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加速引入临床急需境外新药、好药,国家药监局优先审评审批扩围
Di Yi Cai Jing· 2026-01-08 00:17
发布品种目录的方式难以适应药品研发创新及临床需求的快速变化 为了加速引进境外好药、新药,填补国内患者未满足临床需求,除了重大疾病、罕见病领域新药,对于 治疗慢性病、老年病的临床急需境外已上市药品目前也可纳入国家药监局的优先审评审批范围。接下 来,对于符合要求的境外已上市仿制药品种,还有望豁免临床试验,由药企直接提出药品上市许可申 请。 1月7日,国家药监局发布《关于进一步优化临床急需境外已上市药品审评审批有关事项的公告》(以下 简称"公告")。公告再次重申"坚持以临床价值为导向,鼓励申请人在中国开展全球同步研发、同步申 报上市",同时明确"鼓励临床急需境外已上市的原研药及仿制药在境内申报,对于符合要求的可纳入优 先审评审批范围"。 "发布品种目录的方式难以适应药品研发创新及临床需求的快速变化。因此,本公告采取灵活的工作机 制,通过企业申请、国家药监局药品审评中心审评及必要的专家评估,来适应不断变化的临床需 求。"国家药监局称。 为加快审评速度,公告还提到,药品在境外注册上市的研究数据(包括全部临床资料以及必要的药学、 非临床及其他研究资料),境外上市后临床应用情况及安全性监测报告,跨种族/地域应用的获益风险 ...
国家药监局:助力创新药“中国首发”
Xin Hua Wang· 2026-01-07 10:47
新华社北京1月7日电(记者戴小河)我国将对新机制、新靶点的创新药,在沟通交流、临床试验、 注册申报、审评审批全链条强化服务支持,助力创新药"中国首发"。 这是国家药监局局长李利在1月6日召开的全国药品监督管理工作会议上介绍的工作部署。 2025年,我国药品、医疗器械领域临床急需产品上市实现跨越式增长。国家药监局全年批准药品上 市注册申请4087件,其中创新药76个,创历史新高。境内外上市时间差进一步缩短,59件境外新药获临 时进口批准。儿童用药优先审评审批机制持续推进,全年批准儿童药138个。罕见病药品临时进口通道 持续畅通,全年批准罕见病药品48个,有效填补特殊群体用药空白。 回望整个"十四五"期间,我国医药创新的累积效应充分释放。5年间共230个创新药获批,实现大幅 增长;中药领域研发势头强劲,28个中药创新药获批;医疗器械创新生态持续完善,292个创新产品相 继获批,覆盖诊疗、康复、监护等领域。 李利表示,2026年国家药监局将精准施策,重点推进多项工作。药品领域将推动药品试验数据保护 制度落地,研究建立儿童药品、罕见病用药市场独占期制度;对新机制、新靶点创新药,在沟通交流、 临床试验、注册申报、审评审 ...
华海药业涨2.00%,成交额1.26亿元,主力资金净流入215.05万元
Xin Lang Cai Jing· 2026-01-05 02:32
资料显示,浙江华海药业股份有限公司位于浙江省台州市临海市汛桥镇汛大路88号,成立日期2001年2 月28日,上市日期2003年3月4日,公司主营业务涉及多剂型的仿制药、生物药、创新药及特色原料药的 研发、生产和销售。主营业务收入构成为:成品药销售61.86%,原料药及中间体销售36.75%,其他 0.78%,技术服务0.62%。 华海药业所属申万行业为:医药生物-化学制药-化学制剂。所属概念板块包括:仿制药、AI医药、原料 药、生物医药、创新药等。 截至9月30日,华海药业股东户数6.84万,较上期增加1.58%;人均流通股21889股,较上期增加1.23%。 2025年1月-9月,华海药业实现营业收入64.09亿元,同比减少11.57%;归母净利润3.80亿元,同比减少 63.12%。 1月5日,华海药业盘中上涨2.00%,截至10:12,报17.31元/股,成交1.26亿元,换手率0.49%,总市值 259.17亿元。 资金流向方面,主力资金净流入215.05万元,特大单买入816.72万元,占比6.49%,卖出952.02万元,占 比7.56%;大单买入2556.18万元,占比20.30%,卖出2205 ...
