21世纪经济报道记者贺佳雯 北京报道 第十一批集采有了最新进展！ 此前，记者曾参与集采有关座谈会，与国家医保局相关人士、业内专家共同研讨了今年集采规则的考 量。会上，国家医保局价格招采司负责人公布，今年有4.6万家医疗机构参加了本次集采报量，报量的 77％具体到了品牌，23%按通用名报量。 有哪些重点变化值得关注？如何影响企业决策？企业应该如何调整？ 新变一：报量77%具体到品牌，新增"未入围复活" 市场关心集采的焦点还是保障临床用药需求，这也是优化集采措施的重点。 第十一批集采中，最值得关注的新变化就是优化医疗机构报量方式。从既往的化药集采中，医疗机构按 药品通用名报量，变化为此次医疗机构既可像以前那样按通用名报量，也可按具体品牌报量。医疗机构 报量的品牌如果中选，将直接成为该医疗机构的供应企业，提高临床需求与供应的匹配度。 对于这一新变化，北京宣武医院药剂科主任张兰告诉记者，医院报量的核心考虑就是原有实际诊疗现 状，药品的疗效和安全性。尊重临床用药习惯，医院的希望就是集采不要改变原有用药，所以原本用什 么品牌就会报什么品牌。 相对应地，规则也随着医院报量调整——采取更贴近临床用药实际的中选规则。对于医疗机 ...

Investment Rating - The report maintains a "Market Weight" rating for the pharmaceutical and biotechnology industry, indicating that the industry is expected to perform within ±10% of the market index over the next six months [6][29]. Core Insights - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, with a gain of 1.36% from September 5 to September 18, 2025, lagging behind the index by approximately 1.66 percentage points [5][13]. - Most sub-sectors within the industry recorded positive returns during the same period, with the medical research outsourcing and medical equipment sectors leading with increases of 8.17% and 5.83%, respectively, while the chemical preparations sector saw a decline of 0.96% [5][14]. - Approximately 48% of stocks in the industry achieved positive returns, with notable performers including Zhendemedical, which had a weekly increase of 62.30% [15][18]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, gaining 1.36% from September 5 to September 18, 2025, which is 1.66 percentage points lower than the index [5][13]. - Most sub-sectors recorded positive returns, with medical research outsourcing and medical equipment sectors leading [5][14]. - About 48% of stocks in the industry recorded positive returns, with Zhendemedical showing the highest weekly increase [15][18]. - The overall industry valuation remained stable, with a PE ratio of approximately 56.10 times as of September 18, 2025, which is 4.26 times relative to the Shanghai and Shenzhen 300 index [19][29]. 2. Industry News - The report highlights the upcoming release of the 11th batch of national drug procurement rules, with discussions held on various aspects of the procurement process [6][27]. - The National Health Commission issued a notification regarding the 2025 version of medical quality control indicators, emphasizing the importance of a scientific and standardized quality control system [23][26]. 3. Company Announcements - Changchun High-tech announced a collaboration with Denmark's ALK-Abelló A/S for the development and commercialization of specific immunotherapy products in China [28]. 4. Weekly Industry Outlook - The report suggests maintaining a focus on investment opportunities in innovative drugs and sectors with expected business development catalysts, particularly in medical devices and pharmaceutical commerce [29][30].

