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].

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].

2025.06. 18 本文字数：2596，阅读时长大约4分钟 作者 | 第一财经 黄思瑜 周斌 证监会主席吴清话音刚落，6月18日下午，科创板"1+6"改革细则出炉。 6月18日，证监会发布《关于在科创板设置科创成长层 增强制度包容性适应性的意见》（下称《科创 板意见》），明确了科创板科创成长层入层和调入条件。 其中，设置科创板科创成长层，重点服务技术有较大突破、商业前景广阔、持续研发投入大，但目前 仍处于未盈利阶段的科技型企业。未盈利科技型企业全部纳入科创成长层，调出条件实施新老划断。 清华大学国家金融研究院院长、五道口金融学院副院长田轩认为，设置科创成长层这一举措具有非常 重要的意义。成长层突破了过去对拟融资企业规模、盈利等方面的要求与限制，不仅能够根据科创企 业轻资产、高研发投入、未来收益不确定性大等特点，为科技创新型企业提供更为精准的融资平台； 还能够吸引社会资本聚焦科技创新领域，引导资金从传统产业流向具有高附加值和发展潜力的科创产 业，加速科技成果转化，促进产业结构优化升级。 此外，科创板推出6项改革举措，包括对于适用科创板第五套上市标准的企业，试点引入资深专业机 构投资者制度；扩大第五套标准适用 ...