人凝血酶原复合物
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国际医学拟定增10.08亿元;众生药业RAY1225注射液新增适应证获批临床|医药早参
Mei Ri Jing Ji Xin Wen· 2025-12-04 23:20
|2025年12月5日星期五| NO.1国际医学:拟向特定对象增发募资不超过约10.08亿元 国际医学公告,拟向不超过35名特定投资者定向增发A股股票,募集资金总额不超过10.08亿元。募集资 金用于以下用途:智慧康养项目,总投资约7.51亿元,拟投入募集资金约6.38亿元;质子治疗中心二期 项目,总投资9993.13万元,拟投入募集资金9993.13万元;补充流动资金项目,总投资2.7亿元,拟投入 募集资金2.7亿元。 点评:研报认为创新药板块经历回调后估值趋合理,安全边际提升,已进入较好配置窗口。同时提示板 块内存在结构性轮动机会,建议前瞻布局经营周期有望在2026年迎来改善的细分领域。整体观点偏积 极,核心在于"估值回归"与"周期拐点"的双线逻辑 NO.3众生药业RAY1225注射液新增适应证获批临床 众生药业控股子公司广东众生睿创生物科技有限公司自主研发的一类创新多肽药物RAY1225注射液新 增适应证治疗"代谢相关脂肪性肝炎"的药物临床试验获得国家药品监督管理局批准,并收到《药物临床 试验批准通知书》。 点评:众生药业核心在研双靶点创新药RAY1225获批进入MASH(代谢相关脂肪性肝炎)临床试验, ...
天坛生物下属企业人凝血酶原复合物完成Ⅲ期临床试验
Bei Jing Shang Bao· 2025-12-04 10:32
公告显示,人凝血酶原复合物主要用于治疗先天性和获得性凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ缺乏症(单独或联 合缺陷),包括血友病B、抗凝剂过量、维生素K缺乏症等。临床试验结果显示,输注该产品后能显著 提升血友病B患者的凝血因子Ⅱ/Ⅶ/Ⅸ/Ⅹ水平、提高血友病B患者的凝血功能,改善血友病B患者的出血 症状和体征,对血友病B患者具有良好的疗效。 北京商报讯(记者 王寅浩 宋雨盈)12月4日,天坛生物发布公告称,公司下属国药集团贵州生物制药有 限公司研制的"人凝血酶原复合物"完成了Ⅲ期临床试验并取得临床试验总结报告。 ...
12月4日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-04 10:31
Group 1 - China Pacific Insurance has received approval from the financial regulatory authority for Wang Yuhua to serve as a director [1] - Shanghai Bank announced that the regulatory authority has approved Chen Lei's qualification as vice president [2] - Shanghai HuGong has decided to terminate the "Aerospace Equipment Manufacturing Base" fundraising project due to significant changes in project feasibility [3] Group 2 - Dongwang Times plans to reduce its stake by up to 1.20% through share sales [4] - Zhinancun intends to increase its capital by 100 million yuan in its wholly-owned subsidiary, Maigao Securities [5] - Jinxinnong reported a sales revenue of 115 million yuan from pig sales in November [6] Group 3 - Tiantan Biological has completed the Phase III clinical trial of its human prothrombin complex, showing good efficacy and safety for hemophilia B patients [7] - Beijete's subsidiary has signed a framework agreement for equity acquisition to gain control of Yunnan Wenye Nonferrous Metals [8] - Zhongsheng Pharmaceutical's RAY1225 injection has received approval for a new clinical trial indication for treating metabolic-associated fatty liver disease [9] Group 4 - Enhua Pharmaceutical's hydrochloride sulpiride tablets have passed the consistency evaluation for generic drugs [10] - Shenkong Co. plans to invest 60 million yuan in a semiconductor industry fund [11] - Lianhuan Pharmaceutical's subsidiary has received approval for its drug to pass the consistency evaluation for generic drugs [12] Group 5 - Dazhong Transportation has received approval to issue debt financing tools totaling 4.5 billion yuan [13] - Jintian Titanium Industry plans to invest 50 million yuan in an industry merger and acquisition fund [14] - Changchun Gas has committed over 1.7 billion yuan to gas facility upgrades [15] Group 6 - Laimei Pharmaceutical's innovative anti-cancer drug "Nano Carbon Iron" has received approval for clinical trials [16] - Longquan Co. has signed supply contracts worth approximately 50.76 million yuan for nuclear power components [17] - Igor plans to distribute a cash dividend of 1 yuan per 10 shares [18] Group 7 - Xingfa Group's subsidiary has signed a processing agreement for 80,000 tons of lithium iron phosphate [20] - Yunjigroup's director Wang Wanfeng has resigned for personal reasons [21] - Saiseng Pharmaceutical's application for the listing of a new drug has been accepted by the regulatory authority [22] Group 8 - Xinhua Medical has obtained registration certificates for two new medical devices [23] - Chaoying Electronics plans to invest 100 million USD in its Thai subsidiary for an AI circuit board expansion project [24] - Suzhou Planning's application to acquire 100% of Dongjin Aviation has been accepted by the Shenzhen Stock Exchange [25]
天坛生物下属企业获得临床试验总结报告
Zhi Tong Cai Jing· 2025-12-04 09:19
天坛贵州生产的人凝血酶原复合物临床试验结果显示,输注后能显著提升血友病B患者的凝血因子Ⅱ/ Ⅶ/Ⅸ/Ⅹ水平、提高血友病B患者的凝血功能,改善血友病B患者的出血症状和体征,对血友病B患者具 有良好的疗效。同时安全性分析结果显示,该药物在临床应用过程中对血友病B患者具有良好的安全 性。 天坛生物(600161)(600161.SH)发布公告,近日,公司下属国药集团贵州生物制药有限公司(简称"天坛 贵州")研制的"人凝血酶原复合物"完成了Ⅲ期临床试验并取得临床试验总结报告。 ...
