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陆家嘴财经早餐2025年8月2日星期六
Wind万得· 2025-08-01 23:01
Group 1 - The Ministry of Finance and the State Taxation Administration announced the resumption of VAT on interest income from newly issued government bonds, local government bonds, and financial bonds starting from August 8 [1] - The Hong Kong High Court ruled that Zong Fuli cannot withdraw or transfer any assets from the bank account of Jianhao Venture Capital Limited until the litigation results are finalized [1] - The U.S. non-farm payrolls increased by only 73,000 in July, the lowest in nine months, significantly below the expected 110,000, indicating a rapid slowdown in the labor market [1] Group 2 - The central bank emphasized the implementation of a moderately loose monetary policy and enhancing the effectiveness of monetary policy measures [2] - The National Development and Reform Commission plans to accelerate the establishment of new policy financial tools to support private enterprises in major national projects [2] - The Supreme Court issued judicial interpretations on labor disputes, clarifying that agreements not to participate in social insurance are invalid [2] Group 3 - The Ministry of Finance reported six typical cases of local government hidden debt, with Xiamen, Chengdu, and Wuhan East Lake New Technology Development Zone adding hidden debts of 68.396 billion, 61.408 billion, and 10.385 billion respectively [3] Group 4 - The A-share market experienced a decline, with the Shanghai Composite Index falling by 0.37% to 3559.95 points, and the total trading volume for the day was 1.62 trillion [4] - The Hong Kong Hang Seng Index closed down 1.07% at 24507.81 points, marking four consecutive days of decline [5] Group 5 - The Hong Kong Stock Exchange published a consultation summary on optimizing IPO pricing and public market regulations, allowing a reduction in the minimum allocation ratio for IPO book-building from 50% to 40% [5] - The Shanghai Stock Exchange clarified that pre-application consultation is not a mandatory procedure for project acceptance [5] Group 6 - In the electric vehicle sector, July delivery figures showed significant growth for several companies, with Leap Motor surpassing 50,000 deliveries for the first time [9] - The Ministry of Industry and Information Technology issued a digital transformation implementation plan for the machinery industry, aiming for 50% of enterprises to reach a maturity level of two or above by 2027 [10] Group 7 - The State Administration of Foreign Exchange outlined key tasks for foreign exchange management, emphasizing the need for macro-prudential management of cross-border capital flows [21] - The onshore RMB closed at 7.2106 against the USD, down 176 basis points from the previous trading day [21]
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]
8月1日晚间重要公告一览
Xi Niu Cai Jing· 2025-08-01 10:10
雅本化学:与恒瑞医药签署供应战略协议 8月1日晚,雅本化学(300261)发布公告称,公司与江苏恒瑞医药股份有限公司签署《供应战略协 议》,建立面向未来的战略合作伙伴关系。双方将共同推动特定医药中间体及原料药(API)产品的技 术创新与质量升级,强化医药产业链关键环节的协同竞争力。协议有效期为10年,自2025年8月1日起生 效。 资料显示,雅本化学成立于2006年1月,主营业务是创新农药中间体、医药中间体的研发、生产和销 售。 所属行业:基础化工–农化制品–农药 巍华新材:拟收购禾裕泰控股权 8月1日晚,巍华新材(603310)发布公告称,公司与浙江欣禾生物股份有限公司签署股权收购意向协 议,拟以现金方式收购江苏禾裕泰化学有限公司的控股权。此次收购旨在延伸公司产品链,发挥协同效 应,提升公司在行业内的综合竞争力。目前,收购事项尚处于筹划阶段。 资料显示,巍华新材成立于2013年10月,主营业务是研发、生产氯甲苯类和三氟甲基苯类系列产品。 所属行业:基础化工–化学制品–氟化工 富吉瑞:获得200.74万元政府补助 8月1日晚,富吉瑞(688272)发布公告称,公司近日收到政府补助200.74万元。该补助为与收 ...
百奥泰:在研药品BAT5906获药物临床试验批准通知书
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(688177) - 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
2025-08-01 08:30
证券代码:688177 证券简称:百奥泰 公告编号:2025-047 百奥泰生物制药股份有限公司 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 剂型:注射剂 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 百奥泰生物制药股份有限公司(以下简称"百奥泰"或"公司")于近日收到国 家药品监督管理局(以下简称"国家药监局")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》。 考虑到临床研究周期长、投入大,过程中不可预测因素较多,临床试验、审 评和审批的结果以及时间都具有一定的不确定性,容易受到一些不确定性因素的 影响,敬请广大投资者谨慎决策,注意防范投资风险。现将相关情况公告如下: 一、 《药物临床试验批准通知书》基本情况 药品名称:重组抗 VEGF 人源化单克隆抗体注射液 注册分类:1 规格:16mg/0. ...
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:BAT5906获药物临床试验批准
Zhi Tong Cai Jing· 2025-08-01 08:24
Core Viewpoint - The company Baiotai (688177.SH) 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: Drug Development - BAT5906 is a recombinant humanized monoclonal antibody innovative drug developed and produced by the company, classified as an IgG1 full-length antibody with a molecular weight of 149KDa [1] - The drug specifically binds to human VEGF-A165, inhibiting neovascularization [1] - In vitro models show that BAT5906 can block the binding of VEGF to its corresponding receptors, suppressing endothelial cell proliferation and neovascular formation [1] Group 2: Clinical and Safety Profile - In animal studies, BAT5906 demonstrated a longer serum half-life compared to the Fab fragment structure of Ranibizumab, potentially allowing for longer injection intervals in clinical settings [1] - The drug does not trigger antibody-dependent cell-mediated cytotoxicity (ADCC), suggesting a lower incidence of systemic adverse reactions and potentially safer clinical applications [1]
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
Ge Long Hui A P P· 2025-08-01 08:20
格隆汇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。 ...