药品集中带量采购

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因募资管理和使用问题,仙琚制药及相关责任人收警示函
Bei Ke Cai Jing· 2025-09-22 11:43
近日,因募集资金管理和使用问题,浙江仙琚制药股份有限公司(以下简称"仙琚制药")收到中国证券 监督管理委员会浙江监管局出具的行政监管措施决定书。这并非仙琚制药今年首次被监管部门采取措 施。今年上半年,仙琚制药因涉嫌地塞米松磷酸钠原料药价格垄断,被天津市市场监督管理委员会罚没 1.95亿元。 募集资金管理和使用存在问题 9月19日晚,仙琚制药发布公告称,公司及相关人员收到浙江证监局警示函。浙江证监局在现场检查中 发现仙琚制药募集资金管理和使用方面存在以下问题:部分募集资金置换未按规定履行审议程序并披 露,使用募集资金支付与募投项目无关的部分费用,使用闲置募集资金购买银行结构性存款理财产品时 存在募集资金与自有资金混同的情形。 浙江证监局决定对仙琚制药、公司董事长张宇松、总经理金炜华、财务总监王瑶华、董事会秘书张王伟 分别采取出具警示函的监督管理措施,并记入证券期货市场诚信档案。 仙琚制药表示,本次行政监管措施不会影响公司正常的生产经营活动。公司将严格按照有关法律法规和 监管要求,及时履行信息披露义务。 曾涉价格垄断被罚 4月30日,仙琚制药发布公告称,公司收到天津市市场监督管理委员会下发的《行政处罚决定书》(下 ...
第11批集采开标时间地点确定 规则迭代优化
Sou Hu Cai Jing· 2025-09-21 16:42
坚持"稳临床、保质量、防围标、反内卷"的原则,国家医保局细化了第11批集采的规则。 在"稳临床"方面,首先是优化医疗机构报量方式,第11批集采中,医疗机构既可以像以前那样按通用名 报量,也可按具体品牌报量。有4.6万家医疗机构参加了本次集采报量,报量的77%具体到了品牌。 同时合理确定约定采购量。集采把医疗机构报量的60%~80%作为企业竞争标的,这部分也是医疗机构 的约定采购量,剩余部分仍由医疗机构自主选择品牌。 第11批国家药品集中带量采购(下称"第11批集采")将于10月21日在上海开标。按厂牌报量、不再以最 低价为"锚点"、低价中标需晒成本、"未入围复活"等集采规则的迭代优化,备受市场关注。 近日,国家组织药品联合采购办公室(下称"联采办")发布了关于《全国药品集中采购文件(GY- YD2025-1)》(下称"采购文件")的公告。随后,国家医保局官微又发布了联采办对采购文件的视频 解读。 采购文件明确,第11批集采企业申报材料递交的起始时间为2025年10月21日(星期二)早晨7点30分到 上午10点,申报信息公开时间(开标)为上午10点30分。 在"反内卷"方面,此次集采规则优化了最高有效申报价形成 ...
优化锚点价格、监管药品生产线,第11批集采文件正式发布
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-20 14:18
Core Points - The 11th batch of national organized drug procurement documents has been officially released, involving 55 varieties, with eligible companies allowed to apply [1] - The new procurement rules emphasize a "reference price" system rather than simply selecting the lowest bid, allowing medical institutions to report quantities based on both generic names and specific brands [2] - The procurement process aims to ensure clinical demand and quality assurance, with 46,359 medical institutions participating in the reporting process [3] Group 1: Procurement Rules - The new procurement rules include a focus on children's medication supply, with adjustments made to pricing rules for small specifications suitable for children [3] - The 11th batch introduces stricter qualification requirements for bidding companies, including production experience and compliance with Good Manufacturing Practices (GMP) [4][5] - The "reference price" mechanism allows for a more flexible pricing strategy, potentially alleviating issues with previously rejected products being favored in clinical settings [6][8] Group 2: Market Dynamics - The procurement cycle for the 11th batch will run until December 31, 2028, with the opening of bids scheduled for October 21 [2] - The introduction of a "first report leniency" mechanism aims to combat collusion among bidding companies, encouraging transparency and fair competition [9] - The overall goal of the procurement initiative is to create a balanced market where quality and clinical needs are prioritized, moving away from a purely cost-driven approach [7][8]
开标时间地点都定了,一文读懂第11批集采新规则
Di Yi Cai Jing· 2025-09-20 12:24
将临床放在第一位,是此次集采优化措施最大的变化。 第11批国家药品集中带量采购(下称"第11批集采")将于10月21日在上海开标。按厂牌报量、不再以最 低价为"锚点"、低价中标需晒成本、"未入围复活"等集采规则的迭代优化,备受市场关注。 9月20日下午,国家组织药品联合采购办公室(下称"联采办")发布了关于《全国药品集中采购文件 (GY-YD2025-1)》(下称"采购文件")的公告。随后,国家医保局官微又发布了联采办对采购文件的 视频解读。 采购文件明确,第11批集采企业申报材料递交的起始时间为2025年10月21日(星期二)早晨7点30分到 上午10点,申报信息公开时间(开标)时间为上午10点30分,接受申报材料和申报信息公开的地点为上 海市青浦区竹盈路340弄1号。 经电子地图查询,这个地址为上海卓越铂尔曼大酒店(青浦卓越世纪中心店)。 坚持"稳临床、保质量、防围标、反内卷"的原则,国家医保局细化了第11批药品集采的规则。 在"稳临床"方面,首先是优化医疗机构报量方式,第11批集采中,医疗机构既可以前那样按通用名报 量,也可按具体品牌报量。有4.6万家医疗机构参加了本次集采报量,报量的77%具体到了品牌 ...
