Core Viewpoint - The company Baiotai (688177.SH) has received approval from the National Medical Products Administration for clinical trials of its drug BAT5906, targeting additional indications for retinal central vein occlusion-related macular edema and pathological myopia-related choroidal neovascularization [2] Group 1: Drug Approval and Indications - BAT5906 has been approved for clinical trials for multiple indications, including wet age-related macular degeneration (w-AMD), diabetic macular edema (DME), central retinal vein occlusion-related macular edema (CRVO-ME), and pathological myopia-related choroidal neovascularization (pmCNV) [2] - The company has completed Phase I, II, and III clinical studies for the w-AMD indication, and Phase II clinical studies for the DME indication, while CRVO-ME and pmCNV are in the preparation stage for Phase II/III clinical studies [2]

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。 ...

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]

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。 ...

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。 ...

百奥泰生物制药股份有限公司董事会 证券代码：688177 证券简称：百奥泰 公告编号：2025-046 百奥泰生物制药股份有限公司 关于变更办公地址和投资者联系方式的公告 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"公司"）因经营发展需要，于近 日搬迁至新办公地址办公，为便于投资者与公司沟通交流，现将公司主要办公 地址和投资者联系方式的变更情况公告如下： 变更项目 变更前 变更后 广东省广州市黄埔区高新技术产 办公地址 业开发区科学城开源大道 11 号 A6 栋第五层 广东省广州市国际生物岛螺旋二 路 18 号 投资者联 广东省广州市黄埔区科学城科学 系地址 大道 286 号七喜大厦 10 楼 邮政编码 510530 510005 除上述变更外，公司官方网站、投资者热线、电子邮箱等其他联系方式均 保持不变。具体为： 公司官网：http://www.bio-thera.com/ 投资者联系电话：020-32203528 投资者关系邮箱：IR@bio-thera.com 敬请广大投资者 ...

除上述变更外，公司官方网站、投资者热线、电子邮箱等其他联系方式均 保持不变。具体为： 公司官网：http://www.bio-thera.com/ 证券代码：688177 证券简称：百奥泰 公告编号：2025-046 百奥泰生物制药股份有限公司 关于变更办公地址和投资者联系方式的公告 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"公司"）因经营发展需要，于近 日搬迁至新办公地址办公，为便于投资者与公司沟通交流，现将公司主要办公 地址和投资者联系方式的变更情况公告如下： | 变更项目 | | 变更前 | | | 变更后 | | --- | --- | --- | --- | --- | --- | | 办公地址 | 广东省广州市黄埔区高新技术产 业开发区科学城开源大道 号 栋第五层 A6 | | 11 | | 广东省广州市国际生物岛螺旋二 路 18 号 | | 投资者联 | 广东省广州市黄埔区科学城科学 | | | | | | 系地址 | 大道 楼 286 10 | 号七喜大厦 | | ...

Core Viewpoint - Baotai is expected to report a reduced loss for the first half of 2025 compared to the same period last year, with projected net profit attributable to shareholders ranging from -110 million to -140 million yuan, a decrease in loss of 96.85 million to 126.85 million yuan [1] Financial Performance - The projected net profit attributable to shareholders after deducting non-recurring gains and losses is expected to be between -160 million and -190 million yuan, indicating a decrease in loss of 80.33 million to 110.33 million yuan [1] - In the same period last year, the net profit attributable to shareholders was -236.85 million yuan, and the net profit after deducting non-recurring gains and losses was -270.33 million yuan [1] Company Background - Baotai was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on February 21, 2020, with an initial offering price of 32.76 yuan per share and a total of 60 million shares issued [1] - The stock reached a peak price of 78.00 yuan per share on its first trading day but is currently in a state of decline [1] Fundraising Details - The total amount raised from the initial public offering (IPO) was 1.966 billion yuan, with a net amount of 1.876 billion yuan after deducting issuance costs, which is 124 million yuan less than the original plan [2] - The IPO expenses totaled 89.40 million yuan, with 77.83 million yuan paid to the underwriting and sponsoring institutions [2]

Group 1 - The company expects a net loss attributable to shareholders of the parent company for the first half of 2025 to be between -110 million and -140 million yuan, representing a reduction in loss of 96.84 million to 126.84 million yuan compared to the same period last year [2] - The expected net loss attributable to shareholders after deducting non-recurring gains and losses is projected to be between -160 million and -190 million yuan, indicating a reduction in loss of 80.33 million to 110.33 million yuan [2] - The previous year's net loss attributable to shareholders was -236.85 million yuan, with a net loss after deducting non-recurring gains and losses of -270.33 million yuan [4] Group 2 - The company anticipates a decrease in losses due to increased market expansion, with sales of Adalimumab injection (Geleli) expected to rise, contributing an additional revenue of 20 million to 50 million yuan compared to the previous year [6] - Research and development expenses are expected to decrease by 40 million to 70 million yuan compared to the previous year, primarily because several R&D projects have completed Phase III clinical trials, with BAT2206, BAT2306, and BAT2506 currently in the application stage for market approval [6] - BAT2206 has already received FDA approval for market launch in the United States, which has contributed to the reduction in R&D expenses [6]