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。 北京商报讯（记者 丁宁）12月18日晚间，百奥泰（688177）发布公告称，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维拉西塔单抗注射液（以下简称"BAT5906"）药品上市许可申请 的《受理通知书》。 ...

北京商报讯(记者王寅浩宋雨盈)12月18日，百奥泰发布公告称，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维拉西塔单抗注射液(BAT5906)药品上市许可申请的《受理通知书》，适应 症为新生血管性(湿性)年龄相关性黄斑变性(nAMD)。 根据公告，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。 ...

证券代码： 688177 证券简称： 百奥泰 公告编号：2025-070 百奥泰生物制药股份有限公司 关于维拉西塔单抗注射液（BAT5906） 上市许可申请获得受理的公告 受理号：CXSS2500142 适应症：新生血管性（湿性）年龄相关性黄斑变性（nAMD） 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"或"中国 NMPA"）核准签发 的关于公司在研药品维拉西塔单抗注射液（以下简称"BAT5906"）药品上市 许可申请的《受理通知书》。 BAT5906 经审评审批通过后可获发药品批准证书并可投入生产、销售， 因为审评审批的办结时间无法预估，所以本次获得药品上市许可申请受理通 知书对公司近期业绩不会产生影响。 一、 《受理通知书》基本情况 药品名称：维拉西塔单抗注射液 注册分类：治疗用生物制品 1 类 剂型：注射剂 规格：16mg/0.2ml 申请事项：境内生产药品注册上市许可 结论：根据《中华人民共和国行政许 ...

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维拉西塔单抗注射液药品上市 许可申请的《受理通知书》。该药品为治疗用生物制品1类，适应症为新生血管性（湿性）年龄相关性 黄斑变性（nAMD）。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。 ...

格隆汇12月18日丨百奥泰(688177.SH)公布,公司于近日收到国家药监局核准签发的关于公司在研药品维 拉西塔单抗注射液(BAT5906)药品上市许可申请的《受理通知书》。药品名称：维拉西塔单抗注射液， 注册分类：治疗用生物制品 1 类。 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 在猴玻璃体中半衰期比结构为 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。 BAT5906 经审评审批通过后可获发药品批准证书并可投入生产、销售，因为审评审批的办结时间无法 预估，所以本次获得药品上市许可申请受理通知书对公司近期业绩不会产生影响。 ...

人民财讯12月18日电，百奥泰(688177)12月18日公告，公司于近日收到国家药监局核准签发的关于公司 在研药品维拉西塔单抗注射液（简称"BAT5906"）药品上市许可申请的《受理通知书》。申请适应症 为：新生血管性（湿性）年龄相关性黄斑变性（nAMD）。 转自：证券时报 ...

BAT5906 经审评审批通过后可获发药品批准证书并可投入生产、销售，因为审评审批的办结时间无法 预估，所以本次获得药品上市许可申请受理通知书对公司近期业绩不会产生影响。 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 在猴玻璃体中半衰期比结构为 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12月18日丨百奥泰(688177.SH)公布,公司于近日收到国家药监局核准签发的关于公司在研药品维 拉西塔单抗注射液(BAT5906)药品上市许可申请的《受理通知书》。药品名称：维拉西塔单抗注射液， 注册分类：治疗用生物制品 1 类。 ...

在广州黄埔区的国际生物岛上，一家企业的空间坐标，映射出了广州生物医药产业的未来想象空间。百 奥泰，一边紧邻市值超千亿港元的明星企业康方生物，另一边与行业巨头、市值超四千亿元的百济神州 为伍。而置身其中的百奥泰，目前市值为百亿元级别。 在巨头环伺之中，它如何定义自己的赛道?未来的想象空间又源自何处?作为一家扎根黄埔20余年的生物 医药企业，百奥泰面临着怎样的现实桎梏?广州和黄埔又提供了怎样的解决思路?其发展路径，正是观察 和把脉广州生物医药产业高质量发展的一个绝佳样本。 为支持创新药械发展，广州市工信局于2024年牵头发布了广州首批创新药械产品目录，共包含7款创新 药物，其中百奥泰占据4席。目录发布后至今，阿达木单抗(格乐立)、托珠单抗(施瑞立)已与广州市内十 余家三甲医院建立了合作。 发展 从首仿到前沿创新 自2020年上市前后，百奥泰连续保持每年上市1-2个单品的节奏。目前，公司已有5款上市产品，其中阿 达木单抗(格乐立)、贝伐珠单抗(普贝希)、托珠单抗(施瑞立)3款生物类似药已进入医保。以阿达木单抗 为例，该药于2019年上市后，将药品价格从原研药的每针7800元左右降至1000元左右，患者年用药费用 也 ...

