重组抗VEGF人源化单克隆抗体注射液(BAT5906)

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财联社8月4日早间新闻精选
Xin Lang Cai Jing· 2025-08-04 00:28
Group 1 - The People's Bank of China (PBOC) emphasizes the continuation of a moderately loose monetary policy, including lowering the reserve requirement ratio and maintaining ample liquidity [1][2][3] - The Shanghai Securities Association reports that the average commission rate for A-shares in Shanghai reached a new low of 0.201‰ in the first half of 2025, continuing a downward trend [3] - The Ministry of Finance and the State Taxation Administration announced the resumption of value-added tax on interest income from newly issued government bonds, local government bonds, and financial bonds starting August 8, 2025 [4] Group 2 - The National Development and Reform Commission (NDRC) has established a regular communication mechanism with private enterprises to address concerns about "involution" competition, implementing measures such as revising laws and enhancing industry self-discipline [5] - The National Certification and Accreditation Administration has developed new implementation rules for mandatory product certification for mobile power sources and lithium-ion batteries, effective from August 15, 2025 [6] - Eight departments have issued a digital transformation implementation plan for the machinery industry, aiming to establish at least 200 excellent smart factories by 2027 and 500 by 2030 [7] Group 3 - The State Administration for Market Regulation released guidelines for compliance regarding the charging behavior of online trading platforms, prohibiting multiple charges to platform operators and ensuring service provision [8] - Hikvision reported a year-on-year net profit increase of 11.71% for the first half of the year [11] - Ninebot reported a net profit of 1.242 billion yuan for the first half of the year, a year-on-year increase of 108% [11] Group 4 - Baotai announced that its innovative drug BAT5906 has received approval for clinical trials [12] - China Shenhua is planning to issue shares and pay cash for asset acquisitions, with stock trading suspended from August 4 [13] - Boeing is facing a strike action from approximately 3,200 workers starting midnight on August 4, according to union resolutions [20]
8月4日早间新闻精选
news flash· 2025-08-04 00:14
6、国家认监委制定了《强制性产品认证实施规则 移动电源、锂离子电池和电池组(试行)》。新版规 则自2025年8月15日起实施。 智通财经8月4日早间新闻精选 1、央行近日召开2025年下半年工作会议暨常态长效推动中央巡视整改工作推进会。其中提到,继续实 施好适度宽松的货币政策,降低存款准备金率,灵活运用多种货币政策工具,保持流动性充裕。 2、央行副行长宣昌能会见来访的美中贸易全国委员会董事会代表团。双方就中美经贸关系、中国宏观 经济政策、金融业开放等议题进行深入沟通。 3、上海证券同业公会的最新数据显示,2025年上半年,上海地区A股平均佣金率以0.201‰再创新低, 延续了近年来的下行趋势。 4、财政部、税务总局公告,自2025年8月8日起,对在该日期之后(含当日)新发行的国债、地方政府 债券、金融债券的利息收入,恢复征收增值税。 5、上周五召开的国家发展改革委新闻发布会上介绍,在促进民营经济高质量发展方面,国家发展改革 委已建立与民营企业常态化沟通交流机制,对企业普遍关心的"内卷式"竞争问题,正在统筹采取修订法 律、出台政策、完善标准、强化行业自律等举措。 7、八部门印发《机械工业数字化转型实施方案》,目 ...
