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派林生物:关于全资子公司获得药品注册临床试验受理通知书的公告
Zheng Quan Ri Bao· 2026-02-05 12:12
(文章来源:证券日报) 证券日报网讯 2月5日,派林生物发布公告称,公司之全资子公司广东双林生物制药有限公司收到国家 药品监督管理局核准签发的人凝血酶药品注册临床试验《受理通知书》。 ...
派林生物人凝血酶临床试验获受理
Bei Jing Shang Bao· 2026-02-05 12:09
Core Viewpoint - The company has received approval for a clinical trial of its human thrombin drug, which is expected to enhance its product line and overall competitiveness in the long term [1] Group 1: Company Announcement - The company announced that its wholly-owned subsidiary, Guangdong Shuanglin Biological Pharmaceutical Co., Ltd., has received the acceptance notice for the clinical trial registration of human thrombin from the National Medical Products Administration [1] - The approval for the clinical trial will not impact the company's current performance but is expected to enrich the product line in the long term [1] Group 2: Strategic Implications - The new product will help optimize the company's product structure and improve the comprehensive utilization rate of raw plasma, thereby enhancing profitability [1] - This development is anticipated to further strengthen the company's core competitiveness in the market [1]
2月5日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-05 10:16
Group 1 - Company Jianhui Information plans to acquire 38% equity in Boke Guoxin for RMB 73.71 million, increasing its stake from 32% to 70%, making Boke Guoxin a subsidiary [1] - Company Guangshengtang's innovative drug GST-HG141 for hepatitis B has completed the enrollment of 578 participants in its Phase III clinical trial [2] - Company Hongjing Optoelectronics is establishing a partnership with a target scale of RMB 290 million, contributing RMB 3 million as a limited partner [3] Group 2 - Company Hongchang Technology intends to acquire 21% equity in Liangzhi Joint, which will make it the controlling shareholder with a 51% stake [4] - Company Xiexin Integrated has not yet received any orders in the "space photovoltaic" sector, which remains in the exploratory phase [5] - Company Xianheng International plans to reduce its shareholding by up to 3%, amounting to a maximum of 12.28 million shares [6] Group 3 - Company Furuijia plans to reduce its repurchased shares by up to 2%, totaling 18.93 million shares [7] - Company Tianqimo is planning to issue shares and pay cash to acquire assets, leading to a temporary suspension of its stock [8] - Company Shuangqiang Technology's director plans to reduce his holdings by up to 0.32% [9] Group 4 - Company Bairun plans to adjust the conversion price of its bonds due to stock prices falling below 85% of the conversion price [11] - Company Dongnan Network has won an EPC project worth RMB 994 million [12] - Company Anhui Energy has appointed Xu Wengong as the new general manager following the resignation of Fang Shiqing [13] Group 5 - Company Lijun plans to invest up to USD 3 million to establish subsidiaries in Hong Kong and Peru [14] - Company Zhenghe Ecology has signed a strategic cooperation agreement with the government of Beijing's Miyun District [15] - Company First Venture has elected Guo Chuan as the chairman of its board [16] Group 6 - Company Changxin Bochuang's shareholder has terminated an agreement to transfer 14.5 million shares [17] - Company Hengrui Medicine's HR091506 tablet application has been accepted by the National Medical Products Administration [18] - Company Hengrui Medicine's SHR-1894 injection has received approval for clinical trials [20] Group 7 - Company Longshen Rongfa has obtained a medical device production license [21] - Company Western Securities reported that its new borrowings exceeded 20% of its net assets [22] - Company Rongfa Nuclear Power's subsidiary has won a project worth RMB 101 million [23] Group 8 - Company Taiji Industry's subsidiary has a pre-bid for the Huahong FAB9B project with a bid amount of RMB 3.778 billion [24] - Company Suzhou High-tech plans to increase its investment in a subsidiary by RMB 780 million through a debt-to-equity swap [26] - Company Electric Power Investment's vice president has resigned due to work changes [27] Group 9 - Company Hengwei Technology reported a 30.13% increase in net profit for 2025 [28] - Company Fangsheng Pharmaceutical's subsidiary has received a drug production license [29] - Company Pilin Bio's subsidiary has received a notice for clinical trial acceptance for a hemostatic drug [31] Group 10 - Company Zhongxin Fluorine Material has received approval for a stock issuance to specific investors [32] - Company Shanhe Intelligent expects a total transaction amount with related parties to be RMB 1.197 billion in 2026 [33] - Company Warner Pharmaceutical's partner has completed Phase I clinical trials for a new drug [34]
派林生物:子公司人凝血酶注册临床试验申请获受理
Xin Lang Cai Jing· 2026-02-05 08:46
Core Viewpoint - The company announced that its wholly-owned subsidiary, Guangdong Shuanglin Biopharmaceutical Co., Ltd., has received the acceptance notice for the clinical trial registration of human thrombin from the National Medical Products Administration [1] Group 1: Regulatory Approval - The National Medical Products Administration has reviewed and accepted the drug registration application based on Article 32 of the Administrative Licensing Law of the People's Republic of China [1] - The human thrombin is indicated for external use only, aimed at controlling minor bleeding from capillaries and small veins when standard surgical techniques are ineffective or impractical [1] Group 2: Product Usage - The product can be used in conjunction with absorbable gelatin sponges for enhanced hemostatic effect [1]
派林生物(000403.SZ):人凝血酶获得药品注册临床试验受理通知书
Ge Long Hui A P P· 2026-02-05 08:12
格隆汇2月5日丨派林生物(000403.SZ)公布,公司之全资子公司广东双林生物制药有限公司(简称"广东 双林")收到国家药品监督管理局核准签发的人凝血酶药品注册临床试验《受理通知书》。人凝血酶申 报适应症:仅可外用,用于毛细血管和小静脉有渗血和轻微出血,且通过标准手术技术控制出血无效或 不切实际时的辅助止血。本品可与可吸收明胶海绵等结合使用。 ...
