盐酸托莫西汀胶囊
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太极集团盐酸托莫西汀胶囊仿制申请获受理,原研停供下,神经系统药物市场谁主沉浮?
Ge Long Hui· 2025-09-29 03:48
Core Insights - Tai Chi Group's subsidiary Southwest Pharmaceutical has had its application for the generic version of Atomoxetine Hydrochloride Capsules accepted, with the original product set to cease supply in the Chinese market by January 2024 [1][2] - Atomoxetine, originally developed by Eli Lilly, is a non-stimulant medication recommended for treating ADHD in children and adolescents, with significant sales growth in the Chinese market [2][4] Company Developments - Southwest Pharmaceutical is currently the only company actively pursuing a 4th category new registration for the generic version of Atomoxetine Hydrochloride Capsules [4] - The company has increased its investment in the neuropsychiatric drug sector, with total R&D expenditure rising from 14.6 million to 28.2 million yuan from 2021 to 2024, representing an increase in revenue proportion from 1.20% to 2.28% [13][15] Market Context - The total sales of neuropsychiatric drugs in the hospital market are projected to exceed 110 billion yuan in 2024, with major market players including Renfu (21.31% market share), Shiyao Group (16.8%), and Yangtze River Pharmaceutical (approximately 13%) [4] - In 2021, the sales of Atomoxetine Hydrochloride Capsules in the full-terminal hospital market surpassed 300 million yuan, reflecting a year-on-year growth rate of 46.64% [2][4]
河北通报丽珠、北陆等药企未及时配送药品
经济观察报· 2025-06-10 11:40
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].
河北通报丽珠、北陆等药企未及时配送药品
Jing Ji Guan Cha Wang· 2025-06-10 09:13
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]