北陆药业(300016) - 2025年9月19日投资者关系活动记录表
2025-09-19 08:22
Group 1: Overall Business Performance - The company aims to become one of the "Top 100 Pharmaceutical Manufacturers in China" with a dual-driven business model of chemical and traditional Chinese medicine [1] - In H1 2025, the company achieved a revenue of CNY 584.21 million, a year-on-year increase of 23.27% [1] - Net profit attributable to shareholders reached CNY 29.97 million, up 53.35% year-on-year [1] - The net profit excluding non-recurring gains and losses was CNY 29.74 million, reflecting a 55.58% increase year-on-year [1] Group 2: Chemical Medicine Segment - The company’s contrast agent products have been included in national and local centralized procurement, leading to increased sales [2] - Sales revenue from contrast agent products reached CNY 338.88 million, a year-on-year growth of 21.11% [2] - Sales from hypoglycemic products amounted to CNY 68.22 million, with a modest growth of 2.22% [2] - Raw material drug sales increased to CNY 53.40 million, showing a significant growth of 45.81% [2] Group 3: Traditional Chinese Medicine Segment - The company expanded its traditional Chinese medicine product matrix to 59 varieties, with 21 currently in production and sales [3][4] - The "Nine Flavor Heart-Calming Granules" is recognized as the first approved pure Chinese medicine for generalized anxiety disorder [3] - Sales revenue from traditional Chinese medicine reached CNY 118.19 million, reflecting a year-on-year increase of 32.84% [4] Group 4: Research and Development - R&D investment totaled CNY 39.03 million, a 10.09% increase compared to the previous year [5] - The company has 34 projects under review or in development, enhancing its product pipeline diversity [5] - The company continues to focus on the contrast agent field, with several products and raw materials approved for market [5][6] Group 5: International Expansion - The company successfully expanded its overseas market, with products exported to South America, Africa, and Asia [8] - Overseas revenue reached CNY 74.29 million, a year-on-year growth of 30.41% [8] - The company has received certifications such as EU GMP and Brazil ANVISA GMP, facilitating further internationalization of its products [8] Group 6: Production Capacity Development - The company is enhancing its production capabilities, with ongoing construction and acceptance of various production bases [10] - The Cangzhou branch aims to become a leading production base for gadolinium raw materials [10] - The establishment of the Bozhou production base is expected to significantly increase production capacity and diversify product forms [10]
汉森制药:四磨汤口服液在广东联盟金莲花等中成药集中带量采购项目中获得中选限量可按需采购资格
Mei Ri Jing Ji Xin Wen· 2025-09-02 05:26
Group 1 - The company, Hansen Pharmaceutical, has confirmed that its product, Si Mo Tang Oral Liquid, has been selected for procurement in multiple projects, including the Beijing-Tianjin-Hebei "3+N" alliance and the fourth batch of centralized procurement in Fujian [2] - The product has also received selected qualification in the fifth round of drug centralized procurement in Jiangsu Province and has limited procurement qualifications in the Guangdong alliance for Jin Lianhua and other traditional Chinese medicine projects [2]
复星医药: 复星医药2025年半年度报告摘要
Zheng Quan Zhi Xing· 2025-08-26 16:24
Core Viewpoint - Shanghai Fosun Pharmaceutical Group Co., Ltd. reported a slight increase in total assets and net assets attributable to shareholders, while facing a decrease in operating income due to centralized procurement policies affecting drug sales. However, the revenue from innovative drugs showed steady growth [1][2]. Financial Performance - Total assets at the end of the reporting period reached approximately 118.83 billion RMB, a 1.16% increase from the previous year [1]. - Net assets attributable to shareholders were approximately 47.40 billion RMB, reflecting a 0.29% increase year-on-year [1]. - The weighted average return on net assets improved to 3.58%, up by 0.92 percentage points compared to the previous year [1]. Revenue and Profitability - Operating income decreased compared to the previous year, primarily due to the impact of centralized procurement policies on drug sales [1][3]. - The total profit and net profit attributable to shareholders increased, mainly due to the sale of remaining shares in Unicorn II Holdings Limited [2][3]. - The net profit attributable to shareholders, excluding non-recurring gains and losses, was reported at 550 million RMB for the second quarter of 2025, showing a quarter-on-quarter increase of 140 million RMB [3]. Cash Flow and Efficiency - The net cash flow from operating activities increased year-on-year, attributed to improved supply chain management and operational efficiency [2][3]. Shareholder Structure - As of the end of the reporting period, the total number of shareholders was approximately 230,000, with the largest shareholder, Shanghai Fosun High Technology Group Co., Ltd., holding 20.65% of the shares [2][3]. Debt and Financial Ratios - The asset-liability ratio stood at 49.24%, slightly up from 48.98% at the end of the previous year [7]. - The EBITDA interest coverage ratio improved to 7.62, compared to 5.70 in the previous year [7].
