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科创板第五套标准重启后,首家创新医疗器械IPO获受理
Zheng Quan Shi Bao· 2025-11-06 12:57
Core Viewpoint - The Shanghai Stock Exchange has accepted the IPO application of Shenzhen Core Medical Technology Co., Ltd., marking it as the first innovative medical device company to be accepted under the newly restarted fifth set of listing standards [1][4]. Group 1: Company Overview - Core Medical is focused on providing artificial heart products and has developed 5 implantable and 6 interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration approval stage [3]. - The company's first commercialized product, the Corheart6, is the smallest and lightest magnetic levitation implantable artificial heart globally, with the highest cumulative implantation volume and market share in China [3]. Group 2: Financial Status - As of June 30, 2025, Core Medical reported a cumulative undistributed profit of -367 million yuan, indicating it is still in a non-profitable state [4]. - The company aims to raise 1.217 billion yuan through its IPO to support product development, establish an industrialization base for artificial hearts, and enhance its marketing network and digital infrastructure [4]. Group 3: Investment and Market Position - Core Medical has undergone multiple rounds of financing, attracting investments from notable shareholders including Hillhouse Capital, Zhengxin Valley Investment Management, and others [6]. - The acceptance of Core Medical's IPO application under the fifth set of standards exemplifies the Shanghai Stock Exchange's efforts to broaden financing channels for innovative enterprises [5].
3只新股大涨,中一签最高赚3万
Core Viewpoint - The Science and Technology Innovation Board (STAR Market) in China has welcomed the listing of three unprofitable companies, marking a significant moment in the implementation of the "1+6" reform, which aims to support innovative enterprises in various high-tech sectors [1][11]. Group 1: New Listings - Three companies, He Yuan Bio (禾元生物), Xi'an Yicai (西安奕材), and Bibete (必贝特), have collectively listed on the STAR Market, becoming the first batch of new registered companies under the STAR Market's growth tier [1][3]. - These companies will be included in the STAR Market's growth tier from the day of their listing, expanding the "hard technology army" of the board [1][3]. Group 2: Market Performance - On the listing day, the three new stocks opened high, with Xi'an Yicai surging by 361%, He Yuan Bio increasing by 203%, and Bibete rising by 175%. By the end of the trading day, their respective gains were approximately 199%, 213%, and 74% [3][4]. Group 3: Company Profiles - He Yuan Bio specializes in innovative drug development, particularly in recombinant human albumin derived from rice, with its core product expected to be approved for market by July 2025. The company has a pipeline of eight drugs, with significant revenue growth projected from 2022 to 2024 [6][7]. - Bibete focuses on developing innovative drugs for major diseases, with one product already approved and several others in various stages of clinical trials. The company has not yet generated revenue but is advancing its commercialization efforts [8]. - Xi'an Yicai is a semiconductor company specializing in 12-inch silicon wafers, ranking first in China and sixth globally in terms of production capacity. Despite significant revenue growth from 2022 to 2024, the company remains unprofitable due to high initial investments and costs [8][9]. Group 4: Regulatory Context - The "1+6" reform implemented in June 2023 has successfully introduced a growth tier for unprofitable companies on the STAR Market, allowing for a broader range of high-tech sectors to access public capital markets [11][12]. - As of October 28, 2025, 22 companies have utilized the STAR Market's fifth set of standards for listing, with many transitioning from research and development phases to commercialization [11][12].
