香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 Peijia Medical Limited 沛嘉醫療有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股 份 代 號：9996） 自願公告 2025年1月1日至2025年6月30日期間 的未經審核營運數據 本公告由沛嘉醫療有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願 刊發，以向本公司股東及潛在投資者提供有關本集團最新業務及產品開發進 展的最新資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團截至2025年6月30日止六 個月（「報告期間」）的若干未經審核營運數據及比較數字列如下。 1月1日至6月30日期間 | 2025年 | 2024年 | 變動 | | --- | --- | --- | | 人民幣百萬元 | 人民幣百萬元 | % | 收入 約350.0–360.0 301.2 約16.2–19.5 本集團收入增長持續的主要驅動因素如下： (i) 我 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 沛嘉醫療有限公司 (「本公司」)（於開曼群島註冊成立的有限公司） 呈交日期: 2025年8月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09996 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | 本月底法 ...

Core Insights - The medical robotics industry has entered a complex phase by 2025, with evolving product forms, clearer clinical pathways, and a more rational capital environment [1] - The third Global Medical Robotics Conference focuses on the systematic upgrade of intelligent surgical systems, the construction of a full-chain ecosystem, and global pathways [1][2] Event Details - The conference will take place on September 5-6, 2025, at the Beijing Zhongguancun National Independent Innovation Demonstration Zone Exhibition and Trading Center [4] - The agenda includes a variety of topics such as technological systems and intelligent evolution, commercialization and hospital system implementation, and global strategies [5][8][9] Industry Trends - The next-generation surgical robots will emphasize AI integration to enhance autonomy and system collaboration efficiency [7] - The conference aims to redefine how surgical rooms and hospitals can be transformed through robotics [13] Challenges and Opportunities - The event will address challenges in integrating surgical robots with hospital systems and constructing a leading global R&D framework [12] - It will explore the commercialization pathways for surgical robots, including market comparisons and procurement decision-making processes [12] Recognition and Awards - The MedRobot annual awards have become one of the most recognized technology awards in China's medical robotics field, highlighting key players and innovations [16]

Core Viewpoint - As of July 18, 160 stocks reached their 52-week highs, with notable performances from China New Economy Investment (00080), Aoyuan Group Equity (02905), and Zhong An Holdings Group (08462) showing high growth rates of 288.89%, 55.28%, and 50.00% respectively [1][2]. Summary by Category 52-Week High Performers - China New Economy Investment (00080) closed at 0.440, with a peak price of 0.700, achieving a growth rate of 288.89% [2]. - Aoyuan Group Equity (02905) closed at 0.218, with a peak price of 0.250, achieving a growth rate of 55.28% [2]. - Zhong An Holdings Group (08462) closed at 0.221, with a peak price of 0.228, achieving a growth rate of 50.00% [2]. - Other notable performers include Hualian International (00969) with a growth rate of 40.13% and Zhongke Bio (01237) with a growth rate of 37.25% [2]. Additional High Performers - Wanma Holdings (06928) closed at 0.550 with a growth rate of 30.43% [2]. - Lepu Biopharma-B (02157) closed at 7.940 with a growth rate of 24.54% [2]. - Other stocks with significant growth include ZhiJianYueDong (06860) at 17.14% and China Jindian Group (08281) at 17.12% [2]. 52-Week Low Performers - The document also lists stocks that reached their 52-week lows, with XI Ernan CO-U (09311) showing a decline of 16.10% [6]. - Other notable declines include XI Ernan CO (07311) at -12.62% and Haotian International Construction Investment (01341) at -5.70% [6].

