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博雅生物:公司2025年9月30日含信用账户合并名册的股东人数为30204户
Zheng Quan Ri Bao· 2025-10-13 12:13
Core Insights - The company reported that as of September 30, 2025, the number of shareholders, including those with credit accounts, is 30,204 [2] Company Summary - The company, 博雅生物, has provided an update on its shareholder count, indicating a total of 30,204 shareholders as of the specified date [2]
长春高新(000661.SZ):子公司三价流感病毒裂解疫苗(BK-01佐剂)临床试验申请获得批准
Ge Long Hui A P P· 2025-10-13 12:11
格隆汇10月13日丨长春高新(000661.SZ)公布,子公司——长春百克生物科技股份公司(简称"百克生 物")收到国家药品监督管理局对其三价流感病毒裂解疫苗(BK-01佐剂)下发的《药物临床试验批准 通知书》。百克生物自主研发了本次获批临床的三价流感病毒裂解疫苗(BK-01佐剂),该疫苗接种对 象为60岁及以上人群,接种后可刺激机体产生更强的免疫应答。该疫苗采用流感病毒裂解疫苗工艺技术 路线,配伍以公司自主研发的佐剂,保证疫苗安全性的同时提高了疫苗的免疫原性,与传统裂解流感疫 苗相比,可激发机体产生更高水平的保护性抗体,为老年人群提供有效的防护。 ...
长春高新:子公司三价流感病毒裂解疫苗(BK-01佐剂)临床试验申请获得批准
Ge Long Hui· 2025-10-13 12:09
格隆汇10月13日丨长春高新(000661.SZ)公布,子公司——长春百克生物科技股份公司(简称"百克生 物")收到国家药品监督管理局对其三价流感病毒裂解疫苗(BK-01佐剂)下发的《药物临床试验批准 通知书》。百克生物自主研发了本次获批临床的三价流感病毒裂解疫苗(BK-01佐剂),该疫苗接种对 象为60岁及以上人群,接种后可刺激机体产生更强的免疫应答。该疫苗采用流感病毒裂解疫苗工艺技术 路线,配伍以公司自主研发的佐剂,保证疫苗安全性的同时提高了疫苗的免疫原性,与传统裂解流感疫 苗相比,可激发机体产生更高水平的保护性抗体,为老年人群提供有效的防护。 ...
凯普生物:10月13日召开董事会会议
Mei Ri Jing Ji Xin Wen· 2025-10-13 12:02
Core Viewpoint - Capbio (SZ 300639) announced the convening of its sixth second board meeting on October 13, 2025, to discuss various proposals, including providing guarantees for its wholly-owned subsidiary and replacing some collateral under a syndicated loan [1] Financial Performance - For the first half of 2025, Capbio's revenue composition was as follows: molecular diagnostic products accounted for 67.65%, medical testing services for 29.07%, and medical service income for 3.27% [1] Market Position - As of the report, Capbio's market capitalization stood at 3.6 billion yuan [1]
长春高新子公司三价流感病毒裂解疫苗(BK-01佐剂)临床试验申请获批准
Zhi Tong Cai Jing· 2025-10-13 11:17
长春高新(000661)(000661.SZ)公告,公司子公司百克生物收到国家药品监督管理局对其三价流感病 毒裂解疫苗(BK-01佐剂)下发的《药物临床试验批准通知书》,同意开展预防疫苗相关型别流感病毒引 起的流行性感冒的临床试验。 ...