3只新股大涨,中一签最高赚3万
21世纪经济报道· 2025-10-28 12:28
Core Viewpoint - The article discusses the recent listing of three unprofitable companies on the STAR Market, marking a significant event as it is the first time in two years that unprofitable enterprises have been allowed to go public under the new "1+6" reform policy, expanding the "hard technology" sector on the STAR Market [1][3][10]. Group 1: New Listings - Three companies, He Yuan Bio (禾元生物), Xi'an Yicai (西安奕材), and Bibete (必贝特), were listed on October 28, 2023, under the STAR Market's growth layer for innovative companies [1][3]. - These companies are the first batch of new registrations since the implementation of the "1+6" reform, which aims to support unprofitable enterprises in the technology sector [1][10]. Group 2: Market Performance - On the listing day, all three stocks opened high, with Xi'an Yicai surging by 361%, He Yuan Bio by 203%, and Bibete by 175%. By the end of the trading day, their respective increases were approximately 199%, 213%, and 74% [3][4]. Group 3: Company Profiles - He Yuan Bio specializes in innovative drug development, particularly in recombinant human albumin derived from rice, with a projected revenue of 133.997 million yuan in 2022, increasing to 252.161 million yuan in 2024, but still reporting net losses [6][11]. - Bibete focuses on developing innovative drugs for major diseases, with a projected revenue of 0 yuan for 2022-2024, and net losses of 1.88 billion yuan in 2022 and 1.73 billion yuan in 2024 [7][11]. - Xi'an Yicai operates in the semiconductor industry, specifically in the production of 12-inch silicon wafers, with revenues projected to grow from 1.055 billion yuan in 2022 to 2.121 billion yuan in 2024, but also reporting significant net losses [8][9]. Group 4: STAR Market Reforms - The "1+6" reform introduced in June 2023 has successfully set up a growth layer for the STAR Market, allowing unprofitable companies to list under the fifth set of standards, which has already seen 32 existing unprofitable companies included [10][12]. - The STAR Market has supported 22 biopharmaceutical companies under the fifth set of standards since its inception, with many transitioning from research phases to commercialization [10][11]. Group 5: Future Outlook - The article highlights the potential for further expansion of the fifth set of standards to include more cutting-edge technology sectors such as artificial intelligence and commercial aerospace, which require significant upfront investment and have long development cycles [14].
资本赋能 科创板科创成长层创新药企打造发展新范式
Zhong Zheng Wang· 2025-10-24 13:43
从经营业绩来看,上述创新药企正加速从研发投入期迈向商业化收获期,2024年合计实现营业收入319 亿元,同比增长54.39%。在研发成果上,上述公司已成功推出20款具备"全球新"属性的国家1类新药, 推动10款创新药物在17项适应症的治疗上取得国家药品审评中心"突破性疗法"认定。 截至目前,科创板科创成长层共有13家创新药企,总市值近5000亿元。上市以来,相关公司在科创板支 持下,累计已推动25款新药获批上市。 中证报中证网讯(记者黄一灵)10月28日,创新型生物医药企业"禾元生物"将在上交所科创板上市,并自 上市之日起纳入科创板科创成长层。 禾元生物是科创板第五套标准重启后首家过会的企业。科创板第五套标准,作为境内资本市场允许无收 入、未盈利的企业发行上市的首次探索,近年来不仅助力众多创新药企突破资金瓶颈、加速研发创新 药,更有效带动了创新药领域的投资热潮。相关数据显示,2019年至今,我国创新药产业在一、二级市 场的累计融资规模已超过万亿元。在资本活水的浇灌下,创新药研发活动迎来了前所未有的活跃期。目 前,我国创新药研发管线约占全球的1/4。 ...
IPO上市前的准备工作、上市规范、股改要点一览
梧桐树下V· 2025-08-31 03:45
Core Viewpoint - The article discusses the gradual expansion of the policy effects of the fifth set of listing standards on the Sci-Tech Innovation Board, which supports high-quality, unprofitable innovative companies to go public. It emphasizes the importance of companies preparing for IPOs by following the guidelines outlined in the "Domestic IPO Practical Manual (Enterprise Perspective)" [1][3]. Group 1: IPO Preparation - The first part of the manual consists of six chapters that cover essential tasks, participants, listing conditions, and overall processes that companies need to understand before going public. It also includes guidance on selecting intermediary institutions and assessing the feasibility of listing [6][3]. - Companies should differentiate their strategies based on whether they are within the application period or outside it. For those within the application period, they need to control incremental changes and review past data, while those outside should focus on clarifying their balance sheets as of December 31 of the previous year [7][6]. Group 2: Listing Norms - The second part introduces a "Five-Step Method" for listing norms, which includes adjustments to equity structure, organizational structure, business processes, financial norms, and ERP implementation. Each step is elaborated in detail [13][11]. - The manual emphasizes the importance of tax planning and the differences in tax treatment before and after the IPO, highlighting the need for companies to be aware of their tax obligations during the listing process [11][19]. Group 3: Share Reform Key Points - The third part focuses on key considerations for share reform, including how to choose the timing for share reform and the necessary preparations. It provides practical, step-by-step guidance for companies [19][21]. - Companies are advised to avoid selecting certain month-end dates for share reform due to potential complications and are encouraged to choose more favorable dates [19][21]. Group 4: Other Important Matters - The fourth part discusses capital operations during the IPO process, including the roles of various departments and case studies of IPO reviews in key industries. It aims to facilitate understanding of the integration of investors, mergers and acquisitions, and equity incentives [24][27]. - The manual also highlights the importance of planning for inquiries related to the IPO, particularly the financial department's role in addressing data-related questions [27][24].