泸州老窖:2024年度每10股派45.92元丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-01 16:32
分组1 - Luzhou Laojiao announced a cash dividend of 45.92 RMB per 10 shares for the fiscal year 2024, totaling approximately 6.759 billion RMB [1] - *ST Huike's control change may terminate as the parties involved have sent a notice to withdraw from the share transfer agreement [2] - Raise Technology plans to acquire 49% of Sichuan Maikelong Vacuum New Materials Co., Ltd. for 231 million RMB, making it a subsidiary [3] 分组2 - Baotai received clinical trial approval for its innovative drug BAT5906, targeting retinal conditions [4] - Huate Dain's subsidiary signed an exclusive distribution agreement for melatonin granules in mainland China, with the product expected to be approved by July 2025 [5] - Jinghe Integration is planning to issue H-shares and list on the Hong Kong Stock Exchange [6] 分组3 - Huatian Technology intends to establish a new subsidiary for advanced packaging with a total investment of 2 billion RMB [7] - Wehua New Materials is in preliminary discussions to acquire controlling interest in Jiangsu Heyutai Chemical Co., Ltd. [8] - Zhongyou Engineering's subsidiary received a project award in Iraq worth approximately 18.032 billion RMB [9] 分组4 - Chipone expects to achieve a revenue of 584 million RMB in Q2 2025, a 49.90% increase quarter-on-quarter [10] - Chang'an Automobile reported a 14.34% year-on-year increase in July sales [10] - Cangge Mining's net profit increased by 38.8% year-on-year in the first half of the year [10]
百奥泰: 百奥泰 自愿披露关于重组抗VEGF人源化单克隆抗体注射液(BAT5906)获得药物临床试验批准通知书的公告
Zheng Quan Zhi Xing· 2025-08-01 16:13
Core Viewpoint - Baiotai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its recombinant humanized monoclonal antibody injection BAT5906, targeting retinal central vein occlusion-related macular edema (CRVO-ME) and pathological myopia-related choroidal neovascularization (pmCNV) [1] Group 1: Drug Approval Details - The drug name is recombinant humanized monoclonal antibody injection, classified as a type 1 drug, with a specification of 16mg/0.2ml [1] - The clinical trial application was accepted on May 8, 2025, and has met the requirements for drug registration [1] Group 2: Drug Characteristics - BAT5906 is an innovative drug developed by Baiotai, an IgG1 full-length antibody with a molecular weight of 149KDa, specifically binding to human VEGF-A165 to inhibit neovascularization [2] - In vitro models show that BAT5906 can block the binding of VEGF to its receptors, inhibiting endothelial cell proliferation and neovascular formation [2] - The serum half-life of BAT5906 is longer than that of the Fab fragment-based drug Ranibizumab, potentially allowing for longer injection intervals [2] - The drug does not trigger antibody-dependent cell-mediated cytotoxicity (ADCC), suggesting a lower incidence of systemic adverse reactions and potentially safer clinical applications [2] Group 3: Clinical Trial Status - As of the announcement date, BAT5906 has received approval for clinical trials for several indications: wet age-related macular degeneration (w-AMD), diabetic macular edema (DME), CRVO-ME, and pmCNV [3] - The company has completed Phase I, II, and III clinical studies for w-AMD, while Phase II for DME is complete and Phase III is in the final stages of patient recruitment [3] - Clinical research for CRVO-ME and pmCNV is in the preparation stage for Phase II/III trials [3]
百奥泰BAT5906临床试验获批准
Bei Jing Shang Bao· 2025-08-01 12:29
Core Viewpoint - Company Baiotai (688177) has received approval from the National Medical Products Administration for its investigational drug BAT5906, which targets retinal central vein occlusion-related macular edema (CRVO-ME) and pathological myopia-related choroidal neovascularization (pmCNV) [1] Group 1 - BAT5906 is a recombinant humanized monoclonal antibody innovative drug developed and produced by the company [1] - The drug is an IgG1 type full-length antibody with a molecular weight of 149KDa [1] - BAT5906 specifically binds to human VEGF-A165, inhibiting neovascularization [1]
百奥泰:在研药品BAT5906获药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2025-08-01 08:32
人民财讯8月1日电,百奥泰(688177)8月1日晚间公告,公司于近日收到国家药品监督管理局核准签发的 关于公司在研药品重组抗VEGF人源化单克隆抗体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑 水肿(CRVO-ME)和病理性近视的脉络膜新生血管(pmCNV)的《药物临床试验批准通知书》。 ...
