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美股异动 | FDA拟要求新疫苗必须做安慰剂对照测试 疫苗板块逆市走低
智通财经网· 2025-05-01 15:52
智通财经APP获悉,周四,疫苗板块逆市走低,截至发稿,葛兰素史克(GSK.US)跌超1.9%,赛诺菲 (SNY.US)跌近1%,默沙东(MRK.US)跌超1.2%,阿斯利康(AZN.US)跌1.7%,辉瑞(PFE.US)跌超1.5%, BioNTech(BNTX.US)跌超2.5%,Moderna(MRNA.US)跌超3.7%,诺瓦瓦克斯医药(NVAX.US)跌超3%。 消息面上,据多家美国媒体周三晚间援引卫生与公众服务部(HHS)消息报道,美国食品药品监督管理局 (FDA)正计划要求所有新疫苗在获批前必须进行安慰剂对照临床试验。这项新政策标志着美国疫苗审批 机制的一次重大转变。 目前对于"新疫苗"的定义仍存在不确定性。根据报道,这项政策预计不会适用于流感疫苗。HHS指出, 流感疫苗已被使用和验证超过80年,其成分每年调整以应对变异的病毒株,具有成熟的安全记录,因此 可能不在本次政策覆盖范围内。 在被问及是否会对已完成安全性研究的疫苗重新审查时,HHS的回应主要集中在新冠疫苗上,对其他类 型疫苗则未予置评。 根据外媒最早披露的消息,该新规意味着未来新疫苗在进行安全性测试并申请上市许可前,必须在临床 试验中引入 ...
疫苗市场“万马齐喑”,康希诺有望盈利上岸,但增长潜力与瓶颈都很明显丨看财报
Tai Mei Ti A P P· 2025-04-30 12:43
Core Viewpoint - 康希诺 has shown significant improvement in its financial performance, with a notable reduction in losses and a positive revenue growth trajectory, indicating a potential recovery from the impacts of the COVID-19 pandemic [2][3][4]. Financial Performance - In Q1 2025, 康希诺 reported revenue of 1.074 billion yuan, a year-on-year increase of 20.02%, while the net loss attributable to shareholders was 11.55 million yuan, down from a loss of 170 million yuan in the same period last year [2]. - The company achieved a substantial reduction in losses due to several factors, including the absence of one-time special losses from the previous year, increased market share of its meningococcal products, and additional government subsidies [2][4]. - For the full year 2024, 康希诺's revenue grew by 137.01% to 846 million yuan, with a narrowed net loss of 379 million yuan [3]. Market Position and Competitiveness - 康希诺's performance stands out in a challenging vaccine market, where most domestic vaccine manufacturers reported declines in revenue [4][3]. - The company’s meningococcal vaccine, 曼海欣, has become a key revenue driver, contributing significantly to its Q1 2025 revenue [7][10]. - Despite the overall decline in the meningococcal vaccine market, 康希诺's products have shown growth, with 曼海欣's approval and sales expected to continue expanding [9][10]. Product Pipeline and Future Prospects - 康希诺 has two approved meningococcal vaccines, with 曼海欣 being the primary revenue contributor, and is actively pursuing market expansion both domestically and internationally [6][10]. - The company is also awaiting approval for its 13-valent pneumococcal conjugate vaccine, which could further enhance its product portfolio, although competition in this segment is strong [11]. - The future growth potential of 康希诺 remains uncertain, as its current and upcoming products may not provide significant long-term growth opportunities [11].
欧林生物(688319)每日收评(04-30)
He Xun Cai Jing· 2025-04-30 08:30
Core Viewpoint - The stock of Olin Bio (688319) shows a strong overall score of 57.61, indicating a robust performance in the market [1]. Price and Cost Analysis - The current main cost is 15.98 CNY, with a 5-day average cost of 15.83 CNY, a 20-day average of 15.34 CNY, and a 60-day average of 14.15 CNY [1]. - The stock has not experienced any limit-up or limit-down events in the past year [1]. Northbound Capital Data - The holding amount is 422,200 shares, accounting for 0.1% of the circulating shares [1]. - The net purchase yesterday was 48,200 shares, with a daily increase ratio of 0.012% [1]. - The 5-day increase ratio is 0.005%, while the 20-day increase ratio is -0.028% [1]. Technical Analysis - The short-term resistance level is at 15.99 CNY, while the short-term support level is at 15.58 CNY [2]. - The mid-term resistance level is at 16.39 CNY, and the mid-term support level is at 12.79 CNY [2]. - The current short-term and mid-term trends are unclear, awaiting direction from main capital [2]. K-Line Patterns - The K-line pattern indicates a "friend attack" and a bottom reversal, suggesting potential upward movement [2]. - However, the presence of a long upper shadow indicates significant resistance at higher price levels, suggesting that upward momentum may be hindered [2]. Fund Flow Data - As of April 30, 2025, the net outflow of main capital was 1.277 million CNY, representing -3% of the total transaction amount [2]. - There was a net inflow of 1.6169 million CNY from large orders, while large orders saw a net outflow of 2.894 million CNY [2]. - Retail investors experienced a net outflow of 461,900 CNY [2]. Financial Data - The latest financial report shows an earnings per share of -0.017 CNY and an operating profit of -0.07 billion CNY [2]. - The price-to-earnings ratio is not available, but the sales gross margin is reported at 93.43% [2]. - The net profit stands at -7,041,533.34 CNY [2]. Related Industries/Concepts - The stock is associated with sectors such as bioproducts (0.60%), biovaccines (0.43%), innovative drugs (0.52%), and western development (0.47%) [2].