IPO上市前的准备工作、上市规范、股改要点一览
梧桐树下V· 2025-08-10 06:17
Core Viewpoint - The article discusses the gradual implementation of the fifth set of listing standards on the Sci-Tech Innovation Board, which is expected to attract more innovative technology companies to go public in China [1]. Group 1: Preparation for IPO - The first part of the manual includes six chapters that cover essential tasks, participants, listing conditions, and overall processes that companies need to understand before going public [8]. - Companies should develop strategies based on whether the IPO initiation point falls within the reporting period, categorizing them into strategies for within and outside the reporting period [8][10]. - When assessing the feasibility of going public, companies must consider potential substantive obstacles and issues that may affect the IPO process, such as sudden shareholding changes and changes in the main business [10]. Group 2: Listing Norms - The second part introduces the "Five-Step Method" for listing norms, which includes adjustments to equity structure, organizational structure, business process refinement, financial system standardization, and ERP implementation [19]. - Each step of the "Five-Step Method" is elaborated upon, providing a systematic approach for companies to follow [19]. Group 3: Share Reform Key Points - The third part focuses on important timing for IPOs, considerations for share reform, and strategies to reduce listing costs, with a significant emphasis on share reform [25]. - Detailed explanations are provided on how to choose the right timing for share reform and the necessary preparations [27]. Group 4: Other Important Matters - The fourth part discusses other capital operations during the IPO process, departmental work arrangements, and highlights case studies from key industries [30]. - It includes analysis of six representative IPO review cases, focusing on regulatory concerns and common issues faced by companies in those industries [32].
科创板“新五套”再破冰:必贝特过会两年半终获批文
Group 1 - The core viewpoint of the article is that Guangzhou Bibet Pharmaceutical Co., Ltd. has finally received its IPO approval after a lengthy process, reflecting the challenges and changes in the regulatory environment for biotech companies in China [1][2][3] - Bibet's IPO journey began during the "golden window period" of the STAR Market's fifth set of standards, which allowed unprofitable biotech companies to go public, but the overall IPO pace tightened in 2023 [2][3] - The approval of Bibet's IPO may signify a substantial restart of the fifth set of standards, with other similar companies also awaiting review [2][3] Group 2 - Bibet focuses on innovative drug development for major diseases such as cancer and autoimmune diseases, with six core products currently in clinical trials, including BEBT-908, which has submitted a Pre-NDA application [4][5] - The company has incurred significant R&D expenses totaling 342 million yuan from 2020 to 2022, with a continuous expense ratio above 90%, leading to cumulative losses of 422 million yuan by the end of 2022 [5][6] - The company plans to issue up to 70 million shares, raising approximately 2.005 billion yuan, with a post-listing valuation likely between 9 billion to 11 billion yuan [6]
时报观察|审核提速 科创板第五套标准迎“尖子生”
证券时报· 2025-07-22 23:52
Group 1 - The core viewpoint of the article highlights the approval of He Yuan Bio's registration application by the China Securities Regulatory Commission (CSRC), marking it as the first company to fully navigate the review process under the newly restarted fifth listing standard of the Sci-Tech Innovation Board [1] - The approval process for He Yuan Bio took just over ten working days, indicating a shift towards a more inclusive and efficient regulatory approval mechanism [1] - Other companies in the IPO queue under the fifth standard include Bei Xin Life, Si Zhe Rui, Heng Run Da Sheng, and Bi Bei Te, all from the pharmaceutical sector, which are unprofitable but possess core technologies [1] Group 2 - The fifth listing standard has been a crucial pathway for unprofitable hard-tech companies to access the capital market since the establishment of the Sci-Tech Innovation Board, particularly benefiting complex product technology firms with significant funding needs and long R&D cycles [2] - A total of 20 pharmaceutical companies have successfully listed under this standard, and it has now expanded to include more cutting-edge technology fields such as artificial intelligence, commercial aerospace, and low-altitude economy, facilitating easier financing for these hard-tech enterprises [2] - The acceleration of the review process is not about lowering standards but rather about reforming the system to allow truly impactful companies with significant market influence and technological achievements to list without being hindered by their unprofitability [2]
