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智飞生物(300122.SZ):撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗的注册申请
Xin Lang Cai Jing· 2026-01-28 14:43
公司自主研发的四价流感病毒裂解疫苗(6月龄-35月龄人群)、流感病毒裂解疫苗(6月龄-35月龄人 群),用于预防疫苗相关型别的流感病毒引起的流行性感冒。公司于2024年9月至2024年10月分别向国 家药品监督管理局提交两款儿童型流感疫苗的注册上市申请并获得受理。两款疫苗临床试验结果显示, 全人群免疫原性数据整体优于已上市对照疫苗,达到预设研究标准,且安全性良好。鉴于流感病毒的变 异性特征及儿童群体免疫系统的特殊性,为更全面科学地评价疫苗临床使用效果,结合公司研发策略与 市场对高品质儿童疫苗的需求,经审慎评估,公司决定撤回上述药品注册申请。公司将稳步推进补充研 究,持续完善临床证据链,继续推进上市申报工作。 格隆汇1月28日丨智飞生物(300122.SZ)公布,全资子公司安徽智飞龙科马生物制药有限公司(简称"智 飞龙科马")于近日收到国家药品监督管理局核准签发的《药品注册申请终止通知书》,同意智飞龙科 马撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗的注册申请。 ...
智飞生物四价流感病毒裂解疫苗、流感病毒裂解疫苗3岁以下人群扩龄申请未获批准
Xin Lang Cai Jing· 2026-01-28 14:12
此前,智飞生物于 2024 年 9 月至 2024 年 10 月分别向国家药品监督管理局提交这两款儿童型流感疫苗 的注册上市申请并获得受理。(智通财经 李科文) 1月28日,智飞生物公告,公司全资子公司智飞龙科马于近日收到国家药品监督管理局核准签发的 《药 品注册申请终止通知书》 , 同意智飞龙科马撤回儿童型四价流感病毒裂解疫苗(6 月龄-35 月龄人群) 和流感病毒裂解疫苗(6 月龄-35 月龄人群)的注册申请。 ...
智飞生物:公司通过多项举措优化经营策略,优化商业合作与产品推广策略
Zheng Quan Ri Bao Wang· 2026-01-28 13:44
证券日报网讯1月28日,智飞生物(300122)在互动平台回答投资者提问时表示,公司通过多项举措优 化经营策略,优化商业合作与产品推广策略,加快自研产品上市节奏,控制相关风险,调整债务结构, 推动完成存量债务置换,促进公司可持续发展。公司技术平台及在研管线布局请持续关注公司的信息披 露。 ...
智飞生物撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗注册申请
Bei Jing Shang Bao· 2026-01-28 10:39
北京商报讯(记者 丁宁)1月28日晚间,智飞生物(300122)发布公告称,公司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")于近日收到国家药品监督管理局核准签发的《药品注 册申请终止通知书》,同意智飞龙科马撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗的注册申 请。 智飞生物表示,鉴于流感病毒的变异性特征及儿童群体免疫系统的特殊性,为更全面科学地评价疫苗临 床使用效果,结合公司研发策略与市场对高品质儿童疫苗的需求,经审慎评估,公司决定撤回上述药品 注册申请。公司将稳步推进补充研究,持续完善临床证据链,继续推进上市申报工作。 ...
生物制品板块1月28日跌1.98%,百普赛斯领跌,主力资金净流出12.52亿元
Group 1 - The biopharmaceutical sector experienced a decline of 1.98% on January 28, with Baipusais leading the drop [1] - The Shanghai Composite Index closed at 4151.24, up 0.27%, while the Shenzhen Component Index closed at 14342.9, up 0.09% [1] - Notable gainers in the biopharmaceutical sector included Kanghua Biological, which rose by 3.02% to a closing price of 74.70, and Liaoning Chengda, which increased by 2.55% to 12.86 [1] Group 2 - Baipusais saw a significant drop of 10.57%, closing at 58.18, with a trading volume of 57,400 shares and a transaction value of 342 million [2] - Other notable decliners included Kangla Weishi, down 6.16% to 10.97, and Jinchuan Protein, down 5.90% to 46.58 [2] - The biopharmaceutical sector experienced a net outflow of 1.252 billion in main funds, while retail investors saw a net inflow of 653 million [2] Group 3 - Rongchang Biological had a net inflow of 38 million from main funds, representing 6.49% of its total, while it faced a net outflow of 58.99 million from retail investors [3] - Liaoning Chengda also saw a net inflow of 14.86 million from main funds, but a net outflow of 15.01 million from retail investors [3] - The overall trend indicates a mixed sentiment in the biopharmaceutical sector, with main funds withdrawing while retail investors are actively buying [3]
智飞生物跌4.18% 东方财富在历史高位维持增持评级
Zhong Guo Jing Ji Wang· 2026-01-28 08:41
东方财富证券股份有限公司研究员何玮2021年4月29日发布研报《智飞生物(300122)2020年报点 评:自研代理双轮驱动 自研产品进入收获期》称,维持智飞生物"增持"评级。 (责任编辑:徐自立) 中国经济网北京1月28日讯 智飞生物(300122.SZ)今日股价下跌,截至收盘报17.86元,跌幅 4.18%。 2021年5月17日,智飞生物股价创下历史最高点231.19元。 ...
