12月29日，又一药企复合磷酸氢钾注射液（膳维喜）获国家药监局批准上市，作为磷酸补充剂用于临床。这款年销超4亿元、同比增长27.3%的临床"硬通 货"，在持续增长的市场中迎来了又一位竞争者。 在这次获批前，国内已有24家药企拥有该品种的生产批文，其中19家已通过一致性评价，市场竞争格局已相当稳定。然而，申报热情不减。目前仍有15家药 企提交了3类仿制药上市申请，正处于审评审批的阶段。这反映出企业对该品种市场价值的持续看好。 截图来源：全终端医院销售数据库 截图来源：企业公告 复合磷酸氢钾注射液是临床纠正成人及儿童低磷血症的关键药物，尤其在患者无法经口补充时，是维持生命体征稳定的静脉磷钾"精准补给方案"。与常规营 养制剂不同，其定位于满足特定临床场景下的电解质精准补充，属于治疗性刚需。该品种被纳入国家医保乙类目录多年，临床认知与使用已高度成熟。 市场数据印证了其价值。据摩熵医药数据库显示，该品种近三年在全终端医院市场保持稳定增长，2024年销售额突破4亿元，同比增长27.3%，在血液代用 品与灌注液品类中稳居市场前列。此次获批，正值该市场处于明确的扩容时期。 | 按受理号浏览(13) | 按品种浏览(1) | ...

Group 1 - The core point of the article discusses the frequent changes in top management at companies like Kang En Bei, questioning the effectiveness of such changes in boosting performance during challenging times [1][6] - Kang En Bei has recently experienced a wave of executive turnover, with the resignation of Chairman Jiang Yi and board member Jiang Qian, both of whom were expected to serve until August 2027 [2][3] - The company has a history of management changes, with significant shifts occurring since the entry of Zhejiang Guomao Group in 2020, leading to concerns about the stability of its strategic direction [8][9] Group 2 - Kang En Bei's financial performance has stagnated, with revenue figures from 2020 to 2024 showing minimal growth, and the latest quarterly report indicating a slight year-on-year revenue increase of 1.27% [10][11] - The company's revenue breakdown for the first three quarters of 2025 shows that the traditional Chinese medicine segment remains the largest contributor, but sales of key products have not recovered, and the health consumer goods segment is still underperforming [10] - The stock price of Kang En Bei has been in decline, with a reported market value of 11.69 billion yuan, down approximately 80% from its peak [11]

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].

Core Points - Shanghai Sunshine Pharmaceutical Procurement Network announced the suspension of procurement qualifications for acetylcysteine effervescent tablets produced by Zhejiang Jinhua Kang En Bei Biological Pharmaceutical Co., Ltd. [1] - The suspension is based on the National Medical Products Administration's announcement regarding 28 batches of non-compliant drugs [1]. Company Overview - Zhejiang Jinhua Kang En Bei Biological Pharmaceutical Co., Ltd. is a subsidiary of Zhejiang Kang En Bei Pharmaceutical Co., Ltd. (600572) and specializes in chemical pharmaceuticals [1]. - The company holds a leading position in specialized chemical raw materials and freeze-dried, controlled-release formulations in China [1]. - It is recognized as a key pharmaceutical enterprise in Zhejiang Province and a national high-tech enterprise [1]. - The company was established in April 1958 and became a member of Kang En Bei Group in September 1996, achieving indirect listing in 2007 [1]. - In April 2020, the Zhejiang Provincial State-owned Assets Supervision and Administration Commission became the actual controlling shareholder [1].

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].