科创第五套上市公司市值表现如何?解构标准重启隐含的价值导向
Tai Mei Ti A P P· 2025-07-22 12:16
Core Insights - The reactivation of the fifth listing standard on the Sci-Tech Innovation Board (STAR Market) aims to support high-growth technology companies, particularly in the biopharmaceutical sector, by allowing companies without profits to list based on expected market capitalization and R&D achievements [1][19] - The biopharmaceutical industry, especially innovative drug companies, faces longer investment periods and higher uncertainty due to strict regulatory requirements for product approval, making them highly reliant on capital [1][19] - Since the reactivation in June 2025, companies like He Yuan Bio and Bei Xin Life have made significant progress, signaling a positive outlook for other biopharmaceutical firms still in clinical stages [2] Market Performance - The innovative drug sector has seen a remarkable stock performance in 2025, driven by favorable policy changes, relaxed procurement policies, and the growth of commercial health insurance, which enhances market expectations for innovative drugs [3] - The 20 companies that successfully listed under the fifth standard have achieved a total market capitalization of 364.12 billion, with an average increase of 79.10% since the beginning of 2025 [3][7] Financial Performance - In 2024, the 20 companies reported a combined revenue exceeding 14.3 billion, a year-on-year growth of 45%, with 16 companies generating over 1 billion in revenue [12][16] - The total R&D expenses for these companies accounted for 67% of their total revenue, indicating a high dependency on external financing for continued innovation [16][18] R&D and Innovation - The 20 companies listed under the fifth standard have collectively developed 45 drug varieties, with 22 classified as first-class new drugs or innovative biological products, covering various advanced therapeutic areas [8][10] - The number of candidate products in the R&D pipeline for these companies has exceeded 200, showcasing their commitment to innovation and market expansion [8] Regulatory Environment - The reactivation of the fifth standard reflects a shift in regulatory focus towards recognizing the inherent risks and long timelines associated with technology innovation, moving away from traditional financial metrics [19][20] - The introduction of a "Sci-Tech Growth Tier" aims to enhance information disclosure and regulatory oversight for companies listed under the fifth standard, ensuring a balance between support and supervision [22]
IPO周报:1家过会、1家获批文,科创板第五套标准审核提速
Di Yi Cai Jing· 2025-07-20 09:46
Group 1 - Two companies terminated their IPO applications last week, both from the Shenzhen Stock Exchange: Guangdong Zhengyang Sensor Technology Co., Ltd. and Guizhou Duocai New Media Co., Ltd. [1] - Wuhan Heyuan Biotechnology Co., Ltd. became the first company to pass the IPO review under the new fifth standard of the Sci-Tech Innovation Board, after a wait of over two years [2][3] - Shenzhen Beixin Life Technology Co., Ltd. also passed the IPO review on July 18, 2023, after being in the queue for over two years [2][3] Group 2 - Guizhou Duocai New Media faced a single business risk, as its IPTV business accounted for over 99% of its revenue from 2019 to the first half of 2022 [4][5] - The company failed to submit its registration after 28 months post-approval, leading to the termination of its IPO application [4] - Guangdong Zhengyang Technology's cash dividend policy raised concerns, with a cumulative dividend payout of 83% of its net profit from 2020 to 2022, which is considered excessive [5][6] Group 3 - The new policies introduced on June 18, 2023, aimed to support high-quality, unprofitable tech companies in going public, including the reintroduction of the fifth standard for the Sci-Tech Innovation Board [2] - The review process for companies applying under the fifth standard has seen new developments, with three other companies still in the queue: Harbin Sizherui Intelligent Medical Equipment Co., Ltd., Shanghai Hengrun Da Biological Technology Co., Ltd., and Guangzhou Bibete Pharmaceutical Co., Ltd. [3]