证券研究报告 2026 年 3 月 3 日 湘财证券研究所 行业研究 医疗耗材行业报告 国产 PFA 前景可期 核心要点： ❑ 心脏电生理技术存在较强的现实刚需性 我国 2020 年城乡居民疾病死因构成中，心血管疾病在所有病因中高居首 位，心脏电生理技术被广泛应用于临床心律失常疾病诊断和治疗，但目前 整体渗透率仍然较低，叠加人口老龄化因素的推动，未来存在较大的市场 刚需。 ❑ 电生理技术不断迭代，临床优效显著 标测技术方面，三维心脏电生理手术在二维心脏电生理手术基础上作出了 重大改进，更加精确的显示出病变部位情况。消融技术方面，射频消融技 术已经较为成熟；冷冻消融术式主要用于房颤治疗，安全性更高；脉冲电 场消融（PFA）也正在快速发展，能够在消融目标心肌组织的同时避免对 周围组织造成损伤，有效解决了现有术式的痛点，临床应用潜力较大。近 年来心脏电生理技术在房颤、室上性心动过速等的临床治疗指南或专家共 识中的推荐级别也得到了提升。 ❑ 国产 PFA 有望弯道超车 PFA 技术为国产企业提供了一个弯道超车的契机。在传统的射频消融领域， 外资品牌凭借深厚的临床积淀和完整的"三维标测系统+消融导管"闭环 生态占据绝对 ...

2026年1月18日公告显示，公司已收回一笔账龄超5年的应收账款609.94万元，债权债务关系结清，预计 对2026年度财务状况产生积极影响。 公司状况 2026年1月5日，公司临时股东会审议通过增加经营范围并修订公司章程的议案，可能涉及业务拓展。 股票近期走势 经济观察网根据公开信息，江苏硕世生物科技股份有限公司(股票代码：688399)近期有以下事件值得关 注，这些事件可能对公司经营或市场表现产生影响。 业绩经营情况 2026年1月30日，公司发布业绩预告，预计2025年度归属于母公司所有者的净利润为-2,940万元至-4,400 万元，较上年同期亏损扩大，主要受行业竞争加剧、医疗集采及增值税税率调整等因素影响。正式年报 尚未发布，需关注后续披露。 财务状况 2026年2月11日，股价报68.75元/股，当日下跌2.01%，主力资金净流出479.48万元，成交额3901.39万 元。融资余额方面，截至2026年2月2日，公司融资余额为3.92亿元，占流通市值比例较高，处于近一年 90%分位水平。 未来发展 2025年12月实际控制人续签《一致行动协议》，以及公司产品被列入世界卫生组织应急使用清单等，可 能 ...

Core Viewpoint - The long-term procurement agreement between HeFu China and Mingji Hospital has attracted market attention, leading to regulatory scrutiny from the Shanghai Stock Exchange regarding the implications of such agreements on the company's business model and industry practices [1][3]. Group 1: Agreement Details - HeFu China signed a long-term procurement agreement with Mingji Hospital for the purchase of in vitro diagnostic reagents and consumables, with a total procurement amount of no less than 600 million yuan over 96 months, equating to an eight-year contract duration [1]. - The company stated that the annual procurement amount from Mingji Hospital is expected to be less than 10% of its annual revenue, indicating minimal impact on the company's overall performance [1][2]. Group 2: Regulatory Response - The Shanghai Stock Exchange issued a regulatory letter to HeFu China, requesting clarification on the commercial rationale behind the long-term agreement, its alignment with industry norms, and the replicability of such agreements [1][3]. - HeFu China responded that the minimum procurement amount aligns with past purchasing patterns from Mingji Hospital and is significantly lower than the hospital's total procurement of drugs and medical consumables during the same period [2]. Group 3: Risks and Challenges - The agreement includes a minimum procurement obligation, with penalties for non-compliance; however, it also allows for negotiations if the minimum is not met due to reasons beyond the hospital's control, raising questions about the enforceability of the minimum commitment [2][3]. - HeFu China is facing pressure from a projected net loss of 25 to 36 million yuan, attributed to price declines in the in vitro diagnostic sector and fluctuations in order volumes due to centralized procurement policies [3]. Group 4: Market Performance - HeFu China's stock experienced a significant increase of 342.92% from October 27 to December 19 last year, becoming a market star, but has since seen a decline of nearly 40% from its peak as of February 4 [4].

