证券代码：688399 证券简称：硕世生物 公告编号：2026-006 二、对公司的影响 上述《医疗器械注册证》的取得，丰富了公司产品种类，扩充了公司在体外 诊断领域的布局，不断满足多元化的临床需求，将增强公司综合竞争力，有利于 进一步提高公司的市场拓展能力。 三、风险提示 上述产品获证后的实际销售情况取决于未来市场的推广效果以及市场的实 际需求，公司目前尚无法预测其对公司未来业绩的影响。敬请广大投资者谨慎投 资、注意投资风险。 特此公告。 江苏硕世生物科技股份有限公司 关于自愿披露取得医疗器械注册证的公告 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、准确性和完整性依法承担法律责任。 江苏硕世生物科技股份有限公司（以下简称"公司"）近日收到国家药品监 督管理局签发的医疗器械注册证（体外诊断试剂），具体信息如下： 一、医疗器械注册证的具体情况 | 序号 | 产品名称 | 注册编号 | 注册证 | 注册 | 预期用途 | | --- | --- | --- | --- | --- | --- | | | | | 有效期 | 分类 | | | | 呼吸道合胞 ...

Core Viewpoint - Shuoshi Bio (688399.SH) reported a decline in revenue and an increase in net losses for the fiscal year 2025, indicating ongoing financial challenges for the company [1]. Financial Performance Summary - The total operating revenue for 2025 was 340.38 million yuan, a decrease of 2.64% compared to the previous year [2]. - The operating profit was -30.89 million yuan, a significant decline from a profit of 8.81 million yuan in the previous year, representing a change of -450.49% [2]. - The total profit was -31.62 million yuan, down from a profit of 0.42 million yuan in the previous year, marking a change of -855.06% [2]. - The net profit attributable to shareholders was -39.71 million yuan, worsening from a loss of 0.20 million yuan in the previous year [2]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -103.83 million yuan, an increase in loss from -71.84 million yuan in the previous year [2]. Cash Flow and Other Metrics - The net cash flow from operating activities was 146 million yuan, showing a significant increase of 228.97% year-on-year [3]. - In 2024, the company achieved an operating revenue of 350 million yuan, a decrease of 13.29% compared to the previous year [3]. - The net profit attributable to shareholders for 2024 was -0.20 million yuan, an improvement from -37.4 million yuan in the previous year [3]. - The net profit attributable to shareholders after deducting non-recurring gains and losses for 2024 was -71.84 million yuan, compared to -429.20 million yuan in the previous year [3]. Company Background - Shuoshi Bio was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on December 5, 2019, with an initial issuance of 14.66 million shares at a price of 46.78 yuan per share [4]. - The total funds raised from the initial public offering amounted to 685.79 million yuan, with net proceeds of 612.93 million yuan, exceeding the original plan by 210.28 million yuan [4]. - The company intended to use the raised funds for the construction of its headquarters industrial park in Taizhou [4].

Core Viewpoint - The company reported a total operating revenue of 340 million yuan for the fiscal year 2025, reflecting a year-on-year decline of 2.64% and a net loss attributable to shareholders of 39.71 million yuan [1] Group 1: Financial Performance - The company achieved total operating revenue of 340 million yuan, which is a decrease of 2.64% compared to the previous year [1] - The net loss attributable to the parent company's shareholders was 39.71 million yuan [1] - The net loss after deducting non-recurring gains and losses was 104 million yuan [1] Group 2: Business Environment - The company's main business showed stable development during the reporting period [1] - The decline in revenue from self-produced diagnostic reagent products was influenced by intensified industry competition and ongoing medical procurement [1] - The value-added tax rate for self-produced diagnostic reagents was adjusted to 13%, contributing to the revenue decline [1]

Core Viewpoint - The company reported a total operating revenue of 340 million yuan for the year 2025, reflecting a year-on-year decline of 2.64% and a net loss attributable to the parent company of 39.71 million yuan, alongside a net loss of 104 million yuan after deducting non-recurring gains and losses [1] Group 1: Financial Performance - The total operating revenue for 2025 was 340 million yuan, which is a decrease of 2.64% compared to the previous year [1] - The net loss attributable to the parent company was 39.71 million yuan [1] - The net loss after deducting non-recurring gains and losses was 104 million yuan [1] Group 2: Business Environment - The company's main business showed stable development during the reporting period [1] - The decline in revenue from self-produced diagnostic reagent products was influenced by intensified industry competition and the ongoing implementation of centralized procurement in the medical sector [1] - An adjustment in the value-added tax rate for self-produced diagnostic reagents to 13% also contributed to the revenue decline [1]

Group 1 - The company, Shuoshi Biotechnology, announced a projected total revenue of 340.38 million yuan for 2025, representing a year-on-year decline of 2.64% [2] - The net profit attributable to the parent company is expected to be -39.71 million yuan, indicating an expanded loss of 37.71 million yuan compared to the previous year [2]

