和元生物前三季度实现营业收入1.8亿元

Core Viewpoint - He Yuan Biotechnology (Shanghai) Co., Ltd. reported stable revenue with a slight reduction in net loss for the first three quarters of 2025, indicating resilience in a challenging market environment [1] Company Performance - For the first three quarters of 2025, He Yuan Biotechnology achieved operating revenue of 180 million yuan, remaining flat compared to the same period last year; net loss was 162 million yuan, a reduction of 27.65 million yuan year-on-year [1] - The company secured over 120 million yuan in new CDMO orders, assisting clients in obtaining 16 IND approvals in China and the U.S., including 2 from the FDA [1] - As of September 2025, the company has accumulated 60 IND approvals covering various advanced fields such as oncolytic viruses and AAV gene therapy, positioning it among the leaders in the domestic industry [1] Business Segments - In the first three quarters of 2025, the revenue from the cell and gene therapy CRO business was approximately 61.99 million yuan, a year-on-year increase of 2.81% [1] - Revenue from the cell and gene therapy CDMO business was approximately 96.70 million yuan, a decline of 9.72% year-on-year, influenced by the types of CDMO orders executed and the progress of different projects [1] - Other main business segments, including research reagents and cell storage services, generated revenue of approximately 21.39 million yuan, reflecting a significant growth of 55.99% year-on-year [1] Research and Development - He Yuan Biotechnology invested approximately 34.66 million yuan in R&D during the first three quarters of 2025, accounting for 19.22% of its operating revenue [2] - The company added 1 new invention patent and 6 domestic registered trademarks, along with multiple applications for new patents and trademarks [2] Production Capacity - The company has established 11 GMP vector production lines and 18 GMP cell production lines at its industrial base in Shanghai, with fermentation and cell culture capabilities ranging from 5L to 2000L [3] - The first phase of the industrial base is fully operational, and the capacity utilization rate is expected to increase as client pipelines and orders grow [3] - He Yuan Biotechnology has implemented an intelligent R&D system to enhance efficiency in vector screening and process development, providing comprehensive services from drug discovery to commercial production [3] Market Position and Strategy - The company serves over 14,700 research laboratories through its CRO business and is steadily advancing in overseas markets using targeted marketing strategies [3] - He Yuan Biotechnology is actively expanding into the regenerative medicine sector, exploring new business avenues such as stem cells and exosomes through joint laboratories and participation in standard-setting [3] Industry Outlook - The cell and gene therapy industry is still in a growth phase, as evidenced by the approval of several high-priced CAR-T therapies in the recent national insurance directory adjustments [4]