国家卫生健康委有关负责人就白皮书发布答记者问
news flash· 2025-04-30 07:03
国家卫生健康委有关负责人就白皮书发布答记者问 金十数据4月30日讯,问:中方如何评价美国在抗击新冠疫情过程中的表现?答:面对新冠疫情,美国 未能及时有效作出应对,导致美国成为"全球第一抗疫失败国"。美国不仅自身应对疫情不力,还以各种 方式妨碍、破坏抗疫国际合作。美国政府蓄意隐瞒本国疫情,误导了其他国家和世界卫生组织的研判。 美国政府公开表示将在疫苗供应和接种上推行"美国优先",一面超量囤积疫苗、大搞"疫苗民族主义", 一面发起"反中国疫苗计划",散布谣言恶毒攻击抹黑中国疫苗。美国有关智库批评美国在对外援助上 的"迟疑"只会让自身"在有巨大需求的时刻被看作自私的孤立主义者"。 (新华社) ...
Cell重磅发现:打疫苗就像买房,位置很重要!
生物世界· 2025-04-30 06:06
撰文丨王聪 编辑丨王多鱼 排版丨水成文 免疫接种,是将无害的病原体版本 (疫苗抗原) 引入人体,它会经过淋巴结,淋巴结就像免疫"训练营", 训练人体抵御真正的病原体。 疫苗通过诱导长寿命 浆细胞 (PC) 分泌中和抗体以及生成 记忆 B 细胞 (Bmem) ,从而预防反复感染和 疾病。长寿命浆细胞已分化到终末阶段,只能分泌靶向最初抗原的特异性和亲和力固定的抗体。相比之 下,Bmem 有可能在被膜下增殖灶 (SPF) 中迅速分化为短寿命浆细胞,或者重新进入次级生发中心 (GC) ,进一步多样化其 B 细胞受体 (BCR) ,以提高其对原始抗原的亲和力,并扩大其对抗原变体的 特异性。后者对于弱交叉反应性的记忆 B 细胞获得针对快速变异的呼吸道病原体的更高亲和力至关重要。 因此,浆细胞 (PC) 与记忆 B 细胞 (Bmem) 之间的命运抉择对于疫苗接种的效果以及有效体液免疫的 形成至关重要。 2025 年 4 月 28 日,澳大利亚 Garvan医学研究所的研究人员在 国际顶尖学术期刊 Cell 上发表了题为: Macrophages direct location-dependent recall of B c ...
粤开市场日报-20250429
Yuekai Securities· 2025-04-29 09:08
证券研究报告 | 策略点评 2025 年 04 月 29 日 投资要点 分析师:孟之绪 执业编号:S0300524080001 电话: 邮箱:mengzhixu@ykzq.com 投资策略研究 粤开市场日报-20250429 今日关注 指数涨跌情况:今日 A 股主要宽基指数涨跌各半。截止收盘,沪指跌 0.05%, 收报 3286.65 点;深证成指跌 0.05%,收报 9849.80 点;创业板指跌 0.13%, 收报 1931.94 点;科创 50 涨 0.10%,收报 1003.87 点。总体上全天个股涨多 跌少,Wind 数据显示,全市场 3556 只个股上涨,1670 只个股下跌,184 只个 股收平。沪深两市今日成交额合计 10221 亿元,较上个交易日缩量约 342 亿 元。 行业涨跌情况:今日申万一级行业涨跌各半,美容护理、机械设备、传媒、 轻工制造和基础化工行业领涨,涨幅分别为 2.60%、1.44%、1.27%、1.04%和 0.87%,公用事业、综合、石油石化、煤炭和社会服务行业领跌,跌幅分别为 1.78%、0.97%、0.55%、0.51%和 0.47%。 板块涨跌情况:今日涨幅居前概念 ...
