证券代码：002038 证券简称：双鹭药业 双鹭药业上市公司投资者关系活动记录表 中进入国家集采的药品有替莫唑胺、来那度胺、奥硝唑，进入省际联盟 及地方集采的药品有重组人粒细胞刺激因子注射液、胸腺五肽、白介素 -2、白介素-11 等药品，前一类均有超过 50%的价格下降，后一类也在平 均 15%左右的价格下降，这也导致公司主营业务 2023 年、2024 年出现 较大波动，扣除甲流流行期间相关抗流感产品畅销的因素，销售收入均 出现了较大下降。至 2025 年前三季度，公司主营业务收入同比呈现 15.40%的下降，至目前来那度胺、奥硝唑已淡出公司销售收入前十名产 品目录，替莫唑胺的下降幅度也逐步收窄。由此可见，这些产品对公司 的影响已逐步弱化，未来新产品的增量变化才是公司未来业绩能否恢复 增长的关键。 2、请介绍一下公司近两年新上市产品的集采中标情况，能否使公 司再次进入稳步增长局面。 最近两年，公司新上市的新产品在国家药品集采中中标的有抗真菌 产品伏立康唑片、伏格波列糖片、普瑞巴林口服溶液、依帕司他片、阿 加曲班、赛洛多辛胶囊等，这些产品大多是上市不久即赶上国家集采而 中标，特别是抗真菌产品伏立康唑片目前已进 ...

Group 1: National Drug Procurement - The 11th batch of national drug centralized procurement includes 55 drugs, covering common medications in areas such as anti-infection, anti-allergy, anti-tumor, blood sugar, blood pressure, and blood lipid reduction [1] - The average price difference of selected products has significantly narrowed compared to previous batches, indicating a more competitive environment [1] - Measures such as excluding products with a scale below 100 million yuan from procurement and setting "anchor prices" have been implemented to maintain a reasonable selection rate and promote rational competition among companies [1] Group 2: Xingqi Eye Pharmaceutical - Xingqi Eye Pharmaceutical reported a revenue of approximately 1.904 billion yuan for the first three quarters, a year-on-year increase of 32.27% [2] - The net profit attributable to shareholders reached approximately 599 million yuan, reflecting a substantial year-on-year growth of 105.98% [2] - The increase in revenue is primarily driven by the sales growth of eye drop products, showcasing the company's strong market competitiveness in a challenging environment [2] Group 3: Novartis - Novartis reported a total revenue of 41.196 billion USD for the first three quarters, representing an 11% year-on-year growth [3] - Revenue from the Chinese market for the same period reached 3.2 billion USD, with a year-on-year growth of 5% [3] - The company has ten blockbuster products with cumulative sales exceeding 1 billion USD, indicating solid market competitiveness despite a slowdown in growth in China [3] Group 4: Qianxin Biotech and Roche - Qianxin Biotech announced a global exclusive licensing agreement with Roche for its self-developed long-acting dual antibody QX031N, receiving an upfront payment of 75 million USD [4] - The agreement includes potential milestone payments of up to 995 million USD and tiered royalties on future product sales [4] - This collaboration highlights Qianxin Biotech's R&D competitiveness and the recognition of Chinese innovative pharmaceutical companies by multinational firms, potentially attracting more capital to the Chinese innovation drug sector [4] Group 5: Haili Biotech - Haili Biotech responded to a regulatory inquiry regarding its semi-annual report, explaining the high accounts receivable due to industry pressures and efforts to maintain core customer relationships [5] - The company indicated that the increase in accounts receivable is a strategic move, but it may pose long-term risks if collections are ineffective [5] - Investors are advised to closely monitor the company's accounts receivable management and industry conditions to assess its long-term investment value [5]

Core Viewpoint - The company aims to actively participate in national drug procurement while optimizing its product structure and enhancing its core competitiveness to maintain stable development in response to industry policy changes [1]. Group 1 - The company announced on September 26 that it will respond to industry policy changes [1]. - The company plans to actively engage in national drug procurement [1]. - The company is focused on market expansion and improving its product structure to increase risk resistance [1]. Group 2 - The company aims to enhance its core competitiveness [1]. - The company strives to achieve stable development amidst changing industry dynamics [1].

