Core Viewpoint - The Chinese traditional medicine industry is undergoing significant regulatory and market changes, leading to a rapid phase of industry reshuffling and upgrading as the deadline for new registration regulations approaches [1][2][4]. Regulatory Changes - The new regulations set to take effect on July 1, 2026, will require clear safety information on drug labels, pushing the industry towards higher quality standards and potentially leading to the delisting of products with ambiguous safety data [2][6]. - Current data indicates that over 40,000 of the 57,000 approved traditional Chinese medicine (TCM) products have unclear safety information, which will impact products with unclear clinical value and high safety risks [3][4]. Industry Dynamics - The dual pressures of funding and technology are intensifying the differentiation among companies, with larger firms able to invest in data compliance and mergers, while smaller firms struggle with funding and may abandon low-value licenses [4][5]. - The market share is expected to concentrate among high-quality enterprises, leading to a significant increase in industry concentration and a shift towards innovative and improved traditional medicines [4][5]. Market Performance - Recent earnings forecasts indicate a recovery in the TCM sector, with leading companies like Jiangzhong Pharmaceutical and Yiling Pharmaceutical showing significant profit growth, with Yiling expected to turn a loss of 7.25 billion yuan in 2024 into a profit of 1.2 to 1.3 billion yuan in 2025, marking a profit increase of up to 279.43% [7]. Quality and Pricing Trends - The upcoming centralized procurement and adjustments to the basic drug catalog are expected to accelerate industry upgrades, with a focus on quality over price, as the market will likely see a reduction in low-quality products [8][9]. - The new procurement process will include a comprehensive quality evaluation system to ensure that different manufacturers produce equivalent therapeutic effects and quality, addressing the challenges posed by the complexity of TCM ingredients [9].

Core Viewpoint - The Chinese traditional medicine (CTM) industry is undergoing significant regulatory and market changes, leading to a phase of "low-quality" product elimination and industry upgrading as the deadline for new registration regulations approaches [1][2]. Regulatory Changes - The new regulations, effective from July 1, 2026, will require clear safety information on CTM product labels, with products marked as "unclear" facing delisting [1]. - The regulations aim to address the lack of safety information in CTM product labels, which has been a significant issue, with over 40,000 product approvals marked as "unclear" in critical safety areas [3]. Industry Impact - The regulatory countdown is causing a notable impact on the industry, with many companies voluntarily canceling or transferring low-value approvals due to increasing compliance costs [1][4]. - The industry is expected to see a fundamental shift in market dynamics, with a concentration of market share among high-quality enterprises as low-efficiency approvals are eliminated [4][5]. Financial Performance - Recent earnings forecasts indicate a recovery in the CTM sector, with leading companies like Jiangzhong Pharmaceutical and Yiling Pharmaceutical showing significant profit growth due to improved cost management and marketing reforms [7]. - Yiling Pharmaceutical is projected to turn a profit of 1.2 to 1.3 billion yuan in 2025, marking a substantial turnaround from a loss in 2024 [7]. Market Dynamics - The upcoming fourth batch of centralized procurement for CTM is set to further accelerate industry upgrades, with a focus on quality and compliance [8]. - The procurement process will involve a comprehensive evaluation of quality, with strict penalties for non-compliance, ensuring that only high-quality products remain in the market [9]. Future Outlook - The industry is expected to continue moving towards high-quality development over the next 3-5 years, with a focus on modernizing classic formulations and innovating new products [5][6]. - The establishment of a comprehensive quality evaluation system for CTM is crucial for ensuring product efficacy and safety, which will be essential for the industry's global competitiveness [9].

Core Viewpoint - The Chinese traditional medicine (CTM) industry is undergoing significant regulatory and market changes, leading to a phase of "low-quality" product elimination and industry upgrade as the deadline for new registration regulations approaches [1][2][4]. Regulatory Changes - The new regulations, effective from July 1, 2026, will require clear safety information on CTM product labels, with products marked as "unclear" facing delisting [1][4]. - A significant number of CTM approvals, approximately 40,000, currently lack essential safety information, which will impact products with unclear clinical value and high safety risks [4]. Industry Dynamics - The dual pressure of funding and technology is intensifying the differentiation among industry players, with leading companies able to enhance their core products and acquire quality approvals, while smaller firms struggle with funding and research capabilities [5]. - The industry landscape is expected to fundamentally change post-regulation, with a reduction in ineffective approvals and a concentration of market share among high-quality enterprises [5][6]. Market Trends - The market for CTM is anticipated to shift towards high-quality development, focusing on classic formulations and innovative products, while the concentration of market share will increase as low-market-share products exit [8][9]. - Recent performance reports indicate a recovery in the CTM sector, with leading companies like Jiangzhong Pharmaceutical and Yiling Pharmaceutical showing significant profit growth due to cost improvements and marketing reforms [9][10]. Pricing and Competition - The upcoming centralized procurement process is expected to enhance market competition, leading to potential cost reductions for high-quality products as low-quality options are phased out [8][11]. - The new procurement regulations will include a comprehensive quality evaluation system to ensure that different manufacturers' products meet consistent efficacy and quality standards [12].

