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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
截至9月30日,智飞生物股东户数13.16万,较上期减少3.17%;人均流通股10750股,较上期增加 3.28%。2025年1月-9月,智飞生物实现营业收入76.27亿元,同比减少66.53%;归母净利润-12.06亿元, 同比减少156.10%。 分红方面,智飞生物A股上市后累计派现73.18亿元。近三年,累计派现31.94亿元。 机构持仓方面,截止2025年9月30日,智飞生物十大流通股东中,香港中央结算有限公司位居第三大流 通股东,持股3356.08万股,相比上期减少278.88万股。易方达创业板ETF(159915)位居第五大流通股 东,持股2415.90万股,相比上期减少405.65万股。华泰柏瑞沪深300ETF(510300)位居第六大流通股 东,持股2042.08万股,相比上期减少96.46万股。招商国证生物医药指数A(161726)位居第九大流通 股东,持股1615.47万股,相比上期减少274.48万股。易方达沪深300医药ETF(512010)位居第十大流 通股东,持股1499.56万股,相比上期减少470.11万股。 责任编辑:小浪快报 11月11日,智飞生物涨1.16%,成交额8.9 ...
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
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
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]
晚间公告|11月11日这些公告有看头
Di Yi Cai Jing· 2025-11-11 10:21
Key Points - *ST Zhengping's stock will resume trading on November 12, 2025, after a significant increase of 152.42% from September 1 to October 28, 2025, with 21 days of trading halts and 5 instances of abnormal trading fluctuations [3] - Dongfang Zhizao plans to acquire 70% of Nantong Saifu Machinery Equipment Co., Ltd. for 27.4887 million yuan, making it a subsidiary [4] - Zhifei Biology received approval for clinical trials of a combined vaccine for adolescents and adults to prevent diphtheria, tetanus, and whooping cough [5] - CITIC Securities has been approved by the CSRC to issue up to 50 billion yuan in short-term corporate bonds [6] - Bangji Technology intends to terminate a major asset restructuring involving the acquisition of several companies, stating that current operations will not be adversely affected [7] - Dekeli is planning to issue S-shares and list on the Singapore Exchange as part of its global strategy [8] - Emei Mountain A announced that Leshan State Investment will transfer 90% of its stake in Emei Mountain Leshan Buddha Tourism Group to another state-owned entity without compensation, maintaining the current control structure [9] Performance Summary - Xincheng Development reported a contract sales amount of approximately 1.419 billion yuan in October 2025, with cumulative sales of about 16.468 billion yuan from January to October [11] - Huadong Holdings sold 242,500 pigs in October 2025, with a 19.85% month-on-month increase and a 20.80% year-on-year increase [13] - Xiamen Airport's passenger throughput in October was 2.5548 million, a year-on-year increase of 1.56% [14] Shareholding Changes - Huaguang Huaneng executives plan to reduce their holdings, with the chairman and several executives intending to sell up to 171,200 shares each [16] - Hot景 Biology announced a share buyback plan of 100 million to 200 million yuan for employee stock ownership or incentives [17] - Aladdin's controlling shareholder's stake decreased from 46.27% to 44.76% due to the dissolution of a partnership [18] - JianKai Technology's controlling shareholder plans to transfer 3% of the company's shares [19] - Yuyuan Holdings intends to repurchase shares worth 200 million to 300 million yuan at a price not exceeding 8.6 yuan per share [20] Major Contracts - China Oil Engineering's subsidiary won a project in Kazakhstan worth approximately 3.003 billion yuan for the construction of ethane and propane pipelines [22] - Dash Intelligent signed a contract for an intelligent display technology park project worth 12.7652 million yuan, which will positively impact its market share in the enterprise park sector [24]
智飞生物青少年及成人组分百白破疫苗临床试验获批
Bei Jing Shang Bao· 2025-11-11 09:46
Core Viewpoint - Zhifei Biological's subsidiary has received approval for clinical trials of a new vaccine aimed at preventing infectious diseases caused by diphtheria, tetanus, and whooping cough [1] Group 1 - Zhifei Biological announced that its wholly-owned subsidiary, Beijing Zhifei Lvzhu Biological Pharmaceutical Co., Ltd., has obtained the clinical trial approval notice from the National Medical Products Administration [1] - The vaccine is an adsorbed acellular diphtheria, tetanus, and pertussis (DTPa) combined vaccine intended for adults and adolescents [1] - The clinical trials will focus on preventing infections caused by diphtheria, tetanus, and whooping cough [1]
智飞生物:子公司吸附无细胞百白破(组分)联合疫苗(成人及青少年用)临床试验获批
Xin Lang Cai Jing· 2025-11-11 09:01
Core Viewpoint - The company announced that its wholly-owned subsidiary, Beijing Zhifei Lvzhu Biological Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of an acellular combined vaccine for adults and adolescents, aimed at preventing infections caused by diphtheria, tetanus, and whooping cough [1] Group 1 - The vaccine is designed to prevent infectious diseases caused by diphtheria, tetanus, and whooping cough [1] - The approval allows the company to initiate clinical trials for the vaccine [1]