Core Viewpoint - The National Drug Centralized Procurement Office has announced the new centralized procurement document, emphasizing principles of clinical stability, quality assurance, prevention of collusion, and reduction of competition pressure in the pharmaceutical industry [1][3]. Summary by Sections Centralized Procurement Announcement - The announcement requires participating drugs to obtain valid domestic registration by September 28 and complete information submission on the National Medical Insurance Service Platform, with the bidding ceremony scheduled for October 21, 2025 [1]. Changes in Procurement Rules - The new procurement rules introduce a "benchmark price" for the same drug category, set at 50% of the average unit comparable price of validly declared companies and the higher value of the lowest unit comparable price. Companies can qualify for selection if their bid is below 1.8 times the benchmark price, a shift from the previous model that focused solely on the lowest price [3]. Participation and Reporting - A total of 46,359 medical institutions participated in the reporting, with 77% reporting by brand name and 23% by generic name. The drug list remains unchanged with 55 varieties, but mainstream specifications and prices have been noted [3]. Sodium Bicarbonate Injection Reporting - The total reported quantity of sodium bicarbonate injection across 31 provinces reached 71.5665 million units, with unspecified brands accounting for 47.45% of the total [5][9]. Manufacturer Performance - Among the specified brands, six manufacturers reported over 1 million units, with Shijiazhuang Fourth Pharmaceutical Company leading at 9.6542 million units, followed by Hebei Tiancai Pharmaceutical Co., Ltd. at 5.6166 million units [7][9]. Regional Preferences - Regional preferences for manufacturers are evident, with Yunnan showing a strong preference for Hebei Tiancai Pharmaceutical, while Shijiazhuang Fourth Pharmaceutical has a balanced national coverage [9][10]. Market Dynamics Ahead of Bidding - As the bidding date approaches, the market dynamics for sodium bicarbonate injection are expected to shift, influenced by brand preferences and the flow of unspecified brands, with companies that possess capacity, quality, and clinical recognition likely to emerge as winners in this round of procurement [10].

Summary of the Conference Call on the 11th National Drug Procurement Industry Overview - The conference call discusses the 11th batch of National Drug Procurement in China, focusing on the pharmaceutical industry and its regulatory environment. Key Points and Arguments Core Objectives of the 11th Batch Procurement - The primary goal remains "stabilizing clinical use" by ensuring continuity of essential medications and minimizing drug substitutions, with a reported actual reporting rate of around 50% for drugs not reported by brand name [1][8] Changes in Procurement Rules - Introduction of brand-name reporting and quantity distribution mechanisms aims to reduce competition and ensure drug quality, but may limit new entrants, particularly those with innovative formulations [1][6] - The requirement for at least two years of formulation production experience and GMP compliance documentation is expected to impact around 50 product approvals, potentially excluding new entrants [1][5][19] Competitive Landscape - The average number of competing companies per product has increased to 16, indicating intensified competition compared to 13 in the previous batch [5][15] - The new pricing anchor mechanism (average price at 50% and minimum price at 1.8 times) has limited effectiveness, as most bids remain below the average price [1][16] Marketing and Sales Strategies - Companies are encouraged to invest in marketing to drive hospital reporting from the product launch phase, rather than waiting for procurement results [1][17] Price Reduction Expectations - The anticipated price reduction in this batch is expected to be more severe than in the previous batch, with some products facing competition from over 16 companies [15] - The overall average price reduction is unlikely to be milder than in the 10th batch, with significant downward pressure on prices due to intense competition [15] Regulatory Stability and Future Outlook - Future procurement rules are expected to stabilize, with the National Healthcare Security Administration favoring large enterprises to optimize the industry [2][24] - The continuation of the "one product, dual regulation" policy may affect the execution of brand-name reporting, potentially leading to adjustments in the future [21] Major Drug Categories in the 11th Batch - Key drugs in this procurement include Dapagliflozin (7.5 billion), Cefazolin (4 billion), and Oseltamivir granules (2.5 billion), with significant discrepancies between actual sales prices and set limits [23] Implications of New Regulations - The two-year production experience requirement has raised concerns about its relevance to product quality and may lead to insufficient competition in certain categories [20] Other Important Considerations - The cancellation of the minimum price preference and the introduction of a revival mechanism for non-selected companies are designed to enhance market participation but may not significantly alter competitive dynamics [8][11] - The overall sentiment indicates that while the rules aim to stabilize the market, the competitive pressure remains high, making price increases unlikely [10][24]

Core Viewpoint - The release of the 11th batch of centralized drug procurement documents marks a significant shift in procurement strategies, focusing on stabilizing clinical drug supply and optimizing procurement measures [1][3]. Group 1: Changes in Procurement Rules - The new procurement rules allow medical institutions to report procurement volumes based on brand names as well as generic names, reflecting respect for clinical needs and choices of healthcare providers [3]. - The procurement process will no longer adopt the lowest bid approach, aiming for a more balanced evaluation of bids [1]. Group 2: Quality Control and Compliance - The new procurement guidelines emphasize higher quality control standards for bidding companies, prioritizing those with stable quality and clinical recognition [5]. - Companies found to engage in collusion or other violations will face strict penalties, including being banned from participating in centralized procurement for a minimum of 6 months and up to 5 years [9]. Group 3: Transparency and Fair Competition - The procurement process will adhere to principles of transparency and fairness, opposing excessive competition among bidders [11]. - All bidding companies are required to commit to not quoting below cost and must provide a rationale for any bids below the "anchor price," detailing cost components such as manufacturing costs and profit margins [11].