智通港股通活跃成交|10月13日
智通财经网· 2025-10-13 11:05
Core Insights - On October 13, 2025, Alibaba-W (09988), SMIC (00981), and Xiaomi Group-W (01810) were the top three stocks by trading volume in the Southbound trading of the Stock Connect, with trading amounts of 22.61 billion, 12.67 billion, and 9.13 billion respectively [1] - In the Southbound trading of the Shenzhen-Hong Kong Stock Connect, Alibaba-W (09988), Xiaomi Group-W (01810), and SMIC (00981) also ranked as the top three, with trading amounts of 9.69 billion, 6.19 billion, and 5.05 billion respectively [1] Shanghai-Hong Kong Stock Connect Top Active Companies - Alibaba-W (09988) had a trading amount of 22.61 billion with a net buy of -2.18 billion [1] - SMIC (00981) recorded a trading amount of 12.67 billion with a net buy of -1.81 billion [1] - Xiaomi Group-W (01810) had a trading amount of 9.13 billion with a net buy of +0.13 billion [1] - Tencent Holdings (00700) had a trading amount of 9.13 billion with a net buy of -3.31 billion [1] - The Yingfu Fund (02800) saw a trading amount of 5.42 billion with a net buy of +5.21 billion [1] - Hua Hong Semiconductor (01347) had a trading amount of 5.17 billion with a net buy of +0.79 billion [1] - Other notable companies included Hang Seng China Enterprises (02828), ZTE Corporation (00763), Meituan-W (03690), and Kingsoft Corporation (03888) with varying trading amounts and net buys [1] Shenzhen-Hong Kong Stock Connect Top Active Companies - Alibaba-W (09988) had a trading amount of 9.69 billion with a net buy of +0.55 billion [1] - Xiaomi Group-W (01810) recorded a trading amount of 6.19 billion with a net buy of +0.76 billion [1] - SMIC (00981) had a trading amount of 5.05 billion with a net buy of +1.29 billion [1] - Tencent Holdings (00700) had a trading amount of 4.47 billion with a net buy of +0.86 billion [1] - Hua Hong Semiconductor (01347) saw a trading amount of 3.04 billion with a net buy of +0.56 billion [1] - Other companies such as Yingfu Fund (02800), Meituan-W (03690), ZTE Corporation (00763), WuXi Biologics (02269), and Innovent Biologics (01801) also participated with varying trading amounts and net buys [1]
石药集团:依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-10-13 11:05
Core Viewpoint - The announcement highlights the acceptance of a new drug application for the product Icodextrin α injection by the National Medical Products Administration of China, aimed at long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered weekly [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss while also lowering blood glucose levels and improving cardiovascular and metabolic indicators [1] Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results showed significant weight reduction compared to placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit a larger patient population [2]
石药集团(01093):依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
智通财经网· 2025-10-13 11:03
Core Viewpoint - The application for the new drug, Idaglutide α injection, developed by the subsidiary of the company, has been accepted by the National Medical Products Administration of China for long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss, while also lowering blood glucose levels in a glucose-dependent manner and improving cardiovascular and metabolic indicators [1] Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results showed significant weight reduction compared to placebo, along with notable decreases in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower incidence rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit more patients [2]
石药集团(01093.HK):依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
Ge Long Hui· 2025-10-13 10:58
Core Viewpoint - The new drug application for the injection of Idaglutide α developed by Stone Pharmaceutical Group has been accepted by the National Medical Products Administration of China, targeting long-term weight management in overweight or obese adults [1] Company Summary - Stone Pharmaceutical Group's subsidiary, Stone Pharmaceutical Group Baike (Shandong) Biopharmaceutical Co., Ltd., is responsible for the development of the new drug [1] - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] Product Details - The drug is classified as a Class 1 new drug for therapeutic biological products, aimed at weight management alongside diet control and increased physical activity [1] - It selectively binds and activates GLP-1 receptors, leading to appetite suppression and reduced food intake, while also lowering blood glucose levels in a glucose-dependent manner [1] - The product shows benefits in cardiovascular and metabolic indicators [1] Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results indicate that the product significantly reduces weight compared to a placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids [1] - The safety and tolerability of the product are reported to be good, with lower rates of gastrointestinal adverse events compared to similar marketed drugs [1] Dosing and Administration - The dosing regimen is noted to be quicker and simpler, achieving the target maintenance dose within just four weeks [1]
百克生物:三价流感病毒裂解疫苗临床试验申请获批
Zheng Quan Shi Bao Wang· 2025-10-13 10:40
Core Viewpoint - 百克生物 has received approval for its trivalent influenza virus split vaccine (BK-01 adjuvant) from the National Medical Products Administration, which is expected to enhance immune response in the elderly population, marking a significant step in flu prevention for this vulnerable group [1][2]. Group 1: Vaccine Development - The trivalent influenza virus split vaccine (BK-01 adjuvant) is specifically designed for individuals aged 60 and above, aiming to stimulate a stronger immune response compared to traditional vaccines [2]. - The company has developed a product matrix for adjuvanted influenza vaccines, including both trivalent and quadrivalent options, with the quadrivalent vaccine already receiving clinical trial approval [1][2]. - The World Health Organization has recommended the removal of the B/Yamagata strain from the Northern Hemisphere flu vaccine components, highlighting the importance of the trivalent vaccine in flu epidemic control [1]. Group 2: Impact on Company - If the trivalent vaccine successfully completes clinical trials and receives market approval, it will enhance the company's vaccine development pipeline and provide new vaccination options for the elderly, thereby expanding its market reach [2]. - The company reported a significant increase in R&D investment, amounting to 98.2 million yuan, which represents 34.47% of its revenue, compared to 85.5 million yuan and 13.83% in the same period last year [4]. - The company is focusing on a diverse pipeline of 13 vaccine products and 3 monoclonal antibodies for infectious disease prevention, with strategies including upgrades, filling domestic gaps, and technological breakthroughs [4].