Core Viewpoint - The announcement indicates that the company’s subsidiary, Bohui Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for a lyophilized rabies vaccine, which is intended to stimulate immune response against rabies [1] Group 1: Company Developments - Bohui Innovation announced that its subsidiary has jointly applied for a rabies vaccine with Beijing Baihui Biotechnology Co., Ltd. [1] - The rabies vaccine is designed to prevent rabies by using purified rabies virus antigens to stimulate the immune response [1] - The approval for clinical trials is a significant step in the vaccine development process, although the company notes that drug development involves high investment, high risk, and long cycles [1] Group 2: Market Context - Currently, the domestic market for human rabies vaccines includes manufacturers such as Chengdu Kanghua Biological Products Co., Ltd. and Beijing Minhui Biotechnology Co., Ltd. [1] - The company acknowledges potential risks associated with drug development, including clinical trial outcomes not meeting expectations and delays in regulatory approvals or market entry [1] - The approval for the clinical trial is not expected to have a significant impact on the company's short-term performance [1]

证券代码：300318 证券简称：博晖创新 公告编号：临 2026-001 北京博晖创新生物技术集团股份有限公司 关于控股孙公司联合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 孙公司博晖生物制药股份有限公司（以下简称"廊坊博晖"）与北京百晖生物科 技有限公司（以下简称"百晖生物"）联合申报的冻干人用狂犬病疫苗（人二倍 体细胞），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：冻干人用狂犬病疫苗（人二倍体细胞）； 受理号：CXSL2500917； 通知书编号：2026LP00096； 药品类型：预防用生物制品； 注册分类：3.3； 申请人：博晖生物制药股份有限公司、北京百晖生物科技有限公司； 适应症：接种本疫苗后，可刺激机体产生抗狂犬病病毒免疫力。用于预防狂 犬病。 审查结论：根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理 法》及有关规定，经审查，2025 年 10 月 21 日受 ...

Core Viewpoint - The in vitro diagnostic (IVD) sector is experiencing significant growth, with a notable increase in stock performance among key companies in the industry, driven by strong downstream demand and market expansion [1] Group 1: Market Performance - As of September 22, the IVD sector saw an overall increase of 3.13%, ranking high on the stock performance list [1] - Notable stock performances include: - Bohui Innovation reached a limit-up - Lide Man surged by 11.76% - Shuoshi Biology and Daan Gene increased by 9.17% and 9.01% respectively - Other companies like Dongfang Biology, Shengxiang Biology, Mingde Biology, BGI, Libang Instruments, and Wantai Biology also saw gains exceeding 6% [1] Group 2: Industry Growth - The IVD industry is primarily utilized in hospital laboratories, independent clinical laboratories (ICL), health check centers, epidemic prevention stations, and blood stations [1] - The downstream demand is robust, with IVD growth nearing 20% [1] - In 2018, the revenue from public hospitals for IVD products reached 315.7 billion yuan, with a year-on-year growth rate of 12.48% [1] - Key clients such as ICL and health check centers are also experiencing growth rates around 20% or higher [1] Group 3: Market Size and Comparison - The Chinese IVD industry size reached 71.3 billion yuan in 2018, reflecting a year-on-year growth of 25.6%, significantly outpacing the global IVD market growth of 6.0% [1] - The strong downstream demand is driving rapid growth in the upstream market size [1] - The IVD sector is nurturing large enterprises, and the favorable conditions in specific segments make leading stocks with performance support worth monitoring [1]

Core Viewpoint - Beijing Bohui Innovation Biotechnology Group Co., Ltd. announced that its subsidiary, Guangdong Weirun Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of intravenous human immunoglobulin [1] Company Summary - The approval allows Guangdong Weirun Biopharmaceutical to commence clinical trials for its intravenous human immunoglobulin product [1]

