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大批中成药将退出市场
21世纪经济报道· 2026-01-27 09:37
记者丨 唐唯珂 编辑丨季媛媛 中成药淘汰赛序幕拉开!大批中成药将退出市场。 距离2026年7月1日仅剩半年时间,国家药监局《中药注册管理专门规定》第七十五条的 落地进入最后窗口期。 这一被业内称为中成药"生死条款"的规定明确,自2023年7月1日施行满三年起,说明书 【禁忌】【不良反应】【注意事项】任意一项仍标注"尚不明确"的中成药,再注册申请 将依法不予通过。这意味着,国内现存约5 . 7万个中成药有效批准文号中,超7 0%存在安 全信息标注问题的批文将面临淘汰,一场由监管驱动的中药产业深度出清正式进入攻坚 阶段。 此次监管新政的核心,是彻底终结中成药说明书长期以来的"尚不明确"时代,倒逼药品 持有人补齐上市后安全数据短板。 中国食品药品监管杂志此前研究显示,2018年版《国家基本药物目录》中2 6 8个中成药品 种的465份说明书里,不良反应、禁忌、药物相互作用的标注率仅为2 0 . 6 4%、3 0 . 1%和 1 . 0 7% , 大 量 品 种 依 靠 模 糊 表 述 完 成 上 市 后 的 市 场 流 通 。 而 随 着 再 注 册 大 考 临 近 , 这 种"模糊免责"的模式已彻底失去生存空间。 ...
中成药再注册大考进入半年倒计时
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-27 09:01
21世纪经济报道记者唐唯珂 距离2026年7月1日仅剩半年时间,国家药监局《中药注册管理专门规定》第七十五条的落地进入最后窗 口期。 这一被业内称为中成药"生死条款"的规定明确,自2023年7月1日施行满三年起,说明书【禁忌】【不良 反应】【注意事项】任意一项仍标注"尚不明确"的中成药,再注册申请将依法不予通过。这意味着,国 内现存约5.7万个中成药有效批准文号中,超70%存在安全信息标注问题的批文将面临淘汰,一场由监 管驱动的中药产业深度出清正式进入攻坚阶段。 此次监管新政的核心,是彻底终结中成药说明书长期以来的"尚不明确"时代,倒逼药品持有人补齐上市 后安全数据短板。 中国食品药品监管杂志此前研究显示,2018年版《国家基本药物目录》中268个中成药品种的465份说明 书里,不良反应、禁忌、药物相互作用的标注率仅为20.64%、30.1%和1.07%,大量品种依靠模糊表述 完成上市后的市场流通。而随着再注册大考临近,这种"模糊免责"的模式已彻底失去生存空间。 国家药监局的监管动作已提前落地,2025年全年发布多批中成药说明书修订公告,活力苏口服液、固肾 生发丸、小活络制剂等多款常用品种均被要求补充三大核心 ...