Core Viewpoint - The Hong Kong innovative medical device sector has seen significant growth this year, with the Hang Seng Healthcare Index rising over 50% year-to-date, driven by profit recovery and valuation adjustments [1][3]. Group 1: Market Dynamics - The National Medical Products Administration (NMPA) has announced ten measures to support the innovation and development of high-end medical devices, further enhancing long-term investment expectations for innovative medical device companies [1][3]. - The current investment environment is warming, leading to increased focus on the validation of innovative technologies and their commercial potential [3][9]. Group 2: Company Performance - Peijia Medical (09996) has experienced a stock price increase of over 95% year-to-date, significantly outperforming the index and bringing its market capitalization to around HKD 5 billion [1][3]. - The company has established itself as a leading brand in the Chinese transcatheter aortic valve replacement (TAVR) market, with a market share increase from 5% in 2021 to over 25% currently [4][10]. Group 3: Product Development and Innovation - Peijia Medical is advancing its product pipeline, with its second-generation TAVI product nearing market approval and its third-generation product expected to enter the market in the first half of next year [4][10]. - The company has a robust pipeline that includes innovative technologies such as non-glutaraldehyde cross-linked valves and shockwave calcification reconstruction technology, positioning it well against competitors [10][12]. Group 4: Market Potential - The TAVR market in China is projected to grow significantly, with an expected compound annual growth rate (CAGR) of 36.6% from 2021 to 2030, reaching approximately 109.5 billion yuan by 2030 [9][11]. - The current TAVR penetration rate in China is only 5.7% of the global total, indicating substantial growth potential for the market [11]. Group 5: Future Outlook - Peijia Medical aims to solidify its position as the leading TAVR brand in China by expanding its product offerings and increasing market share to 25-30% by 2025 [4][12]. - The company is also pursuing international expansion, with plans to apply for CE certification for its products and engage in global clinical studies [12][13].

Core Viewpoint - The neurointervention industry has undergone significant changes since the introduction of centralized procurement in 2021, leading to drastic price reductions and a shift in market dynamics, with a notable increase in the market share of domestic products and a concentration of market share among leading companies [1][2]. Group 1: Price Changes and Market Dynamics - The average price of spring coils dropped from 12,000 yuan to around 6,400 yuan, a decrease of 46.82%, with the highest drop reaching 66% [1]. - The minimum winning price for spring coils is now approximately 3,244 yuan, while the average price for intracranial thrombectomy stents has fallen from 26,900 yuan to below 4,000 yuan [1]. - The market share of domestic neurointervention products surged from less than 10% to 26% by 2024, indicating a significant shift in the competitive landscape [1]. Group 2: Financial Performance of Leading Companies - Despite gaining market share, leading companies in the neurointervention sector have faced continuous losses, with notable losses reported by companies such as MicroPort Brain Science and Guichuang Tongqiao [2]. - By 2024, these companies have turned profitable, with MicroPort Brain Science achieving a net profit of 249 million yuan, marking a significant turnaround from previous losses [2]. Group 3: Revenue Growth Factors - Revenue growth for leading companies has been substantial, with Guichuang Tongqiao's neurointervention business experiencing revenue growth rates of 463%, 108%, 64%, and 38.4% from 2021 to 2024 [3][4]. - The number of approved and commercialized products has increased significantly, with MicroPort Brain Science expanding from 8 to 25 products from 2021 to 2024 [5]. Group 4: Sales and Market Expansion Strategies - Centralized procurement has accelerated the commercialization of neurointervention products, leading to increased sales volumes despite lower prices [7][9]. - Companies like MicroPort Brain Science have expanded their product reach to approximately 520 hospitals, significantly increasing their market presence [8]. Group 5: Cost Management and Efficiency - Leading companies have focused on improving operational efficiency to reduce costs, with Guichuang Tongqiao reducing its sales and distribution expenses from 31% to 22.3% of total revenue [14]. - Companies have also optimized their supply chains and production processes, with MicroPort Brain Science achieving a 90% localization rate for raw materials by the end of 2023 [15][16]. Group 6: International Market Expansion - In response to domestic market pressures, leading companies are increasingly targeting international markets, with MicroPort Brain Science conducting over 50 overseas training and academic exchange events in 2024 [10][11]. - Guichuang Tongqiao reported international business revenue of 22.6 million yuan in 2024, a 58.2% increase, indicating successful market penetration in Europe and Asia [11].

Summary of Key Points Core Viewpoint - As of July 3, a total of 120 stocks reached their 52-week highs, indicating a strong market performance with notable leaders in the list [1]. Group 1: Top Performers - The top three stocks with the highest increase rates are: - 富誉控股 (Fuyou Holdings) at 90.76%, closing at 0.435 with a peak of 0.475 [1] - 信义能源 (Xinyi Energy) at 65.00%, closing at 1.200 with a peak of 1.980 [1] - 中国三三传媒 (China San San Media) at 42.86%, closing at 1.710 with a peak of 1.900 [1] Group 2: Additional Notable Stocks - Other notable stocks include: - ITE HOLDINGS at 34.21% increase, closing at 0.047 with a peak of 0.051 [1] - 星凯控股 (Xingkai Holdings) at 30.00%, closing at 0.480 with a peak of 0.650 [1] - 北京北辰实业股份 (Beijing Beichen Industrial) at 26.47%, closing at 0.940 with a peak of 1.290 [1] Group 3: Overall Market Trends - The overall trend shows a significant number of stocks achieving new highs, reflecting positive investor sentiment and market conditions [1].

