第五套上市标准
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第五套重启后,首单“人工心”械企核心医疗冲刺科创板IPO
Hua Er Jie Jian Wen· 2025-11-17 12:48
Core Viewpoint - The resumption of the fifth set of IPO standards on the Sci-Tech Innovation Board has led to significant developments for innovative medical device companies, with Shenzhen Core Medical Technology Co., Ltd. being the first to have its IPO application accepted under these new standards, focusing on artificial hearts [1][2]. Company Overview - Core Medical specializes in artificial hearts, reporting a revenue of 94 million yuan in 2024, which represents a growth of over 400% year-on-year, despite a net loss of 132 million yuan during the same period [1]. - The revenue surge is attributed to the successful market launch of its magnetic levitation implantable left ventricular assist device, Corheart® 6, which has generated substantial income [1][4]. Product Details - Corheart® 6 is the first commercially available third-generation magnetic levitation artificial heart, recognized for being the smallest and lightest of its kind globally, weighing only 0.8 kg, which is nearly 50% lighter than its competitor, Abbott's HeartMate 3 [3][4]. - The production cost of Corheart® 6 is approximately 70,000 yuan per unit, with a selling price of 247,200 yuan, resulting in a gross margin close to 70% [9]. Market Challenges - The high price of Corheart® 6, along with the overall surgical costs reaching up to 700,000 yuan, limits the affordability for many patients in China, posing a challenge for its commercialization [1][9]. - Core Medical faces competition not only from Abbott but also from domestic companies like Tongxin Medical and Aerospace Taiheart, which have already launched their products [6][11]. International Expansion - To expand its market, Core Medical aims to penetrate overseas markets, particularly the U.S., where it has yet to initiate clinical trials for Corheart® 6, although it has received approvals in Colombia and Ukraine [6][7]. - The company has other products, such as DuoCor® 2 and CorVad® 4.0/6.0, which are expected to gain approval in the U.S. by 2030, indicating a longer timeline for revenue realization [7]. Industry Landscape - The global heart failure market is projected to grow, with the number of heart failure patients expected to rise from 62.98 million in 2024 to 71.51 million by 2033, presenting a significant opportunity for artificial heart technologies [11]. - However, the emergence of alternative therapies, such as minimally invasive atrial shunt devices, poses additional competition for artificial heart products [11].
科创板改革进一步增强制度包容性适应性
Jin Rong Shi Bao· 2025-06-19 03:15
Core Viewpoint - The China Securities Regulatory Commission (CSRC) has released the "Opinions on Setting Up a Growth Layer in the Sci-Tech Innovation Board" to enhance the inclusiveness and adaptability of the system, allowing unprofitable tech companies to list under the fifth set of standards [1][2]. Group 1: Establishment of the Growth Layer - The Growth Layer is designed to serve tech companies with significant technological breakthroughs and broad commercial prospects that are currently unprofitable [2]. - Companies in the Growth Layer will have a special stock designation "U" (Unprofitable) [2]. - New unprofitable tech companies can be removed from the Growth Layer if they meet specific profit and revenue criteria [2]. Group 2: Rationale for the Growth Layer - The establishment of the Growth Layer aims to reinforce the capital market's support for technological innovation and stabilize market expectations [2]. - It provides a controlled "experimental space" for more inclusive policy measures and facilitates better risk identification for investors [2]. Group 3: Reform Measures - Six reform measures have been introduced to enhance the inclusiveness of the system for quality tech companies [4]. - The first measure involves introducing a pilot program for seasoned professional institutional investors to assess the innovation attributes and future potential of companies [4]. - The second measure is a pilot IPO pre-review mechanism to improve communication services for quality tech companies [5][6]. - The third measure expands the applicability of the fifth set of standards to include more frontier technology sectors such as artificial intelligence and commercial aerospace [6]. Group 4: Additional Policies - Additional policies support unprofitable tech companies in conducting capital increases for existing shareholders and improving the institutional mechanisms for supporting listed companies [7].
科创板迎新一轮改革,“1+6”细则出炉
第一财经· 2025-06-18 12:16
Core Viewpoint - The establishment of the Sci-Tech Innovation Board's "Growth Layer" aims to enhance the inclusivity and adaptability of the system for unprofitable technology companies with significant technological breakthroughs and strong commercial prospects, thereby providing a more precise financing platform for these firms [1][3]. Summary by Sections Introduction of the Growth Layer - The new "Growth Layer" will include all unprofitable technology companies, allowing them to access capital markets despite their current lack of profitability [3][4]. - This initiative is expected to attract social capital towards technology innovation, facilitating the transformation of scientific achievements and optimizing industrial structure [1][3]. Reform Measures - Six reform measures have been introduced alongside the Growth Layer, including the introduction of seasoned professional institutional investors for companies under the fifth listing standard [2][8]. - The scope of the fifth listing standard will be expanded to include more frontier technology sectors such as artificial intelligence and commercial aerospace [10][11]. Conditions for Exiting the Growth Layer - New unprofitable technology companies can exit the Growth Layer if they meet specific profitability criteria, such as achieving positive net profits over the last two years or having a positive net profit with revenue exceeding 100 million yuan in the last year [4][11]. Investor Protection and Risk Disclosure - The reforms include measures for risk disclosure and investor protection, such as adding a "U" (Unprofitable) designation to the stock names of companies in the Growth Layer and requiring enhanced risk assessments by securities firms [4][5]. Future Development Paths - Future development of the Growth Layer should focus on improving institutional frameworks, enhancing collaboration with other capital market segments, and fostering deep integration with the technology innovation ecosystem [5].