和元生物： 以创新驱动发展 抢滩再生医学赛道

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].