智飞生物(300122) - 关于公司撤回药品注册申请的公告
2026-01-28 08:40
证券代码:300122 证券简称:智飞生物 公告编号:2026-06 重庆智飞生物制品股份有限公司(以下简称"公司")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")于近日收到国家药品监督 管理局核准签发的《药品注册申请终止通知书》,同意智飞龙科马撤回儿童型四 价流感病毒裂解疫苗和流感病毒裂解疫苗的注册申请。现将相关情况公告如下: 一、药品基本情况 药品名称:四价流感病毒裂解疫苗(6 月龄-35 月龄人群)、流感病毒裂解 疫苗(6 月龄-35 月龄人群) 注册分类:预防用生物制品 3.3 类 受理号:CXSS2400106、CXSS2400118 通知书编号:2026L00065、2026L00064 重庆智飞生物制品股份有限公司 关于撤回药品注册申请的公告 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。 好。鉴于流感病毒的变异性特征及儿童群体免疫系统的特殊性,为更全面科学地 评价疫苗临床使用效果,结合公司研发策略与市场对高品质儿童疫苗的需求,经 审慎评估,公司决定撤回上述药品注册申请。公司将稳步推进补充研究,持续完 善临床证据链,继续推进 ...
医药生物行业周报:医药零售高质量发展政策发布,行业有望加速整合利好龙头
东方财富· 2026-01-28 00:30
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [3] Core Insights - The recent policy released by the Ministry of Commerce and eight other departments aims to promote high-quality development in the pharmaceutical retail industry, which is expected to accelerate industry consolidation and benefit leading companies [6][28] - The pharmaceutical retail sector is anticipated to see improved performance expectations due to favorable policies, with a recommendation to focus on quality pharmacy enterprises such as Yifeng Pharmacy and Dazhenglin [6][33] Market Performance - The pharmaceutical and biotechnology index decreased by 0.39% this week, outperforming the CSI 300 index by 0.23 percentage points, ranking 27th in industry performance [11] - Year-to-date, the pharmaceutical and biotechnology index has increased by 6.66%, outperforming the CSI 300 index by 5.1 percentage points, ranking 16th [11] - The best-performing sub-sector this week was pharmaceutical commerce, which rose by 4.26%, while chemical pharmaceuticals fell by 1.11% [17] Stock Performance - Among 478 pharmaceutical and biotechnology stocks, 338 stocks increased, representing 70.71% of the total [22] - The top five A-share stocks by performance this week were: *ST Changyao (+70.37%), Hualan Biological Engineering (+32.21%), Kangzhong Medical (+25.47%), Hanshang Group (+20.06%), and Wanze Shares (+19.04%) [22] - In the Hong Kong market, 116 pharmaceutical and biotechnology stocks saw 32 stocks rise, accounting for 27.59% [25] Industry News and Policies - The Ministry of Commerce and other departments released an opinion on promoting high-quality development in the pharmaceutical retail industry, proposing 18 specific measures to enhance service quality and optimize industry structure [28] - The FDA granted fast-track designation to CM336, a dual antibody developed by Kangnuo, for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia [31] Recommendations - The report suggests focusing on quality pharmacy enterprises in light of the favorable policies for the pharmaceutical retail sector [33] - It also highlights the potential for vaccine companies in response to the recent Nipah virus cases in India, recommending attention to companies like Zhifei Biological, Kangtai Biological, Watson Bio, and CanSino [34]
逾950家A股披露2025业绩预告,高增长赛道浮现!机构建议:2026年投资锁定这些方向→
Xin Lang Cai Jing· 2026-01-27 12:24
Market Overview - The A-share market exhibited a fluctuating and differentiated pattern last week, with major indices showing mixed performance and active rotation among hot sectors [1][7] - Institutions generally hold an optimistic outlook, believing the market is likely to trend upward [1][7] - As of January 25, over 950 companies have disclosed their 2025 earnings forecasts, with around 40% of these companies showing positive performance [1][7] Semiconductor Industry - The semiconductor industry, particularly companies related to artificial intelligence, data center construction, and domestic substitution, is expected to see strong earnings growth in 2025 [1][8] - Notable companies include: - Zhongwei Semiconductor expects revenue of approximately 1.122 billion yuan, a