片仔癀连跌8日,盘中跌近1%,至2020年6月以来新低!中药ETF(560080)跌近2%,最新单日吸金近4000万元!众生药业业绩扭亏为盈
Sou Hu Cai Jing· 2026-01-27 06:36
Core Viewpoint - The A-share pharmaceutical sector has gained renewed investor interest due to the resurgence of COVID-19 cases in India, leading to fluctuations in the Chinese medicine ETF (560080) and notable stock performance among key companies in the sector [1][6]. Group 1: Market Performance - The Chinese medicine ETF (560080) experienced a nearly 2% decline on January 27, following a more than 1.4% increase the previous day, with trading volume surpassing 85 million yuan [1]. - Notable declines were observed in key stocks within the ETF, including Zhongsheng Pharmaceutical down over 7% and Yiling Pharmaceutical down over 5%, with several others also experiencing declines [3]. Group 2: Valuation Insights - The latest price-to-earnings ratio (PE TTM) for the index tracked by the Chinese medicine ETF (560080) is 24.57, indicating that the valuation is below 81.27% of the time since the index was published in May 2015, suggesting a favorable valuation opportunity [4]. Group 3: Company News - Zhongsheng Pharmaceutical announced a projected net profit of 260 million to 310 million yuan for 2025, marking a significant turnaround with an increase of 186.91% to 203.62% year-on-year [7]. - Yiling Pharmaceutical also forecasted a net profit of 1.2 billion to 1.3 billion yuan for 2025, indicating a key operational turning point [7]. - Kangyuan Pharmaceutical received approval for clinical trials of a new traditional Chinese medicine aimed at treating children's adenoid hypertrophy, marking a step forward in innovation [7]. Group 4: Industry Trends - The Chinese traditional medicine market is projected to exceed 700 billion yuan in 2024, driven by stable demand amid an aging population, although pricing volatility has been influenced by inventory adjustments and procurement policies [8]. - The industry is experiencing a consolidation trend, with leading companies capturing over half of the market revenue and profits, while ongoing policy focus on innovation and quality development is reshaping the competitive landscape [8].
国信证券医药生物业2026年投资策略:关注创新出海 重视新技术方向
智通财经网· 2026-01-27 02:48
Group 1 - The core viewpoint is that innovative drugs are expected to show significant excess returns in 2025, driven by continuous BD overseas expansion, excellent clinical data, and policy support [1] - The CXO sector is anticipated to experience substantial growth due to the recovery in demand and improved investment environment in the global pharmaceutical industry [1] - The report emphasizes the importance of focusing on new technologies, particularly bispecific antibodies, small nucleic acid drugs, AI healthcare, and brain-computer interface innovations [3] Group 2 - Domestic supply and demand are relatively stable, with national health expenditure showing a year-on-year growth of 4.7% from January to November 2025, marking a positive turnaround after two years of decline [2] - The medical insurance fund's income and expenditure growth rates continue to decline, with total income of 2.63 trillion yuan (+2.9%) and expenditure of 2.11 trillion yuan (+0.5%) from January to November [2] - The report suggests that the commercialization of new drug forms is entering a critical phase, with significant clinical data supporting the application of B-cell depletion therapies in autoimmune diseases [3] Group 3 - Investment recommendations include focusing on innovative overseas expansion and new technology directions, with suggested stocks such as Mindray Medical, WuXi AppTec, and others [4] - The report highlights the potential for explosive growth in the global market for brain-computer interfaces, supported by policy incentives and technological breakthroughs [3]
政策助力中医药产业高质量发展,产品创新有望加快推进
Xuan Gu Bao· 2026-01-26 14:37
目前全国2199个县市,包括一些市辖区,共建有3099个紧密型县域医共体。超过40%的县级中医医院牵 头组建了县域医共体。此前,国务院办公厅发布《关于提升中药质量促进中医药产业高质量发展的意 见》,提出在遵循中医药的规律和特点上,利用循证医学等手段,积极促进人用经验向临床证据转化, 并鼓励开展已上市中成药评价研究,提升临床价值证据等级。 1月26日,国家卫健委召开新闻发布会,介绍推广三明医改经验,促进中医药传承创新发展有关情况。 会上,国家中医药局医政司司长孟庆彬介绍,近年来,国家出台一系列政策措施,加快推进县级中医院 高质量发展,同时也鼓励有条件的县级中医医院牵头组建县域医共体,带动提升县域中医药服务能力。 公司方面,据上证报表示, 陇神戎发:公司主要业务为医药产品,医疗产品,保健卫生产品的研究开发;中成药,保健食品,原料 药,少量医药中间体,化学药品的生产和销售。 *免责声明:文章内容仅供参考,不构成投资建议 上证报援引研究机构观点称,强化中药产业链协同,优化产业结构布局,头部企业外延并购节奏有望加 快。在保证质量和临床疗效的基础上,中药新药评审加快,有望推动更多优质中药创新产品快速上市。 *风险提示:股 ...
