Core Viewpoint - The recent suspension of procurement qualifications for acetylcysteine effervescent tablets produced by Zhejiang Jinhua Kang En Bei Pharmaceutical Co., Ltd. due to non-compliance with regulations poses significant challenges for the company, particularly during its critical transformation phase into "Traditional Chinese Medicine (TCM) Health" [2][3][9]. Group 1: Company Performance and Financial Impact - In 2022, the sales revenue of acetylcysteine effervescent tablets was nearly 300 million yuan, with a year-on-year growth of over 16% in 2023, estimated to reach approximately 350 million yuan, accounting for over 5% of total revenue [2]. - The company's revenue for the first half of 2025 was 3.358 billion yuan, with a net profit of 354 million yuan, both showing a decline, continuing the downward trend from 2024 [5]. - The core chemical drug business saw a revenue drop of 11.22% in the first half of 2025, primarily due to the failure to win bids in the national centralized procurement [5][10]. Group 2: Quality Control and Regulatory Issues - The National Medical Products Administration announced the suspension of sales and recall measures for acetylcysteine effervescent tablets due to non-compliance with specifications, which directly impacts the business line reliant on this product [3][8]. - The quality issues have exposed vulnerabilities in the company's quality control processes, raising concerns about its strategic execution capabilities [2][11]. Group 3: Strategic Transformation Challenges - The company is undergoing a critical transformation into "TCM Health," facing difficulties as traditional Chinese medicine revenues are projected to decline in 2024, and the chemical drug sector has suffered quality setbacks [2][9]. - The company's recent restructuring efforts, including the introduction of a state-owned entity as a controlling shareholder, have not alleviated the pressures from price reductions in centralized procurement and rising raw material costs [9][10]. - Despite increasing R&D investments, the company's R&D intensity has decreased, indicating challenges in maintaining competitive innovation levels [10]. Group 4: Market Position and Brand Value - As of September 16, 2025, the company's market value was 11.384 billion yuan, ranking 23rd in the TCM sector, reflecting a significant decline in industry standing [8]. - The recent quality crisis is expected to have long-term implications for brand value and consumer trust, particularly in the respiratory medication sector [11].

近日，齐鲁晚报·齐鲁壹点记者从上海阳光医药采购网获悉，上海市医药集中招标采购事务管理所发布关于暂停浙江金华康恩贝生物制药有限公司生产的乙 酰半胱氨酸泡腾片采购资格的通知。 各医药机构、药品生产企业： 根据国家药品监督管理局发布的《国家药监局关于28批次不符合规定药品的通告（2025年第30号）》，暂停浙江金华康恩贝生物制药有限公司生产的乙酰半 胱氨酸泡腾片采购资格。 浙江金华康恩贝生物制药有限公司是浙江康恩贝制药股份公司（600572）控股的一家专业化学制药公司。在特色化学原料药和冻干、缓控释制剂方面具有国 内领先优势，是浙江省重点医药骨干企业和国家重点高新技术企业。 公司前身为浙江金华制药厂，成立于1958年4月，1996年9月转制成为康恩贝集团的成员企业，2007年公司依托康恩贝制药股份公司实现了间接上市，2020年 4月浙江省国资委成为实际控股人。 | | 公司概况 About Us | | --- | --- | | > | 公司简介 | | > | 企业文化 | | > | 企业荣誉 | | > | 组织架构 | | > | 发展足迹 | | へ | 质量管控 | 新闻热线电话0531-851932 ...

Core Viewpoint - The procurement qualification of Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. for acetylcysteine effervescent tablets has been suspended due to non-compliance with regulations as per the announcement from the Shanghai Sunshine Pharmaceutical Procurement Network and the National Medical Products Administration [1][2]. Group 1: Company Performance - In the first half of 2025, Kang'enbei achieved operating revenue of 859 million yuan and net profit of 53.93 million yuan, accounting for 25.58% and 15.25% of Kang'enbei Pharmaceutical's total revenue and net profit respectively [1]. - The acetylcysteine effervescent tablets are a key product for Kang'enbei, with sales revenue of approximately 300 million yuan in 2022 and an estimated 350 million yuan in 2023, representing over 5% of total revenue for the year [2]. Group 2: Regulatory Issues - The National Medical Products Administration reported that one batch of acetylcysteine effervescent tablets produced by Kang'enbei did not meet regulatory standards, specifically regarding its characteristics [1]. - The suspension of procurement qualifications affects not only Kang'enbei but also 16 other companies, indicating a broader issue within the pharmaceutical industry regarding compliance with drug regulations [4]. Group 3: Market Impact - Kang'enbei's main business revenue in the first half of 2025 was 3.315 billion yuan, a year-on-year decrease of 2.68%, influenced by the failure to win bids in national procurement for acetylcysteine effervescent tablets and price reductions in other products [2].

Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions [3][5]. Group 1: Non-compliant Drugs - Five batches of fusidic acid cream produced by Aomei Pharmaceutical Factory failed due to particle size issues [3]. - Two batches of loratadine syrup from Want Pharmaceutical (Hainan) Co., Ltd. did not meet standards related to impurities [3]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group's Chao Hu Jinchen Pharmaceutical Co., Ltd. failed due to relative density [3]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet dissolution rate standards [3]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical characteristics [3]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet weight difference standards [3]. - Two batches of Qili San from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [3]. Group 2: Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [5]. - The NMPA requires provincial drug supervision departments to investigate potential illegal activities by the companies involved and to publicly disclose the results of these investigations [5].

Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, highlighting quality control issues in the pharmaceutical industry [1][2][3]. Summary by Categories Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical are non-compliant due to particle size [1] - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) are non-compliant due to related substances [1] - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group is non-compliant due to relative density [1] - Two batches of tosylate capsules from Shaanxi Xiyue Pharmaceutical are non-compliant due to dissolution rate [1] - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical is non-compliant due to physical properties [1] - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhou Pharmaceutical are non-compliant due to weight differences [1] Additional Non-compliance Findings - Two batches of Qili Powder from Hubei Minkan Pharmaceutical are non-compliant due to content measurement [2] - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical are non-compliant due to dosage discrepancies [2] - Two batches of red peony from Sichuan Jinke Pharmaceutical and Sichuan Yixiangkang Pharmaceutical are non-compliant due to physical properties [2] - Three batches of red ginseng (red ginseng slices) from multiple companies are non-compliant due to identification issues and pesticide residue [2] - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical is non-compliant due to impurities [2] - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical is non-compliant due to content measurement [2] Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as halting sales and conducting recalls [3] - Investigations into the causes of non-compliance are required, along with corrective actions [3] - Provincial drug supervision departments are instructed to investigate potential illegal activities by the companies involved [3] Public Awareness Initiatives - The NMPA has provided educational information regarding the significance of various non-compliance indicators, such as particle size, related substances, relative density, dissolution rate, physical properties, weight differences, content measurement, identification, pesticide residues, total reducing sugars, impurities, and moisture content [4][5]

Summary of Key Points Core Viewpoint - The National Medical Products Administration (NMPA) has announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions from the involved companies [1][3]. Group 1: Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical are non-compliant due to particle size issues [1] - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) are non-compliant due to related substances [1] - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group is non-compliant due to relative density [1] - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical are non-compliant due to dissolution rate [1] - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical is non-compliant due to physical properties [1] - Two batches of Twenty-Five Flavor Coral Pills from Tibet Shenhui Pharmaceutical are non-compliant due to weight differences [1] Group 2: Additional Non-compliance Cases - Two batches of Qili Powder from Hubei Minkan Pharmaceutical are non-compliant due to content measurement [2] - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical are non-compliant due to dosage discrepancies [2] - Two batches of red peony from Sichuan Jinke Pharmaceutical and Sichuan Yixiangkang Pharmaceutical are non-compliant due to physical properties [2] - Three batches of red ginseng (red ginseng slices) from multiple companies are non-compliant due to identification issues and pesticide residue [2] - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical is non-compliant due to impurities [2] - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical is non-compliant due to content measurement [2] Group 3: Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [3] - Investigations into the causes of non-compliance are required, along with corrective actions [3] - Provincial drug supervision departments are instructed to investigate potential illegal activities by the companies involved [3]

Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions from the involved companies [1][3]. Summary by Categories Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical Factory failed due to particle size issues [1]. - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) Co., Ltd. did not meet standards due to related substances [1]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial (Group) Co., Ltd. failed due to relative density [1]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet standards due to dissolution rate [1]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical properties [1]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet standards due to weight differences [1]. Additional Non-compliance Cases - Two batches of Qili Powder from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [2]. - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical Co., Ltd. did not meet standards due to dosage discrepancies [2]. - Two batches of red peony from Sichuan Jinke Pharmaceutical Co., Ltd. and Sichuan Yixiangkang Pharmaceutical Co., Ltd. failed due to physical properties [2]. - Three batches of red ginseng (red ginseng slices) from multiple companies failed due to identification issues and pesticide residue [2]. - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical Co., Ltd. did not meet standards due to impurities [2]. - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical Co., Ltd. failed due to content determination [2]. Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [3]. - Investigations into the causes of non-compliance are required, and the NMPA will pursue legal actions against any violations [3]. - The NMPA provided public education on the significance of various non-compliance indicators, including particle size, related substances, relative density, dissolution rate, physical properties, weight differences, content determination, identification, pesticide residues, total reducing sugars, impurities, and moisture content [3][4].