Core Viewpoint - The company Changshan Pharmaceutical is facing multiple crises including financial deterioration, failed collective procurement, and high debt, challenging its aspirations for a turnaround through innovative drugs [2][3]. Financial Performance - In the first half of 2025, the company reported total revenue of 492 million yuan, a year-on-year decline of 13.42%, and a net profit attributable to shareholders of -29.09 million yuan [2]. - The company experienced a significant drop in second-quarter performance, with revenue decreasing nearly 10% quarter-on-quarter to 233 million yuan and a net profit loss of 32.87 million yuan, a staggering decline of 322.67% [4][5]. - The gross profit margin fell to 5% in the second quarter, marking a new low, and the overall gross profit margin for the first half of 2025 was 14.54%, down 8.28 percentage points year-on-year [6][8]. Business Segments - The company's main business remains heavily reliant on the heparin industry chain, with low molecular weight heparin preparations and heparin raw materials contributing 60.57% of total revenue [11]. - The revenue from low molecular weight heparin preparations was 204 million yuan, accounting for 41.46% of total revenue, but sales volume dropped by 19.17% year-on-year due to collective procurement policies [11][12]. Market Dynamics - The domestic heparin market is characterized by intense competition, with leading companies dominating the raw material export market, putting pressure on Changshan Pharmaceutical in the mid-to-low-end preparation market [13][14]. - The collective procurement policy has significantly reduced heparin preparation prices by over 50%, severely compressing profit margins for traditional product lines [14]. Innovation and R&D - The company’s R&D expenses decreased by 30.13% in the first half of 2025, primarily due to reduced direct investment in clinical trials for its drug Abenatide, which has faced delays in approval processes [17][18]. - The competitive landscape for GLP-1 drugs is intensifying, with several similar products already on the market, raising concerns about the differentiation and market potential of Changshan Pharmaceutical's Abenatide [18][19]. - The clinical progress of another innovative drug, CSCJC3456, has been slow, with the company still in the patient enrollment phase for its Phase I trial, lagging behind industry averages [19].

Core Viewpoint - Heng Rui Medicine's HRS9531 injection application has been accepted by the National Medical Products Administration, marking a significant step in the competitive landscape of GLP-1/GIP dual receptor agonists in China [1][12]. Group 1: Product Development and Clinical Trials - HRS9531 is designed for long-term weight management in adults with a BMI of ≥28 kg/m² (obesity) or ≥24 kg/m² (overweight) with at least one weight-related comorbidity [3]. - The drug operates by activating both GLP-1 and GIP receptor pathways, which enhances weight loss and glucose control, showcasing a synergistic effect [3]. - Phase III clinical trials demonstrated that the 6mg dose group achieved an average weight loss of 19.2%, with 44.4% of participants losing ≥20% of their body weight [4]. Group 2: Market Position and Competition - HRS9531 is the first GLP-1/GIP dual receptor agonist to submit a market application in China, positioning it as a leading candidate in the domestic market [4][6]. - The drug's efficacy is comparable to that of the leading product, Tirzepatide, which showed a 20.9% weight loss in a similar study [6]. - The competitive landscape is intensifying, with multiple domestic companies, including Innovent Biologics and others, preparing to launch their own GLP-1 products by 2025 [7][10]. Group 3: Commercialization and Future Outlook - Heng Rui has established a global commercialization strategy for HRS9531, including a significant licensing deal with Kailera Therapeutics worth up to $59.25 billion [6]. - The market for GLP-1 drugs is projected to face price competition as several products are expected to launch in the next 1-2 years, potentially reshaping the market dynamics [8][12]. - The approval of HRS9531 is anticipated to provide effective and accessible treatment options for overweight and obese patients in China, enhancing the country's pharmaceutical innovation status globally [12][14].