Group 1 - Shouyao Holdings is planning to issue H-shares and list on the Hong Kong Stock Exchange, with discussions ongoing with intermediaries regarding the specifics of the listing [1] - Jiangsu Guoxin's subsidiary, Guoxin Mazhou, has completed the trial operation of a 1000MW coal-fired power unit, which is set to officially commence operations on December 12, 2025 [2] - Yuekang Pharmaceutical's mRNA tumor vaccine has received clinical trial approval from the National Medical Products Administration for treating advanced solid tumors [3] Group 2 - Dongli New Science plans to invest 666 million yuan in the restructuring of SAIC Hongyan, acquiring approximately 14.66% equity post-restructuring [4] - Longsheng Technology is set to invest approximately 350 million yuan in the establishment of an intelligent robot innovation center in Wuxi [5] - Shangwei Co. has received a government subsidy of 2.212 million yuan, which accounts for 13.53% of its audited net profit for 2024 [6] Group 3 - Anglikang has received drug registration certificates for Diclofenac Sodium Enteric-Coated Tablets and approval for a supplemental application for Sacubitril/Valsartan Sodium Tablets [7] - Guangzhou Development has received acceptance notices for the registration of 8 billion yuan in medium-term notes and 6 billion yuan in short-term financing bonds [8] - Kebo Da plans to increase capital by 21.2 million euros (approximately 174 million yuan) in its wholly-owned subsidiary in Germany [9][10] Group 4 - Changguang Huaxin has received a total of 11.6672 million yuan in government subsidies, including 8.0552 million yuan related to income [11] - Haizheng Pharmaceutical's subsidiary has received a European Pharmacopoeia suitability certificate for its raw material [12] - Qianjin Pharmaceutical's subsidiary has received a drug registration certificate for Lurasidone Hydrochloride Tablets, used for treating schizophrenia [13] Group 5 - Daimai Co. has received a warning letter from the Shanghai Securities Regulatory Bureau due to failure to timely disclose a significant event related to a fire incident [14] - ST Changyao's subsidiary has recently ceased production due to financial difficulties and competitive pressures in the photovoltaic industry [15] - Guodian Power is investing in the construction of a 2×1000MW expansion project at the Ganbi Power Plant, with a total dynamic investment of 7.218 billion yuan [16] Group 6 - Kaichuang International's subsidiary has completed the handover of a tuna purse seine vessel, expected to be operational by 2026 [16] - Tieke Rail plans to sign an energy management agreement for a distributed photovoltaic project, which is expected to save approximately 1.441 million yuan in electricity costs over 25 years [18] - Bailian Co. plans to sign a land compensation agreement with Friendship Logistics, with a total compensation of 103 million yuan [19] Group 7 - Dayu Water-saving's subsidiary has been pre-awarded two high-standard farmland construction projects, with total expected amounts of 137 million yuan and 135 million yuan respectively [20] - Tianma Technology reported a total eel output of approximately 1197.15 tons in November, with sales prices ranging from 53,000 yuan/ton to 89,000 yuan/ton [21] - Guorui Technology's subsidiary has been shortlisted for the GXLF project with a bid of 76 million yuan [22] Group 8 - Qingdao Food's deputy general manager has resigned for personal reasons [23] - Guosheng Zhike plans to use up to 900 million yuan of idle funds for cash management [24] - Guodian Nanrui plans to use up to 23 billion yuan of idle funds for entrusted wealth management [25] Group 9 - Jiahuan Energy plans to merge its wholly-owned subsidiary, Zhejiang Jiahuan Hydrogen Peroxide Co., Ltd., through an overall absorption merger [26] - Ganyue Expressway reported vehicle toll service revenue of 309 million yuan for November [27] - Jinling Hotel's chairman has resigned due to work changes [28] Group 10 - Lisheng Pharmaceutical's subsidiary has received drug registration certificates for Apremilast Tablets [29] - Baotai has received a positive opinion from the European Medicines Agency for Gotenfia® for various inflammatory conditions [30] - ST Zhisheng has been awarded a smart city governance project with a bid amount of 104 million yuan [31] Group 11 - Chenxi Aviation and its related personnel have received administrative regulatory measures from the Shaanxi Securities Regulatory Bureau due to financial reporting issues [32] - Portong Medical has appointed Xia Canglan as the new deputy general manager [33] - Maide Medical plans to repurchase shares with a total amount between 20 million and 40 million yuan [34] Group 12 - Jimin Health plans to establish a joint venture with a total investment of 600 million yuan, focusing on AI and software development [35] - Beilu Pharmaceutical has received a drug registration certificate for Pioglitazone Metformin Tablets [36] - Hainan Mining plans to entrust the overall management of the Shiluo Iron Mine to a construction company for three years, with a total contract amount of approximately 818 million yuan [38] Group 13 - Huiyu Pharmaceutical has received a drug registration certificate for Nicardipine Hydrochloride Injection [39] - Baoland has received a government subsidy of 10 million yuan related to income [40] - Qingdao Port has terminated the acquisition of 100% equity in an oil company and 50% equity in Rizhao Shihua due to regulatory concerns [41]

来源：智通财经网 百奥泰(688177.SH)发布公告，公司于近日收到了欧洲药品管理局(以下简称"EMA")的通知， Gotenfia®(BAT2506，戈利木单抗注射液)获得EMA人用药品委员会(以下简称"CHMP")积极意见。 CHMP建议欧盟委员会(EC)批准Gotenfia®上市，用于治疗类风湿关节炎，幼年特发性关节炎，银屑病 关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 BAT2506是百奥泰根据中国国家药品监督管理局(以下简称"NMPA")、美国食品药品监督管理局(以下简 称"FDA")、EMA生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的 抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而 抑制TNF-α的活性。 BAT2506(戈利木单抗注射液)的原研药为美国强生公司的Simponi® (欣普尼®)。根据强生公司2024年年 度报告，Simponi®2024年在全球的销售额为21.90亿美元。 ...