如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 06609 | 說明 | H股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | 事件 | | 已發行股份（不包括庫存股份）數 目 | | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | 每股發行/出售價 (註4) | 已發行股份總數 | | 於下列日期開始時的結存(註1) | 2026年1月21日 | | ...

Core Viewpoint - The profitability of Xinwei Medical is becoming increasingly clear, with a significant growth forecast for 2025, marking its entry into the profit zone, alongside the acceptance of its innovative self-expanding intracranial drug-eluting stent application by the National Medical Products Administration [1][4]. Financial Performance - Xinwei Medical's 2025 revenue is projected to be between 400 million to 410 million yuan, representing an approximate 44% increase from 278 million yuan in 2024 [6]. - The company expects a pre-tax profit of 80 million yuan, a substantial turnaround from a pre-tax net loss of 12 million yuan in 2024, indicating an increase of nearly 800% [6]. Product Development and Market Position - The growth is primarily driven by the collaborative expansion of the entire product line, particularly in the ischemic stroke sector, where new products and technologies have led to a steady increase in market share [7]. - The sales volume of large-caliber aspiration catheters has seen a 60% year-on-year increase in the first half of 2025, with expectations of over 200% growth for the year [8]. - The "Great Wall" intracranial stent has achieved rapid commercial sales, covering 200 new cooperative hospitals in the first half of the year, significantly boosting the sales of related products [8]. Cost Management and Operational Efficiency - Xinwei Medical's overall gross margin rose to nearly 70% in the first half of 2025, while the sales and management expense ratio decreased by 8 percentage points to 37%, showcasing effective cost control [9]. - The financial characteristics of revenue growth, profit increase, and cost reduction indicate a shift from reliance on financing cash flow to a self-sustaining growth model [9]. Innovation and Long-term Strategy - The acceptance of the self-expanding intracranial drug-eluting stent application highlights the company's leading position in innovation, addressing critical treatment needs in the market [12]. - Xinwei Medical has developed a comprehensive product pipeline for stroke treatment and prevention, including devices for thrombectomy, aneurysm, and stenosis, with several products receiving "priority review" status [12]. - The company is also exploring advanced fields such as the interventional brain-machine interface project, which is expected to begin clinical trials by the end of 2026, potentially expanding its growth horizons [12]. Conclusion - Xinwei Medical's solid profitability, comprehensive product pipeline, leading innovation capabilities, and clear ecological layout constitute its core competitive advantages, gradually gaining market recognition for its investment value [14]. - Short-term growth will be supported by full product line expansion and cost control optimization, while long-term prospects are bolstered by innovative products and strategic positioning in emerging fields [14].

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 重新提交 公司名稱： 上海心瑋醫療科技股份有限公司 (於中華人民共和國註冊成立的有限責任公司) 呈交日期： 2026年1月22日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 06609 | 說明 | H股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | 事件 | ...

Core Viewpoint - The profitability of Xinwei Medical is becoming increasingly clear, with a significant leap in revenue and profit projected for 2025, marking its entry into the profit zone [1][4]. Financial Performance - Xinwei Medical forecasts a revenue of approximately 400 million to 410 million yuan for 2025, representing a growth of about 44% compared to 278 million yuan in 2024 [6]. - The company expects a pre-tax profit of 80 million yuan, a substantial turnaround from a pre-tax net loss of 12 million yuan in 2024, indicating an increase of nearly 800% [6]. - Adjusted pre-tax profit is projected to reach 77 million yuan, showcasing a clear improvement in profitability quality and capability [6]. Product and Market Development - The growth is primarily driven by the collaborative expansion of the entire product line, particularly in the ischemic stroke sector, where new products and technologies have led to a steady increase in market share [7]. - The sales volume of large-caliber suction catheters has seen a 60% year-on-year increase in the first half of 2025, with an expected annual sales growth of over 200% [7]. - In the hemorrhagic stroke sector, the "Great Wall" intracranial stent has achieved rapid commercial sales, covering 200 new cooperative hospitals in the first half of the year, significantly boosting the sales of spring coil products [8]. Cost Management and Operational Efficiency - Xinwei Medical's overall gross margin has rebounded to nearly 70%, while the sales and management expense ratio has decreased by 8 percentage points to 37%, indicating effective cost control [9]. - The financial characteristics of revenue growth, profit increase, and cost reduction suggest that the company has moved away from a financing-dependent growth model to a self-sustaining cycle of product expansion and profitability [9]. Innovation and Long-term Strategy - The acceptance of the self-expanding intracranial drug-eluting stent application by the National Medical Products Administration represents a significant breakthrough in the company's innovation pipeline [11]. - This product addresses critical treatment needs for intracranial atherosclerotic stenosis and is expected to fill a market gap, enhancing the company's competitive edge in neurointervention [11]. - The company is also advancing its brain-machine interface project, which is expected to begin formal clinical trials by the end of 2026, potentially opening new growth avenues [12]. Conclusion - Xinwei Medical's solid profitability, comprehensive product pipeline, leading innovation capabilities, and clear ecological layout constitute its core competitive advantages, gradually gaining market recognition for its investment value [14]. - Short-term growth will be supported by full product line expansion and cost management optimization, while long-term prospects will be bolstered by innovative products and strategic positioning in emerging fields [14].

