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山东赛托生物科技股份有限公司关于子公司收到化学原料药欧洲CEP证书的公告
Core Viewpoint - The company has received the CEP certificate for Dexamethasone raw material from the European Directorate for the Quality of Medicines (EDQM), which allows it to sell this product in international markets that recognize the CEP certification [1][3]. Group 1: Company Information - The company’s subsidiary, Shandong Sry Pharmaceutical Co., Ltd., received the CEP certificate for Dexamethasone, a synthetic corticosteroid used for various medical treatments [1][2]. - The certificate is valid for five years starting from June 17, 2025, and is identified by the number CEP2024-325-Rev00 [1][2]. Group 2: Product and Market Impact - Dexamethasone is used in treating autoimmune diseases, allergic conditions, and as an adjunct therapy for certain acute infections [1][2]. - The global demand for Dexamethasone raw material was 15 tons in 2022, with only five other companies holding valid CEP certificates for this product [2]. - The acquisition of the CEP certificate is expected to enhance the company's competitiveness in the chemical raw material market and expand its product line [3].
3.62亿天价罚单!医药垄断黑幕曝光,幕后操盘手竟是“药贩子”
Xin Lang Zheng Quan· 2025-06-18 09:34
Core Viewpoint - The recent penalty imposed by the State Administration for Market Regulation has exposed a hidden monopoly network in the pharmaceutical industry, with significant financial repercussions for the involved parties [1]. Group 1: Monopoly Scheme - A gathering organized by an individual named Guo in November 2021 led to a verbal agreement among four pharmaceutical companies to stop price competition and collectively raise prices [2]. - To evade regulatory scrutiny, the companies coordinated price hikes through Guo, using communication methods such as WeChat and phone calls [2]. Group 2: Price Surge - Following the agreement, the four companies collectively halted supply in January 2022, causing a severe market supply shortage [3]. - The price of the raw material dexamethasone skyrocketed from 8,000 yuan per kilogram to 13,800 yuan, marking a 72% increase [3]. - The price of dexamethasone injection surged from 0.35 yuan per unit to nearly 100 yuan, with some hospitals in Guangxi purchasing it at 60 yuan per unit, reflecting an alarming increase [3]. Group 3: Penalties and Legal Framework - The leniency policy in antitrust cases played a crucial role, with Tianyao Pharmaceutical receiving an 80% reduction in fines after self-reporting and providing key evidence, resulting in a total penalty of 69.19 million yuan [4]. - In contrast, Xianju Pharmaceutical faced a maximum fine of nearly 195 million yuan due to its failure to apply for leniency [4]. - All responsible individuals from the four companies were fined 600,000 yuan each [4]. Group 4: Regulatory Environment - The case is part of a broader trend, with multiple antitrust cases in the pharmaceutical sector being investigated in recent years, including those involving acetic acid and other raw materials [5]. - The regulatory framework has been strengthened with the introduction of the "Raw Material Drug Antitrust Guidelines" in 2021 and the "Drug Sector Antitrust Guidelines" set for 2025, establishing a comprehensive regulatory system [5]. - Antitrust enforcement is increasingly focused on essential sectors like pharmaceuticals, with new major cases leading to price reductions of up to 62% for involved drugs [5].