WEIGUANG BIOLOGICAL(002880)
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深圳市卫光生物制品股份有限公司关于收到药品注册临床试验受理通知书的公告
Shang Hai Zheng Quan Bao· 2025-12-24 19:16
Group 1 - The company, Shenzhen Weiguang Biological Products Co., Ltd., has received a clinical trial acceptance notice for subcutaneous immunoglobulin from the National Medical Products Administration [1][2] - The drug is classified as a Class 3.2 therapeutic biological product, with a specification of 2g/bottle (20%, 10ml), aimed at treating primary immunodeficiency diseases (PID) [1][3] - Currently, there are no approved subcutaneous immunoglobulin products in the domestic market, while several have been approved overseas, including CSL Behring's HIZENTRA, Takeda's CUVITRU, and Grifols' XEMBIFY [1][4] Group 2 - The company will actively promote the subsequent progress of the clinical trial and fulfill its information disclosure obligations in a timely manner [1][5] - The approval timeline and outcome for the clinical trial remain uncertain, and the company advises investors to make cautious decisions [1][5]
卫光生物:关于收到药品注册临床试验受理通知书的公告
Zheng Quan Ri Bao· 2025-12-24 12:11
Core Viewpoint - Shenzhen Weiguang Biological Products Co., Ltd. has received the acceptance notice for the clinical trial application of subcutaneous human immunoglobulin production from the National Medical Products Administration [2] Group 1 - The company announced the receipt of the clinical trial application acceptance notice on December 24 [2] - The clinical trial is for domestically produced subcutaneous human immunoglobulin [2]
12月24日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-24 10:12
Group 1 - Jizhi Co., Ltd. plans to acquire at least 51% equity in Pumai Technology through cash payment, aiming to gain control over the company, which is a leading enterprise in the field of robot performance testing and calibration in China [1] - Yaxing Chemical's subsidiary intends to transfer 7.14% equity for 60 million yuan to another fund under the same control, indicating strategic investment movements within the same management group [2] - Weigao Bio's application for clinical trials of subcutaneous human immunoglobulin has been accepted by the National Medical Products Administration, targeting primary immunodeficiency diseases [3] Group 2 - Sentai Co., Ltd.'s controlling shareholder plans to increase shareholding by at least 100 million yuan within 12 months, aiming to enhance confidence in the company's future [4] - Health元's subsidiary has received acceptance for the marketing authorization application of Lecanemab injection, which is intended for moderate to severe plaque psoriasis patients [5][11] - Sunshine Nuohuo has signed a technical development contract for the STC008 injection project, with a total payment of 500 million yuan, indicating significant investment in cancer treatment [6] Group 3 - Hunan YN has been designated as a delivery warehouse for lithium carbonate by the Guangzhou Futures Exchange, enhancing its position in the lithium market [7] - Tianji Co., Ltd. is pushing for the industrialization of lithium sulfide material preparation, although it faces risks in commercialization [8] - Yuandong Bio has received FDA approval for Methylene Blue injection, expanding its product portfolio in the U.S. market [10] Group 4 - Nanshan Aluminum has established a wholly-owned subsidiary in Hainan with an investment of 5 million yuan, focusing on high-end aluminum products [13] - ST Xifa plans to acquire 50% equity in Lhasa Beer, aiming for full ownership, with the transaction currently in the planning stage [14] - Hengrui Medicine's SHR-A1904 injection has been included in the list of breakthrough therapy products, indicating its potential in treating advanced gastric cancer [12] Group 5 - Chengdu Gas is planning to merge three subsidiaries, streamlining operations and enhancing efficiency [26] - Baoli Electric intends to invest 50 million yuan to establish a wholly-owned subsidiary focused on key equipment and solutions in energy storage [27] - Huadian International has successfully put the second unit of its Longkou Phase IV project into commercial operation, marking a significant milestone in its energy production capacity [34]
卫光生物:收到药品注册临床试验受理通知书
Xin Lang Cai Jing· 2025-12-24 09:20
Core Viewpoint - The company has received a clinical trial application acceptance notice from the National Medical Products Administration for its subcutaneous human immunoglobulin product, indicating progress in its drug development pipeline [1] Group 1: Product Information - The drug is named subcutaneous human immunoglobulin, with a specification of 2g/bottle (20%, 10ml) [1] - It is classified as a Class 3.2 therapeutic biological product [1] - The drug is indicated for primary immunodeficiency diseases (PID), including X-linked agammaglobulinemia, common variable immunodeficiency, and immunoglobulin G subclass deficiency [1]
卫光生物(002880.SZ):皮下注射人免疫球蛋白收到药品注册临床试验受理通知书
Ge Long Hui A P P· 2025-12-24 09:20
Core Viewpoint - Weigao Biologics (002880.SZ) has received a clinical trial application acceptance notice from the National Medical Products Administration for subcutaneous immunoglobulin production, indicating progress in its drug development pipeline [1] Group 1: Company Developments - Weigao Biologics has been granted the acceptance notice for the clinical trial application of subcutaneous immunoglobulin (SCIG) [1] - SCIG contains broad-spectrum antibodies, specifically immunoglobulin G (IgG), which can enhance the IgG levels in patients [1] - The product aims to neutralize toxins and assist in the elimination of bacteria, viruses, and other pathogens, thereby improving the immune response and infection resistance [1]
卫光生物(002880) - 关于收到药品注册临床试验受理通知书的公告
2025-12-24 09:15
证券代码:002880 证券简称:卫光生物 公告编号:2025-059 药品名称:皮下注射人免疫球蛋白 申请事项:境内生产药品注册临床试验 规 格:2g/瓶(20%, 10ml) 深圳市卫光生物制品股份有限公司 关于收到药品注册临床试验受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误 导性陈述或重大遗漏。 近日,深圳市卫光生物制品股份有限公司(以下简称公司)收到国家药品监 督管理局签发的皮下注射人免疫球蛋白境内生产药品注册临床试验申请《受理通 知书》(受理号:CXSL2501109)。现将相关情况公告如下: 一、申请注册药品的基本情况 三、同类产品市场情况 目前国内尚无皮下途径给药的SCIG产品获批,海外已有多款SCIG产品批准 上市,代表性产品主要有CSL Behring公司的HIZENTRA®、Takeda公司的 CUVITRU®、Grifols公司的XEMBIFY®等。 四、对公司的影响及风险提示 根据国家相关法律规定,公司皮下注射人免疫球蛋白已获得临床试验注册申 请受理,审批时间与结果尚不确定,公司将积极推进该项目的后续进展,并及时 履行信息披露义务。敬请广 ...