知前沿，问智研。智研咨询是中国一流产业咨询机构，十数年持续深耕产业研究领域，提供深度产业研 究报告、商业计划书、可行性研究报告及定制服务等一站式产业咨询服务。专业的角度、品质化的服 务、敏锐的市场洞察力，专注于提供完善的产业解决方案，为您的投资决策赋能。 2020-2025年中国中成药产量统计图 数据来源：国家统计局，智研咨询整理 上市企业：云南白药（000538）,同仁堂（600085）,片仔癀（600436）,白云山（600332）,太极集团 （600129）,东阿阿胶（000423）,九芝堂（000989）,贵州百灵（002424）,葵花药业（002737）,吉林敖 东（000623） 相关报告：智研咨询发布的《2026-2032年中国中成药行业发展形势分析及产业前景规划报告》 根据国家统计局数据显示：2025年12月中国中成药产量为19.4万吨，同比增长2.1%；2025年中国中成药 累计产量为181.4万吨，累计下降7.7%。 ...

中药的价值不存在于"民族自豪"和"爱国叙事"里，而存在于临床效果和科学证据中。 近日，"大批中成药将退出市场"的消息引发关注。根据国家药监局《中药注册管理专门规定》第七十五 条相关规定，2026年7月1日之后，现存中成药在申请再注册时，其"中药说明书"的禁忌、不良反应、注 意事项中任何一项仍为"尚不明确"的，依法将不予再注册。媒体报道称，该规定将导致大量中成药因为 达不到要求而被淘汰，受影响的主要是"僵尸"批文品种，即徒有上市许可，却长期不生产不销售，缺乏 上市后药物警戒及不良反应监测数据的药品。 《2022国家中药监管蓝皮书》显示，我国目前有中成药生产企业约2400家，拥有中药品种9000余个，但 大量品种存在低水平重复、临床价值不明确等问题，批文数量与产业质量严重不匹配。国务院办公厅 2025年2月印发的《关于提升中药质量促进中医药产业高质量发展的意见》明确提出，逐步完善中成药 批准文号退出机制，指导改良一批，依法淘汰一批。实施中药再注册新规，是中药产业从"数量扩 张"向"质量优先"转型的必然选择，也是监管层推动中医药高质量发展的关键一步。 业内认为，对于尚未达到新规要求的中成药企业来说，接下来的选择无非 ...

Core Viewpoint - The new regulation from the National Medical Products Administration (NMPA) will eliminate ambiguous safety information in traditional Chinese medicine (TCM) product labels, significantly impacting over 70% of existing TCM approvals by 2026 [1][2]. Group 1: Background and Current Situation - The regulation, referred to as the "life and death clause" for TCM, will take effect on July 1, 2026, and aims to address the lack of safety information in TCM product labels [1]. - Currently, there are approximately 57,000 approved TCM products in China, with over 40,000 labels indicating "unclear" safety information in categories such as contraindications and adverse reactions [2]. Group 2: Impact on TCM Products - The regulation is expected to reduce the number of marketable TCM products by 30%-40%, primarily affecting those with unclear clinical value and high safety risks [2]. - Existing products on the market, such as Ban Lan Gen and Lianhua Qingwen, will not be directly affected and can continue to be used by consumers [3]. Group 3: Industry Transformation - The regulation signifies a shift in the TCM industry from quantity expansion to quality prioritization, addressing issues of low clinical value and redundancy among TCM products [4]. - An estimated 20%-30% of TCM approvals may exit the market in the next 3-5 years due to the new registration requirements [4]. Group 4: Cost Implications for Companies - Companies will face increased research costs to comply with the new safety evaluation requirements, which can range from hundreds of thousands to millions of yuan per product [6]. - Despite the increased costs, experts believe that this will not lead to a significant rise in TCM prices due to market competition and the potential for cost dilution through scale production [7]. Group 5: Long-term Industry Outlook - The regulation is seen as a necessary step for the modernization of TCM, aligning with international practices for drug safety information [7]. - The NMPA has established communication mechanisms and support channels to assist companies in meeting the new requirements, particularly for urgently needed products [7].

