Company Overview - He Yuan Bio, established in 2006, specializes in the research and development of plant-derived recombinant protein expression technology and products, aiming to create world-class biopharmaceuticals based on plant bioreactor technology [5]. - The company has developed two core technology platforms: a high-efficiency recombinant protein expression platform and a protein purification platform, achieving a recombinant protein expression yield of 20-30g/kg and a purification purity of 99.9999% [14][19]. Product Pipeline - The core product, HY1001 (recombinant human albumin), is expected to receive domestic approval by July 2025 and has completed FDA Type C communication for its Phase III clinical trial design in the U.S. [2][27][28]. - Other products in the pipeline include HY1002 (lactoferrin lysozyme oral solution), HY1003 (α-1 antitrypsin), and additional candidates targeting various medical conditions, with a total of 19 recombinant proteins under development [2][25]. Market and Competition - The domestic human recombinant albumin market is projected to grow from 39.5 billion RMB in 2024 to 57 billion RMB by 2030, with a CAGR of 6% [3][41]. - Currently, 62.9% of the domestic market is supplied by imports, with He Yuan Bio positioned as a leading domestic player in the recombinant HSA market, indicating strong potential for import substitution [3][42]. - The global demand for HSA is expected to reach 800 tons by 2030, with emerging markets heavily reliant on imports [3][41]. Cost and Production Advantages - The production cost of HY1001 is projected to be significantly lower than that of plasma-derived human albumin, with estimates suggesting a cost reduction of over 50% once the 120-ton production line is fully operational [54][56]. - The company has established a commercial-scale production line capable of producing 10 tons of HSA per year and is expanding to a 120-ton capacity by 2024 [22]. Clinical and Regulatory Progress - HY1001 has shown non-inferiority to plasma-derived human albumin in clinical trials, demonstrating comparable efficacy and safety profiles [52][49]. - The product has been recognized by FDA experts as a "historical innovation," supporting its global clinical trial design [28]. Future Outlook - The market for recombinant human albumin is expected to expand significantly, with projected sales revenue for HY1001 reaching approximately 15.67 billion RMB by 2030, driven by increasing treatment rates for liver cirrhosis and low albumin levels [58]. - The company anticipates a growing demand for its products, particularly in light of the limitations of plasma-derived products and the increasing focus on safety and supply stability [45][47].

医药行业 证券研究报告 |深度报告 2025/12/01 水稻胚乳里的生物密码： 禾元生物重组蛋白技术的产业化革命 | 证券分析师: | 程晓东 | | --- | --- | | 分析师登记编号: | S1190511050002 | | 证券分析师: | 李忠华 | | 分析师登记编号: | S1190524090001 | P2 报告摘要 核心结论：禾元生物是国内植物源重组蛋白药物领军者，以独创水稻胚乳细胞生物反应器技术打破血浆依赖，核心产品 HY1001（重组人白蛋白）国内先发上市、美国推进III期，成本远低于血浆来源，120吨产能+全球化布局支撑2030年营 收超30亿，技术壁垒与商业化确定性突出，具备高投资价值。 一、公司与核心技术：植物源蛋白产业化闭环，指标全球领先。公司拥有二大核心技术平台：1、重组蛋白高效表达平 台：历经三代迭代，重组蛋白表达量达20-30g/kg，核心依赖胚乳特异性启动子改造等专利技术；2、蛋白纯化平台：纯 度达99.9999%，内毒素符合中美药典，纯化成本较微生物体系降30%+。 二、产品管线：HY1001领跑，多梯队支撑增长。（1）核心产品 HY1001：2025年7月 ...

