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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)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-08-27 14:04
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].
国家药监局通告28批次药品不符合规定
Zhong Guo Xin Wen Wang· 2025-08-27 13:28
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]
国家药监局发布通告28批次药品不符合规定
Yang Shi Wang· 2025-08-27 09:29
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]
国家药监局今天通告28批次药品不符合规定
Yang Shi Xin Wen· 2025-08-27 09:18
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].
华邦健康(002004) - 002004华邦健康投资者关系管理信息20250826
2025-08-26 11:14
Group 1: Company Strategy and Performance - The company is committed to a "big health" development strategy, focusing on pharmaceuticals and medical services, and aims to enhance its full industry chain model, which includes raw materials, formulations, functional skincare products, and health management [2][3]. - For the first half of 2025, the company achieved a total revenue of CNY 594.5 million, a year-on-year increase of 0.39%, and a net profit attributable to shareholders of CNY 38.8 million, up 23.90% [3][4]. Group 2: Financial Health and Assets - As of June 30, 2025, the company's goodwill stood at CNY 2.032 billion, accounting for 6.85% of total assets, primarily from acquisitions of subsidiaries [4]. - The company maintains a good cash flow and plans to distribute a cash dividend of CNY 2 per 10 shares, pending approval at the upcoming shareholder meeting [6]. Group 3: Business Segments and Growth Areas - The pharmaceutical segment is seeing steady growth, with new product approvals and a focus on expanding market share in both prescription and retail markets [7][13]. - The agricultural chemical segment reported revenue of CNY 3.45 billion in the first half of 2025, a 3.26% increase year-on-year, with net profit rising by 436.21% [11]. - The tourism segment is leveraging its diverse resources across several 5A scenic areas, with a focus on enhancing visitor experience and increasing marketing efforts [12][13]. Group 4: Future Outlook and Investment Value - The company plans to continue expanding its pharmaceutical and healthcare services, with new product development and market expansion as key growth drivers [13][14]. - The company emphasizes its strong asset base, with three listed subsidiaries that are leaders in their respective fields, and a commitment to maintaining high dividend payouts [15].
华邦健康:多领域协同发力 上半年业绩实现稳步提升
Zheng Quan Shi Bao Wang· 2025-08-19 14:28
Core Insights - Company reported a revenue of 5.945 billion yuan for the first half of 2025, a year-on-year increase of 0.39%, and a net profit attributable to shareholders of 388 million yuan, a significant increase of 23.9% [1] - The company plans to distribute a cash dividend of 2 yuan per 10 shares, reflecting its commitment to shareholder returns [1] - The company has established a diversified structure with a focus on the health industry, covering five major sectors: pharmaceuticals, medical services, agrochemicals, new materials, and tourism [1] Pharmaceutical Sector - The company has strengthened its R&D investment, with several products receiving approvals, including the first generic version of calcipotriol betamethasone ointment, marking a significant breakthrough in psoriasis treatment [2] - The company is consolidating its prescription market advantage while actively expanding into domestic and overseas raw material markets, and has launched functional skincare products to enhance its product matrix [2] Medical Sector - The company has added new specialty clinics in its Chongqing Songshan Hospital, enhancing its medical service capabilities and achieving steady growth in consumer healthcare and health management [2] - The Beijing Huasheng Rehabilitation Hospital has increased its bed capacity to 457, with a steady rise in patient visits and solid progress in key rehabilitation disciplines [2] Agrochemical Sector - The agrochemical sector is experiencing a recovery in profitability due to improved supply-demand dynamics and price increases in certain product segments [3] - The company’s agrochemical business is stabilizing and contributing to overall performance growth [3] New Materials Sector - The new materials sector has seen an increase in orders and improved gross margins due to recovering demand and cost advantages [3] Tourism Sector - The tourism sector continues to show steady improvement, with the company actively seizing industry opportunities and enhancing market competitiveness [3] Strategic Focus - The company aims to continue developing a full industry chain model centered on "big health," integrating raw materials, formulations, functional skincare, health management, and medical services for sustainable long-term growth [3]
6月24日晚间重要公告一览
Xi Niu Cai Jing· 2025-06-24 10:33
Group 1 - China State Construction won multiple major projects with a total amount of 21.53 billion yuan, accounting for 1.0% of the audited revenue for 2024 [1] - Zhongtai Chemical's subsidiary has fully launched a methanol upgrading demonstration project, which will further reduce production costs [1] - Wide Special Materials expects a net profit increase of approximately 367.51% year-on-year for the first half of 2025, driven by improved demand and internal optimization [1][2] Group 2 - Longdi Group plans to exercise its preferential subscription rights to participate in the convertible bond issuance of its associate company, Yongqi Electronics, with an investment of no more than 89.249 million yuan [3] - Dayou Energy's subsidiary Mengjin Coal Mine has resumed production after a 38-day suspension due to an accident, with an annual capacity of 1.2 million tons [5] - Shanying International plans to repurchase shares worth between 500 million and 1 billion yuan, with a maximum repurchase price of 2.50 yuan per share [7] Group 3 - Huatai Securities has been approved to issue up to 10 billion yuan in technology innovation bonds to support investment in the technology innovation sector [9] - Weixin Kang's cooperative product, an injectable multivitamin, has passed