"千辛万苦，终于排上了。" 一位投资人难掩激动，记录了这一刻：上周必贝特终于通过科创板IPO注册，距离IPO敲钟越来越近。 此时，这家广州创新药公司已经在A股大门前来回徘徊了三年之久。 这是今年6月科创板第五套上市标准重启后，又一家站在A股大门外的创新药企业，此前禾元生物、北 芯生命已经走到前面。另一边，港股医药IPO钟声不断，十倍股频现，涨幅令人惊叹。 处在周期性底部多年，中国医药复苏景象出现。见证生物医药国运级突破，IPO大门也徐徐拉开，港股 医药赚钱效应正当时，有投资人欣然将2025年称为"医药翻身之年"。 "我们始终认为创新药是最性感的"，在机构内部边缘化已久的医药投资人终于露出久违的笑容。 科创板窗口 创新药正在排队IPO "生物医药的春天来了。" 重要一幕无疑是科创板的IPO大门向药企敞开。回望过去两年，曾为未盈利药企打开融资大门的科创板 第五套上市标准一度陷入"零受理"僵局，直到今年6月证监会主席吴清在2025陆家嘴论坛上宣布，重启 未盈利企业适用科创板第五套标准上市。 这意味着，停滞许久的医疗企业终于迎来了IPO的窗口。 随后很快，禾元生物顺利过会，成为科创板第五套上市标准重启后的首家药企。成 ...

新 周 期 。 作者 I 周佳丽 报道 I 投资界PEdaily 随后很快，禾元生物顺利过会，成为科创板第五套上市标准重启后的首家药企。成立于 2 0 0 6年，禾元生物利用水稻胚乳细胞基因表达平台研发植物源医药产品，业内称之为"稻 米造血"。 今年7月，其核心产品HY10 01（重组人白蛋白注射液）获批上市。 身后投资 机构包括上海同盛、贝达药业、光谷生物基金以及倚锋资本等。 紧接着，北芯生命IPO也通过审核。成立于20 1 5年，北芯生命专注于心血管疾病精准诊疗 创新医疗器械研发、生产和销售。十年来，公司集结了红杉中国、国投创合、松禾资本、 倚锋资本、启明创投、泰煜投资、鲲鹏一创等众多知名机构。这是重启科创板第五套上市 标准后，短短一个月内第二家成功过会的生物医药企业。 " 千 辛 万 苦，终 于 排 上 了 。 " 一位投资人难掩激动，记录了这一刻：上周必贝特终于通过科创板IPO注册，距离IPO敲 钟越来越近。此时，这家广州创新药公司已经在A股大门前来回徘徊了三年之久。 这是今年6月科创板第五套上市标准重启后，又一家站在A股大门外的创新药企业，此前 禾元生物、北芯生命已经走到前面。另一边，港股医药IPO ...

Core Insights - July 18 marked a significant day for the capital market with multiple key approvals from the China Securities Regulatory Commission (CSRC) [1] - The approvals indicate an acceleration in the review process for quality mergers and acquisitions, as well as a more inclusive approach for IPOs on the Sci-Tech Innovation Board [1][7] Group 1: Mergers and Acquisitions - The CSRC approved China Shipbuilding Industry Company’s absorption merger with China Shipbuilding Heavy Industry Company, marking a significant step in the integration of two major listed platforms under the China Shipbuilding Group [2] - The merger is the first to complete the Shanghai Stock Exchange review and CSRC registration under the new restructuring regulations, setting a precedent for future mergers [2] - ChipLink Integrated Circuit Manufacturing Co. received approval for a significant asset restructuring deal, involving the acquisition of 72.33% of ChipLink Yuezhou Integrated Circuit Manufacturing for a total transaction value of 5.897 billion yuan, despite both companies currently being unprofitable [2][3] Group 2: Initial Public Offerings (IPOs) - Wuhan Heyuan Biotechnology Co. became the first company to receive IPO registration approval under the newly restarted fifth set of standards on the Sci-Tech Innovation Board [4] - Heyuan Biotechnology plans to raise 2.4 billion yuan for the construction of a recombinant human albumin production base, new drug development, and to supplement working capital [5] - Shenzhen Beixin Life Technology Co. also passed the listing review under the new standards, focusing on high-performance innovative medical devices for cardiovascular interventions [5] - Yushu Technology has initiated the IPO counseling process, with plans for a comprehensive evaluation of its listing conditions by October 2025 [5][6]