天坛生物(600161.SH)下属企业获得临床试验总结报告
智通财经网· 2025-12-04 09:17
天坛贵州生产的人凝血酶原复合物临床试验结果显示,输注后能显著提升血友病B患者的凝血因子Ⅱ/ Ⅶ/Ⅸ/Ⅹ水平、提高血友病B患者的凝血功能,改善血友病B患者的出血症状和体征,对血友病B患者具 有良好的疗效。同时安全性分析结果显示,该药物在临床应用过程中对血友病B患者具有良好的安全 性。 智通财经APP讯,天坛生物(600161.SH)发布公告,近日,公司下属国药集团贵州生物制药有限公司(简 称"天坛贵州")研制的"人凝血酶原复合物"完成了Ⅲ期临床试验并取得临床试验总结报告。 ...
天坛生物:完成Ⅲ期临床试验总结报告
Xin Lang Cai Jing· 2025-12-04 09:12
天坛生物公告,旗下天坛贵州研发的"人凝血酶原复合物"已完成Ⅲ期临床试验并取得总结报告。该产品 主要用于治疗先天性和获得性凝血因子缺乏症,包括血友病B等。临床试验结果显示,该药物能显著提 升血友病B患者的凝血因子水平,改善出血症状,具有良好疗效和安全性。研发投入为4239.63万元。天 坛贵州将向国家药品监督管理局递交注册申请,但审评进度和取得药品注册证书的时间尚不确定。产品 获批后可生产并上市销售。 ...
天坛生物(600161.SH):下属企业获得临床试验总结报告
Ge Long Hui A P P· 2025-12-04 09:12
格隆汇12月4日丨天坛生物(600161.SH)公布,近日,北京天坛生物制品股份有限公司下属国药集团贵州 生物制药有限公司研制的"人凝血酶原复合物"完成了Ⅲ期临床试验并取得临床试验总结报告。 产品名称:人凝血酶原复合物,适应症:本品主要用于治疗先天性和获得性凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ缺 乏症(单独或联合缺陷)包括: 1.凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ缺乏症,包括血友病B; 2.抗凝剂过量、维生素K缺乏症; 3.因肝脏疾病导致的凝血机制紊乱,肝脏疾病导致的出血患者需要纠正凝血功能障碍时; 4.各种原因所致的凝血酶原时间延长而拟做外科手术患者,但对凝血因子V缺乏者可能无效; 5.治疗已产生因子Ⅷ抑制物的血友病A患者的出血症状; 6.逆转香豆素类抗凝剂诱导的出血。 天坛贵州生产的人凝血酶原复合物临床试验结果显示,输注后能显著提升血友病 B 患者的凝血因子Ⅱ/ Ⅶ/Ⅸ/Ⅹ水平、提高血友病B 患者的凝血功能,改善血友病 B 患者的出血症状和体征,对血友病 B 患者 具有良好的疗效。同时安全性分析结果显示,该药物在临床应用过程中对血友病 B 患者具有良好的安 全性。 ...
天坛生物:人凝血酶原复合物完成Ⅲ期临床试验
Zheng Quan Shi Bao Wang· 2025-12-04 09:11
人民财讯12月4日电,天坛生物(600161)12月4日公告,近日,公司下属国药集团贵州生物制药有限公 司研制的"人凝血酶原复合物"完成了Ⅲ期临床试验并取得临床试验总结报告。人凝血酶原复合物临床试 验结果显示,输注后能显著提升血友病B患者的凝血因子Ⅱ/Ⅶ/Ⅸ/Ⅹ水平、提高血友病B患者的凝血功 能,改善血友病B患者的出血症状和体征,对血友病B患者具有良好的疗效。同时安全性分析结果显 示,该药物在临床应用过程中对血友病B患者具有良好的安全性。 ...