卫光生物:股东会审议通过《关于向银行申请综合授信额度的议案》
Zheng Quan Ri Bao Wang· 2025-12-23 07:12
Group 1 - The core point of the article is that Weiguang Biological (002880) announced the approval of a proposal to apply for a comprehensive credit line from banks during its fourth extraordinary general meeting of shareholders in 2025 [1] Group 2 - The announcement was made on the evening of December 22 [1] - The proposal was passed during a shareholder meeting, indicating a strategic move by the company to enhance its financial capabilities [1] - The comprehensive credit line is expected to support the company's operational and growth initiatives [1]
卫光生物(002880) - 2025年第四次临时股东会决议公告
2025-12-22 11:00
证券代码:002880 证券简称:卫光生物 公告编号:2025-058 深圳市卫光生物制品股份有限公司 2025 年第四次临时股东会决议公告 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。 特别提示: 1.本次股东会召开期间无否决议案的情况; 2.本次股东会未涉及变更以往股东会已通过议案的情况。 一、会议召开和出席情况 (一)会议召开情况 1.会议召开时间: 2.现场会议召开地点:广东省深圳市光明区光明街道光侨大道 3402 号公司办公 楼 4 楼会议室。 3.会议召开方式:现场投票和网络投票相结合。 4.会议召集人:公司董事会。 5.会议的召集、召开符合《公司法》《上市公司股东会规则》《公司章程》等 的规定。 (二)会议出席情况 (1)现场会议:2025 年 12 月 22 日 15:00。 (2)网络投票:通过深圳证券交易所交易系统进行网络投票的时间为 2025 年 12 月 22 日 9:15–9:25、9:30–11:30、13:00–15:00;通过深圳证券交易所互联网投票 系统投票的时间为 2025 年 12 月 22 日 9:15 至 15:00 ...
卫光生物(002880) - 2025年第四次临时股东会的法律意见书
2025-12-22 10:46
上海市锦天城(深圳)律师事务所 法律意见书 上海市锦天城(深圳)律师事务所 关于深圳市卫光生物制品股份有限公司 2025 年第四次临时股东会的 法律意见书 地址:深圳市福田中心区福华三路卓越世纪中心 1 号楼 21-23 层 电话:0755-82816698 传真:0755-82816898 上海市锦天城(深圳)律师事务所 法律意见书 2025 年第四次临时股东会的 法律意见书 致:深圳市卫光生物制品股份有限公司 上海市锦天城(深圳)律师事务所(以下简称"本所")接受深圳市卫光生物 制品股份有限公司(以下简称"公司")的委托,指派律师出席公司 2025 年第 四次临时股东会(以下简称"本次股东会"),并根据《中华人民共和国公司法》 (以下简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证券 法》")、《上市公司股东会规则》(以下简称"《股东会规则》")等法律、 法规和规范性文件以及现行有效的《深圳市卫光生物制品股份有限公司章程》(以 下简称"《公司章程》")的相关规定,对本次股东会相关法律事项进行见证并 出具本法律意见书。公司已向本所提供了本所律师为出具本法律意见书所必需的 原始书面材料、副本材料 ...
卫光生物今日大宗交易折价成交67万股,成交额1579.19万元
Xin Lang Cai Jing· 2025-12-19 09:12
12月19日,卫光生物大宗交易成交67万股,成交额1579.19万元,占当日总成交额的55.89%,成交价23.57元,较市场收盘价 25.9元折价9%。 | 交易日期 | 证券代码 | 证券简称 | 成交价格 | 成交量 | 成交金额 买方营业部 | | 卖方营业部 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | (元) | (万股/万份) | (万元) | | | | 2025-12-19 | 002880 | 卫光生物 | 23.57 | 67.00 | 1,579.19中信证券股份有限 | | 国元证券股份有限 | | | | | | | 公司深圳分公司 | | 公司深圳深圳湾证 | | | | | | | | 券营业部 | | ...