Core Viewpoint - The article discusses the recent submission of listing materials by Hengrun Dashing, a biopharmaceutical company, under the fifth set of listing standards on the Sci-Tech Innovation Board, highlighting the trend of allowing unprofitable companies to list, which supports the development of high-quality technology enterprises [2][3][9]. Group 1: Company Overview - Hengrun Dashing is a biopharmaceutical company focused on innovative immune cell therapy products, particularly in the treatment of malignant blood diseases and solid tumors [6]. - The company has a pipeline of 11 research projects, including 10 major products utilizing technologies such as CAR-T and CAR-NK [6]. - As of the date of the prospectus, all products are still in the research and development phase, with no commercial sales or profitability expected in the near future [5][6]. Group 2: Financial Performance - The company has reported significant projected losses for the upcoming years, with net profits expected to be -273.71 million yuan, -283.65 million yuan, and -187.76 million yuan for 2022, 2023, and 2024 respectively [5]. - Cumulative undistributed profits amount to -904.15 million yuan as of the report date [5]. Group 3: Listing Standards and Market Context - The fifth set of listing standards on the Sci-Tech Innovation Board is designed for companies with complex product technologies, high capital requirements, and long research cycles, particularly in the biopharmaceutical sector [9]. - Since the establishment of the Sci-Tech Innovation Board in 2019, 54 unprofitable companies have successfully listed, with 22 of them achieving profitability post-listing [9]. - The resumption of the fifth set of listing standards is seen as a positive move to enhance the inclusivity and adaptability of the regulatory framework for high-quality unprofitable technology enterprises [3][9].

Core Viewpoint - The approval of Wuhan Heyuan Biotechnology Co., Ltd. for IPO marks the first successful case under the restarted fifth listing standard of the Sci-Tech Innovation Board, reflecting the regulatory support for innovative technology companies [1][2]. Group 1: Company Overview - Wuhan Heyuan Biotechnology, established in 2006, focuses on the blue ocean market of "recombinant human albumin" and is expected to launch its core product, HY1001, soon after completing Phase III clinical trials [1]. - Currently, Heyuan's revenue primarily comes from pharmaceutical excipients and research reagents, with its core innovative drug still in development and not yet generating income, leading to a loss [2]. Group 2: Industry Context - As of now, 20 companies have utilized the fifth listing standard on the Sci-Tech Innovation Board, with 19 being innovative drug development firms and 1 in high-end medical device development [2]. - In 2024, these 20 companies are projected to achieve a combined revenue exceeding 14 billion yuan, representing a growth of over 40% compared to 2023, with 16 companies generating over 100 million yuan in revenue [2]. - By the first quarter of 2025, these companies continued to show growth, achieving a total revenue of 3.78 billion yuan, a year-on-year increase of 29.27% [2]. Group 3: Regulatory Environment - The implementation of the "1+6" policy measures for the Sci-Tech Innovation Board aims to enhance inclusivity and adaptability in the regulatory framework, promoting deeper integration of technological and industrial innovation [3]. - The pace of IPO applications has accelerated, with over 30 applications received in the first half of the year, of which more than 70% are from the Sci-Tech Innovation Board, facilitating a positive cycle among technology, capital, and industry [3].

