Core Viewpoint - The company Baiotai (688177) has received the acceptance notice from the National Medical Products Administration for its investigational drug BAT5906, a recombinant humanized monoclonal antibody [1] Group 1: Drug Information - BAT5906 is an 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 of angiogenesis show that BAT5906 can block the binding of VEGF to its corresponding receptors, suppressing endothelial cell proliferation and new blood vessel formation [1]

Core Viewpoint - The company Baiotai has received approval from the National Medical Products Administration for the marketing authorization application of its investigational drug, BAT5906, which is indicated for neovascular (wet) age-related macular degeneration (nAMD) [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 to inhibit neovascularization [1]

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 ...

Core Viewpoint - The company Baiotai has received the acceptance notice from the National Medical Products Administration for the marketing authorization application of its investigational drug, Vela-sitran monoclonal antibody injection [1] Group 1: Product Information - Vela-sitran is classified as a Class 1 biological product for the treatment of neovascular (wet) age-related macular degeneration (nAMD) [1] - BAT5906 is an innovative drug developed and produced by Baiotai, characterized as a recombinant humanized monoclonal antibody [1] - The drug is an IgG1 type full-length antibody with a molecular weight of 149 kDa, specifically binding to human VEGF-A165 to inhibit neovascularization [1]

Core Viewpoint - The company Baiotai (688177.SH) has received a notice of acceptance from the National Medical Products Administration for its investigational drug, BAT5906, which is a monoclonal antibody injection aimed at treating diseases related to abnormal blood vessel growth [1] Group 1: Drug Information - BAT5906 is a recombinant humanized monoclonal antibody classified as a Class 1 therapeutic biological product [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 receptors, suppressing endothelial cell proliferation and new blood vessel formation [1] Group 2: Pharmacokinetics and Safety - In animal studies, BAT5906 demonstrated a longer half-life in the vitreous of monkeys 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 cellular cytotoxicity (ADCC), suggesting a lower incidence of systemic adverse reactions and potentially safer clinical applications [1] Group 3: Regulatory Status and Impact - Upon approval, BAT5906 will receive a drug approval certificate and can be produced and marketed [1] - The timeline for the review and approval process is uncertain, indicating that the acceptance notice will not have an immediate impact on the company's recent performance [1]

Core Viewpoint - The company Baiotai (688177) has received the acceptance notice from the National Medical Products Administration for its investigational drug BAT5906, which is aimed at treating neovascular (wet) age-related macular degeneration (nAMD) [1] Group 1 - The drug BAT5906 is an injectable monoclonal antibody [1] - The application for BAT5906's market approval has been officially accepted [1] - The targeted indication for BAT5906 is neovascular (wet) age-related macular degeneration (nAMD) [1]

Core Viewpoint - The company Baiotai (688177.SH) has received a notice of acceptance from the National Medical Products Administration for its investigational drug, BAT5906, which is a monoclonal antibody injection aimed at treating diseases related to abnormal blood vessel growth [1] Group 1: Drug Information - BAT5906 is a recombinant humanized monoclonal antibody, classified as a Class 1 therapeutic biological product [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 receptors, suppressing endothelial cell proliferation and new blood vessel formation [1] Group 2: Safety and Efficacy - In animal studies, BAT5906 demonstrated a longer half-life in the vitreous of monkeys compared to the Fab fragment structure of Ranibizumab, potentially allowing for longer injection intervals in clinical use [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] Group 3: Regulatory Status - Upon approval, BAT5906 will receive a drug approval certificate and can be produced and marketed [1] - The timeline for the review and approval process is uncertain, indicating that the acceptance notice will not impact the company's short-term performance [1]

Core Insights - The article highlights the strategic positioning of Baotai in the competitive landscape of the biopharmaceutical industry in Guangzhou, particularly in the Huangpu District, where it is surrounded by major players like Kangfang Biotech and BeiGene [1] Group 1: Company Development - Baotai has maintained a steady pace of launching 1-2 products annually since its IPO in 2020, with five products currently on the market, including three biosimilars that have entered the medical insurance system [2] - The company has established a strong market position in the biosimilar sector, with its core products being the first domestic biosimilars in their respective categories [2] - Baotai's strategy is twofold: short-term reliance on biosimilars for cash flow and survival, while long-term focus on innovative drugs to build core competitiveness [2] Group 2: Innovation and Challenges - Baotai is developing BAT8006, a promising drug for platinum-resistant ovarian cancer, which is currently in Phase III clinical trials and is among the leading candidates in domestic research [3] - The company reported a revenue of 684 million yuan for the first three quarters of the year, a year-on-year increase of 17.57%, while its net profit loss narrowed by 38.72% [4] - Despite the progress, Baotai faces challenges in market competition for biosimilars and difficulties in the hospital entry of innovative drugs due to their non-inclusion in medical insurance [4] Group 3: Policy Support and Market Access - The Guangzhou Municipal Health Commission has introduced measures to facilitate the entry of innovative drugs into hospitals, requiring medical institutions to discuss the inclusion of these drugs within one month of the product directory release [5] - Baotai's products have been included in the first batch of innovative drug lists in Huangpu District, which offers financial incentives for medical institutions to procure these products [7] - The introduction of the "Puhui Kang" insurance product aims to enhance access to local innovative drugs, with a reimbursement rate of up to 60% for residents [7][8] Group 4: Talent and Infrastructure - The competition in the biopharmaceutical industry is fundamentally a competition for talent, necessitating a supportive ecosystem for research and living conditions [6] - Transportation issues and housing shortages on the International Bio Island pose challenges for attracting and retaining talent [6] - The development of a comprehensive industrial and living ecosystem is crucial for fostering a sense of belonging among employees and ensuring long-term commitment [6]

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。 ...