Core Viewpoint - Recently, Hefei China (603122) signed a long-term procurement agreement with Nanjing Mingji Hospital and Suzhou Mingji Hospital, which has attracted market attention and led to regulatory scrutiny from the Shanghai Stock Exchange [1][3]. Group 1: Agreement Details - The long-term procurement agreement stipulates that Mingji Hospital will purchase in vitro diagnostic reagents and consumables from the company, with a total procurement amount of no less than 600 million yuan over a period of 96 months [1]. - The company expects that the annual procurement amount from Mingji Hospital will be less than 10% of its annual revenue, indicating minimal impact on the company's overall performance [3]. Group 2: Regulatory Response - The Shanghai Stock Exchange issued a regulatory letter to Hefei China, requesting clarification on the business model, industry competition environment, and the commercial rationale behind the long-term agreement [3]. - Hefei China responded that the minimum procurement amount aligns with Mingji Hospital's past purchasing scale and is significantly lower than its total procurement of drugs and medical consumables during the same period [3]. Group 3: Contractual Obligations - The agreement includes a minimum procurement amount of 600 million yuan, with Mingji Hospital obligated to compensate if the total procurement does not meet this amount, although there are provisions for negotiation in case of non-party-related reasons for not meeting the minimum [4]. - The company indicated that it would review the execution of the contract annually and make adjustments if deviations are found, although uncertainties remain regarding the ability to meet the minimum procurement amount [4]. Group 4: Financial Performance - Hefei China is facing pressure with a projected net loss of 25 million to 36 million yuan for 2025, marking its first loss since going public, primarily due to price declines in the in vitro diagnostic industry and fluctuations in order volumes [5]. - The company's stock price experienced a significant increase of 342.92% from October 27 to December 19, 2025, but has since declined nearly 40% from its peak as of February 4 [5].

Group 1 - The company Kewah Bio expects a net loss attributable to shareholders of 580 million to 740 million yuan for 2025, with basic earnings per share loss estimated at 1.1276 to 1.4387 yuan [1] - In the same period last year, the company reported a net loss of approximately 641 million yuan, with a basic earnings per share loss of 1.2687 yuan [1] - The primary reason for the performance change is significant adverse impact from asset impairment provisions, which the company plans to assess and test comprehensively based on industry trends and actual operating conditions [1] Group 2 - The IVD industry is facing intensified competition due to policy changes and market pressures, leading to a decline in both revenue scale and product gross margins year-on-year [1] - Factors such as medical procurement policies, DRG payment reform, mutual recognition of test results, adjustments in testing service fees, and unbundling of testing packages are reshaping the competitive landscape of the industry [1] - The demand for certain routine testing projects is contracting, coupled with downward pressure on product prices, which directly affects the company's profitability [1]

Group 1 - The company expects a significant increase in net profit for the year 2025, projecting a range of CNY 244.99 million to CNY 287.99 million, which represents an increase of CNY 120 million to CNY 163 million compared to the previous year, translating to a year-on-year growth of 96.01% to 130.41% [3] - The net profit attributable to the parent company, excluding non-recurring gains and losses, is estimated to be between CNY 229.54 million and CNY 269.54 million, indicating an increase of CNY 135 million to CNY 175 million from the previous year, with a year-on-year growth of 142.80% to 185.11% [3] - The previous year's net profit attributable to the parent company was CNY 124.99 million, with a net profit excluding non-recurring gains and losses of CNY 94.54 million [4] Group 2 - The substantial growth in net profit is attributed to the gradual release of growth potential from various product lines following their inclusion in centralized procurement, as well as the company's ongoing international development strategy and improved operational management [6] - The company has communicated with its auditing firm regarding the performance forecast, and there are no significant discrepancies between the company and the auditors concerning the forecast [3]