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 上海心瑋醫療科技股份有限公司 (於中華人民共和國註冊成立的有限責任公司) | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 H | | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 06609 | 說明 | H股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | 每股發行/出售價 (註4) | 已發行股份總數 | | 於下列日期開始時的結存(註1) | 2026年1月15日 | | 30,713,304 | | 852,50 ...

Core Viewpoint - The company, Xinwei Medical-B (6609.HK), experienced a significant stock price increase of 14.1% to HKD 57.85 following the announcement of its expected revenue growth and product development progress [1] Financial Performance - The company anticipates revenue for the fiscal year ending December 31, 2025, to be between RMB 400 million and RMB 410 million, representing an increase of at least 43.9% compared to the revenue of RMB 278 million for the fiscal year ending December 31, 2024 [1] - The company expects to report a pre-tax profit of approximately RMB 80 million, a substantial improvement from the pre-tax net loss of RMB 12 million for the fiscal year ending December 31, 2024 [1] Product Development - The company announced that its self-expanding intracranial drug-eluting stent's registration application has been accepted by the National Medical Products Administration of the People's Republic of China [1] - This stent is designed for the treatment of intracranial atherosclerotic stenosis, providing support and opening for narrowed and obstructed lumens, while effectively preventing in-stent restenosis [1] - Currently, there are no similar products approved for market globally, indicating that the company's research and development progress is at a leading level within the industry [1]

Core Viewpoint - The company expects to achieve significant revenue growth and profitability by the end of 2025, driven by new product launches and increased sales in various medical segments [1] Financial Performance - The company projects revenue of approximately 400 million to 410 million yuan for the year ending December 31, 2025, representing an increase of at least 43.9% compared to the revenue of 278 million yuan for the year ending December 31, 2024 [1] - The expected pre-tax profit is around 80 million yuan, a substantial improvement from the pre-tax net loss of 12 million yuan for the year ending December 31, 2024 [1] Growth Drivers - The turnaround from loss to profit is primarily attributed to the launch of new products and technologies for ischemic stroke, the commercialization of intracranial stents, increased sales of other hemorrhagic stroke products, and sustained growth in interventional pathway product sales [1]

Core Viewpoint - The company, Xinwei Medical-B (06609), has seen its stock price increase by over 12%, currently trading at HKD 56.55, with a transaction volume of HKD 2.8647 million. The company anticipates significant revenue growth and profitability improvements in the coming years [1]. Financial Performance - Xinwei Medical expects to achieve revenue between approximately RMB 400 million to RMB 410 million for the fiscal year ending December 31, 2025, representing a year-on-year increase of at least 43.9% [1]. - The company forecasts a pre-tax profit of approximately RMB 80 million, indicating a turnaround from previous losses [1]. Growth Drivers - Revenue growth is primarily attributed to the launch of new products and technologies for ischemic stroke, an increase in market share for ischemic stroke products, and the commercialization of intracranial stents [1]. - Continued sales growth in interventional access products and effective cost control measures have contributed to a reduction in expense ratios [1]. Product Development - Xinwei Medical announced that its self-expanding intracranial drug-eluting stent registration application has been accepted by the National Medical Products Administration. This product is designed for the treatment of intracranial atherosclerotic stenosis, providing support and patency to narrowed and obstructed lumens while effectively preventing in-stent restenosis [1]. - Currently, there are no similar products approved for market globally, positioning the company at the forefront of this product development within the industry [1].

Core Viewpoint - The company, Xinwei Medical (心玮医疗-B), is experiencing significant stock price appreciation and is projecting substantial revenue growth for the fiscal year ending December 31, 2025, driven by new product launches and market share gains in the ischemic stroke segment [1] Group 1: Financial Performance - Xinwei Medical expects to achieve revenue between approximately RMB 400 million and RMB 410 million, representing a year-on-year increase of at least 43.9% [1] - The company anticipates a pre-tax profit of approximately RMB 80 million, marking a turnaround from previous losses [1] - Revenue growth is attributed to the launch of new products and technologies for ischemic stroke, increased market share, and effective cost control measures [1] Group 2: Product Development - The company announced that its self-expanding intracranial drug-eluting stent registration application has been accepted by the National Medical Products Administration [1] - This stent is designed for the treatment of intracranial atherosclerotic stenosis, providing support and patency to narrowed and obstructed lumens while effectively preventing in-stent restenosis [1] - Currently, there are no similar products approved for market globally, indicating that the company is at the forefront of this product development within the industry [1]

Core Viewpoint - The company, 心玮医疗-B (06609), anticipates significant revenue growth for the fiscal year ending December 31, 2025, projecting earnings between approximately RMB 400 million and RMB 410 million, representing an increase of at least 43.9% compared to RMB 278 million for the fiscal year ending December 31, 2024 [1] Revenue Growth Drivers - The revenue growth is driven by the launch of new products and technologies for ischemic stroke and an increase in market share for ischemic stroke products [1] - The commercialization of intracranial stents and increased sales of other hemorrhagic stroke products contribute to the revenue growth [1] - Continuous growth in sales of interventional access products also supports the revenue increase [1] - Effective cost control measures in sales costs and administrative expenses have reduced the company's expense ratio [1] Profitability Expectations - The company expects to achieve a pre-tax profit of approximately RMB 80 million during the reporting period, a significant improvement compared to a pre-tax net loss of RMB 12 million for the fiscal year ending December 31, 2024 [1]