博雅生物（300294）(300294.SZ)公告，公司收到国家药品监督管理局核准签发的人凝血因子Ⅸ《药物 临床试验批准通知书》，获同意开展用于凝血因子Ⅸ缺乏症(血友病B)患者的出血治疗的临床试验。 ...

证券代码：300294 证券简称：博雅生物 公告编号：2026-005 华润博雅生物制药集团股份有限公司 关于公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证公告内容真实、准确和完整，没有虚假记载、 误导性陈述或重大遗漏。 近日，华润博雅生物制药集团股份有限公司（以下简称公司）收到国家药品 监督管理局核准签发的人凝血因子Ⅸ《药物临床试验批准通知书》（通知书编号： 2026LP00442）。现将有关情况公告如下： 一、药品的基本情况 受理号：CXSL2501008； 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，公司 的人凝血因子Ⅸ符合药品注册的有关要求，同意开展用于凝血因子Ⅸ缺乏症（血 友病B）患者的出血治疗的临床试验。 适应症：凝血因子Ⅸ缺乏症（血友病B）患者的出血治疗。 上述产品在生产、上市销售前，还需履行的主要审批程序包括：开展临床试 验、提交药品上市许可申请、通过国家药品监督管理局审批后，获得药品注册批 件。 截至披露日，人凝血因子Ⅸ项目累计研发投入约人民币1,632万元。 二、同类产品情况 经查询国家药品监督管理局相关信息，目前境内已获批上市人凝血因子Ⅸ的 企业有山东 ...

Investment Rating - The report maintains a positive outlook on the blood products industry, suggesting that the supply-demand relationship will gradually improve, leading to performance recovery for companies in this sector [10][34]. Core Insights - The blood products industry is characterized by a clear long-term growth trajectory, supported by a favorable regulatory environment for plasma collection and an expanding product range among companies [12][34]. - Short-term performance has been impacted by supply-demand mismatches, with a notable decline in profitability observed in 2025 due to excess supply and price reductions [19][36]. - The report highlights the importance of white albumin and immunoglobulin (IVIG) as core products, with a stable demand expected despite recent price pressures [33][34]. Summary by Sections Market Review - The report notes a decline of 0.85% in the medical index, underperforming the CSI 300 index by 1.22 percentage points, ranking 21st among 30 sectors [6]. - The top-performing stocks in the medical sector include Aidi Te, Zhendai Medical, and Olin Bio, while the worst performers include Beixin Life and Huayuan Bio [6]. Industry and Stock Events - The report emphasizes the recovery of plasma collection activities post-pandemic, which has led to increased supply and a shift in the market dynamics for blood products [19][26]. - The report identifies key companies to watch, including Tian Tan Biological and Bo Ya Biological, as they are expected to benefit from the industry's growth [12][34]. Overall Perspective and Investment Themes - The report suggests focusing on innovative drugs, medical devices, and the blood products sector, highlighting the potential for significant growth driven by domestic differentiation and international expansion [10][12]. - The report also discusses the ongoing consolidation in the industry, particularly among state-owned enterprises, which may enhance market concentration and operational efficiencies [46]. Supply and Demand Dynamics - The report indicates that the supply of blood products is expected to tighten in 2026 due to a slowdown in plasma collection growth and a decrease in imported white albumin supply [30][34]. - Demand for white albumin remains robust, with sales showing signs of stabilization despite recent challenges [33][34]. Future Outlook - The report anticipates a gradual return to a balanced supply-demand relationship in the blood products industry, which could lead to improved financial performance for key players [34][36]. - The potential for new product introductions and market expansions is highlighted as a significant driver for future growth in the sector [12][34].

