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多起死亡事件后,一批中药注射液或被淘汰
Jing Ji Guan Cha Bao· 2025-10-19 06:44
Core Viewpoint - The recent announcement by the National Medical Products Administration, National Health Commission, and National Administration of Traditional Chinese Medicine regarding the post-marketing research and evaluation of traditional Chinese medicine (TCM) injections marks the strictest regulatory measures in history, aiming to enhance the safety and efficacy of these products for patients [1][2][3]. Group 1: Regulatory Changes - The new policy mandates that all TCM injections approved before the 2019 revision of the Drug Administration Law must undergo post-marketing research, which includes proactive evaluations, mandatory assessments, and legal eliminations of certain products [1][2]. - The policy's implementation is a response to the frequent severe adverse reactions associated with TCM injections, which have raised public concerns about their safety [3][12]. Group 2: Market Impact - The market for TCM injections was over 100 billion in public medical institutions in 2016, but has since halved due to regulatory and reimbursement policies [7][11]. - The new regulations may lead to a significant reshaping of the TCM injection industry, potentially eliminating low-quality products and companies that cannot meet the new standards [13]. Group 3: Safety Concerns - Adverse reactions from TCM injections account for 12% of all reported adverse reactions, with a quarter of these stemming from injections, highlighting the serious risks involved [2]. - The complexity of TCM injection components and their direct intravenous administration increase the likelihood of severe allergic reactions compared to oral TCM [2][6]. Group 4: Research and Evaluation Challenges - Companies face challenges in conducting post-marketing research due to high costs and unclear guidelines for evaluating efficacy, which complicates the process of proving the effectiveness of TCM injections [7][8][11]. - The evaluation process will require a clear understanding of adverse reactions and their causes, as well as the establishment of quality management throughout the production process [12][13]. Group 5: Historical Context - The call for re-evaluation of TCM injections has been ongoing for nearly two decades, with previous attempts failing due to various industry challenges [11][12]. - The establishment of an expert working group in December 2023 signifies a renewed commitment to addressing the safety and efficacy of TCM injections [12].
多起死亡事件后,一批中药注射液或被淘汰
经济观察报· 2025-10-19 06:41
作者: 张铃 封图:图虫创意 传统中药多为口服,消化系统代谢能显著降低毒性,而中药注 射液成分复杂,直接注入静脉,易引发过敏性休克等严重速发 型过敏反应。近几年,张铭就耳闻目睹了多起与中药注射液相 关的严重不良反应/事件,其中包括一些引发过较大舆情的案 例。 "让中药注射液做更充分的安全性和有效性研究,对患者是件大好事。"10月16日,看到有关部门近日发布 的一份征求意见稿后,华中地区某三甲医院主任医师张铭忍不住叫好。 10月9日,国家药监局、国家卫健委与国家中医药局联合发布了《关于进一步推进药品上市许可持有人加 快开展中药注射剂上市后研究和评价工作的公告(征求意见稿)》。这份意见稿要求在《中华人民共和国 药品管理法》(2019年修订)实施前上市的中药注射液都需要进行上市后研究——主动评价一批、责令评 价一批、依法淘汰一批。这是史上最严的中药注射液监管措施。 中药注射液是特殊历史时期的产物,第一支中药注射液诞生于1941年,属于抗战时期的应急药品。此后几 十年,中药注射液行业野蛮生长,目前,有超过130种中药注射液品种,其中包括多款年销售额超10亿元 的重磅品种。这些注射液覆盖心脑血管病、肿瘤、感染疾病等多种 ...
中药注射剂迎来“大淘汰”时代
Xin Lang Cai Jing· 2025-10-14 08:24
智通财经记者 | 黄华 智通财经编辑 | 谢欣 10月9日,据国家药监局官网,中药注射剂上市后研究评价工作将进一步加快开展。 国家药监局现已起草《国家药监局 国家卫生健康委 国家中医药局关于进一步推进药品上市许可持有人加快开展中药注射剂上市后研究和评价工作的公告 (征求意见稿)》(下称"《加快中药注射剂上市后研究(征求意见稿)》"),并向社会公开征求意见。 通俗理解这一通知便是,国家药监局、国家卫健委、国家中医药局一起向中药注射剂的厂商喊话,要求其进一步开展上市后研究和评价工作。 中药注射剂在中国医药行业内充满争议,它诞生于缺医少药的特殊历史时期,上市之初的药品审评环境远不如现在。随后,产业经历了几十年的发展,产品 的商业销售规模远在百亿元人民币之上。 但在临床方面,注射中药注射剂之后的死亡案例至今仍在发生。而如果翻阅近十年的《国家药品不良反应监测年度报告》,中药注射剂在每一年的报告中均 有提及。在新产业背景下,加速对中药注射剂开展的上市后研究和评价工作,可视为一次淘汰与洗牌。 药品监管升级 早在今年10月官宣加快中药注射剂上市后研究评价工作之前,包括国家药监局在内的监管机构早已做了一系列准备工作。 其中,智 ...