天坛生物“增收不增利”血液制品龙头遭遇增长阵痛
Xin Lang Cai Jing· 2025-11-07 10:01
Core Insights - Tian Tan Biological Products (600161.SH) has shown high growth in recent years but reported a significant decline in net profit in its Q3 2025 report, indicating a situation of "increased revenue but decreased profit" [1] Financial Performance - For the first three quarters of 2025, the company's operating revenue increased by 9.62% year-on-year, reaching 4.465 billion yuan, while net profit attributable to shareholders dropped by 22.16% to 819 million yuan [1] - In Q3 2025, net profit saw a substantial decline of 42.84%, with gross profit margin falling from 55% in the same period last year [1] Factors Affecting Profitability - The decline in profit is attributed to three main factors: 1. Price pressure due to national drug procurement policies that have led to a continuous decline in prices of core products like human albumin and intravenous immunoglobulin [1] 2. Rising costs, with operating costs increasing by 37.87%, significantly outpacing revenue growth [1] 3. Difficulties in cash collection, as accounts receivable and notes receivable increased compared to the previous year [1] Cash Flow and Asset Quality - The company's cash flow and asset quality have deteriorated, with cash reserves dropping from 4.805 billion yuan to 1.898 billion yuan, a decline of over 60% [1] - The net operating cash flow was only 117 million yuan, a dramatic drop of 91% year-on-year [1] - The decline in cash flow is attributed to changes in sales credit policies and increased tax burdens, reflecting a need to relax credit conditions to maintain sales, leading to slower cash inflow and increased liquidity pressure [1] Industry Dynamics - Tian Tan Biological has relied on its extensive plasma collection resources, owning 107 plasma collection stations, accounting for approximately 20% of the national collection volume [2] - However, this resource advantage is being challenged by technological advancements, such as the approval of the world's first plant-based recombinant human albumin, which reduces reliance on human plasma [2] - The industry is shifting from a "resource-driven" model to a "technology and scale-driven" model, indicating a significant change in competitive dynamics [2] Conclusion - The profit decline of Tian Tan Biological is reflective of broader changes in the blood product industry, influenced by procurement policies, rising costs, and technological innovations [2]
天坛生物“增收不增利” 血液制品龙头遭遇增长阵痛
Xin Lang Zheng Quan· 2025-11-07 09:17
Core Viewpoint - TianTan Bio, a leading company in China's blood products industry, is experiencing a significant decline in profitability despite revenue growth, raising concerns about the underlying industry dynamics and potential shifts in competition [1][6]. Revenue and Profitability - In the first three quarters of 2025, TianTan Bio reported a revenue increase of 9.62%, reaching 4.465 billion yuan, but the net profit attributable to shareholders decreased by 22.16% to 819 million yuan [1][2]. - The third quarter saw a dramatic net profit decline of 42.84%, with gross margin dropping from 55.33% to 43.81% year-on-year [1]. Factors Affecting Profitability - Price pressure is a significant factor, as national drug procurement policies have led to a decline in prices for key products like human albumin and intravenous immunoglobulin, shifting the industry from a "price protection" strategy to a "price reduction for volume" competition [1][2]. - Costs have risen sharply, with operating costs increasing by 37.87%, significantly outpacing revenue growth, driven by higher expenses in plasma collection, labor, electricity, and compliance [2]. - Collection difficulties are evident, with accounts receivable surging from 262 million yuan to 2.221 billion yuan, a growth of over seven times, indicating increased credit risk [2]. Cash Flow and Asset Quality - The company's cash flow and asset quality have deteriorated, with cash reserves plummeting from 4.805 billion yuan to 1.898 billion yuan, a decline of over 60% [3]. - Operating cash flow net amount fell by 91% to 117 million yuan, attributed to changes in sales credit policies and increased tax burdens, reflecting a slowdown in cash inflow and heightened liquidity pressure [3][4]. Industry Dynamics - The traditional resource advantage of TianTan Bio, based on its extensive plasma collection network, is under threat from technological advancements [5]. - New products, such as plant-based recombinant human albumin, are emerging, potentially disrupting the reliance on human plasma and altering the industry's cost structure and competitive landscape [5]. Future Outlook - TianTan Bio's profit decline is indicative of broader changes in the blood products industry, driven by procurement policies, rising costs, and technological innovations [6]. - The company must find a new balance between resource control, technological breakthroughs, and scale effects to navigate the ongoing transformation in the industry [6].