9月26日，据CDE官网显示，太极集团旗下西南药业提交的盐酸托莫西汀胶囊4类仿制上市申请已获受理，该产品原研于2024年1 月停止中国市场供应。据摩熵医药数据库显示，目前盐酸托莫西汀在国内主要有胶囊剂和口服溶液，其中，持有胶囊剂生产批 文的药企（进口+国产）达10家。 | 【神经系统药物】【2024】全终端医院销售额-正亚分析TOP10 | | | | --- | --- | --- | | O TOP10 O TOP50 | 数量降序 | 维度:MAH/生产企业 | 截图来源：CDE 盐酸托莫西汀（择思达）原研为礼来，2002年在美国上市，主要用于治疗儿童和青少年的注意缺陷/多动障碍（ADHD）的非兴 奋型药物，也是美国儿童青少年精神病协会（AACAP）推荐的治疗ADHD的一线药物。2007年，盐酸托莫西汀胶囊在中国获批 上市，与再普乐、百优解及欣百达并称为礼来在中国中枢神经产品线中的四大核心药品。摩熵医药数据显示，盐酸托莫西汀胶 囊在2021年全终端医院市场的销售额突破3亿元，同比增长率达46.64%，2025年（截至Q2）其销售额已超1亿元。 | 会播音 | 药品名称 | 药品类型 | 申请类型 | 注 ...

Core Viewpoint - The article highlights the ongoing issues with the timely supply of drugs and medical devices following centralized procurement in various regions of China, indicating a significant number of products have not established delivery relationships post-selection, which raises concerns about the reliability of selected suppliers [1][9]. Group 1: Issues with Drug Supply - As of May 31, 2023, 443 drug specifications have not established timely delivery relationships after centralized procurement in Guangzhou, with nearly 70% of the 221 identified underperforming products having a delivery rate of 0 [9][10]. - The Hebei Provincial Medical Procurement Center has announced that certain companies will be rated as "generally" untrustworthy due to inadequate delivery services, including Suzhou Terui Pharmaceutical and Lizu Group, which are involved in multiple national procurement batches [2][5]. Group 2: Specific Products and Companies - Lizu Group's voriconazole injection was selected in the eighth batch of national procurement at a price of 29.19 yuan per unit, a significant drop from its previous market price of 700-800 yuan, reflecting a price reduction of over 90% [2]. - Northland Pharmaceutical's iohexol injection was selected in the seventh batch of national procurement at a price of 91.3 yuan per unit, being the only contrast agent selected in that batch [3]. Group 3: Regulatory Framework and Consequences - The Hebei Provincial Medical Procurement Center has established a credit evaluation system for pharmaceutical pricing and procurement, categorizing untrustworthy behavior into four levels: "general," "medium," "serious," and "particularly serious" [7]. - Companies identified as untrustworthy may face consequences such as written warnings, risk notifications on procurement platforms, and restrictions on the procurement qualifications of related drugs and materials [7]. Group 4: Broader Supply Issues - Beyond medical institutions, there are also reported supply shortages in designated pharmacies, with 422 drugs not supplied, affecting various products and involving 289 manufacturers [8].

Core Viewpoint - The announcement from the Hebei Provincial Medical Supplies Procurement Center indicates that several companies are being rated as "generally" untrustworthy due to inadequate delivery services for selected products in the national centralized procurement process [1][2][3] Group 1: Companies Involved - Companies listed for potential untrustworthiness include Suzhou Terui Pharmaceutical, Sihuan Pharmaceutical, Lijun Group, Jiangxi Yongfeng Kande Pharmaceutical, Guangdong Saifeng Pharmaceutical, Beijing Fule Technology, and Beijing Beilu Pharmaceutical [1][2] - Lijun Group's voriconazole injection was selected in the eighth batch of national procurement at a price of 29.19 yuan per unit, down from a previous market price of 700-800 yuan, representing a price drop of over 90% [1] - Beilu Pharmaceutical's iopamidol injection was selected in the seventh batch of national procurement at a price of 91.3 yuan per unit, being the only contrast agent selected in that batch [1] Group 2: Regulatory Framework - The Hebei Provincial Medical Security Bureau established a credit evaluation system for drug pricing and procurement in late 2020, categorizing untrustworthy behavior into four levels: "general," "moderate," "serious," and "particularly serious" [3] - The "general" untrustworthiness rating applies to companies that fail to fulfill procurement or delivery contracts without valid reasons and do not notify procurement agencies in advance, provided it does not severely impact clinical treatment [3] - Once a company is rated as untrustworthy, the provincial procurement center will implement measures such as written warnings, risk notifications on procurement platforms, and restrictions on procurement qualifications [3] Group 3: Broader Industry Context - The issue of supply shortages is not limited to medical institutions; designated pharmacies in Hebei also face significant shortages, with 422 drugs reported as unavailable [4] - Other regions, including Liaoning, Hainan, and Guangzhou, have also reported issues with selected companies failing to deliver drugs on time since the implementation of centralized procurement policies [4] - As of May 31, 2023, 443 drug varieties had not established timely delivery relationships post-procurement, with nearly 70% of the identified varieties having a delivery rate of 0% [4] Group 4: Future Developments - By the end of 2024, 612 companies were rated as generally untrustworthy, 76 as moderately untrustworthy, 40 as seriously untrustworthy, and 7 as particularly seriously untrustworthy [5] - A new standard for credit evaluation will be implemented starting from the third quarter of 2025, simplifying the rating system from four levels to three: "untrustworthy," "seriously untrustworthy," and "particularly seriously untrustworthy" [6]