第11批国家组织药品集采报量:回应临床真实需求
Jing Ji Ri Bao· 2025-08-18 01:56
Core Viewpoint - The recent launch of the 11th batch of national drug centralized procurement emphasizes the importance of accurate reporting by medical institutions, introducing new rules to accommodate diverse medication needs while allowing for independent procurement of non-selected drugs outside the procurement agreement [2][5]. Group 1: Reporting Rules and Requirements - The reporting period for this centralized procurement is from August 6 to August 25, requiring participation from all public and military medical institutions [2]. - New reporting rules allow medical institutions to report either by drug name or by brand, providing flexibility in meeting clinical needs [2][4]. - Institutions can choose to report some drugs by name and others by brand, with no limit on the number of brands that can be reported [2]. Group 2: Demand Determination and Procurement - Medical institutions must consider clinical demand changes and ensure that total reported quantities are not less than 80% of the average procurement volume for 2023 and 2024 [4]. - For drugs with increasing usage trends, institutions are encouraged to report quantities at or above 100% of historical averages, while those with limited indications can report lower quantities based on actual usage [4]. - Institutions are allowed to adjust reported quantities based on specific circumstances, such as departmental changes or temporary usage [4]. Group 3: Procurement Flexibility and Market Dynamics - Institutions are encouraged to prioritize selected drugs but are not restricted to them; they can procure non-selected drugs based on actual needs [5]. - Since 2018, a total of 435 drugs have been procured through 10 batches of centralized procurement, which has helped reduce costs for patients and facilitated the inclusion of new drugs in the medical insurance list [5]. - The procurement process aims to maintain clinical stability, ensure quality, and prevent unethical practices such as collusion among suppliers [5].
优化规则满足群众多元用药需求
Jing Ji Ri Bao· 2025-08-18 01:30
Core Points - The eleventh batch of national drug centralized procurement has officially started, with new reporting rules that include an option for reporting by brand name to meet diverse medication needs [1][2] - Public medical institutions, including grassroots healthcare facilities, are required to participate in the reporting process from August 6 to August 25 [1] - The new reporting rules allow institutions to report either by drug name or by brand, providing flexibility in meeting clinical needs [1][2] Reporting Guidelines - If a reported brand is not selected, the corresponding volume will be managed by the province's main supply enterprise, and institutions must fulfill the agreement volume with that enterprise [2] - Institutions must ensure that total reported volumes are not less than 80% of the average procurement volume for 2023 and 2024 [2][3] - Institutions can adjust reported volumes based on actual needs, especially for drugs with fluctuating demand due to seasonal diseases or other factors [3] Clinical Needs and Procurement - The procurement policy encourages the use of selected drugs but allows for the purchase of non-selected drugs if clinical needs are not met [3] - Since 2018, a total of 435 drugs have been procured through 10 batches of centralized procurement, with ongoing adjustments to improve drug accessibility and quality for the public [3][4] - The procurement process aims to balance clinical stability, quality assurance, and fair competition among suppliers [4]
第十一批国家组织药品集采报量启动 优化规则满足群众多元用药需求
Jing Ji Ri Bao· 2025-08-17 23:56
Core Points - The eleventh batch of national organized drug procurement has officially started, with new reporting rules introduced to enhance the procurement process and meet diverse public medication needs [1][2] - Medical institutions are required to report their procurement needs from August 6 to August 25, 2023, and must participate in the reporting process as per government regulations [1][2] - The new reporting rules allow institutions to report by brand name, which respects clinical choices and addresses patient concerns about brand preferences [1][2] Reporting Rules - Medical institutions can report either by drug name or by specific brand, with no limit on the number of brands that can be reported [1][2] - If a reported brand is not selected, the procurement responsibility will shift to the main supplier in the province, and institutions must fulfill the agreement quantity with that supplier [2] - Institutions must ensure that total reported quantities are not less than 80% of the average procurement volume for 2023 and 2024 [2][3] Clinical Demand Considerations - Institutions are encouraged to report quantities based on actual clinical needs, with specific guidelines for drugs with increasing usage trends [2][3] - For drugs with uncertain demand, such as those related to seasonal diseases, institutions can adjust their reported quantities accordingly [3] - Institutions are allowed to reduce reported quantities for drugs with expected lower usage due to departmental adjustments or temporary needs [3] Procurement Principles - The procurement process will adhere to principles of maintaining clinical stability, ensuring quality, preventing collusion, and avoiding excessive competition [4] - Companies are advised to conduct cost-benefit analyses and engage in rational pricing while resisting illegal practices such as collusion [4] Historical Context - Since 2018, ten batches of national organized drug procurement have resulted in the purchase of 435 types of drugs, contributing to reduced costs for patients and facilitating the inclusion of new drugs in the medical insurance catalog [3]