重组人白蛋白注射液(OsrHSA
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禾元生物上市首日高开202.82%
Bei Jing Shang Bao· 2025-10-28 01:48
Core Viewpoint - He Yuan Bio (688765) has successfully listed on the Sci-Tech Innovation Board, marking it as one of the first newly registered companies in the Sci-Tech Growth tier, with a significant opening increase of 202.82% to a price of 88 CNY per share on its debut [1] Company Overview - He Yuan Bio is an innovative biopharmaceutical company that possesses a globally leading plant bioreactor technology platform [1] - The company has established an independent intellectual property rights system for its rice endosperm cell bioreactor expression system and has developed a comprehensive plant molecular pharming industrialization system [1] - He Yuan Bio has developed multiple products including drugs, pharmaceutical excipients, and research reagents based on its rice endosperm cell bioreactor expression system [1] Product Pipeline - Currently, the company has a total of 8 drug candidates in its research pipeline [1] - The most advanced product, recombinant human serum albumin injection (OsrHSA, HY1001), has received approval from the National Medical Products Administration and has been successfully launched [1] - Additionally, 2 drugs are in Phase II clinical trials, 2 drugs are in Phase I clinical trials, and 1 drug has been approved to commence clinical trials [1] - The company has several other drugs in the research and development stage and has not yet achieved profitability [1]
今日,科创板科创成长层“迎新”!
Zheng Quan Shi Bao· 2025-10-28 00:05
Core Points - Three unprofitable companies, He Yuan Bio, Xi'an Yicai, and Bibet, will debut on the Sci-Tech Innovation Board, marking a smoother path for unprofitable hard-tech enterprises to go public [1][2] - The launch of the Sci-Tech Innovation Board's "1+6" policy aims to reform and optimize the listing system for unprofitable tech companies, facilitating deeper integration of technological and industrial innovation [1][2][7] Group 1: Company Listings - He Yuan Bio and Bibet are listed under the fifth set of standards, breaking the listing drought since June 2023, with He Yuan Bio being the first to receive registration approval under this standard [2][10] - He Yuan Bio has eight drugs in its pipeline, with its recombinant human albumin injection approved for market use in July 2023 [2][10] - Bibet has a class 1 innovative drug, BEBT-908, approved for market, while several other products are in various clinical trial phases [2][10] - Xi'an Yicai, a leading manufacturer of 12-inch silicon wafers, is listed under the fourth set of standards, aiming to enhance production capacity with the funds raised [3][10] Group 2: Regulatory Changes - The introduction of a differentiated lock-up mechanism for offline investors aims to attract long-term investment by increasing the lock-up ratio and duration for unprofitable companies [4][5] - The new lock-up structure includes three tiers for A-class investors, with varying lock-up ratios and periods, encouraging institutional investors to focus on long-term value [4][6] - The "1+6" reform has led to the acceptance of 26 new companies, including eight unprofitable ones, since its launch [7][11] Group 3: Market Impact - The reforms have resulted in a more diverse market structure, with improved review efficiency and transparency, fostering a better investment environment for long-term capital [8] - The enthusiasm for Sci-Tech Innovation Board ETFs has surged, with 21 new ETFs launched within four months, totaling 105 ETFs and a combined scale of 300 billion yuan [8][12] - The number of investor accounts with trading permissions for the Sci-Tech Innovation Board's growth layer has reached 7.58 million, indicating strong market engagement [14][15]
A股申购 | 禾元生物开启申购 共有8个在研药品管线
Zhi Tong Cai Jing· 2025-10-27 23:09
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 core product HY1001 has completed its Phase III clinical trial for liver cirrhosis with hypoalbuminemia, achieving its primary and secondary endpoints with good safety profiles [1][3] Clinical Trials and Regulatory Communication - The company has engaged in discussions with the FDA regarding the design of an international multi-center Phase III clinical trial for HY1001, which, upon successful completion, could lead to approval for all current indications of plasma-derived human serum albumin [2][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 43.37% as of December 31, 2024 [4]
禾元生物开启申购 共有8个在研药品管线
Zhi Tong Cai Jing· 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 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]