the consistency evaluation, enhancing its market potential [10] - Jinpu Titanium's controlling shareholder will have 35 million shares auctioned, accounting for 3.55% of the company's total share capital [11] Group 4 - China Pharmaceutical plans to waive its preferential purchase rights for a 24% stake in Chongqing Medical Health Industry Co., with a base transfer price of 2.206 billion yuan [12] - Beijia Clean plans to reduce its shareholding by 1.99% due to funding needs [13] - Anpelon has obtained a design patent for a brake sensor, enhancing its technological capabilities [14] Group 5 - Zhongyue Holdings' subsidiary has received approval for a clinical trial application for a new drug, indicating progress in its pharmaceutical development [14] - Lijun Group's YJH-012 injection has been approved for clinical trials, showcasing its potential in treating gout [16] - Yageer has sold financial assets totaling 4.176 billion yuan, representing 10.13% of its audited net assets for 2024 [15] Group 6 - Tailing Micro expects a net profit increase of approximately 267% year-on-year for the first half of 2025, driven by customer demand and product sales [19] - Baotai plans to invest 287 million yuan to acquire a 51% stake in Shaanxi Wanhao Titanium Technology Co., enhancing its production capabilities [21] - Laime Pharmaceutical has received a drug registration certificate for azithromycin granules, expanding its product portfolio [23] Group 7 - KQ Bio has received approval for a new veterinary vaccine, marking a significant advancement in its product offerings [25] - Robotech signed a contract worth approximately 17.1 million euros, representing over 12.82% of its audited revenue for 2024 [26] - Alloy Investment is planning a control change, leading to a temporary suspension of its stock [27] Group 8 - Huabang Health's subsidiary has received approval for two dermatological drugs, indicating growth in its pharmaceutical pipeline [28] - Lingxiao Pump Industry plans to invest 60 million yuan in wealth management products, optimizing its financial strategy [29] - Jinzhong Technology has won projects totaling 113 million yuan, accounting for 6.39% of its expected revenue for 2024 [31] Group 9 - Yifan Pharmaceutical's subsidiary has received approval for a clinical trial of a growth hormone injection, indicating progress in its research and development [32] - Guiguan Electric plans to invest 395 million yuan in a photovoltaic project, reflecting its commitment to renewable energy [33] - Rili Technology intends to repurchase shares worth between 10 million and 20 million yuan, supporting its stock performance [34] Group 10 - Xingye Securities' chairman has resigned, leading to a change in leadership [35] - Jinko Solar has achieved third-party certification for its high-efficiency solar cells, setting a new industry record [37] - Changan Automobile's controlling shareholder has changed its name, reflecting a rebranding effort [38]
百诚医药(301096) - 301096百诚医药投资者关系管理信息2025-002
2025-06-20 11:08
Group 1: Company Overview and Investment Activities - The company is Hangzhou Baicheng Pharmaceutical Technology Co., Ltd., with stock code 301096 and abbreviation Baicheng Pharmaceutical [1] - The investor relations activities include online meetings and strategy sessions held from June 9 to June 20, 2025 [2] - Key participants include the Chairman and General Manager, Lou Jinfang, and the Financial Director and Board Secretary, Cheng Dandan [2] Group 2: Drug Development Progress - The company has multiple new drug pipelines, with 2 IND approvals for Class 1 new drugs targeting areas such as the nervous system and oncology [3] - The global market for central nervous system drugs exceeded $500 billion in 2023, with China's market at approximately ¥173.4 billion, indicating significant growth potential [3] - The central nervous system drug market in China is projected to grow from about ¥40 billion in 2025 to ¥200 billion by 2030 [3] Group 3: Specific Drug Projects - BIOS-0623 is a novel pain relief drug with advantages such as rapid onset and lower effective doses, showing superior efficacy compared to pregabalin [4] - BIOS-0632 is a strong AAK1 kinase inhibitor that demonstrates faster onset and better efficacy in diabetic neuropathic pain models compared to existing treatments [4] - BIOS-0629, a potential Best-in-Class second-generation XPO1 inhibitor, shows significant anti-tumor efficacy in various cancer models [5][6] Group 4: Market Trends and Opportunities - The global market for anti-tumor drugs reached $235.7 billion in 2023, with China's market at approximately ¥280 billion, driven by increasing cancer incidence [5] - The autoimmune disease drug market is expected to grow from $113.7 billion in 2018 to $176.7 billion by 2030, with a CAGR of 3.7% globally and over 20% in China [6][7] Group 5: Improved Drug Development - The company has over 20 projects in the improved drug category, with 11 receiving clinical approval, indicating a robust pipeline [10] - The market for improved drugs in China is expected to reach ¥560 billion by 2025, suggesting a favorable investment return [11][12] Group 6: Subsidiary Development - The subsidiary, Saimer Pharmaceutical, aims to become a global supplier of raw materials and formulations, with a production area of over 260 acres and 16.3 million square meters of GMP-compliant facilities [13][14] - Saimer has successfully registered 435 projects and has 49 products approved, showcasing its strong production capabilities [14] Group 7: CRO Business Status - The CRO/CDMO industry is experiencing a downturn due to cautious investment and increased competition, leading to a decline in orders [15][16] - Recent regulatory changes are expected to positively impact the CRO/CDMO sector, potentially restoring investment enthusiasm [16][17] Group 8: International Expansion Plans - The company is accelerating its internationalization efforts, establishing partnerships to enhance global resource connectivity [19] - Saimer has obtained the EU CEP certificate for minoxidil, marking a significant step in international business expansion [19]