Core Insights - The company, Shuoshi Biotechnology (688399.SH), reported a total operating revenue of 340.38 million yuan for the year 2025, reflecting a year-on-year decline of 2.64% [1] - The net profit attributable to the parent company was -39.71 million yuan, which represents an increase in losses by 37.71 million yuan compared to the previous year [1] - The net profit attributable to the parent company after deducting non-recurring gains and losses was -103.83 million yuan, with losses widening by 31.99 million yuan year-on-year [1] Business Performance - The company's main business showed stable development; however, it faced challenges due to intensified industry competition and ongoing medical procurement reforms [1] - The revenue from self-produced diagnostic reagent products decreased, partly due to an adjustment in the value-added tax rate to 13% [1] - The company is actively implementing cost reduction and efficiency enhancement measures, aiming to fully explore potential improvements in quality and efficiency [1] - It is expected that the overall gross profit margin will remain stable compared to the same period last year [1]

Financial Performance - Total revenue for 2025 was CNY 340.38 million, a decrease of 2.64% compared to the previous year[4] - Net profit attributable to shareholders of the parent company was a loss of CNY 39.71 million, an increase in loss of CNY 37.71 million year-on-year[9] - The net profit attributable to shareholders of the parent company after deducting non-recurring gains and losses was a loss of CNY 103.83 million, an increase in loss of CNY 31.99 million year-on-year[9] - Basic earnings per share were CNY -0.47, compared to CNY -0.02 in the previous year[5] Assets and Equity - Total assets at the end of the reporting period were CNY 3,553.83 million, a decrease of 4.98% from the beginning of the period[9] - Shareholders' equity attributable to the parent company was CNY 2,929.90 million, a decrease of 9.87% from the beginning of the period[9] Operational Insights - The company’s gross profit margin is expected to remain stable compared to the previous year despite industry competition and VAT adjustments[9] - The company has focused on R&D, maintaining a relatively high intensity of investment in product development[11] - The company has faced a reduction in government subsidies received during the reporting period[10] Shareholder Changes - The number of shares increased by 48% due to a capital reserve conversion plan implemented in June 2025[11]

Performance Overview - The company expects a net profit attributable to shareholders of the parent company for 2025 to be between -29.4 million and -44 million yuan, indicating an expanded loss compared to the previous year due to intensified industry competition, medical procurement, and VAT rate adjustments [2] Financial Status - The company announced the recovery of an accounts receivable over 5 years old amounting to 6.0994 million yuan, which is expected to have a positive impact on the financial status for 2026 [3] Company Developments - A temporary shareholders' meeting on January 5, 2026, approved the expansion of the business scope and amendments to the company's articles of association, which may involve business expansion [4] Stock Performance - As of February 11, 2026, the stock price was 68.75 yuan per share, down 2.01% for the day, with a net outflow of 4.7948 million yuan in main funds and a trading volume of 39.0139 million yuan. The financing balance as of February 2, 2026, was 392 million yuan, representing a high proportion of the circulating market value, at the 90th percentile level over the past year [5] Future Development - The actual controller renewed the "Joint Action Agreement" in December 2025, and the company's products were included in the World Health Organization's emergency use list, which may support long-term development [6]

Market Overview - The medical device sector increased by 0.9% on February 4, with SAIKOSHI leading the gains [1] - The Shanghai Composite Index closed at 4102.2, up 0.85%, while the Shenzhen Component Index closed at 14156.27, up 0.21% [1] Top Performers - SAIKOSHI (688338) closed at 32.11, up 10.15% with a trading volume of 63,600 shares and a transaction value of 197 million [1] - SHUOSHI BIO (6638889) closed at 71.46, up 5.69% with a trading volume of 15,900 shares and a transaction value of 113 million [1] - BAOLAIT (300246) closed at 13.51, up 2.74% with a trading volume of 166,100 shares and a transaction value of 224 million [1] Underperformers - KANGZHONG MEDICAL (688607) closed at 57.80, down 4.26% with a trading volume of 46,300 shares [2] - SINO MEDICAL (688108) closed at 22.70, down 3.77% with a trading volume of 170,600 shares and a transaction value of 387 million [2] - SANYOU MEDICAL (688085) closed at 21.05, down 3.08% with a trading volume of 39,800 shares and a transaction value of 84 million [2] Capital Flow - The medical device sector experienced a net outflow of 132 million from institutional investors, while retail investors saw a net outflow of 191 million [2] - Speculative funds had a net inflow of 323 million into the sector [2] Individual Stock Capital Flow - MAIRUI MEDICAL (300760) had a net inflow of 86.91 million from institutional investors, while retail investors had a net outflow of 169 million [3] - LIANSHENG MEDICAL (688271) saw a net inflow of 44.32 million from institutional investors, with a net outflow of 76.86 million from retail investors [3] - HUAKANG CLEAN (301235) had a net inflow of 31.25 million from institutional investors, while retail investors experienced a net outflow of 52.92 million [3]

Core Viewpoint - Shuoshi Biotechnology (688399) is expected to report significant losses for the year 2025, with net profit projections indicating a loss between 29.4 million to 44 million yuan, reflecting a worsening financial situation compared to the previous year [1][3] Performance Disclosure Highlights - The company anticipates a net profit loss attributable to shareholders of 29.4 million to 44 million yuan for the year 2025 [1][3] - The projected net profit loss after excluding non-recurring gains and losses is expected to be between 81.9 million to 123 million yuan [1][3] Company Announcement Summary - The anticipated losses are attributed to several factors, including intensified industry competition, the advancement of centralized procurement in the medical sector, a reduction in government subsidies, and adjustments in the value-added tax rate for self-produced testing reagents [1][3]