登录新浪财经APP 搜索【信披】查看更多考评等级 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 ■ 申请内容：申报仿制药质量和疗效一致性评价。 审批结论：根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意 见》（国发〔2015〕44号）和《关于仿制药质量和疗效一致性评价工作有关事项的公告》（2017年第 100号）的规定，经审查，本品视同通过仿制药质量和疗效一致性评价。 醋酸地塞米松片为肾上腺皮质激素类药，主要用于过敏性与自身免疫性炎症性疾病。如结缔组织病，严 重的支气管哮喘，皮炎等过敏性疾病，溃疡性结肠炎，急性白血病，恶性淋巴瘤等。 本公司醋酸地塞米松片已批准上市的规格为0.75mg，药品批准文号为：国药准字H33020822，目前产品 执行标准为国家药品监督管理局药品注册标准YBH21732025。 三、对公司的影响及风险提示 浙江仙琚制药股份有限公司（以下简称"公司"）于近日收到国家药品监督管理局核准签发的关于醋酸地 塞米松片的《药品补充申请批准通知书》（通知书编号：2025B03820），公司醋酸地塞米松片通过仿 制药质量 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 非标准审计意见提示 □适用 √不适用 董事会审议的报告期利润分配预案或公积金转增股本预案 √适用 □不适用 是否以公积金转增股本 证券代码：000788 证券简称：北大医药 公告编号：2025-060 一、重要提示 本半年度报告摘要来自半年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规划，投 资者应当到证监会指定媒体仔细阅读半年度报告全文。 所有董事均已出席了审议本报告的董事会会议。 □是 √否 公司经本次董事会审议通过的利润分配预案为：以595,987,425股为基数，向全体股东每10股派发现金红 利0.30元（含税），送红股0股（含税），不以公积金转增股本。 董事会决议通过的本报告期优先股利润分配预案 □适用 √不适用 二、公司基本情况 1、公司简介 ■ 2、主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是 √否 ■ 3、公司股东数量及持股情况 单位：股 ■ 持股5%以上股东、前10名股东及前10名无限售流通股股东参与转融通业务出借股份情况 □适用 √不适用 前10名股东及前10名无限售流通股股东因转融通出借/归还原因导 ...

Core Viewpoint - Tianyao Pharmaceutical's subsidiary Tianyao Heping has received approval for two types of peritoneal dialysis solutions, which will enhance the company's market competitiveness in this product line [1][2]. Group 1: Product Approval and Market Impact - Tianyao Heping's peritoneal dialysis solutions (lactate-G1.5% and lactate-G2.5%) have passed the consistency evaluation for generic drugs, allowing them to be marketed [1]. - The domestic sales forecast for lactate-G1.5% is projected to be 1.548 billion yuan in 2023 and 1.689 billion yuan in 2024, while lactate-G2.5% is expected to generate sales of 743 million yuan in 2023 and 840 million yuan in 2024 [1]. - The approval will lead to appropriate support in medical insurance payments and priority procurement by medical institutions [1]. Group 2: Company Strategy and Development - The company is committed to an integrated development strategy of raw materials and formulations, focusing on steroid hormones and amino acid raw materials [2]. - Tianyao Pharmaceutical has made significant progress in new product research and development, consistency evaluation, and drug registration, with 32 products passing the consistency evaluation and 18 obtaining drug registration certificates [2]. - Several key formulation products have achieved annual sales exceeding 100 million yuan [2].