Core Viewpoint - The upcoming regulatory changes in traditional Chinese medicine (TCM) are perceived as a necessary industry "slimming down," primarily targeting "zombie approvals" that have little to no market presence, rather than posing a significant threat to the overall market supply [1][3]. Regulatory Changes - The new regulations, effective from July 1, 2026, stipulate that if any safety information such as contraindications or adverse reactions remains "unclear" in the product's instructions after three years, the drug will not be eligible for re-registration [3][10]. - Most of the approvals expected to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with negligible or zero market sales [3][4]. Industry Response - Industry insiders express that the costs associated with updating the required safety data are manageable, with estimates ranging from several thousand to tens of thousands of yuan per approval [4][7]. - Companies are likely to abandon these "zombie approvals" voluntarily, as they represent ongoing liabilities without significant market impact [5][9]. Market Dynamics - The real concern for the industry lies in the ongoing centralized procurement of TCM and the upcoming adjustments to the national essential drug list, which will significantly influence the core profits and survival of companies [10][11]. - The centralized procurement process, set to include 90 products with a market scale of over 45 billion yuan, raises questions about the future pricing and competitiveness of TCM products [10][11]. Future Outlook - The regulatory timeline provides a lengthy window for companies to adapt, with many already completing re-registration for key products [6][8]. - The adjustments to the essential drug list are anticipated to be more impactful than the registration regulations, as they will determine which products can access the main hospital channels [10][11].

近日，一条关于大批中成药将退出市场的报道在市场中刷屏。 前述报道提及的《中药注册管理专门规定》，是国家药监局在2023年2月10日下发的，自2023年7月1日 起施行，目的是为促进中医药传承创新发展，遵循中医药研究规律，加强中药新药研制与注册管理。 该规定表示，中药新药研制应当坚持以临床价值为导向，重视临床获益与风险评估，发挥中医药防病治 病的独特优势和作用，注重满足尚未满足的临床需求。 该报道称，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。 真实情况是否如此？ 接受第一财经记者采访的中成药企业人士倾向认为，该政策影响到的更多是"僵尸"批文品种，后者有注 册证，但长期不生产不销售，缺乏上市后的药物警戒以及不良反应监测数据等。当前，要补课的话，投 入相对会比较大，有些药企可能在权衡经济效益后，会放弃再注册工作。 ...

2026.01. 28 本文字数：2398，阅读时长大约4分钟 作者 | 第一财经 林志吟 近日，一条关于大批中成药将退出市场的报道在市场中刷屏。 该报道称，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。 真实情况是否如此？ 有多家中成药企业对第一财经记者表示，该政策于2023年下发后，他们已在开展完善说明书安全工作，政 策带来的影响较小。 "公司产品再注册相关工作均有安排，再注册期之前都会完成修订，对公司不会产生影响。"国内头部中成 药企业人士对第一财经记者表示。 西南一家上市中成药企董事长告诉第一财经记者，政策出台的背景，也是希望药企重视作为药品上市持有人 的主体责任，更加要重视药品的安全性。以往一些中成药企不太重视基础研究，政策给予了三年过渡期。而 政策于2023年出台后，他们内部就对涉及的相关中成药品种进 ...

"僵尸"批文品种，指的是有注册证，但长期不生产不销售。 近日，一条关于大批中成药将退出市场的报道在市场中刷屏。 该报道称，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。 真实情况是否如此？ 接受第一财经记者采访的中成药企业人士倾向认为，该政策影响到的更多是"僵尸"批文品种，后者有注 册证，但长期不生产不销售，缺乏上市后的药物警戒以及不良反应监测数据等。当前，要补课的话，投 入相对会比较大，有些药企可能在权衡经济效益后，会放弃再注册工作。 多家药企回应影响较小 中成药是指在中医药理论指导下，以中医处方为依据，以中药饮片为原料，按照国家规定的生产工艺和 质量标准加工制备而成的药物剂型。 前述报道提及的《中药注册管理专门规定》，是国家药监局在2023年2月10日下发的，自2023年7月1日 起施行，目的是为促进中医药传 ...