Core Viewpoint - The announcement indicates that Bohui Innovation's subsidiary has received regulatory approval for a new drug, which is a significant milestone for the company in the biopharmaceutical sector [1] Group 1: Company Developments - Bohui Innovation's subsidiary, Hebei Bohui, has developed a drug called "Human Coagulation Factor VIII" [1] - The drug has been granted a drug registration certificate by the National Medical Products Administration, with the approval number Guoyao Zhunzi S20250068 [1] - The product is specified in a dosage of 200 IU per bottle and is intended for the treatment of Hemophilia A and acquired Factor VIII deficiency-related bleeding [1]

Group 1 - Shareholder of Okoyi plans to reduce holdings by up to 1.89% of the company's shares, amounting to a maximum of 3 million shares due to personal funding needs [1] - Tianchuang Fashion is planning a change in control, leading to continued suspension of its stock trading, expected to last no more than 3 trading days [2] - China Electric Power Construction Company reported a new contract amount of 10,317.55 billion yuan for the first 11 months of 2025, a year-on-year decrease of 1.65% [3] Group 2 - Pilin Bio's wholly-owned subsidiary received approval for a clinical trial of a drug, indicating progress in its product development [4] - Yihong Medical obtained two medical device registration certificates for diagnostic kits, enhancing its product portfolio [5] - Aohong Electronics plans to use up to 450 million yuan of idle fundraising for cash management, targeting safe and liquid financial products [6] Group 3 - China Electric Power Construction signed a contract worth approximately 6.626 billion yuan for a natural gas booster station project in Turkey, with a construction period of about 55 months [7] - Baosheng Co. won a bid for a power cable project in Singapore, valued at around 1.2 billion yuan, marking the largest overseas order in its history [8] - *ST Xinyan's stock will resume trading on December 24, 2025, following a capital increase plan that will raise its total share capital to 3.29 billion shares [9] Group 4 - Ningbo Construction's subsidiary signed a construction contract worth 428 million yuan for an engineering project with a duration of 990 days [11] - Lianhuan Pharmaceutical's subsidiary received approval for a drug that passed the consistency evaluation for generic drugs, enhancing its market competitiveness [12] - Zhongjie Automotive received a project designation for a new electric air conditioning compressor, with expected sales of approximately 29.86 million USD over its lifecycle [13] Group 5 - Biopharmaceuticals' major shareholder plans to increase holdings by 50 million to 100 million yuan, indicating confidence in the company's future [14] - Haizheng Pharmaceutical's subsidiary received approval for a veterinary drug product, expanding its product offerings in the animal health sector [15] - *ST Songfa's subsidiary signed contracts for the construction of 8 vessels, with a total contract value between 200 million to 400 million USD [16] Group 6 - Shandong Pharmaceutical Glass announced the resignation of its chairman due to age reasons, indicating a potential leadership transition [17] - Xinno Wei's subsidiary received approval for a clinical trial of a monoclonal antibody drug, indicating advancements in its drug development pipeline [18] - Ningbo Huaxiang's subsidiary secured an order for robot joints, expected to positively impact future business performance [19][20] Group 7 - China Resources Double Crane's subsidiary received approval for a clinical trial of a drug aimed at treating a genetic eye disease, reflecting ongoing R&D efforts [21] - Huaxin Technology's shareholders set a transfer price of 56.69 yuan per share for a block of shares, indicating active shareholder engagement [22] - Xinhua Net announced the resignation of its president due to job relocation, suggesting potential changes in management [23] Group 8 - Taiji Group plans to transfer a 40% stake in a subsidiary to focus on its core pharmaceutical business, enhancing operational efficiency [24] - Huaxin Construction's shareholder plans to increase holdings by 200 million to 400 million yuan, reflecting confidence in the company's prospects [25] - Dongjie Intelligent is planning to issue shares and cash for asset acquisition, with stock trading suspended until further notice [26] Group 9 - Wanrun New Energy was designated as a delivery warehouse for lithium carbonate futures, indicating its strategic position in the market [27] - Prolo Pharmaceutical's subsidiary received a drug registration certificate for an influenza treatment, expanding its product range [28] - Saiwu Technology invested 5 million yuan in a private equity fund focused on smart vehicles and energy innovation, indicating strategic investment in growth sectors [29] Group 10 - Bohui Innovation's subsidiary received approval for a clinical trial of an immunoglobulin drug, indicating progress in its product development [30] - Bohui Innovation's subsidiary also received a drug registration certificate for a coagulation factor product, enhancing its therapeutic offerings [31] - Hanghua Co. plans to allocate 146 million yuan of surplus fundraising for a new green printing materials project, reflecting a commitment to sustainability [32] Group 11 - Nova Star Cloud obtained a loan commitment letter from a bank for a share repurchase plan, indicating financial support for its capital management strategy [33] - Jimin Health established a joint venture for technology innovation, indicating a strategic move to enhance its technological capabilities [34] - Huili Pharmaceutical received a drug registration certificate for a medication used in treating digestive ulcers, expanding its product portfolio [35]

