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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。 ...
百奥泰: 百奥泰 关于变更办公地址和投资者联系方式的公告
Zheng Quan Zhi Xing· 2025-07-31 16:15
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 ...
百奥泰(688177) - 百奥泰 关于变更办公地址和投资者联系方式的公告
2025-07-31 08:15
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 | | ...
破发股百奥泰上半年减亏 2020年上市即巅峰募19.7亿元
Zhong Guo Jing Ji Wang· 2025-07-30 02:58
上市首日,百奥泰盘中创下上市以来最高价78.00元/股。目前该股处于破发状态。 经财务部门初步测算,百奥泰预计2025年半年度实现归属于母公司所有者的净利润与上年同期相比,将 减少亏损,实现归属于母公司所有者的净利润为-11,000.00万元到-14,000.00万元,减少亏损9,684.58万 元到12,684.58万元;预计归属于母公司所有者扣除非经常性损益后的净利润为-16,000.00万元 到-19,000.00万元,将减少亏损8,033.49万元至11,033.49万元。 上年同期,百奥泰归属于母公司所有者的净利润-23,684.58万元;归属于母公司所有者的扣除非经常性 损益的净利润-27,033.49万元。 百奥泰于2020年2月21日在上交所科创板上市,发行价格为32.76元/股,发行股份数量为6000万股,保 荐机构为中国国际金融股份有限公司,保荐代表人为谢显明、赵泽宇,广发证券股份有限公司、摩根士 丹利华鑫证券有限责任公司为联席主承销商。 中国经济网北京7月30日讯百奥泰(688177.SH)昨日晚间披露2025年半年度业绩预告的自愿性披露公告。 百奥泰首次公开发行股票募集资金总额为19. ...
百奥泰生物制药股份有限公司2025年半年度业绩预告的自愿性披露公告
Shang Hai Zheng Quan Bao· 2025-07-29 17:36
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]
晚间公告丨7月29日这些公告有看头
第一财经· 2025-07-29 13:57
Key Points - The article summarizes important announcements from various listed companies in the Shanghai and Shenzhen stock markets, providing insights for investors [2] Major Events - Xizang Tianlu experienced significant abnormal fluctuations in the trading of its convertible bonds, with a cumulative price increase exceeding 100% over seven trading days, leading to a closing price of 481.80 CNY per bond, representing a premium of 381.80% over the face value [3][4] - Huqin Technology plans to acquire 6% of Jinghe Integrated's shares for 2.393 billion CNY, with a transfer price of 19.88 CNY per share [4][5] - Liyuan Technology's actual controller received a criminal judgment for violating information disclosure regulations, resulting in a one-year prison sentence with a one-and-a-half-year probation and a fine of 3.3 million CNY [6] - Huashi Technology's general manager had the detention measures lifted, allowing him to resume his duties [7] - Dongfang Materials' chairman resigned for personal reasons but will continue as a board member [8] - WuXi AppTec adjusted its share repurchase price limit to a maximum of 114.15 CNY per share [9] - ST Haihua's subsidiary plans to acquire 100% of Lixin Dingsheng for 43 million CNY [10] - Xizang Tourism clarified that it has not engaged in business cooperation related to the Yarlung Tsangpo River project amid stock price volatility [11][12] - Yabont Chemical decided to terminate its planned external investment in Gansu Haotian Technology [13] - Zhongbei Communication's subsidiary terminated its acquisition of a 55% stake in PT. Semesta Energi Services due to unmet conditions [14] - Quzhou Development plans to purchase shares of Xiandai Electronics and raise matching funds, leading to a temporary stock suspension [15] - Shenli Co. terminated its control change plan due to the buyer's failure to pay the agreed transaction price [16] Performance Reports - Greenland Holdings reported a 16.93% year-on-year increase in contract sales amounting to 21.752 billion CNY in Q2 2025 [17][18] - Lujiazui's net profit for the first half of 2025 was 815 million CNY, a decrease of 7.87% year-on-year [19] - Hongfa Co. achieved a net profit of 964 million CNY in the first half of 2025, reflecting a 14.19% increase [20] - Nanya New Materials expects a net profit increase of 44.69% to 71.82% in the first half of 2025 [21] - ST Tianwei anticipates a significant net profit increase of approximately 2064.85% year-on-year [22] - Fudan Microelectronics expects a net profit decrease of 39.67% to 48.29% in the first half of 2025 [23][24] - Sains expects a net profit decrease of 57.53% to 60.13% despite revenue growth [25] - Baotai anticipates a net loss reduction of 110 million to 140 million CNY in the first half of 2025 [26] Major Contracts - China CNR signed several major contracts totaling approximately 32.92 billion CNY [27] - Wantong Intelligent Control entered into an exclusive authorization agreement in the embodied intelligence field [28] - Anhui Construction won a bid for a highway concession project with an estimated total investment of 3.614 billion CNY [29] - Tiantian Technology's subsidiary signed a procurement order worth 400 million CNY for copper-lithium composite strips [30] - Daoshi Technology signed a strategic cooperation agreement related to humanoid robots [31] Shareholding Changes - Suzhou Planning's shareholders plan to reduce their holdings by up to 4.5% [32] - Jiahe Meikang's shareholder plans to reduce holdings by up to 3% [33] - Huaye Fragrance's controlling shareholder plans to reduce holdings by up to 3% [34] - Lanfeng Biochemical's shareholder plans to reduce holdings by up to 2.61% [35] - Anji Food's actual controller plans to reduce holdings by up to 2% [37] - Saiwei Electronics' National Integrated Circuit Fund reduced its holdings by 1.06% [38] - Lakala's Lenovo Holdings reduced its holdings by 535,960 shares [39] Share Buybacks - Shima Power plans to repurchase shares worth 300 million to 400 million CNY [40]
