和元生物成立于2013年，专注于为细胞和基因治疗领域的先导研究和药物研发提供一体化CRO（合同 研究组织）/CDMO（合同研发与生产组织）服务。 面对细胞与基因治疗研发的高技术门槛，和元生物持续深化技术创新。"CRO/CDMO企业竞争力主要体 现在核心技术能力、GMP平台实力、项目管理能力等多个方面。"潘讴东告诉记者，"自2006年投身创 业以来，二十年来我始终专注于细胞与基因治疗领域，亲历并推动着这一前沿赛道的技术创新。" "以病毒载体为例，其是CGT药物的重要载体。在病毒载体方面，我们的工艺技术在国际上已经达到了 领先水平。"潘讴东介绍。据了解，目前公司拥有包括分子生物学平台、实验级病毒载体包装平台、细 胞功能研究平台、SPF级动物实验平台、基因载体和细胞治疗工艺开发平台等全面的细胞和基因治疗 CRO/CDMO技术平台，在载体开发、病毒包装等关键环节具备领先的研发能力。 站在生物医药创新的前沿，细胞和基因治疗（CGT）行业有着非常高的技术壁垒，但总有一些企业凭借 坚定的战略定力和强大的技术实力，穿越行业周期，实现跨越式发展。 作为登陆科创板的CGT第一股，和元生物深耕细胞与基因治疗领域十余年，自主研发形成 ...

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]