上海凯宝股价小幅下跌 实控人一致行动人减持992万股
Jin Rong Jie· 2025-07-31 17:10
Company Overview - Shanghai Kaibao's stock price is reported at 6.80 yuan, down 0.87% from the previous trading day, with a trading range of 6.77 to 6.93 yuan and a total transaction amount of 354 million yuan [1] - The company specializes in the research, production, and sales of traditional Chinese medicine, with key products including Tan Re Qing injection [1] Shareholder Activity - The controlling shareholder's concerted action partner, Xinxiang Kaiyi Trading Co., Ltd., reduced its stake in the company by 9.92 million shares between July 24 and July 30, accounting for 0.9485% of the total share capital [1] Financial Performance - In the first quarter of 2025, the company achieved an operating income of 401 million yuan and a net profit of 84.29 million yuan [1] Market Activity - On July 31, the main funds experienced a net outflow of 31.2036 million yuan [2]
一只蚊子引发的投资风暴!从驱蚊液到RNA检测,疫情催生4大掘金赛道
Sou Hu Cai Jing· 2025-07-25 01:00
Core Viewpoint - The outbreak of Chikungunya fever in Shunde has led to a significant increase in confirmed cases, prompting a global alert and creating four major investment opportunities in related industries [1]. Group 1: Diagnostic Testing Companies (Short-term beneficiaries) - Da An Gene (002030) and Wanfu Biology (300482) are positioned to benefit from the surge in demand for diagnostic testing [3]. - Rundu Biotech (688193) is the only listed company in China focusing on RNA virus diagnostics, with a significant increase in orders expected due to the urgent need for Chikungunya virus nucleic acid testing kits [5]. - The government procurement demand for Rundu Biotech's products is clear, with a 200% increase in orders expected by July 2025 [5]. Group 2: Mosquito Control Companies (Interrupting transmission chain) - The leading mosquito repellent company in A-shares has a market share of 16.2% in electric mosquito repellent liquid, with a notable 80% increase in sales through Douyin [3]. - The company has a significant market share of over 60% for its mosquito repellent products, with plans to launch portable products in 2024 [4]. - Noposion (002215) has a high efficacy insecticide with over 90% knockdown rate against Aedes mosquitoes, winning a government project worth 30 million yuan in Foshan [6][7]. Group 3: Therapeutic Drug Companies (Symptom relief) - Tan Re Qing injection has been recommended in the Dengue fever treatment guidelines, potentially extending its use to Chikungunya fever treatment [8]. - Yiling Pharmaceutical (002603) has received approval for Lianhua Qingwen capsules as an auxiliary treatment for mosquito-borne diseases in Southeast Asia, with growing international demand [10]. Group 4: Vaccine Development Companies (Long-term layout) - Companies are collaborating with international pharmaceutical firms to develop vector-borne virus vaccines, with preclinical research for Chikungunya vaccine expected to start in 2025 [12]. - Watson Bio (300142) has an mRNA technology platform that is compatible with vector-borne vaccine development, indicating a strong potential for future vaccine projects [13].
患者输液两小时后离世,专家:中药注射液风控仍有短板
Core Viewpoint - The safety concerns surrounding traditional Chinese medicine (TCM) injection solutions, particularly the case of a patient who died after receiving a Schisandra injection, have reignited discussions about the risks associated with these products and the need for improved regulatory oversight [1][3][11]. Industry Overview - The market for TCM injection solutions has seen a significant decline, with total market size dropping from 831.3 billion in 2015 to 479.8 billion in 2023, a nearly 50% reduction [7]. - Major companies in the sector, such as ST Longjin and Dali Pharmaceutical, have faced severe financial difficulties, with ST Longjin's revenue declining by 36.19% to 0.48 billion in 2024 [8][9]. - Despite the challenges, some companies remain optimistic about the potential for TCM injections, with predictions that products like Kanyuan Pharmaceutical's Hot Toxic Ning injection could benefit from increased insurance coverage and expanded indications [5]. Regulatory Environment - The National Medical Products Administration (NMPA) has been actively revising the instructions for TCM injections, adding warnings about severe allergic reactions and requiring monitoring after administration [11][12]. - Recent changes in the 2023 medical insurance drug directory have relaxed some payment restrictions on TCM injections, allowing for broader use in clinical settings [13][14]. - However, the existing risk management system still has shortcomings, such as delayed implementation of revised instructions and insufficient training for medical staff on proper medication use [12]. Safety Concerns - Reports indicate that adverse reactions to TCM injections, particularly allergic reactions, are common, especially among older patients [3][6]. - The complexity of TCM injection formulations and the potential for contamination during production contribute to safety risks [6][10]. - The industry faces ongoing scrutiny regarding the quality control of TCM injections, with calls for stricter regulations and better monitoring of adverse reactions [10][15]. Future Outlook - The TCM injection industry must navigate its way out of the current downturn by focusing on product upgrades, regulatory compliance, and enhancing safety monitoring systems [10][16]. - Companies are encouraged to adopt modern scientific methods to assess the safety of TCM injections and to implement stricter quality control measures [16].