Policy Developments - The National Healthcare Security Administration (NHSA) introduced measures to support the high-quality development of innovative drugs, focusing on five key areas: increasing R&D support, integrating innovative drugs into basic medical insurance and commercial health insurance directories, supporting clinical applications, enhancing multi-payment capabilities, and strengthening security measures [2] - A total of 16 specific measures were proposed to support the entire chain of innovative drug development, indicating a shift from imitation to innovation in China's pharmaceutical industry [2] - In 2024, Chinese pharmaceutical companies completed over 90 overseas licensing transactions, totaling more than $50 billion, showcasing the international competitiveness of Chinese innovative drugs [2] Drug and Device Approvals - Hutchison China MediTech announced the approval of a new drug application for a combination therapy involving savolitinib and osimertinib for treating advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations [4] Capital Markets - Suzhou Zhongxi Biological Information Co., a leader in laboratory automation, completed nearly $10 million in Series A financing, led by CITIC Capital and continued investment from Qiming Venture Partners, to accelerate the development and global promotion of its automated intelligent ecosystem in life sciences [6] - Wuhan Heyuan Biotechnology Co. received approval for its IPO application on the Sci-Tech Innovation Board, marking it as the first company to pass the review under the new listing standards [7] Industry Events - AbbVie announced the acquisition of Capstan Therapeutics for up to $2.1 billion in cash, gaining access to a promising in-development product and proprietary tLNP platform technology for in vivo CAR-T therapies [9] - Changchun High-tech announced plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international brand image [11] Public Sentiment Alerts - Chongqing Pharmaceutical Holdings reported that the total amount of ongoing litigation and arbitration has reached 10.28% of its latest audited net assets, with a total of approximately $16.5 million involved in these cases [13]

Group 1: Policy Support for Innovative Drugs - The National Healthcare Security Administration and the National Health Commission issued measures to support the high-quality development of innovative drugs, focusing on five areas and sixteen specific measures [1] - The measures aim to create a clinical value-oriented environment for innovative drug research and development, establish a diversified payment system, and enhance the accessibility of innovative drugs [1] Group 2: Longhua High-Tech's H-Share Listing - Changchun High-Tech announced plans to issue H-shares and list on the Hong Kong Stock Exchange to deepen its global strategy and accelerate internationalization [2] - The move aligns with the trend of domestic pharmaceutical companies pursuing both domestic and international growth, potentially enhancing the company's international financing capabilities and brand image [2] Group 3: IPO Approval for He Yuan Bio - Wuhan He Yuan Bio's IPO was approved by the Shanghai Stock Exchange, marking the first company to pass under the newly restarted fifth set of listing standards for the Sci-Tech Innovation Board [3] - The company focuses on recombinant human albumin, with its core product expected to be the first recombinant human albumin drug approved in China [3] Group 4: Clinical Trial Acceptance for Microchip Bio - Microchip Bio announced that its clinical trial application for CS231295, a selective Aurora B inhibitor for advanced solid tumors, was accepted by the FDA [4] - This drug is the first of its kind to enter clinical trials globally, showcasing the company's technological strength in innovative drug development [4] Group 5: Angli Kang's Innovation Drug Pipeline - Angli Kang reported that it currently has only one innovative drug project, ALK-N001, which is in the I phase of clinical trials as of the announcement date [5][6] - The company highlighted the long cycle, high investment, and uncertainty associated with innovative drug development, which may temper market speculation [6]

Core Viewpoint - The successful IPO of Wuhan Heyuan Biotechnology Co., Ltd. marks a significant milestone as the first company to pass the listing review under the fifth set of standards for the Sci-Tech Innovation Board since its restart, reflecting the regulatory support for innovative biotech firms [1][3]. Group 1: Company Overview - Wuhan Heyuan Biotechnology, established in 2006, focuses on the "recombinant human albumin" sector, which is considered a blue ocean market [3]. - The company's core product, HY1001 (recombinant human albumin injection), has completed Phase III clinical trials and is expected to receive approval for market launch soon, potentially becoming the first recombinant human albumin drug in China [3]. - Currently, Heyuan's revenue primarily comes from pharmaceutical excipients and research reagents, with its core innovative drug still in development and not yet generating income, leading to a loss [3]. Group 2: Industry Context - As of now, 20 companies have utilized the fifth set of standards for listing on the Sci-Tech Innovation Board, with 19 being innovative drug development firms and 1 in high-end medical device development [4]. - In 2024, these 20 companies collectively generated over 14 billion yuan in revenue, representing a growth of over 40% compared to 2023, with 16 companies achieving revenues exceeding 1 billion yuan, and 4 surpassing 10 billion yuan [4]. - The first quarter of 2025 saw these companies continue their growth trend, achieving a total revenue of 3.78 billion yuan, a year-on-year increase of 29.27% [4]. - From 2018 to the first quarter of 2025, companies under the fifth set of standards have launched 17 new Class 1 drugs, accounting for approximately 12% of the total number of domestic innovative drugs approved during the same period [4]. Group 3: Regulatory Environment - The successful IPO of Heyuan is seen as a practical example of the China Securities Regulatory Commission's policy to enhance the inclusivity and adaptability of the Sci-Tech Innovation Board, particularly in supporting high-quality technology enterprises [3][4]. - The pace of IPO applications on the Sci-Tech Innovation Board has accelerated, with over 30 applications received in the first half of the year, of which more than 70% are from Sci-Tech Innovation Board companies [5].