Financial Performance - The company's overall revenue increased by 39.5% year-on-year, with significant advancements in both transcatheter valve therapy and neurointervention businesses[14] - Revenue for the year ended December 31, 2024, was RMB 615.5 million, an increase of 39.5% compared to RMB 441.1 million in 2023[21] - Gross profit for 2024 was RMB 433.6 million, reflecting a 33.3% increase from RMB 325.4 million in 2023[21] - Revenue from neurointervention and transcatheter valve therapy businesses was RMB 355.5 million and RMB 259.9 million, representing increases of 39.1% and 40.1% respectively compared to the previous year[103] - The gross profit increased by 33.3% to RMB 433.6 million, with a gross margin of 70.5%, down from 73.8% in the previous year[106] - The operating loss decreased by 44.4% to RMB 239.3 million, with the neuro-interventional business achieving a profit of RMB 52.1 million[23] - The company recorded a net loss of RMB 228.5 million, a significant decrease of 41.8% compared to 2023, with the neurointerventional business generating a segment profit of RMB 52.1 million, marking an important milestone in profitability[29] Market Expansion and Product Development - The market share in China's TAVR market expanded to approximately 25%, with sales revenue for TAVR-related products rising by 40.1% to RMB 259.9 million[15] - The total implantation volume exceeded 3,400 units, representing a year-on-year growth of about 37%[15] - The company launched the next-generation adjustable TAVR system, TaurusMax™, and introduced a smaller size specification for existing valves[16] - The company has initiated FDA 510(k) registration for the DCwire® microguidewire to accelerate global expansion[18] - The company restructured its transcatheter valve therapy business to optimize resource allocation and enhance innovation in high-potential projects[17] - The company secured exclusive distribution rights for the YonFlow® blood flow-directed stent in the Greater China region, enhancing its hemorrhagic product pipeline[18] - The partnership with JenaValve for aortic regurgitation technology has led to satisfactory investment returns following a proposed acquisition by Edwards Lifesciences[16] - The company launched the DCwire® micro-guidewire nationwide, achieving first-year revenue of RMB 37.5 million[26] - The new generation TAVR product TaurusMaxTM received regulatory approval, enhancing product performance and surgical efficiency[24] - The company has a comprehensive portfolio of commercialized and in-development products, including seven registered products and multiple in-development products in the transcatheter valve therapy segment[41] Research and Development - The R&D expense ratio decreased from 66.5% to 33.1%, a year-on-year decline of 33.4 percentage points, primarily due to revenue growth and products entering lower R&D expenditure phases[30] - The company has registered 17 products in the Chinese market as of the report date, with expectations to maintain leadership in the neurointerventional sector due to high-quality product offerings and strong brand reputation[28] - The company has received special approval for innovative medical devices under the NMPA's expedited review process[44] - The company is focused on developing innovative solutions for unmet clinical needs in the heart valve disease market[66] - The company is actively developing next-generation products based on clinical feedback to optimize current product performance[85] Operational Efficiency - Non-current assets increased by 18.6% to RMB 1,701.7 million, up from RMB 1,434.5 million in 2023[21] - Total liabilities rose by 61.9% to RMB 644.1 million, compared to RMB 397.9 million in 2023[21] - The sales and distribution expenses increased by 1.0% year-on-year, with the sales and distribution expense ratio decreasing by 20.3 percentage points to 53.3%, resulting in a commercial profit of RMB 105.3 million[30] - Research and development expenses decreased by 30.7% to RMB 203.4 million, primarily due to a reduction in service fees[109] - The company has achieved a market share of approximately 25% in the TAVR market in China, with over 3,400 total implants annually and coverage of about 650 medical institutions as of December 31, 2024[95] Governance and Management - The board consists of three executive directors, four non-executive directors, and four independent non-executive directors[136] - Dr. Zhang, the CEO, has been with the company since May 30, 2012, and oversees overall management, business, and strategic development[137] - The company has established individual employment contracts with employees, covering salary, bonuses, and various employee benefits as per Chinese labor laws[135] - The company has a strong management team with diverse backgrounds in finance, operations, and technology, enhancing its strategic capabilities[161][162][163] - The governance structure includes a mix of experienced professionals from various industries, contributing to the company's strategic direction and oversight[145][147][149] Risks and Challenges - The company has incurred significant operating losses since its inception and may continue to do so in the foreseeable future[187] - The company may not be able to maintain or renew all necessary licenses, permits, and certifications for production[190] - Changes in Chinese government political and economic policies could adversely affect the company's business and growth strategies[197] - The company may face risks associated with strategic alliances or acquisitions, including increased capital requirements and potential dilution of shareholder equity[197] - Potential product liability claims and recalls may arise, and existing insurance may not cover all liabilities[196] Future Outlook - Future growth largely depends on the successful commercialization of in-development products[190] - The company aims to expand its market presence and enhance its product offerings through strategic initiatives and potential acquisitions[176] - The company plans to utilize HKD 1,682.18 million for core product development, with HKD 732.37 million remaining as of December 31, 2023[128] - The company will continue to maintain revenue growth in its neurointerventional business while implementing cost control measures to maximize shareholder value[102]

