证券代码：688238 证券简称：和元生物 公告编号：2026-005 和元生物技术（上海）股份有限公司 2026年第一次临时股东会决议公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容的 真实性、准确性和完整性依法承担法律责任。 重要内容提示： ● 本次会议是否有被否决议案：无 一、会议召开和出席情况 （一）股东会召开的时间：2026年2月26日 （二）股东会召开的地点：上海市临港新片区沧海路3888号 （三）出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及其持有表决权数量的情 况： ■ （四）表决方式是否符合《公司法》及公司章程的规定，股东会主持情况等。 本次股东会由公司董事会召集，董事长潘讴东先生主持，采用现场表决与网络投票相结合的方式召开。 本次会议的召集、召开及表决方式符合《中华人民共和国公司法》《上海证券交易所科创板股票上市规 则》及《和元生物技术（上海）股份有限公司章程》（以下简称"《公司章程》"）的相关规定。 （五）公司董事和董事会秘书的列席情况 1、公司在任董事9人，列席9人； 2、董事会秘书、其他高级管理人员及见证律师列席了会议。 ...

Core Viewpoint - The company, He Yuan Bio, has established itself as a leader in the cell and gene therapy (CGT) industry, leveraging strong technological capabilities and strategic focus to navigate industry cycles and achieve significant growth [1][2]. Group 1: Company Overview - He Yuan Bio, founded in 2013, specializes in providing integrated CRO/CDMO services for cell and gene therapy research and drug development [2]. - The company has developed two core technology clusters: carrier development technology and production process and quality control technology for cell and gene therapy [1]. - As the first CGT company listed on the Sci-Tech Innovation Board, He Yuan Bio has been pivotal in advancing China's biopharmaceutical industry from a follower to a leader [1]. Group 2: Technological Innovation - The company emphasizes continuous technological innovation, with a focus on core technical capabilities, GMP platform strength, and project management [2]. - He Yuan Bio has established comprehensive technology platforms, including molecular biology, virus packaging, and cell function research, achieving leading levels in key areas such as viral vector technology [2]. - R&D expenses for the first three quarters of 2025 reached 34.66 million yuan, accounting for 19.22% of revenue, indicating a strong commitment to innovation [3]. Group 3: AI Integration - The company is actively exploring AI applications in drug development, creating an intelligent R&D system that integrates AI with biological technology [4]. - This dual-driven model of "algorithm innovation + application landing" aims to enhance R&D and production efficiency [4]. Group 4: Market Position and Client Base - He Yuan Bio has built a robust client base, with over 14,700 collaborative research laboratories and more than 600 CDMO projects, including 60 clinical trial approvals [5]. - The company provides a "one-stop" service from laboratory research to commercial production, focusing on technical insight and compliance [5]. Group 5: Future Development and Capacity Expansion - The company is positioned to capitalize on the transition of CGT drug commercialization from "technical breakthroughs" to "scale implementation," supported by technological advancements and policy backing [6]. - The company's Lingang industrial base has commenced full production, featuring 11 GMP vector production lines and 18 GMP cell production lines, placing it among the top in the international industry [6]. - Future capacity utilization at the Lingang base is expected to enhance market share and profitability, supporting growth in the cell and gene therapy sector [6]. Group 6: Expansion into Regenerative Medicine - He Yuan Bio is expanding into regenerative medicine by establishing a wholly-owned subsidiary, He Yuan He Mei, to address industry challenges related to cell safety and traceability [8]. - The company is developing processes for stem cells, immune cells, and exosomes, and is forming strategic partnerships to explore business development paths [8]. Group 7: Internationalization Efforts - The company is pursuing international expansion, aiming to position Chinese cell and gene therapy services on a global scale [8][9]. - He Yuan Bio has achieved a milestone with its Human Fibroblast Extracellular Vesicles being included in the global cosmetics ingredient directory, marking a significant step in its internationalization efforts [9]. Group 8: Commitment to Health and Innovation - He Yuan Bio is dedicated to empowering cell and gene therapy to enhance public health, driven by innovation and collaboration [10].