Group 1 - The core viewpoint of the article is that the Chinese innovative pharmaceutical sector is experiencing a resurgence, with the reopening of the IPO window on the Sci-Tech Innovation Board (STAR Market) leading to increased activity and optimism among investors [1][3][11] - The STAR Market's fifth set of listing standards was reactivated in June 2023, allowing unprofitable biotech companies to pursue IPOs, which had been stalled for two years [3][4] - Several companies, including He Yuan Bio and Bei Xin Life, have successfully passed IPO approvals under the new standards, indicating a growing pipeline of innovative drug companies ready to enter the market [4][5] Group 2 - The Hong Kong stock market has also seen significant gains in the healthcare sector, with the medical and healthcare index rising over 45% in the first half of 2025, outperforming other sectors [8][9] - Notable companies like Song Li Pharmaceutical and Deqi Pharmaceutical have achieved remarkable stock price increases, with some stocks rising tenfold, reflecting a strong recovery in the market [8][9] - The successful IPO of Ying En Bio in April 2023, which saw a first-day surge of over 116%, exemplifies the renewed investor interest and the potential for high returns in the biotech sector [10] Group 3 - The article highlights a shift in investor sentiment towards the pharmaceutical sector, with many previously cautious investors now recognizing the long-term potential of innovative drug companies [11][12] - There has been a notable increase in business development (BD) transactions involving Chinese pharmaceutical assets, indicating growing international recognition of Chinese innovation in drug development [12] - The article suggests that the next 5-10 years could be a favorable period for investment in Chinese innovative pharmaceuticals, as the industry is expected to continue its recovery and growth [12][13]

Core Viewpoint - The article highlights the resurgence of the Chinese biopharmaceutical industry, particularly focusing on the recent openings for IPOs on the STAR Market, signaling a potential recovery and growth phase for innovative drug companies in China [3][5][12]. Group 1: IPO Developments - The STAR Market has reopened its doors for innovative drug companies, with the first successful IPOs occurring after a long hiatus, including companies like He Yuan Bio and Bei Xin Life [5][6]. - Biotech company Bibet has received approval for its IPO after three years of waiting, marking a significant milestone for the company and the industry [3][6]. - The approval of the fifth set of listing standards for unprofitable companies on the STAR Market has revitalized the IPO landscape for the biopharmaceutical sector [5][12]. Group 2: Market Performance - The Hong Kong stock market has seen a remarkable performance in the healthcare sector, with the healthcare index rising over 45% in the first half of 2025, outperforming other industries [9][10]. - Notable stocks like Gilead Sciences and others have experienced significant price increases, with some companies achieving tenfold returns, indicating a strong recovery in investor sentiment [9][10]. - The successful IPO of companies like Ying En Bio, which saw a first-day surge of over 116%, reflects the growing investor interest and confidence in the biopharmaceutical sector [11]. Group 3: Investment Trends - There is a notable shift in investment focus back to the biopharmaceutical sector, with many investors previously hesitant now recognizing the potential for growth and returns [12]. - The article mentions that international investors are increasingly aware of the value of Chinese innovative drug companies, with many regretting missed opportunities in the Hong Kong market [10][12]. - The trend of mergers and acquisitions in the biopharmaceutical space is on the rise, with significant deals indicating a growing recognition of the quality of Chinese assets [12][13].

Group 1 - The core viewpoint of the news is that Wuhan Heyuan Biotechnology Co., Ltd. has successfully passed the listing review by the Shanghai Stock Exchange, marking it as the first company to benefit from the reactivation of the fifth listing standard for unprofitable enterprises on the Sci-Tech Innovation Board [1][4] - Heyuan Biotechnology plans to raise 2.4 billion yuan through its IPO, with approximately 1.658 billion yuan allocated for the construction of a recombinant human albumin industrialization base, while the remaining funds will be directed towards new drug research and development and to supplement working capital [2][3] - The company has been focusing on the research of rice endosperm cell expression systems and the development of recombinant protein drugs since its establishment in 2006, with significant investments in R&D leading to continuous losses [2][4] Group 2 - The fifth listing standard emphasizes "market value + R&D," allowing unprofitable but high-growth technology innovation enterprises to list, particularly in the biopharmaceutical and semiconductor sectors [4][6] - Since the establishment of the Sci-Tech Innovation Board, 20 companies have successfully listed under the fifth standard, all being innovative biopharmaceutical enterprises, with a combined revenue exceeding 14 billion yuan in 2024, reflecting a growth of over 40% compared to 2023 [5][6] - Recent reforms aim to enhance the adaptability and inclusiveness of the Sci-Tech Innovation Board, with new measures introduced to support more frontier technology sectors such as artificial intelligence and commercial aerospace [6][7]

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]