Group 1 - Yunzhi Voice Technology Co., Ltd. listed on the Hong Kong Stock Exchange on June 30, becoming the "first AGI stock" in Hong Kong [1] - Yunzhi was founded in 2012 and has developed AI solutions based on deep learning models, including its core algorithm model UniCore [1] - The company has received investments from notable institutions such as Sequoia Capital, JD.com, and Qualcomm, with a significant investment from Sichuan Innovation and Entrepreneurship Equity Investment Fund in 2017 [1] Group 2 - Moore Threads submitted its prospectus for listing on the Sci-Tech Innovation Board, focusing on full-function GPU chip development [2] - The company supports various workloads including AI computing acceleration and 3D graphics rendering [2] - Chengdu Ciyuan Guoyi Electronic Information Equity Investment Fund invested in Moore Threads in 2023 [2] Group 3 - Wuhan Heyuan Biotechnology Co., Ltd. is preparing for an IPO on the Sci-Tech Innovation Board, with its core product HY1001 nearing market approval [2] - HY1001 is a new drug that has completed Phase III clinical trials and is under priority review by the National Medical Products Administration [2] Group 4 - Yaoke Ankang Technology Co., Ltd. successfully listed on the Hong Kong Stock Exchange on June 23, with significant investment from the National Investment (Guangdong) Technology Achievement Transformation Venture Capital Fund [5] - The company focuses on innovative drug development for cancer, inflammation, and cardiovascular diseases, with multiple candidates in clinical stages [5] Group 5 - Sichuan Southwest Jiaotong Railway Development Co., Ltd. listed on the Beijing Stock Exchange on June 10, specializing in rail transportation infrastructure safety [6] - The company is recognized as a national-level "little giant" enterprise and is the first IPO project of the Sichuan Science and Technology Investment's Academician Fund [6] - Multiple local funds, including Chengdu Lixin Jingrong Fund, participated in the investment of Jiaotong Railway Development [6]

Core Viewpoint - Wu Yuan Bio is the first company to be reviewed under the newly established fifth set of standards for the Sci-Tech Innovation Board, following the announcement of support for unprofitable companies to list [1][7]. Company Overview - Wu Yuan Bio, established in 2006, focuses on innovative drug research and development, with its core product HY1001 (recombinant human albumin injection) having completed Phase III clinical trials and included in the priority review process by the National Medical Products Administration [3][4]. - The company has not yet generated revenue from its core innovative drug products, with current income primarily from pharmaceutical excipients and research reagents [3][6]. - Cumulative R&D investment from 2022 to 2024 is projected to reach 386 million yuan, with a workforce of 178 employees, 122 of whom are dedicated to R&D, indicating a strong focus on innovation [3][6]. Product Development - HY1001 aims to supplement or enhance the levels of human serum albumin in the blood, potentially replacing plasma-derived human serum albumin, which is currently the most widely used blood product in clinical settings [3][4]. - The company has achieved breakthroughs in increasing the expression and purity of recombinant human albumin, reducing production costs, and enhancing clinical safety, earning a second-class National Technology Invention Award for its related technology [4]. Industry Context - As of 2024, 20 companies have been listed under the fifth set of standards, primarily consisting of innovative biopharmaceutical firms, with a combined revenue exceeding 14 billion yuan, reflecting a growth of over 40% from 2023 [6][7]. - In the first quarter of 2025, these companies collectively achieved a revenue of 3.78 billion yuan, marking a year-on-year growth of 29.27% [7]. - The fifth set of standards has facilitated the listing of 17 first-class new drugs, accounting for approximately 12% of the total number of domestically approved innovative drugs from 2018 to the first quarter of 2025, establishing itself as a backbone of China's pharmaceutical innovation [7].