百奥泰:创新药重组抗VEGF人源化单克隆抗体注射液(BAT5906)获临床试验批准
Mei Ri Jing Ji Xin Wen· 2025-08-01 08:30
每经AI快讯,8月1日,百奥泰(688177.SH)公告称,公司收到国家药监局核准签发的关于在研药品重组 抗VEGF人源化单克隆抗体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑水肿(CRVO-ME) 和病理性近视的脉络膜新生血管(pmCNV)的《药物临床试验批准通知书》。BAT5906已获批临床试 验的适应症包括新生血管性年龄相关性黄斑变性(w-AMD)、糖尿病性黄斑水肿(DME)、CRVO- ME和pmCNV。目前,公司已完成BAT5906在w-AMD适应症的I、II、III期临床研究,DME适应症已完 成II期临床,CRVO-ME和pmCNV适应症也在II/III期临床研究准备阶段。 (文章来源:每日经济新闻) ...
百奥泰(688177.SH):BAT5906获药物临床试验批准
智通财经网· 2025-08-01 08:28
百奥泰(688177.SH)公告,公司近日收到国家药品监督管理局核准签发的关于公司在研药品重组抗VEGF 人源化单克隆抗体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑水肿(CRVO-ME)和病理性近视的 脉络膜新生血管(pmCNV)的《药物临床试验批准通知书》。 公告显示,BAT5906是百奥泰自主研发生产的重组人源化单克隆抗体创新药物,为IgG1型全长抗体,分 子量为149KDa,能与人VEGF-A165进行特异性结合,抑制新生血管生成。在体外血管生成模型上, BAT5906能够阻断VEGF与其相应的受体结合,抑制内皮细胞的增殖和新生血管形成。在动物实验中, BAT5906的血清半衰期比结构为Fab片段的雷珠单抗更长,可能会支持临床中更长的注射周期。在用药 安全性上,不会触发抗体依赖的细胞介导的细胞毒性作用(ADCC),因而全身不良反应小,临床应用可 能更安全。 ...
百奥泰(688177.SH):重组抗VEGF人源化单克隆抗体注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-01 08:20
BAT5906是百奥泰自主研发生产的重组人源化单克隆抗体创新药物,为IgG1型全长抗体,分子量为 149KDa,能与人VEGF-A165进行特异性结合,抑制新生血管生成。在体外血管生成模型上,BAT5906 能够阻断VEGF与其相应的受体结合,抑制内皮细胞的增殖和新生血管形成。在动物实验中,BAT5906 的血清半衰期比结构为Fab片段的雷珠单抗更长,可能会支持临床中更长的注射周期。在用药安全性 上,不会触发抗体依赖的细胞介导的细胞毒性作用(ADCC),因而全身不良反应小,临床应用可能更 安全。 格隆汇8月1日丨百奥泰(688177.SH)公布,近日收到国家药品监督管理局核准签发的关于公司在研药品 重组抗VEGF人源化单克隆抗体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑水肿(CRVO- ME)和病理性近视的脉络膜新生血管(pmCNV)的《药物临床试验批准通知书》。 ...
百奥泰:BAT5906获药物临床试验批准通知书
news flash· 2025-08-01 08:11
百奥泰公告,近日收到国家药品监督管理局核准签发的关于公司在研药品重组抗VEGF人源化单克隆抗 体注射液(BAT5906)新增视网膜中央静脉阻塞所致黄斑水肿(CRVO-ME)和病理性近视的脉络膜新生血管 (pmCNV)的《药物临床试验批准通知书》。BAT5906是百奥泰自主研发生产的重组人源化单克隆抗体创 新药物,为IgG1型全长抗体,分子量为149KDa,能与人VEGF-A165进行特异性结合,抑制新生血管生 成。在体外血管生成模型上,BAT5906能够阻断VEGF与其相应的受体结合,抑制内皮细胞的增殖和新 生血管形成。在动物实验中,BAT5906的血清半衰期比结构为Fab片段的雷珠单抗更长,可能会支持临 床中更长的注射周期。在用药安全性上,不会触发抗体依赖的细胞介导的细胞毒性作用(ADCC),因而 全身不良反应小,临床应用可能更安全。 ...