Group 1 - The optimization of the 11th batch of national drug procurement rules aims to prevent excessive low-price competition among companies, ensuring product quality and reasonable profit margins, which benefits generic drug companies with cost advantages and promotes the industry's transition towards innovation [1] - Innovative drug companies are achieving significant research and development results, with Dongyang Sunshine Pharmaceutical successfully listing to support its innovative R&D and international expansion, while companies like Heng Rui Medicine and Di Zhe Medicine have received FDA recognition, accelerating their overseas registration and commercialization processes [1] - Overall, the industry is shifting towards innovation-driven and internationalization strategies, with increased policy support for innovative drugs, enhanced R&D capabilities of domestic pharmaceutical companies, and improved competitiveness of innovative drugs in both domestic and international markets [1] Group 2 - The Vaccine ETF (159643) tracks the Vaccine Biotechnology Index (980015), which selects listed companies involved in bioproducts, vaccine research and development, and related industry chains to reflect the overall performance of the vaccine sector [1] - Investors without stock accounts can consider the Guotai Guozheng Vaccine and Biotechnology ETF Initiated Link A (017185) and Link C (017186) [1]

Core Viewpoint - The hypertension medication market in China is experiencing significant changes due to national centralized procurement, leading to a decline in overall sales and a shift in market dynamics [1][2][18]. Market Overview - The sales scale of hypertension medications in the hospital terminal market has decreased from over 60 billion yuan in 2019 to 47.726 billion yuan in 2024, reflecting a year-on-year decline of 4.16% [2][18]. - Prior to 2018, the market growth rate was consistently above 10%, peaking at 60.932 billion yuan in 2019 [2]. Drug Categories - Drugs acting on the renin-angiotensin system (RAS) hold the largest market share at 41.22%, followed by calcium channel blockers at 37.57% [4]. - Oral medications dominate the market, accounting for over 90% of sales, while intravenous injections represent 8.42% [4]. Top 10 Drugs - The top 10 hypertension medications in 2024 include: 1. Sacubitril/Valsartan 2. Nifedipine Controlled Release 3. Amlodipine Besylate 4. Metoprolol Succinate 5. Lercanidipine 6. Irbesartan/Hydrochlorothiazide 7. Valsartan/Amlodipine 8. Felodipine Controlled Release 9. Valsartan/Hydrochlorothiazide 10. Aliskiren [6][8]. Sales Performance - Among the top 10 drugs, only two achieved positive growth in 2024: Sacubitril/Valsartan with a 30.96% increase and Aliskiren with a 20.89% increase [9]. - Nifedipine Controlled Release, once the market leader, has seen its sales drop significantly, nearing a halving since the implementation of centralized procurement [10][18]. Competitive Landscape - The market is characterized by intense competition, with 27 manufacturers producing Nifedipine Controlled Release, leading to a drastic reduction in its market share [10][12]. - In 2024, foreign companies like Novartis and Bayer continue to dominate the top positions in the hypertension medication market, while six domestic companies have also made it to the top 10 [15][18]. Conclusion - The implementation of centralized procurement has reshaped the hypertension medication market, resulting in a significant decline in sales and a rise of innovative drugs like Sacubitril/Valsartan, which combines blood pressure reduction with heart protection [18].

Core Insights - The eleventh batch of national drug procurement has initiated the reporting of demand from medical institutions, which is crucial for the effectiveness of the procurement process [1] Group 1: Changes in Reporting Rules - A new option for reporting demand by drug brand has been introduced, allowing medical institutions to report based on brand names rather than just generic names, addressing diverse medication needs [2] - A total of 55 drug varieties are involved in this procurement, covering treatment areas such as anti-infection, anti-tumor, anti-allergy, diabetes, and cardiovascular medications, with 480 companies having submitted relevant drug information [2] Group 2: Demand Reporting Flexibility - Medical institutions are generally required to report an annual demand of no less than 80% of the average usage from 2023 to 2024, but exceptions can be made for significant decreases in clinical demand or business adjustments [3] - Institutions may reduce reported quantities based on actual needs, provided they submit a written explanation [3] Group 3: Participation Encouragement - Private medical institutions and retail pharmacies are encouraged to participate in the procurement reporting, facilitating easier access for the public to selected drugs [4] Group 4: Procurement Policy Clarifications - The policy emphasizes that while selected drugs should be prioritized, it does not mandate exclusive use, allowing institutions to procure both selected and non-selected drugs [5] - Since 2018, ten batches of national drug procurement have cumulatively procured 435 types of drugs, improving the affordability and accessibility of medications for the public [5]

Core Viewpoint - The eleventh batch of national organized drug procurement has officially launched, involving 55 varieties of drugs, with optimized reporting rules to enhance participation from medical institutions [1] Group 1: Drug Procurement Details - The new reporting rules allow medical institutions to report demand based on generic names without distinguishing brands, or to specify brands, encouraging participation from recognized companies [1] - Each medical institution is required to report an annual demand of no less than 80% of the average usage for the 2023-2024 period for each drug variety [1] - Medical institutions can provide written explanations for significant decreases in expected usage due to clinical demand changes or business adjustments, allowing for actual demand reporting [1] Group 2: Special Considerations - The reporting system includes specific annotations for essential drug specifications, allowing institutions to determine conversion ratios if the specification has not passed quality and efficacy consistency evaluations [1] - For pediatric formulations that have not passed consistency evaluations and are deemed irreplaceable, institutions can report based on actual needs with appropriate explanations [1]