康泰生物(300601):业绩短期承压 期待新产品放量
Xin Lang Cai Jing· 2025-04-29 02:43
Group 1: Financial Performance - In 2024, the company achieved operating revenue of 2.65 billion yuan, a year-on-year decrease of 23.7%, and a net profit attributable to shareholders of 200 million yuan, down 76.6% year-on-year [1] - For Q1 2025, the company reported operating revenue of 650 million yuan, an increase of 42.9% year-on-year, while the net profit attributable to shareholders was 20 million yuan, a decrease of 58.5% year-on-year [1] - The quarterly breakdown for 2024 shows operating revenues of 450 million yuan (Q1), 750 million yuan (Q2), 820 million yuan (Q3), and 630 million yuan (Q4), with corresponding net profits of 50 million yuan, 110 million yuan, 190 million yuan, and a loss of 150 million yuan [1] Group 2: Vaccine Production and Pipeline - The company experienced a mixed performance in vaccine batch approvals in 2024, with significant increases in several products, including a 3262.5% rise in human diploid rabies vaccine approvals, and a 49.9% increase in 13-valent pneumonia vaccine approvals [2] - The company has multiple products in the research pipeline, with progress reported on several vaccines, including the Sabin strain inactivated polio vaccine and the quadrivalent influenza virus split vaccine [2] - A collaboration agreement with AstraZeneca has been signed to establish a joint venture for the development of innovative vaccines [2] Group 3: Earnings Forecast - The expected earnings per share (EPS) for the company are projected to be 0.34 yuan in 2025, 0.43 yuan in 2026, and 0.52 yuan in 2027 [3]
生物股份(600201):业绩短期承压 持续创新厚积薄发
Xin Lang Cai Jing· 2025-04-29 02:24
Core Viewpoint - The company is experiencing short-term performance pressure due to intensified industry competition and declining product prices, but it maintains a strong focus on innovation and has a solid pipeline of new products, leading to a "buy" rating. Group 1: Financial Performance - In 2024, the company's revenue is projected to be 1.255 billion yuan, a decrease of 21.45%, with a net profit of 109 million yuan, down 61.58% due to increased competition and reduced margins [1] - For Q1 2025, revenue is expected to be 352 million yuan, an increase of 1.06%, while net profit is projected at 76 million yuan, down 27.57% [1] - The company's net profit forecasts for 2025-2027 are adjusted to 251 million, 348 million, and 448 million yuan respectively, with corresponding EPS of 0.22, 0.31, and 0.40 yuan [1] Group 2: Market Position and Product Development - The company's gross margin and net margin for 2024 are 53.86% and 8.30%, respectively, showing declines of 5.33 percentage points and 9.04 percentage points [2] - The company maintains a strong market share in key products, with a 23% market share in pig circovirus vaccines and a 40% market share in brucellosis vaccines [2] - Several major products are set to launch in 2024, expected to contribute to revenue growth in 2025, including over 30 million yuan from the ruminant mycoplasma vaccine and over 10 million yuan from the cat trivalent vaccine [2] Group 3: Research and Development - In 2024, the company invested 179 million yuan in R&D, accounting for 14.25% of its revenue [3] - The company has secured production licenses for several important vaccines, including the Rev.1 strain of the Brucella vaccine, and is developing the world's first mRNA vaccine for feline infectious peritonitis [3] - The safety and efficacy of the African swine fever subunit vaccine meet the standards set by the Ministry of Agriculture and Rural Affairs, and the company is progressing with the review process [3]
解码疫苗企业2024年业绩:深陷“价格战”泥潭,“创新”和“出海”成关键词
21世纪经济报道记者闫硕 北京报道 2024年,受行业政策调整、民众接种意愿下降、市场需求变化等多重因素影响,我国多家疫苗上市企业 业绩均呈现大幅度下滑,行业承压前行。 随着2024年年报陆续披露,在Wind疫苗指数中,2024年营业收入的均值(算数平均)为71.31亿元,而 这一数值在2023年为90.99亿元,同比降低21.63%;2024年净利润均值(算数平均)为7.87亿元,2023 年则为12.22亿元,同比降低35.60%。 财报显示,智飞生物、万泰生物、华兰疫苗等企业营业收入降幅均超50%,沃森生物、百克生物、金迪 克等企业降幅也在30%以上。不过,康希诺在其四价流脑结合疫苗曼海欣®的驱动下,同时其经营受全 球公共卫生事件的影响已经基本消除,去年营收大幅增长130%以上。 | | | | 疫苗企业2024年业绩一栏表(节选; | | 单位:亿元) | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 代理 | 简称 | 2024年曹业收入 | 2023年营业收入 | 同比变动 | 2024年归母净利演 | 2023年归母净利润 | 同 ...
HPV疫苗生态链崩塌:所有参与者都在“失血”
以下文章来源于MedTrend医趋势 ,作者更多精彩资讯 MedTrend医趋势 . 关注我们,带你洞见医疗的未来!MedTrend医趋势——专注于医疗医药、生命科学、医院领域,为您 提供及时、实用的热点资讯、市场概况、行业趋势等精彩内容,旨在建设全面、周到、专业的信息分享 与交流平台。 作者 | MedTrend医趋势 来源 | MedTrend医趋势 导语 :没有任何一个赛道能逃过中国的内卷。 默沙东应该急了。 4月24日,默沙东公布2025 Q1业绩,总体营收小幅下锉,主要原因是两大支柱产品全球药王K药和 HPV疫苗佳达修(Gardasil/Gardasil 9)都未及销售预期。 另外两个数字则惨烈得多——佳达修Q1销售额仅为13.27亿美元,同比大幅下滑41%;其中,默沙 东中国区收入同比下滑62%至6.68亿美元,在默沙东全球的业务份额降至不足5%,跌幅远超公司平 均水平。 | | 2025 | | | 2024 | | | % Change | | --- | --- | --- | --- | --- | --- | --- | --- | | | 10 | 10 | 20 | 3Q | 40 ...