| 证券代码：002382 | 证券简称：蓝帆医疗 | 公告编号：2026-007 | | --- | --- | --- | | 债券代码：128108 | 债券简称：蓝帆转债 | | 蓝帆医疗股份有限公司 关于子公司 Lithonic™冠脉血管内冲击波治疗系统 获得 CE 证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、 误导性陈述或重大遗漏。 近日，蓝帆医疗股份有限公司（以下简称"公司"）接到通知，公司心脑血管事业 部子公司Biosensors Interventional Technologies Pte. Ltd.的Lithonic™冠脉血管内冲击波 治疗系统（以下简称"Lithonic™系统"）获得欧盟CE认证，现将相关情况公告如下： 一、获批产品基本信息 产品名称：Lithonic™ Coronary Intravascular Lithotripsy (IVL) Catheter / Generator 制造商：Biosensors Interventional Technologies Pte. Ltd（新加坡） 有效期至：2031年1月13日 二、产品情 ...

Core Viewpoint - Bluesail Medical's subsidiary, Biosensors Interventional Technologies Pte. Ltd., has received CE certification for its Lithonic™ coronary intravascular shockwave treatment system, which is designed for pre-treatment of severely calcified stenosis, reducing the risk of complications such as vascular perforation and no-reflow [1] Company Summary - The CE certification signifies international recognition of the technology, reinforcing the company's technological advantage in the coronary field [1] - The expected positive impact on the company's operational development due to this certification [1] Industry Summary - The sales of medical devices are influenced by market conditions, indicating a need for cautious investment from stakeholders [1]

Core Viewpoint - Bluesail Medical's subsidiary, Biosensors Interventional Technologies Pte. Ltd., has received EU CE certification for its Lithonic coronary intravascular shockwave treatment system, which is designed for pre-treatment of severely calcified stenosis, reducing the risk of complications such as vascular perforation and no-reflow [1] Company Summary - The certification signifies international recognition of the technology and strengthens the company's competitive advantage in the coronary field [1] - The expected positive impact on the company's operational development is highlighted [1] Industry Summary - The sales of medical devices are influenced by market conditions, indicating a need for cautious investment from stakeholders [1]

Group 1 - The stock price of Bluestar Medical (002382) closed at 6.03 yuan on January 15, 2026, with an increase of 0.67% and a turnover rate of 2.06%, with a trading volume of 205,700 shares and a transaction amount of 125 million yuan [1][2] - On January 15, the net inflow of main funds was 7.8154 million yuan, while the net inflow of speculative funds was 10.0406 million yuan, and retail investors showed a net outflow of 17.856 million yuan [1][2] Group 2 - Bluestar Medical's subsidiary, Shandong Jiwei Medical Products Co., Ltd., is expected to be selected for the national organized procurement of coronary drug-coated balloons, with a proposed selection price of 2,524 yuan [1][2] - The procurement cycle for the selected products will last until December 31, 2028, and medical institutions are required to prioritize the procurement and use of the selected products [1][2]

Core Viewpoint - Bluefan Medical (002382) has shown a slight increase in stock price, but the company is facing significant financial challenges, including declining revenues and profits [1][3]. Financial Performance - As of January 15, 2026, Bluefan Medical's stock closed at 6.03 yuan, with a 0.67% increase and a trading volume of 205,700 hands, amounting to a total transaction value of 125 million yuan [1]. - In the past five days, the company has experienced fluctuations in net capital flow, with a net inflow of 7.82 million yuan from main funds on January 15, 2026, which accounted for 6.24% of the total transaction value [2]. - The company's total market capitalization is 6.073 billion yuan, with a net asset value of 9.707 billion yuan, but it reported a net profit of -286 million yuan, ranking last in the industry [3]. Revenue and Profit Trends - For the first three quarters of 2025, Bluefan Medical reported a main revenue of 4.182 billion yuan, a year-on-year decrease of 10.15%, and a net profit attributable to shareholders of -286 million yuan, down 30.09% year-on-year [3]. - In Q3 2025 alone, the company recorded a main revenue of 1.401 billion yuan, a decline of 15.02% compared to the same quarter the previous year, and a net profit of -151 million yuan, a staggering drop of 153.64% [3]. Industry Comparison - Bluefan Medical's gross profit margin stands at 13.66%, significantly lower than the industry average of 50.62%, placing it in the 122nd position out of 126 companies in the medical device sector [3]. - The company's return on equity (ROE) is -3.56%, which is also below the industry average of 0.23%, ranking 119th out of 126 [3].