Overview - The demand for Edaravone in China is driven by a large population of stroke patients, with sales peaking at 5.548 billion yuan in 2016 [1][8]. - The sales dropped significantly to 1.53 billion yuan by 2024 due to regulatory changes and market dynamics [1][9]. Development History - Edaravone was first approved in Japan in 2001 and introduced to China by Xiansheng Pharmaceutical in 2003 [3][4]. - The market demand grew rapidly from 2015 to 2018, establishing Edaravone as a key product in the neuropharmaceutical sector [3][5]. Market Dynamics - In 2019, Edaravone was included in the first batch of the National Key Monitoring Rational Drug Use Directory, leading to a decline in sales [4][5]. - The seventh batch of national drug procurement initiated in 2022 further impacted sales, with Edaravone being the only drug from the monitoring list to be included in the procurement [5][9]. Industry Chain - The upstream of the Edaravone industry includes raw materials, intermediates, packaging, and pharmaceutical equipment [6]. - The midstream consists of production companies, while the downstream includes hospitals and pharmacies, with hospitals being the primary distribution channel [7]. Market Background - Edaravone is primarily used for treating acute ischemic stroke, with its effectiveness linked to timely administration within 48 hours post-stroke [8]. - The aging population in China has led to an increase in stroke and other neurological disease incidences, with stroke patients reaching 27.461 million by 2024 [8]. Competitive Landscape - The Edaravone market in China is highly concentrated, with 54 approved products from 32 companies as of August 2025 [10]. - Xiansheng Pharmaceutical is the leading company, having launched the first Edaravone injection in China [10][11]. Company Profiles - Xiansheng Pharmaceutical reported a total revenue of 6.635 billion yuan in 2024, with a gross profit of 5.325 billion yuan and a gross margin of 80.25% [11]. - Jilin Boda Pharmaceutical, a key player, has a production capacity of 3 million 10ml and 2 million 20ml Edaravone injections annually, with a revenue of 733.38 million yuan in 2024 [12]. Future Trends - Innovations in Edaravone formulations are expected, including the development of oral tablets, which could enhance patient compliance [13]. - The expansion of insurance coverage and accelerated drug approvals are anticipated to increase market accessibility and demand, although cost control will be essential due to potential pricing pressures from insurance policies [13].

Group 1 - The core point of the article is that 石四药集团 (Shijiazhuang Pharmaceutical Group) has seen a significant stock price increase of nearly 14% following the announcement of obtaining production registration approvals for two pharmaceutical products from the National Medical Products Administration of China [1] - The company has received production registration approvals for 乌拉地尔缓释胶囊 (Urapidil Sustained-release Capsules, 30mg) and 盐酸尼卡地平氯化钠注射液 (Nicardipine Hydrochloride Sodium Injection, 200ml), both classified as Category 3 chemical drugs, marking them as the first domestic company to receive such approvals [1] - Additionally, the company has obtained production registration approval for 盐酸屈他维林注射液 (Sufentanil Hydrochloride Injection, 2ml), classified as a Category 4 chemical drug, also indicating successful consistency evaluation [1] Group 2 - Citigroup's research report indicates that in the 11th round of drug procurement, 石四药集团 has 11 drugs, including Bromhexine, which is expected to account for approximately 1.5% of projected sales in 2024 [1] - The report suggests that the company has a strong chance of winning contracts for peritoneal dialysis solutions and renewing contracts for other products [1] - Citigroup views 石四药集团 as a winner among generic drug companies and the largest beneficiary of drug procurement policies [1]

Core Viewpoint - Kelun Pharmaceutical (002422) announced on September 1 that the 11th round of centralized procurement involves approximately 14 products, most of which are newly approved products, resulting in minimal impact on existing products [1] Group 1: Business Performance - Over the past three years, the revenue and profit of the generic drug segment have shown stable growth, attributed to the company's position as a leading supplier in centralized procurement and the rapid market release of new products [1] - The company has consistently implemented a cost leadership strategy, leading to a year-on-year decrease in the unit production cost of generic drugs [1] Group 2: Current Challenges - In the first half of this year, the generic drug segment faced pressure mainly due to the 10th round of centralized procurement and price declines of some renewed products, while new winning products have not yet contributed to incremental growth [1] Group 3: Future Outlook - Despite the intense competition in the centralized procurement environment and limited profitability per product, the company continues to invest steadily in the research and development pipeline for generic drugs and has adjusted its R&D strategy to focus on advantageous products and pipelines, maintaining a positive outlook for the future [1]