Core Viewpoint - The company announced that its subsidiary, Guangdong Weirun Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of intravenous immunoglobulin [1] Group 1: Company Developments - Guangdong Weirun has been granted a Clinical Trial Approval Notice for intravenous immunoglobulin, allowing it to commence clinical trials [1] - The intravenous immunoglobulin is already marketed and sold both domestically and internationally [1] Group 2: Industry Context - Several domestic blood product companies, including the company's subsidiary Bohui Biopharmaceutical (Hebei) Co., Ltd., Beijing Tiantan Biological Products Co., Ltd., Shandong Taibang Biological Products Co., Ltd., and Hualan Biological Engineering Co., Ltd., have intravenous immunoglobulin products available in the market [1]

Core Viewpoint - The company BoHui Innovation (300318.SZ) has received approval from the National Medical Products Administration for clinical trials of its intravenous immunoglobulin, indicating a significant step in its product development pipeline [1] Group 1: Product Development - BoHui Innovation's subsidiary, Guangdong Weirun Biopharmaceutical Co., Ltd., has been granted a Clinical Trial Approval Notice for intravenous immunoglobulin [1] - The approved indications for the drug include primary immunoglobulin deficiency diseases such as X-linked agammaglobulinemia, common variable immunodeficiency, and IgG subclass deficiency [1] - Secondary immunoglobulin deficiency diseases such as severe infections and neonatal sepsis, as well as autoimmune diseases like primary immune thrombocytopenic purpura and Kawasaki disease, are also included in the approved indications [1]

Core Viewpoint - The company announced that its subsidiary, Guangdong Weilun Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of intravenous immunoglobulin [1] Group 1: Company Developments - Guangdong Weilun has been granted a Clinical Trial Approval Notice for intravenous immunoglobulin, allowing it to proceed with clinical trials [1] - The intravenous immunoglobulin product is already marketed and sold both domestically and internationally [1] Group 2: Industry Context - Several blood product companies in China, including the company's subsidiary Bohui Biopharmaceutical (Hebei) Co., Ltd., Beijing Tiantan Biological Products Co., Ltd., Shandong Taibang Biological Products Co., Ltd., and Hualan Biological Engineering Co., Ltd., have intravenous immunoglobulin products available in the market [1]

Core Viewpoint - The company BoHui Innovation (300318.SZ) announced that its subsidiary BoHui Biopharmaceutical (Hebei) Co., Ltd. has received the Drug Registration Certificate from the National Medical Products Administration for its product Human Coagulation Factor VIII, which is significant for treating hemophilia A and acquired Factor VIII deficiency [1] Group 1 - The newly approved Human Coagulation Factor VIII is designed to correct coagulation dysfunction caused by a lack of this factor, primarily used for the prevention and treatment of bleeding symptoms in hemophilia A patients [1] - The approval of the Drug Registration Certificate enhances the company's product line and is a crucial step for BoHui Biopharmaceutical in improving plasma utilization efficiency [1]