【环球网财经综合报道】国家基本药物目录调整工作迎来关键性制度文件。2月11日，国家卫生健康委、国家发展改革委、工业和信息化部、财政部、商务 部、市场监管总局、国家医保局等11部门联合印发《国家基本药物目录管理办法》（简称《办法》），自发布之日起施行。原国家卫生计生委2015年2月13 日印发的《国家基本药物目录管理办法》同时废止。时隔11年，《办法》的发布被业内视为新版国家基本药物目录即将调整的重要信号。 此次发布的《办法》主要从六个方面进行了修订，其中最引人关注的是完善了目录管理机制，明确提出国家基本药物供应使用与分级诊疗、药品集中采购、 支付报销等政策相衔接。在药品遴选方面，《办法》突出了药品临床价值，明确根据疾病谱变化、药品临床应用实践、药品标准变化、药品新上市情况等进 行动态调整。同时，明确了目录制定程序，包括组建专家库、咨询专家组提出遴选意见、评审专家组进行综合评议、征求成员单位意见以及报批发布等五个 关键环节。 《办法》强调，纳入国家基本药物目录的药品，应当是经国家药监局批准，并取得药品注册证书的药品，以及按国家药品标准炮制的中药饮片。除急救用药 外，独家生产品种纳入目录应当经过单独论证。对于含有 ...

Core Viewpoint - The new regulations for traditional Chinese medicine (TCM) registration, referred to as the "death clause," will require that key safety information be clarified by July 1, 2026, or the products will face delisting. However, many industry insiders view this as an opportunity for the industry to eliminate "zombie approvals" that are no longer commercially viable [1][2][4]. Group 1: Regulatory Changes - The "New Regulations for TCM Registration" will take effect on July 1, 2026, mandating that any TCM product with unclear safety information will not be re-registered [2][3]. - Most of the TCM products likely to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with minimal or zero market sales [2][4]. - The cost for updating safety information for TCM products ranges from thousands to tens of thousands of yuan, with an additional application fee of 9,600 yuan per approval [3][6]. Group 2: Industry Response - Industry experts believe that the impact of the new regulations on the overall sales volume of TCM will be minimal, as many products are already in excess supply [4][6]. - Companies are expected to take advantage of the three-year buffer period to either update their products or voluntarily abandon non-core approvals [10][11]. - The time frame for compliance is seen as generous, allowing companies ample opportunity to meet the new requirements without significant financial strain [8][10]. Group 3: Market Dynamics - The upcoming adjustments to the national essential drug list and the TCM centralized procurement process are viewed as more pressing concerns for the industry than the new registration regulations [10][11]. - The centralized procurement process, set to take place in November 2025, will involve 90 products and a market scale of over 45 billion yuan, raising concerns about future pricing and competition [11][12]. - The adjustment of the essential drug list is anticipated to be a critical window for TCM companies, with significant implications for core product viability and profitability [12].

Core Viewpoint - The new regulations for traditional Chinese medicine (TCM) registration, effective July 1, 2026, are perceived as a "survival deadline" for TCM products, requiring clear safety information or facing market exit. However, the industry views this as an opportunity to eliminate "zombie approvals" that have little market value and are not actively sold [1][2]. Group 1: Regulatory Changes - The new regulation mandates that if any safety information in TCM product labels remains "unclear" after three years, re-registration will be denied, leading to potential market exit for those products [2][3]. - Most of the approvals likely to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with minimal or zero market sales, thus not impacting the overall market supply [2][3]. - The cost for companies to update their product information to comply with the new regulations is manageable, ranging from thousands to tens of thousands of yuan, with a registration fee of 9,600 yuan per approval [2][3]. Group 2: Industry Response - Industry insiders believe that the impact of the new regulations on total sales volume will be minimal, as many companies are already prepared for the changes and have completed re-registration for key products [4][5]. - The time frame provided by the new regulations is considered sufficient for companies to adapt, with many already having completed necessary updates for core products [6][7]. - The registration process is seen as a manageable task rather than a high-cost project, with companies able to utilize existing databases and literature to fulfill safety data requirements [5][6]. Group 3: Market Dynamics - The upcoming centralized procurement of TCM and adjustments to the national essential drug list are viewed as more significant threats to the industry than the registration regulations, with potential impacts on core product profitability [7][8]. - The centralized procurement process is expected to reshape market dynamics, as it may favor unique products while creating challenges for demonstrating clinical equivalence among similar TCM products [8][9]. - The adjustment of the essential drug list is anticipated to be a critical period for TCM companies, with significant implications for their future development and market positioning [9].

Group 1: Company Strategy and Market Conditions - Biopharmaceuticals are a crucial part of the company's "one body, two wings" strategy, facing high investment and long R&D cycles, with the industry currently experiencing a downturn [1] - The CDMO supply side has seen some capacity idling due to a competitive environment, impacting overall profitability [1] - The company is focusing on cost control and optimizing personnel structure to minimize losses [1] Group 2: Product Development and Pipeline - The BC006 injection project is nearing completion of Phase I clinical trials, with a focus on balancing R&D progress and operational performance [1] - The company is actively seeking partnerships in the biopharmaceutical sector [1] Group 3: Sales Performance of Secondary and Tertiary Products - Secondary and tertiary products are showing good growth trends, with specific products like "Gaojie Dingchuan Capsules" expected to maintain last year's growth rate [2] - The "Dizziness Ning" series surpassed 100 million CNY in sales in 2021, aiming for double-digit growth this year [2] - Other products, such as "Shu Yan Qing Spray" and "Compound Cold Granules," are also expected to achieve significant sales growth [2] Group 4: Regulatory and Market Access - The national essential drug list adjustment is led by relevant government departments, and the company has not engaged in any application processes during this period [2] - The timeline for the announcement of the new essential drug list remains uncertain [2]