Core Viewpoint - The recent long-term procurement contract worth 600 million yuan between Mingji Hospital and Hefei China reflects both companies' operational anxieties, with Mingji Hospital needing to implement its expansion plans and Hefei China facing significant performance declines due to industry pressures [1][5][8]. Group 1: Company Performance - Hefei China is experiencing a significant downturn, with a projected revenue decline of 26.67% to 689 million yuan for 2025 and a shift from a net profit of 27.57 million yuan to a loss between 25 million and 36 million yuan [5][7]. - The company's losses are attributed to the implementation of centralized procurement policies in the in vitro diagnostics industry, which have drastically reduced procurement prices and squeezed sales revenue and gross margins [7][11]. - Despite cost control measures, Hefei China is unable to reduce fixed expenses proportionally to its declining revenue, leading to continued financial strain [7][11]. Group 2: Strategic Implications - The partnership between Mingji Hospital and Hefei China is driven by Mingji's urgent need for a stable supply chain to support its expansion plans following its recent IPO, where it raised approximately 555 million HKD [8][11]. - Mingji Hospital's operational model is limited by its higher pricing compared to public hospitals and a narrow customer base, which constrains its growth potential [11][15]. - The exclusive supply agreement with Hefei China may limit Mingji Hospital's ability to negotiate prices and manage costs effectively, especially in a context of increasing centralized procurement [11][12]. Group 3: Contractual Risks - The eight-year procurement agreement includes clauses for price adjustments based on market fluctuations, which could significantly impact Hefei China's profit margins and overall financial health [12][15]. - Payment terms require Hefei China to front nearly four months of payment for supplies, increasing its cash flow pressure amid ongoing losses [13][15]. - The lack of clear fallback provisions in the contract raises concerns about potential disputes and the overall stability of the partnership [12][14].

Core Viewpoint - The company has signed a long-term procurement agreement with Nanjing Mingji Hospital and Suzhou Mingji Hospital, committing to a minimum procurement amount of RMB 600 million over 96 months, which is expected to have a limited impact on the company's annual revenue [2][3][17]. Group 1: Contract Details - The contract stipulates that the total procurement amount from Mingji Hospitals will not be less than RMB 600 million over 96 months, with annual procurement expected to be less than 10% of the company's annual revenue [2][3]. - The contract includes provisions for price adjustments based on changes in procurement prices or project fees, with adjustments effective from the date of the announcement by the government or local procurement platform [2][12]. - The contract has been approved internally and does not constitute a related party transaction or a major asset restructuring [3][10]. Group 2: Parties Involved - Nanjing Mingji Hospital is a foreign-owned limited liability company with a registered capital of approximately USD 19.2 million, established in 2003, and is fully owned by Malaysian Mingji Bimoo Holdings [6][7]. - Suzhou Mingji Hospital is a non-wholly foreign-owned limited liability company with a registered capital of approximately RMB 601.98 million, established in 2004, with major shareholders being Mingji Bimoo Holdings and Suzhou Mingji Investment [8][9]. Group 3: Financial Impact - The contract is expected to positively impact the company's performance in 2026 and subsequent years, enhancing its profitability and competitive strength [17]. - The company emphasizes that the contract's execution will not lead to dependency on the hospitals for its business operations [18]. Group 4: Performance Forecast - The company anticipates a net loss of between RMB 36 million and RMB 25 million for the year 2025, a significant decline compared to the previous year's profit of approximately RMB 27.57 million [22][25]. - The expected loss is attributed to changes in the macro environment, competitive pricing pressures, and increased operational costs due to strategic investments in talent and technology [26].

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]

Group 1 - The core viewpoint of the article highlights that despite a significant drop in the stock price of Mindray Medical, its actual controller, Li Xiting, has recently increased his stake by approximately 200 million yuan, which is relatively minor compared to previous large-scale reductions [1] - Since the beginning of 2023, Li Xiting and his holding platforms have significantly reduced their stakes, cashing out around 2.5 billion yuan in a single quarter, totaling over 10 billion yuan [1] - Industry insiders believe that the domestic medical and consumables procurement continues to face challenges, and the fundamental aspects of the industry have not yet bottomed out, while overseas operations are facing tariff-related risks [1] Group 2 - As of June 2023, the four holding platforms still collectively held 50 million shares of Mindray Medical, but by June 2025, they are expected to disappear from the list of the top ten shareholders [2] - The estimated cash-out amount from these reductions over the two-year period could exceed 10 billion yuan based on average stock prices [2]