Core Viewpoint - The centralized procurement of high-value medical consumables, specifically drug-coated balloons and urological intervention materials, is expected to standardize procurement and usage behaviors, improve industry ecology, and lead to short-term price declines impacting profit margins for some companies, while top domestic enterprises may gain market share through successful bids [1] Group 1: Event Overview - The national procurement office announced the results for centralized procurement of drug-coated balloons and urological intervention consumables, with implementation expected around May 2026 [1] Group 2: Selection Rate and Participation - A total of 227 companies submitted bids for 496 products, with 202 companies winning bids for 440 products, indicating a high overall selection rate which supports industry supply [2] - All 42 products from 32 companies in the drug-coated balloon category were selected, demonstrating a strong match with clinical usage [2] - In the urological intervention category, 170 out of 195 companies won bids for 398 products, including specialized products that meet specific clinical needs [2] Group 3: Performance of Listed Companies - Listed companies such as Lepu Medical, Bluestar Medical, and others achieved successful bids for various drug-coated balloons and urological intervention products, indicating a favorable selection outcome that may allow them to quickly expand their market share [3] Group 4: Procurement Rules and Principles - The procurement process reflects principles of "stabilizing clinical use, ensuring quality, countering internal competition, and preventing collusion," with a focus on maintaining clinical continuity and considering product functionality differences [4] - The selection rules are designed to prevent excessive price undercutting, with a mechanism in place to control price differences based on average bid prices, which has been effective in maintaining price stability [4] - The optimization of procurement rules indicates a maturing policy environment, with the "anti-involution" principle expected to be upheld in the long term [4]

Group 1: Regulatory Developments - The National Healthcare Security Administration (NHSA) is soliciting public opinions on the "Guidelines for Real-World Comprehensive Value Assessment of Drugs" to establish a unified national evaluation system [1] - Huadong Medicine's subsidiary received FDA approval for clinical trials of DR10624, a novel drug targeting metabolic-associated fatty liver disease [1] - Fosun Pharma's subsidiary has had its drug registration application for erythromycin lactobionate injection accepted by the National Medical Products Administration [2] - Stone Pharmaceutical's new drug for hypertension has received FDA approval for clinical trials in the U.S. [3] - Zhi Mei Ru Kang's siRNA therapy for ALS has entered Phase 2 clinical trials [4] Group 2: Market and Corporate Developments - Cap Bio's major shareholders have increased their stake from 31.52% to 33.05% following capital changes and share buybacks [5] - Bluestar Medical's product is expected to be selected for national centralized procurement of drug-coated balloons, which could enhance its market presence [7] - NVIDIA and Eli Lilly have announced a $1 billion collaboration to establish an AI innovation lab focused on drug discovery and development [8] - Dr. Wang Qiang has transitioned from Xiansheng Pharmaceutical to Ganli Pharmaceutical as Senior Vice President and Chief Strategy Officer [9] Group 3: Quality Control and Safety - China Resources Double Crane has addressed recent quality issues with sodium bicarbonate injection products, clarifying that non-compliance was due to packaging issues during transport [10]

Group 1 - The company, Bluefan Medical Co., Ltd., announced that its subsidiary, Shandong Jiwei Medical Products Co., Ltd., is participating in the national centralized procurement of drug-coated balloons, with the company's products expected to be selected for this procurement [1] - This centralized procurement is the first of its kind organized by the state for drug-coated balloon medical consumables, with a procurement cycle lasting until December 31, 2028 [1] - If the company signs the procurement agreement and executes it, it is expected to enhance the market influence of its drug-coated balloon products and support the sustainable development of its cardiovascular business [1]

Core Insights - The sixth batch of centralized procurement for high-value medical consumables in China has been successfully conducted, involving 12 types of medical consumables with 496 products from 227 companies bidding, and 440 products from 202 companies proposed for selection [1] - The procurement includes drug-coated balloons and urological intervention consumables, with a focus on ensuring a diverse supply and meeting clinical needs [2] Procurement Details - Drug-coated balloons, which help alleviate vascular stenosis, were included in this procurement, with 42 products from 32 companies proposed for selection, ensuring high clinical compatibility while reducing costs for patients [2] - Urological intervention consumables, previously a "blank area" in procurement, saw 454 products from 195 companies bidding, with 398 products from 170 companies proposed for selection, addressing complex clinical needs [2] Selection Rules Optimization - The procurement process emphasizes principles such as maintaining clinical stability, ensuring quality, and preventing price undercutting, with a focus on grouping competition based on demand and supply capabilities [2] - A new rule was introduced to prevent extreme price competition, setting a price control benchmark at 65% of the average price when the lowest bid is excessively low, which was triggered in 8 out of 20 competitive groups [3] Market Impact - Leading companies are expected to gain more market share due to their successful bids in this procurement, with notable listed companies like Bluestar Medical and Lepu Medical participating [4] - The procurement is anticipated to standardize the purchasing and usage of medical consumables, thereby improving the industry ecosystem [4]

Group 1 - The stock price of Bluestar Medical (002382) closed at 5.99 yuan on January 14, 2026, with an increase of 0.67% and a trading volume of 184,100 shares, resulting in a transaction amount of 111 million yuan [1] - On January 14, the net inflow of main funds was 7.76 million yuan, indicating increased short-term interest from major investors [2][3] - Bluestar Medical's subsidiary, Shandong Jiwei Medical Products Co., Ltd., is expected to be selected for the national centralized procurement of coronary drug-coated balloons, with a proposed price of 2,524 yuan, and the procurement period extending until December 31, 2028 [2][3]