人民财讯12月23日电，博晖创新（300318）12月23日公告，近日，控股子公司广东卫伦生物制药有限公 司申报的静注人免疫球蛋白，获得国家药监局出具的《药物临床试验批准通知书》，同意开展临床试 验。 ...

Core Viewpoint - The announcement by Bohui Innovation regarding the approval of its drug for treating hemophilia A and acquired factor VIII deficiency highlights a significant advancement in the company's product pipeline and potential market impact [1] Group 1: Company Developments - Bohui Innovation's subsidiary, Bohui Biopharmaceutical (Hebei) Co., Ltd., has received the Drug Registration Certificate from the National Medical Products Administration for its developed drug [1] - The drug is designed to correct coagulation dysfunction caused by a deficiency of human coagulation factor VIII, indicating its therapeutic relevance [1] Group 2: Market Implications - The approved drug is primarily used for the prevention and treatment of bleeding symptoms in patients with hemophilia A and those with acquired factor VIII deficiency, which could address a significant medical need in this patient population [1] - The approval may enhance Bohui Innovation's competitive position in the biopharmaceutical market, particularly in the area of hemophilia treatment [1]

Core Viewpoint - The company announced that its subsidiary, Hebei Bohui Biopharmaceutical Co., Ltd., has received the Drug Registration Certificate from the National Medical Products Administration for its product, Human Coagulation Factor VIII, which is used to treat bleeding symptoms in patients with Hemophilia A and acquired Factor VIII deficiency [1] Group 1 - The approval of the Drug Registration Certificate for Human Coagulation Factor VIII enhances the company's product line [1] - The product is significant for improving plasma utilization efficiency for Hebei Bohui [1] - The drug is primarily used for the prevention and treatment of bleeding symptoms in patients with specific coagulation disorders [1]

每经AI快讯，12月23日，博晖创新（300318）(300318.SZ)公告称，公司控股子公司广东卫伦生物制药 有限公司申报的静注人免疫球蛋白获得国家药品监督管理局出具的《药物临床试验批准通知书》，该通 知书同意开展临床试验。该药物适应症包括原发性免疫球蛋白缺乏症、继发性免疫球蛋白缺陷病和自身 免疫性疾病等。广东卫伦需按批件内容进行临床研究并经国家药品监督管理局审批通过后方可上市。该 药物已在国内外上市销售，国内有多家血液制品企业的静注人免疫球蛋白上市销售。博晖创新提示，药 物研发存在高风险和长周期特点，可能存在临床试验效果不及预期、未能通过相关主管部门审批、上市 时间晚于计划时间或上市后销量未及预期等风险。该批准通知书是研发的阶段性成果，不会对公司近期 业绩产生重大影响。 ...

证券代码：300318 证券简称：博晖创新 公告编号：临 2025-048 北京博晖创新生物技术集团股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 通知书编号：2025LP03517； 药品类型：治疗用生物制品； 注册分类：3.4； 申请人：广东卫伦生物制药有限公司； 适应症：1.原发性免疫球蛋白缺乏症，如 X 联锁低免疫球蛋白血症，常见变 异性免疫缺陷病，免疫球蛋白 G 亚型缺陷病等。2.继发性免疫球蛋白缺陷病，如 重症感染，新生儿败血症等。3.自身免疫性疾病，如原发性血小板减少性紫癜， 川崎病。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，北京博晖创新生物技术集团股份有限公司（以下简称"公司"）控股 子公司广东卫伦生物制药有限公司（以下简称"广东卫伦"）申报的静注人免疫 球蛋白，获得国家药品监督管理局出具的《药物临床试验批准通知书》，同意开 展临床试验。具体情况如下： 一、基本情况 药物名称：静注人免疫球蛋白； 受理号：CXSL2500861； 二、其他相关情况 广东卫伦获得静注人免疫球蛋白的临床试验批准通知书后，须按照批件内容 进 ...

证券代码：300318 证券简称：博晖创新 公告编号：临 2025-047 北京博晖创新生物技术集团股份有限公司 关于控股子公司人凝血因子Ⅷ获得药品注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 北京博晖创新生物技术集团股份有限公司（以下简称"公司"）控股子公司博 晖生物制药（河北）有限公司（以下简称"河北博晖"）研发的药品人凝血因子Ⅷ 于近日收到国家药品监督管理局核准签发的《药品注册证书》，具体情况如下： 一、注册证的主要内容 受理号：CXSS2400077 证书编号：2025S03842 药品名称：人凝血因子Ⅷ 英文名/拉丁名：Human Coagulation Factor Ⅷ 主要成分：人凝血因子Ⅷ 剂型：注射剂 规格：200IU/瓶。每瓶含人凝血因子Ⅷ 200IU，复溶后体积 10ml。 申请事项：药品注册（境内生产） 注册分类：治疗用生物制品 药品注册标准编号：YBS01042025 药品有效期：36 个月 包装规格：中硼硅玻璃模制注射剂瓶，注射用冷冻干燥无菌粉末用氯化丁基 橡胶塞，1 套/盒。1 套包含人凝血因子Ⅷ 1 瓶，灭菌注 ...

博晖创新公告称，其控股子公司广东卫伦申报的静注人免疫球蛋白获国家药监局《药物临床试验批准通 知书》，同意开展临床试验。该药物受理号为CXSL2500861，适用于原发性/继发性免疫球蛋白缺陷 病、自身免疫性疾病等。获批后需按要求开展临床研究并经审批通过方可上市。不过，药物研发风险 高、周期长，此次获批为阶段性成果，暂不会对公司近期业绩产生重大影响。 ...

Core Viewpoint - The company BoHui Innovation (300318.SZ) has received approval from the National Medical Products Administration for its drug, Human Coagulation Factor VIII, which is intended to treat bleeding symptoms in patients with Hemophilia A and acquired Factor VIII deficiency [1] Group 1 - BoHui Bio-Pharmaceutical (Hebei) Co., Ltd., a subsidiary of BoHui Innovation, developed the Human Coagulation Factor VIII [1] - The drug is designed to correct coagulation dysfunction caused by a deficiency of Human Coagulation Factor VIII [1] - The primary applications of the drug include the prevention and treatment of bleeding symptoms in patients with Hemophilia A and during surgical procedures for these patients [1]

证券日报网讯12月5日，博晖创新（300318）在互动平台回答投资者提问时表示，受益于市场需求与产 品布局完善的双重驱动，公司流感检测相关产品近期出现不同程度的增长，具体经营数据请以公司在指 定信息披露媒体发布的公告为准。 ...

Market Overview - The biopharmaceutical sector experienced a decline of 1.72% on December 2, with Aopumai leading the drop [1] - The Shanghai Composite Index closed at 3897.71, down 0.42%, while the Shenzhen Component Index closed at 13056.7, down 0.68% [1] Individual Stock Performance - Dongbao Bio (300239) closed at 5.80, up 1.05% with a trading volume of 93,700 shares and a transaction value of 53.99 million yuan [1] - Aopumai (688293) saw a significant drop of 8.01%, closing at 50.32 with a trading volume of 33,400 shares and a transaction value of 171 million yuan [2] - Other notable declines included Kanghong Pharmaceutical (002773) down 3.78% and Watson Bio (300142) down 3.17% [2] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 456 million yuan from institutional investors, while retail investors saw a net inflow of 270 million yuan [2] - Notable stocks with significant capital inflows included He Yuan Bio (688765) with a net inflow of 17.69 million yuan from institutional investors [3] - Conversely, stocks like Rongchang Bio (688331) and Shenzhou Cell (688520) also saw mixed capital flows, indicating varied investor sentiment [3]