宣泰医药12月31日获融资买入108.38万元,融资余额1.19亿元
Xin Lang Cai Jing· 2026-01-05 01:40
Group 1 - The core viewpoint of the news is that Xuantai Pharmaceutical has experienced a decline in stock performance and financial metrics, indicating potential challenges in its business operations [1][2]. - As of December 31, Xuantai Pharmaceutical's stock fell by 0.21%, with a trading volume of 16.61 million yuan. The net financing buy was -1.30 million yuan, with a total financing and securities balance of 119 million yuan [1]. - The company’s financing balance of 119 million yuan accounts for 2.71% of its market capitalization, which is above the 90th percentile level over the past year, indicating a high level of financing activity [1]. - The company’s revenue composition includes 69.85% from product sales, 9.38% from CRO services, and smaller contributions from other services [1]. Group 2 - As of September 30, the number of shareholders for Xuantai Pharmaceutical was 7,759, a decrease of 3.25% from the previous period, while the average circulating shares per person increased by 229.25% to 58,427 shares [2]. - For the period from January to September 2025, Xuantai Pharmaceutical reported a revenue of 331 million yuan, a year-on-year decrease of 8.59%, and a net profit attributable to shareholders of 63.46 million yuan, down 31.45% year-on-year [2]. - The company has distributed a total of 85.59 million yuan in dividends since its A-share listing [3].
振东制药12月29日获融资买入888.82万元,融资余额3.51亿元
Xin Lang Cai Jing· 2025-12-30 01:25
截至9月30日,振东制药股东户数4.84万,较上期增加4.89%;人均流通股20762股,较上期减少4.66%。 2025年1月-9月,振东制药实现营业收入22.15亿元,同比减少2.42%;归母净利润2036.41万元,同比减 少49.25%。 分红方面,振东制药A股上市后累计派现33.72亿元。近三年,累计派现0.00元。 机构持仓方面,截止2025年9月30日,振东制药十大流通股东中,香港中央结算有限公司位居第二大流 通股东,持股3746.00万股,相比上期增加2948.96万股。 责任编辑:小浪快报 12月29日,振东制药跌1.18%,成交额1.01亿元。两融数据显示,当日振东制药获融资买入额888.82万 元,融资偿还854.26万元,融资净买入34.56万元。截至12月29日,振东制药融资融券余额合计3.51亿 元。 融资方面,振东制药当日融资买入888.82万元。当前融资余额3.51亿元,占流通市值的6.03%,融资余 额超过近一年70%分位水平,处于较高位。 融券方面,振东制药12月29日融券偿还0.00股,融券卖出0.00股,按当日收盘价计算,卖出金额0.00 元;融券余量400.00股,融 ...
齐鲁制药荣获2025“责任耀齐鲁”年度责任企业
Qi Lu Wan Bao· 2025-12-29 07:31
2025年12月27日下午,由山东省卫生健康委员会、山东数字文化集团指导,齐鲁晚报·齐鲁壹点主办的 2025"责任耀齐鲁"山东医疗健康年度盛典暨融媒传播分享会在济南大众传媒大厦举行。现场揭晓了2025 年度"责任医院""责任科室""责任医者""责任企业"等多项荣誉名单,齐鲁制药凭借在药品研发创新、公 益健康帮扶、行业责任践行等领域的卓越表现与坚定担当,成功斩获2025"责任耀齐鲁"年度责任企业殊 荣。 在公益健康与社会责任践行领域,齐鲁制药始终牢记企业公民使命,以实际行动回馈社会。多年来,持 续开展"健康中国 齐鲁同行"系列公益行动,组建专业团队深入基层乡村、社区、偏远地区,开展免费 健康筛查、疾病科普宣讲、药品捐赠等活动。助力提升基层诊疗服务能力,让优质医药资源惠及更多偏 远地区群众。 值得关注的是,在推动医药产业创新升级与健康事业协同发展方面,齐鲁制药于2025年实现多项重要突 破:多款创新药进入临床试验关键阶段;建成国内领先的智能化制药生产基地,通过数字化、智能化改 造提升生产效率与质量管控水平,保障药品稳定供应;同时深化与国内顶尖医疗机构、科研院校的产学 研合作,共建创新研发平台,加速科技成果转化,助 ...