Core Viewpoint - The article discusses the significant impact of centralized procurement (集采) on the pharmaceutical industry in China, highlighting its role in reducing drug and medical supply costs, improving accessibility, and reshaping the industry ecosystem through enhanced regulatory measures and quality assessments [2][4][6]. Group 1: Achievements of Centralized Procurement - Centralized procurement has led to a substantial reduction in drug prices, with examples such as the price of the hepatitis B antiviral drug entecavir dropping from 5000 yuan to 200 yuan, significantly improving patient adherence to treatment [3][4]. - The number of chemical drug manufacturers has decreased from 4800 to below 2200, indicating a consolidation in the industry driven by cost pressures and efficiency improvements [6]. - The proportion of innovative drugs in China's biopharmaceutical R&D pipeline increased from 25% in 2018 to 45% in 2023, reflecting a shift towards innovation as companies redirect savings from marketing to R&D [5][6]. Group 2: Regulatory and Quality Improvements - The centralized procurement system has established a comprehensive regulatory framework involving multiple departments, ensuring quality control and accountability throughout the supply chain [4][15]. - The approval rate for consistency evaluations of generic drugs has risen from 25.2% in 2018 to 89.1% in 2024, indicating improved quality assurance in the production of generics [5]. - The implementation of a "zero tolerance" policy for quality issues has led to rigorous oversight, including unannounced inspections of selected enterprises, enhancing compliance and safety standards [15][18]. Group 3: Market Environment and Competition - The introduction of unified procurement rules has eliminated regional disparities and discriminatory pricing, fostering a more equitable competitive landscape for pharmaceutical companies [7][8]. - The centralized procurement policy encourages competition between original and generic drugs, allowing healthcare providers to choose based on clinical needs while maintaining patient access to essential medications [11][12]. - The market has seen a shift towards a more collaborative ecosystem, with upstream and downstream players in the pharmaceutical supply chain working together to optimize resources and reduce costs [6][8]. Group 4: Challenges and Future Directions - Despite the successes, challenges remain, such as the need for improved public trust in generic drugs and addressing concerns about the quality of low-priced products [9][10]. - The government aims to optimize procurement policies to address emerging issues, focusing on quality assessments and regulatory compliance to ensure patient safety [8][12]. - Future efforts will include enhancing transparency in the procurement process and encouraging pharmaceutical companies to share data on drug evaluations and production practices [19][20].

Core Viewpoint - The company has received the drug registration certificate for Cefprozil Dry Suspension from the National Medical Products Administration, which will enhance its product line and positively impact its development [1][2]. Drug Information - Drug Name: Cefprozil Dry Suspension - Dosage Form: Oral Suspension - Registration Category: Chemical Drug Class 3 - Specification: 2.5g (based on C??H??N?O?S) - License Holder: Hainan Huluwa Pharmaceutical Group Co., Ltd. - Acceptance Number: CYHS2302198 - Drug Approval Number: National Drug Approval H20254800 - Approval Conclusion: The drug meets the registration requirements and has been granted a registration certificate, pending compliance inspection for production quality management [1][2]. R&D and Related Information - Cefprozil is a cephalosporin antibiotic originally developed by Bristol-Myers Squibb Company, indicated for mild to moderate infections caused by sensitive bacteria, including: 1. Streptococcal pharyngitis/tonsillitis 2. Otitis media and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis (including beta-lactamase producing strains) 3. Acute bronchitis secondary bacterial infections and acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis (including beta-lactamase producing strains) 4. Non-complex skin and soft tissue infections caused by bacteria, although abscesses typically require surgical drainage [2]. - The company has invested a total of RMB 4.9474 million (approximately 0.49474 million) in the R&D of this product [2]. - As of the announcement date, eight other companies in China have also been approved to produce Cefprozil Dry Suspension, with a total of 13 specifications approved [2].