发展万亩丹参等中药材种植,潍坊临朐寺头镇构建特色中药材基因库
Qi Lu Wan Bao· 2026-01-26 11:02
齐鲁晚报·齐鲁壹点 王佳潼 通讯员 赵永德 李春臻 从山间一株平凡草药,到标准化商品,再到承载非遗底蕴的产品,从农民肩挑背扛的零星售卖,到合作 社规模化的订单农业,再到直播间里面向全国的生动推介,寺头镇的中草药产业,完成了一场从"泥 土"到"云端",从"产品"到文化的华丽蝶变。 晨光熹微,寺头镇淘宝村的直播间里已氤氲起药香。女主播手持一袋色泽红艳的丹参片,声音清 亮:"我们寺头的丹参,以丹参酮含量高而闻名全国。它色红如丹,质密油润,入口甘醇......",镜头前 丹参片、黄芪片、山楂片、红枣片、桑葚干等保健茶饮铺陈开来,宛如色彩斑斓的草本画卷。她一边将 暗红的丹参片、金黄的黄芪片、鲜红的山楂片放在一起,一边娓娓道来:"黄芪、山楂跟丹参搭配,就 是著名的三通茶,有通淤、通气、通管道之功效……"主播继续口吐莲花,双手不断地调换药材,或化 浊降脂、或补肾益智,或助眠安神、或补血养颜的茶饮组方不断变换。屏幕另一端天南地北的订单纷至 沓来,寺头的山野精灵正凭借一根网线、一方屏幕构建的商路,化作千家万户茶盏里最熨帖的守护。 这片土地与中草药的缘分,深植于农耕文明的年轮里。曾几何时,药香只在山间寂寞飘散。药农们依着 祖辈的 ...
印度暴发尼帕病毒疫情,医疗创新ETF(516820)持续获资金关注
Xin Lang Cai Jing· 2026-01-26 05:43
截至2026年1月26日 13:16,中证医药及医疗器械创新指数(931484)成分股方面涨跌互现,华兰生物领涨 5.00%,英科医疗上涨2.54%,华润三九上涨1.16%;南微医学领跌。医疗创新ETF(516820)下跌最新报 价0.37元。 生物医药概念午后快速拉升,消息面上,1月下旬,印度西孟加拉邦突发尼帕病毒疫情,已造成多名医 护人员感染,泰国、尼泊尔紧急升级防控。 数据显示,截至2025年12月31日,中证医药及医疗器械创新指数(931484)前十大权重股分别为药明康 德、恒瑞医药、迈瑞医疗、爱尔眼科、片仔癀、新和成、华东医药、康龙化成、艾力斯、甘李药业,前 十大权重股合计占比63.75%。 从资金净流入方面来看,医疗创新ETF近6天获得连续资金净流入,最高单日获得4053.70万元净流入, 合计"吸金"8499.86万元,日均净流入达1416.64万元。(数据来源:Wind) 风险提示:基金有风险,投资需谨慎。基金管理人承诺以诚实信用、勤勉尽责的原则管理和运用基金资 产,但不保证本基金一定盈利,也不保证最低收益。基金管理人提醒投资人基金投资的"买者自负"原 则,在做出投资决策后,基金运营状况与基金 ...