Investment Rating - The report maintains a positive outlook on the blood products industry, suggesting that the sector has clear long-term growth potential due to increasing supply and demand elasticity [12][19][36]. Core Insights - The blood products industry is expected to benefit from a more relaxed approval process for plasma collection stations during the 14th Five-Year Plan, leading to increased production capacity and a diverse range of products [12][19]. - The report highlights a significant shift in the industry from a supply surplus to a supply-demand balance, with expectations for improved performance in 2026 as supply constraints tighten and demand remains stable [36][34]. - Key companies to watch include TianTan Biotech, BoYa Bio, and HuaLan Bio, which are expected to see performance improvements as the market stabilizes [12][36]. Summary by Sections Market Review - The report notes that the CITIC pharmaceutical index fell by 0.85%, underperforming the CSI 300 index by 1.22 percentage points, ranking 21st among 30 primary industries [6]. - The top-performing stocks in the sector included AidiTe and ZhenDe Medical, while stocks like BeiXin Life and HuaYuan Bio faced significant declines [6][12]. Industry and Stock Events - The blood products sector has experienced a prolonged adjustment period, with a cumulative decline of 18.1% since early 2025, significantly underperforming the broader pharmaceutical sector [16]. - The report indicates that the performance of major blood product companies has varied, with some like WeiGuang Bio and HuaLan Bio performing better than the sector average [16]. Overall Perspective and Investment Themes - The report emphasizes the transition from a quantity-driven to a quality-driven approach in the innovative drug sector, suggesting a focus on differentiated products and international expansion [10]. - In the medical device sector, there is a notable recovery in bidding volumes for imaging equipment, with companies like MaiRui and LianYing expected to benefit from ongoing upgrades [10]. - The report also highlights the importance of the CXO and life sciences services sectors, predicting a recovery in domestic investment and a return to high growth rates [10]. Blood Products - The blood products industry is characterized by a clear growth trajectory, with both supply and demand expected to show significant elasticity [12][19]. - The report suggests that the industry will see improved performance due to a combination of increased plasma collection and a tightening supply situation, which is expected to stabilize prices and enhance profitability for key players [36][34].

Group 1 - The core viewpoint of the article is that Boya Bio-Pharmaceutical (300294.SZ) has confirmed its strategic focus on the development of blood products and plans to dispose of or divest its non-blood product business at an appropriate time [2][3] - The company has stated that it will fulfill its information disclosure obligations promptly if there are any developments regarding the disposal or divestment of its non-blood product business [2]

（文章来源：证券日报） 证券日报网讯 2月12日，博雅生物在互动平台回答投资者提问时表示，公司二级市场股票价格受到宏观 环境、行业政策、投资者风险偏好等因素影响。公司生产经营情况稳定，具体经营情况及财务状况请参 阅公司公告。 ...

（文章来源：证券日报） 证券日报网讯 2月12日，博雅生物在互动平台回答投资者提问时表示，公司二级市场股票价格受到宏观 环境、行业政策、投资者风险偏好等因素影响。公司生产经营活动正常，公司聚焦主责主业努力做好自 身经营管理工作，不断推动公司实现高质量发展。上市公司股价受多种因素影响，敬请投资者理性投 资，注意投资风险。 ...

格隆汇2月12日丨博雅生物(300294.SZ)在投资者互动平台表示，截至目前，公司暂无更名计划。 ...

经济观察网近期博雅生物（300294）热点事件集中在公司治理和业绩表现方面。2026年2月11日，有投 资者质疑公司在经营亏损背景下高管未减薪，董秘回应称薪酬结构包含浮动绩效部分，已参考行业情 况。2月10日，公司回应发展策略时强调聚焦血液制品主业，外延并购存在不确定性，同时披露控股股 东华润医药近期无新增持计划。2月9日，华润系医药公司业绩总结显示，博雅生物2025年净利润同比大 幅下降，在6家上市公司中表现未达预期。 股票近期走势 博雅生物股价近期呈现震荡下行趋势。截至2026年2月12日最新数据，股价报22.33元，当日下跌 0.76%，近5日累计跌幅0.53%，近20日跌幅扩大至4.08%。资金面上，当日主力资金净流出474.19万元， 散户资金流入占比34%，股价短期技术面支撑位关注22.01元，压力位位于23.75元。同期医药生物板块 下跌0.44%，公司股价表现弱于行业平均水平。 以上内容基于公开资料整理，不构成投资建议。 ...

证券日报网讯2月11日，博雅生物（300294）在互动平台回答投资者提问时表示，公司2026年2月10日含 信用账户合并名册的股东人数为31681户。 ...