Core Insights - The company reported a revenue of 120 million yuan for the first half of 2025, representing a year-on-year growth of 6%, while the net profit attributable to shareholders was a loss of 105 million yuan, reducing the loss by 8.78 million yuan compared to the same period last year [1] Group 1: Business Performance - The cell and gene therapy CRO business generated revenue of 40.70 million yuan, an increase of 3.79% year-on-year, with over 14,000 research laboratory clients served, indicating a continuous improvement in market coverage [1] - The CDMO business revenue was 65.62 million yuan, remaining stable compared to the previous year, with 52 IND approvals obtained for clients and over 540 CDMO projects undertaken, including 5 Phase III clinical projects [1] - The company secured over 90 million yuan in new CDMO orders during the year [1] Group 2: Regenerative Medicine and Capacity Expansion - The regenerative medicine segment made significant progress, including the development of processes for stem cells and immune cells, and collaboration with leading companies and research institutions [2] - The company’s subsidiary successfully registered human dermal fibroblast exosomes in the global cosmetic ingredient directory, expanding opportunities in anti-aging and health management [2] - The first phase of the Lingang industrial base has been fully operational, with production capacity and line numbers ranking among the top in the international industry, enhancing delivery efficiency and customer retention [2] Group 3: Technological Innovation - The company is focusing on technological innovation, with R&D investment of 23.21 million yuan, accounting for 19.37% of revenue, and filing for 2 invention patents and 8 utility model patents [2] - The company has developed an intelligent R&D system leveraging AI technology, including a virus yield prediction model based on BERT, which optimizes production efficiency [3] - AI models have been created for adenoviral vector optimization, utilizing deep learning frameworks to enhance research and development efficiency [3]

Core Viewpoint - The report highlights the ongoing challenges faced by the company in its cell and gene therapy CDMO business, including low order prices and high operational costs, while also emphasizing the potential for growth in the industry supported by favorable policies and technological advancements [1][6][11]. Financial Performance - The company reported a revenue of approximately 119.85 million yuan for the first half of 2025, representing a 6.01% increase compared to the same period last year [4]. - The total profit for the period was a loss of approximately 102.77 million yuan, an improvement from a loss of 113.36 million yuan in the previous year [4]. - The net profit attributable to shareholders was approximately -104.57 million yuan, showing a reduction in losses compared to -113.35 million yuan in the same period last year [4][5]. Industry Overview - The cell and gene therapy sector is identified as a key growth area in biomedicine, with significant advancements in technology and increasing clinical applications [7][11]. - The global pipeline for gene therapies has expanded, with over 4,469 gene therapy projects reported as of mid-2025, indicating a robust growth trajectory in the industry [10][11]. - The industry is characterized by a diverse landscape, with both large enterprises and numerous small to medium-sized companies, leading to a competitive environment [7][11]. Technological Advancements - Continuous innovation in gene editing and delivery technologies is crucial for the advancement of cell and gene therapies, with AI playing a significant role in enhancing research efficiency [8][9]. - Recent breakthroughs in stem cell therapy and regenerative medicine are paving the way for new clinical applications, demonstrating the potential for significant market growth [12][13]. Market Dynamics - The investment landscape for cell and gene therapy is showing signs of recovery in China, with a total financing amount of approximately 4.09 billion yuan in the first half of 2025, up from 2.57 billion yuan in the same period of 2024 [11][12]. - Despite the positive trends, the CDMO sector faces challenges due to the complexity and high costs associated with drug development and production, which may hinder rapid revenue growth [11][12]. Regulatory Environment - The government continues to support the cell and gene therapy industry through various policies aimed at promoting innovation and ensuring quality standards in drug development [14].

Core Insights - The company has evolved from a small 12 square meter incubation base to a production platform of over 77,000 square meters in Lingang, becoming a pioneer in the cell and gene therapy (CGT) sector [2][4] - The chairman emphasizes the importance of perseverance and innovation in driving the company's growth and success in the CGT field [2][3] Company Development - The company started its journey in 2006, initially providing adenoviral vector services to research institutions and gradually expanding its operations [3] - The company has successfully transitioned from a small startup to a major player in the CGT industry, benefiting from a solid foundation laid in its early years [3][4] Capital Market Interaction - The company went public on the New Third Board in 2016, which provided sufficient funding to expand its capabilities in the gene therapy CDMO sector [4] - In 2022, the company successfully listed on the Sci-Tech Innovation Board, and by 2024, its Lingang base's first phase construction was completed and fully operational [4] Industry Trends - Cell and gene therapy is recognized as the "third revolution" in life sciences, with increasing applications in treating various diseases [5] - The company is focused on overcoming challenges in the CGT industry by enhancing its core technologies and expanding its intellectual property protection [5][6] Technological Advancements - The company aims to improve the development and production processes of gene therapy vectors, including the research of AAV viral vectors for rare diseases and the development of non-viral gene therapy vectors [5][6] - The company is investing in large-scale GMP production and quality control technologies to address bottlenecks in the CGT production process [6] Future Strategy - The company plans to leverage its Lingang base to provide comprehensive CRO/CDMO solutions, aiming to reduce costs and accelerate drug development [7][8] - Future initiatives include expanding into stem cell therapy and regenerative medicine, establishing a full-service capability from cell storage to clinical transformation [8] - The company is also looking to grow its CRO and CDMO services internationally, with potential mergers and collaborations to diversify its product offerings in cell and gene therapy [8]