Core Viewpoint - The approval of Mesalazine enteric-coated tablets (0.5g) by the National Medical Products Administration of the People's Republic of China marks a significant advancement for the company in the field of immunotherapy products, enhancing its product line in this area [1] Group 1: Product Approval - The company has received a drug registration certificate for Mesalazine enteric-coated tablets, which is considered equivalent to passing the consistency evaluation of generic drug quality and efficacy [1] - This product is primarily used for the treatment of ulcerative colitis, including both acute episodes and maintenance therapy to prevent recurrence, as well as for the treatment of acute episodes of Crohn's disease [1] Group 2: Mechanism of Action - Mesalazine works by regulating inflammatory indicators in the intestinal mucosa, inhibiting the synthesis of prostaglandins and the formation of inflammatory mediators such as leukotrienes, thereby achieving its anti-inflammatory effects [1] - The product demonstrates significant inhibitory effects on inflammation in the intestinal wall connective tissue, making it a widely used aminosalicylate anti-inflammatory drug globally [1] Group 3: Market Impact - The approval of this product will further enrich the company's product line in the immunotherapy sector, potentially increasing its market presence and competitiveness in the pharmaceutical industry [1]

Group 1 - The company, Prolog Pharma, announced that its wholly-owned subsidiary, Zhejiang Jutai Pharmaceutical Co., Ltd., received a drug registration certificate for Cefaclor capsules from the National Medical Products Administration [1] - The drug is indicated for bacterial infections caused by Streptococcus and other bacteria sensitive to Cefaclor [1] - The projected market size for the Chinese hospital market in 2024 is 455 million capsules, with a sales value of 387 million yuan [1] Group 2 - As of the announcement date, the total R&D investment for Cefaclor capsules amounted to 6.1 million yuan [1] - Obtaining the registration certificate is equivalent to passing the consistency evaluation of generic drug quality and efficacy, which qualifies the product for subsequent centralized procurement [1] - This development is expected to enhance the company's market competitiveness [1]

Core Viewpoint - Yuheng Pharmaceutical (002437) announced that its wholly-owned subsidiary, Pude Pharmaceutical, received approval from the National Medical Products Administration for the injection of multiple vitamins (12) [1] Group 1: Product Approval and Market Potential - The injection of multiple vitamins (12) has passed the consistency evaluation of generic drug quality and efficacy [1] - The product is intended for adult and pediatric patients aged 11 and above, with projected sales in urban public hospitals and county-level public medical institutions in China amounting to 1.916 billion yuan in 2024 [1] Group 2: R&D Investment - Pude Pharmaceutical has invested approximately 3.6706 million yuan in the consistency evaluation work for this product [1]

Group 1 - The core point of the announcement is that Harbin Pharmaceutical Group Co., Ltd. has received approval for its Norfloxacin capsules to pass the consistency evaluation of generic drug quality and efficacy by the National Medical Products Administration [1][2] - The drug Norfloxacin capsules are indicated for urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid, and other salmonella infections [1] - The company has invested approximately 7.5972 million RMB in the research and development of the drug for the consistency evaluation [2] Group 2 - As of the announcement date, there are 586 production licenses for Norfloxacin capsules in China, with 15 manufacturers having passed the consistency evaluation [2] - The retail market sales for Norfloxacin capsules in 2023 were 530 million RMB, while the projected sales for 2024 are 441 million RMB [2] - The approval is expected to enhance the market share and competitiveness of the drug, providing valuable experience for the company in future evaluations of other products [2]

Core Viewpoint - The State Council emphasizes the need to strengthen the evaluation of drug and consumable procurement policies to ensure public confidence in medication [1] Group 1: Policy Evaluation and Implementation - The meeting highlighted the importance of summarizing experiences and addressing shortcomings in drug and consumable procurement policies [1] - There is a push for the standardization and institutionalization of procurement work to ensure its regular implementation [1] Group 2: Healthcare System Improvement - The meeting aims to better promote the coordinated development of the "three medical" systems (medical services, medical insurance, and pharmaceuticals) [1] - It calls for the improvement of public hospital compensation mechanisms to support the innovation capabilities of pharmaceutical companies [1] Group 3: Quality Control and Assurance - There is a focus on enhancing quality supervision across the entire chain of drug and consumable production, circulation, and usage [1] - The initiative includes advancing the consistency evaluation of the quality and efficacy of generic drugs to ensure public safety in medication [1]