Investment Rating - The report maintains a "Buy" rating for the company [4] Core Insights - The commercialization of the core innovative drug, Dazisini, has achieved significant progress, with over 1,500 hospitals covered and a revenue of 55 million yuan in H1 2025 [2][4] - The company has seen a decline in revenue due to price reductions from centralized procurement policies, leading to a downward adjustment in net profit forecasts for 2025-2027 [4] Financial Performance Summary - In H1 2025, the company reported total revenue of 2.017 billion yuan, a decrease of 6.20% year-on-year, with finished drug revenue at 1.175 billion yuan, down 9.68% [1] - The net profit attributable to the parent company was 388 million yuan, a decline of 3.54% year-on-year, while the non-recurring net profit increased by 7.78% to 360 million yuan [1] - The operating cash flow was 393 million yuan, down 17.48% year-on-year, with an EPS of 0.46 yuan [1] Revenue and Profit Forecast - The revenue forecast for 2025 is adjusted to 4.1 billion yuan, with net profit estimates revised to 788 million yuan, reflecting a decrease of 13% from previous estimates [4] - The company is expected to see a gradual recovery in revenue growth, with projections of 4.58 billion yuan in 2026 and 5.068 billion yuan in 2027 [10] R&D Pipeline Progress - The company is advancing its R&D pipeline in the fields of mental health, cardiovascular, and digestive diseases, with several products in various stages of clinical trials [3][9]

湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 说明： 1、主营业务分行业情况中，"医疗业务及其他"为子公司永州方盛天鸿肿瘤医院 有限公司医疗服务业务收入、子公司重庆筱熊猫药业股份有限公司和湖南方盛锐新药业 有限公司（分别于 2024 年 4 月、6 月后不再纳入合并范围）医药销售业务收入、子公司 广东暨大基因药物工程研究中心有限公司的医药技术服务收入、子公司云南芙雅生物科 技有限公司植物提取产品收入； 证券代码：603998 证券简称：方盛制药 公告编号：2025-077 湖南方盛制药股份有限公司 2025年半年度经营数据公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 根据《上市公司行业信息披露指引第六号——医药制造》的 相关规定，湖南方盛制药股份有限公司（以下简称"公司"）现 将 2025 年上半年度主要经营数据披露如下（单位：元，人民币）： | | | ...

Core Viewpoint - Fosun Pharma reported a decline in revenue but an increase in net profit for the first half of 2025, indicating a mixed performance influenced by various factors [1][2]. Financial Performance - In the first half of 2025, Fosun Pharma achieved operating revenue of approximately 19.514 billion yuan, a year-on-year decrease of 4.63% [1]. - The net profit attributable to shareholders was about 1.702 billion yuan, reflecting a year-on-year increase of 38.96% [1]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was approximately 0.961 billion yuan, showing a year-on-year decrease of 23.39% [1]. Asset and Liability Management - As of June 30, 2025, Fosun Pharma's asset-liability ratio was 49.24%, slightly up from 48.98% at the end of 2024 [2]. - The decrease in operating revenue was primarily due to the impact of centralized drug procurement policies, although revenue from innovative drugs showed steady growth [2]. Operational Insights - The company reported a net cash flow from operating activities of 2.134 billion yuan, an increase of 11.90% year-on-year [2]. - Fosun Pharma has signed agreements to dispose of non-core assets totaling over 2 billion yuan since the beginning of 2025 [2]. Business Segments - Fosun Pharma's core business includes pharmaceuticals, medical devices, and health services, with a focus on innovative drugs, mature products, and vaccines [3]. - In the first half of 2025, the company received approvals for 5 indications of 4 innovative drugs and 57 generic drug varieties [3]. - Research and development expenditures totaled 2.584 billion yuan, with 1.717 billion yuan specifically allocated for R&D [3]. Industry Context - The pharmaceutical industry is undergoing significant changes due to the normalization of drug procurement and ongoing support for innovative drug policies [4]. - The company faces risks from policy adjustments, market competition, and potential mismatches between drug development and clinical needs [4]. Strategic Responses - Fosun Pharma aims to track industry and policy trends, enhance R&D efficiency, and optimize product structure [5]. - The company plans to improve operational efficiency and expand market coverage through increased marketing efforts [5].