Why a $34 Million Teva Stock Position Signals Confidence in a Long Repair Story
Yahoo Finance· 2025-12-27 19:23
Core Insights - Pale Fire Capital SE increased its stake in Teva (NYSE:TEVA) by 639,162 shares during the third quarter, adding approximately $16.53 million in value, bringing the total holding to nearly 1.7 million shares valued at $34.13 million as of September 30 [2][3][7] - Teva now represents 3.74% of Pale Fire Capital SE's 13F assets, with shares priced at $31.89, reflecting a 41% increase over the past year, significantly outperforming the S&P 500, which rose about 15% in the same period [4][5] Company Overview - Teva's revenue for the trailing twelve months (TTM) is $16.78 billion, with a net income of $713 million [5] - The company specializes in a broad portfolio of generic medicines, specialty pharmaceuticals, and biopharmaceutical products, focusing on various therapeutic areas including central nervous system disorders, respiratory diseases, oncology, and pain management [9][10] Market Position and Strategy - Teva operates a diversified business model that includes developing, manufacturing, and distributing pharmaceuticals globally, generating revenue from both generic and specialty drug sales [9][10] - The company has stabilized operationally, showing progress in margins and cash generation, supported by cost discipline and steady demand across its product portfolio [11] - Teva's shares are currently trading at a steep discount compared to their past highs, suggesting potential long-term investment opportunities as the company continues to execute and defend cash flows [11][12]
海西新药早盘一度涨超7% 总市值现突破110亿港元
Xin Lang Cai Jing· 2025-12-24 03:21
海西新药(02637)早盘一度涨超7%,截至发稿,股价上涨5.87%,现报140.60港元,成交额1648.03万 港元,总市值突破110亿港元。 来源:新浪港股 公开资料显示,海西新药是一家处于商业化阶段的制药公司,集研发、生产及销售能力于一体,具备在 研创新药的管线。截至招股书披露日,海西新药获批上市的仿制药产品有15款,产品组合涵盖了多个治 疗领域,包括消化系统、心血管系统、内分泌系统、神经系统等。公司亦已建立四款在研创新药的产品 管线,涵盖癌症、眼科及呼吸系统疾病。另外,其当前日均流通市值已达99.4亿港元,高于港股通门槛 要求。 ...
港股异动 | 海西新药(02637)一度涨超7% 总市值现突破110亿港元
智通财经网· 2025-12-24 03:14
智通财经APP获悉,海西新药(02637)一度涨超7%,截至发稿,涨6.1%,报140.9港元,成交额1594.55万 港元,总市值突破110亿港元。 公开资料显示,海西新药是一家处于商业化阶段的制药公司,集研发、生产及销售能力于一体,具备在 研创新药的管线。截至招股书披露日,海西新药获批上市的仿制药产品有15款,产品组合涵盖了多个治 疗领域,包括消化系统、心血管系统、内分泌系统、神经系统等。公司亦已建立四款在研创新药的产品 管线,涵盖癌症、眼科及呼吸系统疾病。另外,其当前日均流通市值已达99.4亿港元,高于港股通门槛 要求。 ...
申万宏源晨会报告-20251217
Shenwan Hongyuan Securities· 2025-12-17 01:52
Group 1: Monetary Policy and Economic Outlook - The monetary policy in 2026 will continue to align with fiscal measures, supporting debt sustainability and fiscal health [2][12] - Interest rate cuts in 2026 may remain restrained due to reduced urgency from anti-involution trends, with a higher probability of one rate cut rather than two [2][12] - The international economic struggle will have financial implications, particularly for the internationalization of the RMB amid intensified US-China competition [2][12] Group 2: Misunderstandings about "Deposit Migration" - There are three main misunderstandings regarding "deposit migration": underestimating excess savings, the speed of market entry, and the investment attributes of excess savings [3][14] - The potential scale of excess savings is estimated to exceed 9.4 trillion, indicating significant funds could enter the stock market [3][14] - The speed of funds entering the market may be underestimated due to reliance on non-bank deposit tracking, which does not accurately reflect the migration of resident funds [3][14] Group 3: Huahai Pharmaceutical (600521) Analysis - Huahai Pharmaceutical is a leading domestic producer of specialty APIs, with a strong focus on global formulation strategies [4][13] - The company has applied for over 70 domestic and international patents in the field of biopharmaceuticals, particularly in immunology and oncology [4][17] - The projected revenue for Huahai Pharmaceutical from 2025 to 2027 is expected to be 8.632 billion, 9.413 billion, and 10.282 billion respectively, with a target market value indicating a potential upside of 30.04% [4][17]