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重组人白蛋白注射液(OsrHSA)
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A股申购 | 禾元生物(688765.SH)开启申购 共有8个在研药品管线
智通财经网· 2025-10-13 22:40
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 developed a comprehensive industrialization system for molecular pharming and has multiple products including drugs, pharmaceutical excipients, and research reagents [1] Drug Pipeline - As of the date of the prospectus, the company has eight drugs in its research pipeline, with the most advanced being recombinant human serum albumin injection (OsrHSA, HY1001), which is nearing approval for market launch [1][2] - The company has completed the majority of the review process for the New Drug Application (NDA) for HY1001, which targets hypoalbuminemia due to liver cirrhosis [1] - Two additional drugs are in Phase II clinical trials, two are in Phase I clinical trials, and one has been approved to commence clinical trials [1] Clinical Trial Progress - The Phase III clinical trial for HY1001 has met its primary and secondary endpoints, demonstrating good safety [1] - The company plans to conduct a global multi-center Phase III clinical study that includes Chinese patients, aiming for simultaneous submissions to the FDA and EMA upon completion [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 [3] - Net losses were reported at approximately -144 million yuan, -187 million yuan, and -152 million yuan for the same years [3] - Key financial metrics indicate 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]