year-on-year increase of about 23%, and a net profit of 284 million yuan, up approximately 107% [8] - Juchip Technology anticipates revenue of 922 million yuan, a 41.44% increase, and a net profit of 204 million yuan, up 91.40% [2] - Baiwei Storage forecasts revenue between 10 billion to 12 billion yuan, a growth of 49.36% to 79.23%, and a net profit of 850 million to 1 billion yuan, a staggering increase of 427.19% to 520.22% [3][9] Pharmaceutical Industry - The pharmaceutical sector is experiencing a "polarized" performance, with over 60 companies disclosing earnings forecasts, about half of which are positive [1][9] - Key performers include: - Zhaoyan New Drug expects a net profit of approximately 233 million to 349 million yuan, a year-on-year increase of 214% to 371% [10] - Shanghai Yizhong anticipates a net profit of 6 million to 7 million yuan, a growth of 760.18% to 903.54% [10] - However, companies like Zhifei Biological are projected to incur significant losses, with an expected net loss of 10.7 billion to 13.7 billion yuan [10][5] Banking Sector - As of January 25, eight listed banks have released earnings reports, with all showing year-on-year growth in net profit [5][11] - Key statistics include: - China Merchants Bank's total assets surpassing 13 trillion yuan, and Industrial Bank exceeding 11 trillion yuan [11] - The highest net profit growth among these banks is from Hangzhou Bank at 12.05%, followed by Shanghai Pudong Development Bank at 10.52% [11] - The growth drivers for banks include improved cost of liabilities and rapid growth in intermediary business income, with Ningbo Bank's net income from fees and commissions increasing by 30.72% [12]
武汉病毒所发现尼帕有效药物!生物疫苗回调,沃森生物、智飞生物跌超6%!生物医药ETF汇添富(159839)收跌超2%,再获超5400万份净申购!
Sou Hu Cai Jing· 2026-01-27 09:32
Group 1 - The core viewpoint of the news highlights a recent pullback in the biopharmaceutical sector, with the Huatai-PineBridge Biopharmaceutical ETF (159839) declining by 2.08% while maintaining high trading volume, with nearly 600 million yuan in transactions for the day [1][4] - The ETF has seen continuous inflows, with a net subscription of over 54 million shares today and a total of over 73 million yuan in the last 10 days [1] - The ETF tracks the Guozheng Biopharmaceutical Index, which includes sectors such as CXO, vaccines, chemical drugs, blood products, and medical aesthetics, with the vaccine sector currently accounting for 15.1% of the index [6] Group 2 - A significant research breakthrough was reported by the Wuhan Institute of Virology, confirming that the oral nucleoside drug VV116 shows significant antiviral activity against the Nipah virus, providing new hope for the prevention and treatment of this high-mortality emerging infectious disease [3] - The biopharmaceutical ETF's major component stocks mostly experienced declines, with Watson Bio and Zhi Fei Bio dropping over 6%, while Sanofi Biopharma saw an increase of over 10% [4][5] - The latest performance forecast from Sanofi Biopharma indicates an expected net profit of approximately 2.9 billion yuan for 2025, representing a year-on-year growth of 311.35% [4] Group 3 - Data from Guoxin Securities indicates a decrease in pharmaceutical holdings among funds, with the overall pharmaceutical holding ratio at 7.97%, down by 1.71 percentage points from the previous quarter [7] - The largest sub-sector in pharmaceutical holdings is chemical preparations and other biological products, while the internet pharmacy and other biological products saw the most significant decline in holdings [9] - The JPM 2026 conference highlighted the acceleration of internationalization among Chinese pharmaceutical companies, with significant technological breakthroughs in areas such as ADC and GLP-1, leading to increased global competitiveness [10][11]