Group 1 - The National Medical Products Administration (NMPA) is seeking public opinion on measures to optimize the lifecycle regulation to support the innovation of high-end medical devices [1] - The NMPA plans to strengthen standardization to lead innovation, including the rapid release of standards for medical exoskeleton robots and radioactive nuclide imaging devices [1] - A total of 308 medical device products were approved for registration by the NMPA in March 2025, including 248 domestic Class III medical devices and 34 imported Class III medical devices [1] Group 2 - Huatai Securities believes that the policy for medical equipment updates will gradually stimulate demand in the medical device sector, benefiting leading companies [1] - The equipment update policy is expected to last for three years and may expand to other areas such as endoscopy, leading to a recovery in hospital procurement [1] - The medical device market is anticipated to see a sustained recovery as previously suppressed demand is gradually released [1] Group 3 - Related companies in the medical device industry chain listed in Hong Kong include Qiming Medical-B (02500), Aikang Medical (01789), MicroPort Scientific Corporation-B (02252), Peijia Medical-B (09996), MicroPort Medical (00853), Kunbo Medical-B (02216), and Yimai Sunshine (02522) [2]

Investment Rating - The investment rating for the company is "Buy" with a target price of 6.88 HKD [8][9]. Core Views - The company is expected to achieve a revenue of 615 million RMB in 2024, representing a year-on-year growth of 39.5%, with a significant reduction in net loss to 228 million RMB [1]. - The TAVR segment is projected to see a revenue increase of 40% year-on-year in 2024, driven by an increase in market share and product iterations [2]. - The neurointervention segment is also expected to grow by 39% year-on-year in 2024, benefiting from new product launches and import substitution opportunities [3]. - Long-term growth is anticipated from the TAVR pipeline, with new products expected to launch from late 2025 [4]. - The company is projected to achieve revenues of 818 million RMB, 1.066 billion RMB, and 1.540 billion RMB in 2025, 2026, and 2027 respectively, with a net loss of 83 million RMB in 2025 turning to a profit of 10 million RMB in 2026 [5][20]. Summary by Sections TAVR Segment - The TAVR segment is expected to generate 260 million RMB in revenue in 2024, with a 40% year-on-year growth, and a market share increase to 25% [2]. - The company plans to expand its market presence by increasing hospital partnerships and launching new products [2]. Neurointervention Segment - The neurointervention segment is projected to achieve 356 million RMB in revenue in 2024, with a 39% year-on-year growth, driven by new product launches and import substitution [3]. - The segment is expected to benefit from regional procurement policies and the introduction of new products [3]. TMV/TTV Pipeline - The TMV/TTV pipeline is progressing well, with potential sales exceeding 2 billion RMB by 2033, supported by ongoing clinical trials and product registrations [4]. Profit Forecast and Valuation - The company is expected to achieve revenues of 818 million RMB in 2025, with a net loss of 83 million RMB, improving to a profit of 10 million RMB in 2026 [5][20]. - A DCF valuation method estimates the target price at 6.88 HKD, reflecting the long-term growth potential of the company's pipeline [5][13].