派林生物:人凝血酶药品注册临床试验获受理
Zhi Tong Cai Jing· 2026-02-05 08:05
Core Viewpoint - The company, Palin Bio (000403.SZ), announced that its wholly-owned subsidiary, Guangdong Shuanglin Biopharmaceutical Co., Ltd., has received the clinical trial acceptance notice for human thrombin drug registration from the National Medical Products Administration of China [1] Group 1 - The approved indication for human thrombin is for external use only, aimed at controlling minor bleeding from capillaries and small veins when standard surgical techniques are ineffective or impractical [1] - The product can be used in conjunction with absorbable gelatin sponges [1]
派林生物(000403.SZ):人凝血酶药品注册临床试验获受理
智通财经网· 2026-02-05 08:01
智通财经APP讯,派林生物(000403.SZ)公告,公司全资子公司广东双林生物制药有限公司(简称"广东双 林")收到国家药品监督管理局核准签发的人凝血酶药品注册临床试验《受理通知书》。人凝血酶申报适 应症为:仅可外用,用于毛细血管和小静脉有渗血和轻微出血,且通过标准手术技术控制出血无效或不 切实际时的辅助止血。本品可与可吸收明胶海绵等结合使用。 ...
派林生物(000403) - 关于全资子公司获得药品注册临床试验受理通知书的公告
2026-02-05 08:00
本公司及董事会全体成员保证信息披露的内容的真实、准确和完整,没有虚假 记载、误导性陈述或者重大遗漏。 证券代码:000403 证券简称:派林生物 公告编号:2026-003 派斯双林生物制药股份有限公司 关于全资子公司获得药品注册临床试验受理通知书的公告 二、药品研发及相关情况 人凝血酶申报适应症:仅可外用,用于毛细血管和小静脉有渗血和轻微出血,且通 过标准手术技术控制出血无效或不切实际时的辅助止血。本品可与可吸收明胶海绵等结 合使用。 经查询,目前国内拥有该产品上市批件的企业包括华兰生物工程股份有限公司及上 海莱士血液制品股份有限公司。 近日,派斯双林生物制药股份有限公司(以下简称"公司")之全资子公司广东双 林生物制药有限公司(以下简称"广东双林")收到国家药品监督管理局核准签发的人 凝血酶药品注册临床试验《受理通知书》(受理号:XCSL2600060),现将有关情况公 告如下: 一、药品基本情况 药物名称:人凝血酶 剂型:冻干粉剂,仅供外用 规格:5000IU/瓶,复溶后体积为 10ml 申请事项:境内生产药品注册临床试验 申请人:广东双林生物制药有限公司 审批结论:根据《中华人民共和国行政许可法》第三 ...
派斯双林生物制药股份有限公司关于全资子公司获得药品注册上市许可受理通知书的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:000403 证券简称:派林生物 公告编号:2026-002 药物名称:人凝血因子IX 剂型:注射剂 规格:500IU/瓶,复溶后10ml 申请事项:境内生产药品注册上市许可 申请人:广东双林生物制药有限公司 派斯双林生物制药股份有限公司 关于全资子公司获得药品注册上市许可受理通知书的公告 本公司及董事会全体成员保证信息披露的内容的真实、准确和完整,没有虚假记载、误导性陈述或者重 大遗漏。 近日,派斯双林生物制药股份有限公司(以下简称"公司")之全资子公司广东双林生物制药有限公司 (以下简称"广东双林")收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通 知书》(受理号:XCSS2600002),现将有关情况公告如下: 一、药品基本情况 五、风险提示 公司已获得人凝血因子IX药品注册上市许可《受理通知书》,具体审批完成时间尚不确定,公司将按 照国家有关规定,积极推进上述研发项目,将根据后续进展情况及时履行信息披露义务,敬请广大投资 者注意投资风险。 审批结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审查,决定予以受理。 ...
派林生物人凝血因子IX药品注册上市许可获受理
Bei Jing Shang Bao· 2026-02-04 09:40
北京商报讯(记者王寅浩宋雨盈)2月4日,派林生物(000403)发布公告称,公司全资子公司广东双林生 物制药有限公司收到国家药品监督管理局核准签发的人凝血因子IX药品注册上市许可《受理通知 书》。根据公告,人凝血因子IX适应症为:对于治疗先天性人凝血因子Ⅸ缺失的乙型血友病患者或因 其它原因引起的人凝血因子Ⅸ含量低下的患者,可显著提升其血液中人凝血因子Ⅸ的水平,从而达到预 防和治疗出血的目的。 ...