百奥泰上半年业绩显著改善 预计减亏超亿元
Zheng Quan Ri Bao· 2025-07-29 13:40
Core Insights - The company, Baiotai Biopharmaceutical Co., Ltd., reported a significant reduction in losses for the first half of 2025, with expected net losses between 1.1 billion to 1.4 billion yuan, a decrease of 970 million to 1.27 billion yuan compared to the same period last year [2] - The sales of the company's first approved biosimilar, Adalimumab Injection (brand name: Geleli®), have contributed to an increase in operating revenue by 20 million to 50 million yuan year-on-year, showcasing the effectiveness of the company's commercialization team [2] - Research and development expenses decreased by 40 million to 70 million yuan during the reporting period, indicating improved cost structure and efficiency [2] Financial Performance - The expected net profit for the first half of 2025 is projected to be between -1.1 billion to -1.4 billion yuan, reflecting a significant narrowing of losses compared to the previous year [2] - The increase in operating revenue is attributed to the successful commercialization of core products, particularly the sales growth of the Adalimumab Injection [2] R&D and Market Strategy - The company has achieved a milestone with the FDA approval of BAT2206, which is crucial for its international strategy [2] - BAT2306 and BAT2506 are currently in the application stage for market approval, indicating a robust pipeline for future growth [2] - The dual focus on biosimilars and innovative drugs is expected to provide strong momentum for the company's long-term development [2]
百奥泰上半年净利预亏1.1亿元至1.4亿元,同比减亏
Bei Jing Shang Bao· 2025-07-29 13:28
Core Viewpoint - Baiotai (688177) is expected to reduce its losses in the first half of 2025, with a projected net profit attributable to shareholders ranging from -110 million to -140 million yuan, indicating a decrease in losses by 96.8458 million to 127 million yuan compared to the previous year [1] Financial Performance - The company anticipates a reduction in losses for the reporting period compared to the same period last year [1] - Revenue from the sales of Adalimumab injection (Geleli) is expected to increase by 20 million to 50 million yuan year-on-year [1] Research and Development - R&D expenses are projected to decrease by 40 million to 70 million yuan compared to the previous year [1] - The reduction in R&D costs is attributed to the completion of several global Phase III clinical trials, with projects BAT2206, BAT2306, and BAT2506 currently in the application stage for market approval [1] - BAT2206 has already received approval from the US FDA for market launch [1]
百奥泰上半年预亏1.1至1.4亿元 股东近期拟减持
Jing Ji Guan Cha Wang· 2025-07-29 10:57
Core Viewpoint - The company Baotai (688177.SH) is expected to report a loss of 110 million to 140 million yuan for the first half of 2025, despite a reduction in losses compared to the previous year, driven by increased sales and reduced R&D expenses [1][2]. Group 1: Financial Performance - The company anticipates a loss of 110 million to 140 million yuan for the first half of 2025 [1]. - The company expects to achieve a reduction in losses compared to the same period last year, primarily due to increased sales of its product, Adalimumab injection (Ge Le Li) [2]. - R&D expenses are projected to decrease by 40 million to 70 million yuan compared to the previous year, as several projects have completed global Phase III clinical trials [2]. Group 2: Product Development and Approvals - As of the end of 2024, the company has received NMPA approval for four products and FDA/EMA approval for two products [1]. - The company has submitted market applications for three products (BAT2206, BAT2306, BAT2506) to NMPA, FDA, and EMA, with BAT2206 already receiving FDA approval [1][2]. Group 3: Management Changes and Shareholder Actions - The company has experienced executive resignations, including non-independent director Liu Cuihua and independent director Wang Jianping, both citing personal reasons [3]. - Shareholder Xinyu Qiheng plans to reduce its stake by up to 8.2816 million shares, representing no more than 2% of the total share capital [3]. Group 4: Market Strategy and Regulatory Environment - The company is focusing on expanding its presence in overseas markets as a key part of its growth strategy [3]. - Recent U.S. policy changes regarding drug pricing are not expected to significantly impact the company, as favorable policies for biosimilars have been introduced [4].