Core Viewpoint - A significant number of traditional Chinese medicine (TCM) products are expected to exit the market due to new regulations from the National Medical Products Administration, which will enforce stricter quality controls and require clearer safety information in product descriptions by July 2026 [1][2]. Regulatory Changes - The new regulations will not only affect the re-registration of TCM products but will also extend the regulatory scope to the entire production process, indicating a comprehensive tightening of quality oversight in the industry [1][3]. - As of May 2023, there are approximately 2,400 TCM manufacturers in China, with around 57,000 approved product numbers, but only about 40,000 are actively sold and have a significant market presence [2]. Impact on Market - The upcoming regulatory changes primarily target products with incomplete clinical safety data, low market share, or those that have not been produced for an extended period, suggesting minimal impact on the general public's access to TCM [2]. - Many TCM products that have established market presence and clinical usage are expected to meet the new requirements, as they have already undergone safety evaluations [2]. Quality Control - The new regulations aim to eliminate non-compliant and immature products from the market, thereby enhancing the overall quality of TCM available to consumers [3]. - Issues such as inconsistent quality due to varying production standards among numerous manufacturers are highlighted, emphasizing the need for stricter regulatory measures [3]. Importance of Product Descriptions - The significance of well-written product descriptions for TCM is underscored, as they must clearly communicate contraindications and potential interactions with Western medicines to avoid adverse effects [4][5]. - Recommendations include using clear and accessible language in product descriptions to ensure that patients and healthcare providers can easily understand the information [5]. Integration of TCM and Western Medicine - The integration of TCM and Western medicine is becoming more prevalent, with many Western practitioners learning to effectively use TCM products [7]. - The approach to patient care emphasizes understanding individual patient needs and avoiding unnecessary polypharmacy by selecting the most appropriate treatment options [7][8]. - TCM is increasingly adapting to modern medical practices, with efforts to align traditional remedies with contemporary scientific understanding [8]. Future Outlook - The ongoing regulatory improvements and the deepening collaboration between TCM and Western medicine are expected to enhance the vitality of TCM, contributing to both national health and global medical knowledge [8].

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。 2026.01. 27 本文字数：676，阅读时长大约1分钟 据21财经，距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。 第 一 财 经 持 续 追 踪 财 经 热 点 。 若 您 掌 握 公 司 动 态 、 行 业 趋 势 、 金 融 事 件 等 有 价 值 的 线 索 ， 欢 迎 提 供 。 专 用 邮 箱 ： bianjibu@yicai.com （注：我们会对线索进行核实。您的隐私将严格保密。） 推荐阅读 地方国资下场低价"扫货"法拍房 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 ...

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。 图/图虫 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 ...

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 ...

Core Viewpoint - Huasheng Technology (SZ000790) has received an administrative regulatory decision from the Sichuan Securities Regulatory Bureau due to various accounting and internal control issues, leading to a requirement for corrective measures and warnings issued to key executives [2][4][5]. Group 1: Accounting Issues - The company has been found to have irregular accounting practices, including misclassification of advertising expenses as intangible assets by its subsidiary Hainan Rongsheng Hong Technology Co., Ltd. in 2021 [2]. - In 2023, another subsidiary, Tibet Kangyu Pharmaceutical Co., Ltd., recognized revenue from medical device sales without actual transfer of control to customers, leading to subsequent returns [2]. - Additionally, sales expenses from Chengdu Yuanhong Mineral Water Co., Ltd. were incorrectly accounted for in other subsidiaries, affecting performance assessment accuracy [2]. Group 2: Non-operational Fund Occupation - In 2021, Hainan Huasheng Development Holding Co., Ltd., a subsidiary, prepaid non-main business contract funds, which were later returned after five months, during which some funds flowed into companies controlled by the actual controller, constituting non-operational fund occupation [3]. Group 3: Internal Control Deficiencies - The internal control systems of the subsidiaries are inadequate, with issues such as improper expense reimbursement documentation and non-compliance with procurement management protocols [3]. - The company lacks a robust internal control system for large non-main business expenditures, leading to non-operational fund occupation in 2021 [3]. Group 4: Executive Accountability - Key executives, including Huang Mingliang (Chairman and President), Li Jun (Vice President and CFO), and Song Gang (Vice President), have been held responsible for the identified accounting and internal control issues [4][5]. Group 5: Company Performance - In 2024, Huasheng Technology reported revenue of 864 million yuan, a year-on-year decrease of 13.89%, and a net profit attributable to shareholders of -6.69 million yuan, down 124.19% [8]. - In the first quarter of 2025, the company achieved revenue of 127 million yuan, a decline of 29.21%, with a net profit of -14.59 million yuan, a drop of 740.09% year-on-year [9].

Group 1: Financial Performance - In 2024, the company's operating revenue decreased by 13.89%, resulting in a net loss due to intensified market competition and rising costs [3] - The decline in revenue and profit was primarily due to the contraction of the construction steel structure business and the ongoing trial production phase of the Shandong Lingkai project, which has not yet generated sales [3] Group 2: Market Position and Competitive Advantage - The company has a strong market presence in the pharmaceutical and health beverage sectors, with key products like Sanqi Tongshu Capsules and Biyuan Shu Oral Liquid included in the National Basic Medical Insurance Catalog [3] - The company ranks first in Chengdu's bottled drinking water market, leveraging unique mineral resources that enhance its product offerings [3] Group 3: Research and Development Focus - Future R&D efforts will concentrate on deepening the development of major traditional Chinese medicine products, particularly those with significant market influence [4] - The company aims to enhance product application range and efficacy stability through quality standard improvements [4] Group 4: Response to Industry Changes - The company is closely monitoring industry policy changes, such as medical insurance payment reforms, to ensure stable business development [4] - Strategies include expanding outpatient market channels and enhancing product quality management to mitigate policy risks [4] Group 5: Future Growth Strategies - The company is considering international market expansion based on strategic planning and market conditions, particularly for its core traditional Chinese medicine products [4] - Plans to extend the product line and develop related health products to meet diverse customer needs are in place [4]