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 ...
智飞生物11月11日获融资买入1.09亿元,融资余额14.32亿元
Xin Lang Cai Jing· 2025-11-12 01:33
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].
美的集团:2025年中期A股利润分配方案10派5元;汇源通信:筹划控制权变更 股票明起停牌丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-11 13:55
分组1 - Midea Group announced a cash dividend distribution plan for the 2025 mid-term A-shares, distributing 5 yuan per 10 shares, totaling 3.448 billion yuan [1] - Huayuan Communication is planning a change in control and will suspend trading of its stock starting November 12, 2025, for up to two trading days [2] - Shangwei New Materials reported a significant stock price increase of 1573.52% from July 9 to November 11, 2025, but its new intelligent robot business is still in the development stage and has not generated revenue [3] 分组2 - Shannon Chip announced that shareholder Shenzhen Xinlianpu pledged 1.27 million shares, accounting for 5.55% of its holdings and 0.27% of the total share capital [4] - Tianji Co., Ltd. reported that its controlling shareholder pledged 39.965 million shares for its own production and operation, representing 64.79% of its holdings and 7.97% of the total share capital [5] - ST Zhengping completed its stock trading situation review and will resume trading on November 12, 2025, with no significant changes in its production and operation [6] 分组3 - Furi Co. reported that its subsidiary Furi New Energy is facing risks of losses despite a 47.78% year-on-year increase in revenue to 168.3981 million yuan for the first three quarters of 2025 [7] - Wentai Technology announced that major shareholders reduced their holdings by 12.4443 million shares, completing the reduction plan [8] 分组4 - Anke Biotech signed a framework agreement for exclusive agency of PA3-17 injection, a CAR-T cell therapy product, in Greater China [9] - Tongxing Technology plans to invest approximately 3.2 billion yuan in a project to produce 100,000 tons of sodium-ion battery cathode materials and 6 GWh of battery cells [10] - Redik plans to establish a joint venture for the development of robotic components, with a registered capital of 100 million yuan [11] 分组5 - Haike New Source signed a strategic cooperation agreement with Kunlun New Materials for the purchase of 596,200 tons of electrolyte solvent over three years [12] - World announced that its diamond micro-drill products for PCB processing are still in the R&D phase and have not generated revenue [13] 分组6 - Xiamen Airport reported a 1.56% year-on-year increase in passenger throughput for October [14] - New City Holdings reported a 7.65% year-on-year increase in total commercial operating revenue for October [15] - Huadong Holdings announced a 0.65% year-on-year decrease in pig sales revenue for October [15] 分组7 - Keykai Technology's controlling shareholder plans to transfer 3% of its shares [15] - Zhongyou Engineering won a joint bid for a project worth approximately 3 billion yuan in Kazakhstan [15] - Weiteng Electric plans to raise no more than 300 million yuan through a private placement for smart manufacturing projects [15]
美的集团:2025年中期A股利润分配方案10派5元;汇源通信:筹划控制权变更,股票明起停牌丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-11 13:53
分组1 - Midea Group announced a cash dividend distribution plan for the 2025 interim A-shares, proposing a payout of 5 yuan for every 10 shares, totaling 3.448 billion yuan [2] - Huayuan Communication is planning a change in control and will suspend trading of its stock starting November 12, 2025, for up to two trading days [3] - Shangwei New Materials reported a significant stock price increase of 1573.52% from July 9 to November 11, 2025, but its new intelligent robot business is still in the product development stage and has not yet generated revenue [4] 分组2 - Shannon Chip announced that shareholder Shenzhen Xinlianpu has pledged 1.27 million shares, accounting for 5.55% of its holdings and 0.27% of the total share capital, for financing purposes [5] - Tianji Co., Ltd. disclosed that its controlling shareholder has pledged 39.965 million shares for its own production and operation, representing 64.79% of its holdings and 7.97% of the total share capital [6] - ST Zhengping completed its stock trading situation review and will resume trading on November 12, 2025, with no significant changes in its production and operation [7] 分组3 - Furi Co., Ltd. reported that its subsidiary Furi New Energy is facing a risk of losses despite a 47.78% year-on-year increase in revenue to 168.3981 million yuan for the first three quarters of 2025 [8] - Wentai Technology announced that major shareholders have reduced their holdings by 12.4443 million shares, completing the reduction plan [9] - Anke Biotech signed a framework agreement for exclusive agency of the PA3-17 injection product in Greater China, which is a CAR-T cell therapy for certain cancers [10] 分组4 - Tongxing Technology plans to invest approximately 3.2 billion yuan in a project to produce 100,000 tons of sodium-ion battery cathode materials and 6GWh battery cells [11] - Redick is collaborating with Aoyi Technology to establish a joint venture for the development of robotic components, with a registered capital of 100 million yuan [12] - Haike New Source signed a strategic cooperation agreement with Kunlun New Materials for the purchase of 596,200 tons of electrolyte solvent over a two-year period [13] 分组5 - World announced that its diamond micro-drills for PCB processing are still in the research and testing phase, with limited revenue impact [14][15] - Huadong Holdings reported a 0.65% year-on-year decline in pig sales revenue for October [16] - Keykai Technology's controlling shareholder plans to transfer 3% of its shares through an inquiry [17]
突发!这家公司停牌核查工作已完成 股票复牌
Xin Lang Cai Jing· 2025-11-11 12:39
Company Announcements - *ST Zhengping has completed the stock suspension review and will resume trading on November 12, confirming normal production and operation without significant changes [1] - Upwind New Materials is in the product development stage for its embodied intelligent robot business, which has not yet achieved mass production or revenue generation [2] - Shannon Chip Innovation's fourth largest shareholder, Shenzhen Xinlianpu, has pledged 1.27 million shares for financing purposes [3] - Qing Shui Yuan's phosphorus trichloride products are primarily used in the production of water treatment agents [4] - Midea Group announced a cash dividend plan of 5 yuan per 10 shares, totaling 3.448 billion yuan, with the record date on November 17 [4] - Huiyuan Communication is planning a change of control, leading to a stock suspension starting November 12 [5] - Shen Gong Co. has clarified that some research reports on its performance forecasts represent only analysts' personal views [6] - World is developing diamond micro-drills for PCB processing, which are still in the R&D phase [6] - Haike New Source has signed an agreement with Kunlun New Materials for the purchase of 596,200 tons of electrolyte solvent [7] - Tongxing Technology plans to invest 3.2 billion yuan in a project to produce 100,000 tons of sodium battery cathode materials and 6 GWh battery cells [8] Investments & Contracts - Zhongjin Irradiation is investing 200 million yuan to build an electronic accelerator intelligent manufacturing project [10] - Hongri Da is collaborating with Te Du Technology and Hongke Tongchuang to establish a joint venture for semiconductor packaging [10] Shareholding Changes - Jian Kai Technology's controlling shareholder Xuanzhao plans to transfer 3% of its shares through a pricing inquiry [12] - Yue Wannianqing's shareholder Hehe Investment intends to reduce its stake by up to 3% [14] Financing & Capital Increase - Weiteng Electric plans to raise up to 300 million yuan through a private placement for various manufacturing projects [22] Other Developments - Zhifei Biological has received approval for clinical trials of a vaccine for adolescents and adults [23] - Shanghai Kaibao has obtained approval for clinical trials of a drug for acute ischemic stroke [24]