禾元生物开启申购 共有8个在研药品管线

Core Viewpoint - He Yuan Bio (688765.SH) has initiated its subscription with an issue price of 29.06 yuan per share, aiming to leverage its innovative plant-based biopharmaceutical technology platform for drug development and commercialization [1] Company Overview - He Yuan Bio is an innovative biopharmaceutical company with a leading global position in plant bioreactor technology, specifically utilizing rice endosperm cell bioreactor expression systems [1] - The company has established a comprehensive industrialization system for Molecular Pharming and has developed multiple products including drugs, pharmaceutical excipients, and research reagents based on its proprietary technology [1] Drug Pipeline - As of the date of the prospectus, the company has eight drugs in its research pipeline, with the most advanced being OsrHSA (HY1001), which has completed most of the review process for its New Drug Application (NDA) and is expected to be approved for market soon [1] - The core product HY1001 targets hypoalbuminemia in liver cirrhosis and has completed its Phase III clinical trial in China, achieving its primary and secondary endpoints with good safety results [1][3] Clinical Trials and Regulatory Communication - He Yuan Bio has engaged in discussions with the FDA regarding the design of an international multi-center Phase III clinical trial for HY1001, which will include Chinese patients [2][3] - The company plans to submit applications for marketing approval to the FDA and EMA after completing the clinical study, aiming for simultaneous market entry in China, the US, and Europe [3] Financial Performance - The company reported revenues of approximately 13.40 million yuan, 24.26 million yuan, and 25.22 million yuan for the years 2022, 2023, and 2024 respectively, while incurring net losses of approximately -144 million yuan, -187 million yuan, and -152 million yuan during the same periods [3][4] - Key financial metrics include total assets of 1.06 billion yuan, equity attributable to shareholders of 601.35 million yuan, and a debt-to-asset ratio of 38.52% for the year ending December 31, 2024 [4]