湖南方盛制药股份有限公司 关于洛索洛芬钠凝胶贴膏获得《药品注册证书》的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-01-25 23:17
Core Viewpoint - The company has received approval for the production of Loxoprofen Sodium Gel Patch, which is expected to enhance its product line in orthopedic medications and improve its competitive position in the market [1][3]. Group 1: Drug Registration and Details - The company's subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has obtained the Drug Registration Certificate for Loxoprofen Sodium Gel Patch from the National Medical Products Administration [1]. - Loxoprofen Sodium Gel Patch is indicated for the treatment of osteoarthritis, muscle pain, and swelling pain after injuries, with significant anti-inflammatory and analgesic effects [1]. - The total investment in this drug project, including research and development, has reached 7.0366 million yuan (approximately 1.01 million USD) as of the announcement date [1]. Group 2: Market Situation of Similar Drugs - A total of 15 companies in China have obtained drug registration certificates for Loxoprofen Sodium Gel Patch, including listed companies such as Jiutian Pharmaceutical, Darentang, and China Resources Sanjiu [2]. - According to Moen Pharmaceutical data, the total sales of Loxoprofen Sodium Gel Patch in hospitals for the first three quarters of 2025 reached 1.349 billion yuan (approximately 190 million USD), with retail sales in physical pharmacies amounting to 142 million yuan (approximately 20 million USD) in the first half of 2025 [2]. - Projected sales for 2024 are expected to be 1.709 billion yuan (approximately 240 million USD) in hospitals and 280 million yuan (approximately 40 million USD) in retail pharmacies [2]. Group 3: Impact on the Company - The approval of Loxoprofen Sodium Gel Patch will enrich the company's product line for orthopedic diseases, which already includes products like Xuanqi Jianguo Tablets and Tenghuang Jianguo Tablets [3]. - This new product is anticipated to enhance the company's competitiveness in the orthopedic medication market and improve overall profitability [3]. - The company emphasizes the importance of drug research and development while maintaining strict quality control in the manufacturing and sales processes [3].
湖南方盛制药股份有限公司关于洛索洛芬钠凝胶贴膏获得《药品注册证书》的公告
Shang Hai Zheng Quan Bao· 2026-01-25 19:08
Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Loxoprofen Sodium Gel Patch, allowing for production and sales, which enhances its product line in orthopedic medications and competitive position in the market [1][4]. Group 1: Drug Registration and Details - The Drug Registration Certificate for Loxoprofen Sodium Gel Patch was approved by the National Medical Products Administration on January 23, 2026 [1]. - Loxoprofen Sodium Gel Patch is indicated for osteoarthritis, muscle pain, and swelling pain after injuries, with significant anti-inflammatory and analgesic effects [1]. - The active ingredient, Loxoprofen Sodium, is a non-steroidal anti-inflammatory drug (NSAID) that works by inhibiting prostaglandin synthesis [1]. Group 2: Market Situation - As of the announcement date, 15 companies in China have obtained the Drug Registration Certificate for Loxoprofen Sodium Gel Patch, including listed companies such as Jiutian Pharmaceutical, Darentang, and China Resources Sanjiu [3]. - According to Moen Pharmaceutical data, the total hospital sales of Loxoprofen Sodium Gel Patch reached 1.349 billion yuan in the first three quarters of 2025, with retail sales in physical pharmacies amounting to 142 million yuan in the first half of 2025 [3]. Group 3: Impact on the Company - The approval of Loxoprofen Sodium Gel Patch enriches the company's product line for orthopedic diseases and enhances its competitiveness in the market, potentially improving overall profitability [4]. - The company has invested a total of 7.0366 million yuan in the drug project, including research and development and technology transfer [2]. - The company emphasizes the importance of drug research and development, maintaining strict quality control in the drug development, manufacturing, and sales processes [4].
方盛制药:子公司洛索洛芬钠凝胶贴膏获得药品注册证书
Xin Lang Cai Jing· 2026-01-25 08:14
方盛制药1月25日公告,2026年1月23日,公司全资子公司广东方盛健盟药业有限公司收到国家药品监督 管理局核准签发的《药品注册证书》,洛索洛芬钠凝胶贴膏已获得药品批准文号并可进行生产。截至本 公告日,国内共有15家企业取得了洛索洛芬钠凝胶贴膏的药品注册证书,其中上市公司为九典制药 (300705)、达仁堂(600329)、华润三九(000999),其他厂家属于非上市公司。 ...