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维拉西塔单抗注射液(BAT5906)
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百奥泰维拉西塔单抗注射液上市许可申请获得受理
Bei Jing Shang Bao· 2025-12-18 12:11
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]
12月18日晚间公告 | 四川路桥获中邮保险举牌;维信诺拟39.18亿元对合肥国显进行二期出资
Xuan Gu Bao· 2025-12-18 12:07
Group 1: Suspension of Trading - Zhongwei Company is planning to acquire the controlling stake of Hangzhou Zhonggui Electronic Technology through a share issuance and raise matching funds, resulting in a stock suspension [1] - Nandu Power's controlling shareholder has terminated the plan for a change in control, leading to the resumption of trading [1] Group 2: Shareholding and Buybacks - Sichuan Road and Bridge has been targeted by Zhongyou Insurance, increasing its shareholding to 5% [2] - Xizang Pharmaceutical plans to repurchase shares worth between 170 million to 200 million yuan, with a maximum repurchase price of 55 yuan per share [3] Group 3: Investments and Operations - Visionox intends to sign the "Investment Cooperation Agreement II" to advance the Hefei 8.6-generation AMOLED production line project, with a second-phase capital of 9.443 billion yuan [4] - Jiangnan New Materials plans to invest approximately 300 million yuan in the development and industrialization of high-end copper-based core materials in the Yingtan High-tech Industrial Development Zone [4] - Haitian Flavoring and Food will maintain a cash dividend ratio of no less than 80% annually for the next three years (2025-2027) [5] - Tianfeng Securities has signed a supplementary agreement to extend the maturity of its original 4 billion yuan subordinated debt by one year with its controlling shareholder Hongtai Group [5] - Qibin Group's subsidiary plans to establish a new energy company in Shenzhen with an investment of 600 million yuan [6] - Jiangsu Guoxin's subsidiary plans to increase capital by 1.8 billion yuan to advance its Phase III 2×100 MW expansion project [7] - Fosun Pharma's subsidiary has signed a "Cooperation and Option Agreement" with ClavisBio, potentially receiving up to 363 million USD in payments [7] - Baotai's application for marketing authorization of the injection of Vilasitamab (BAT5906) has been accepted [8] - Zhengye Technology has signed sales contracts for X-ray equipment totaling 120 million yuan [9] - Jinqilin's CRH380D train brake pads have passed small-scale trials [10]
百奥泰维拉西塔单抗注射液上市许可申请获受理
Bei Jing Shang Bao· 2025-12-18 10:35
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]
百奥泰:公司在研药品维拉西塔单抗注射液(BAT5906)上市许可申请获受理
Xin Lang Cai Jing· 2025-12-18 09:25
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]
百奥泰(688177.SH):维拉西塔单抗注射液(BAT5906)上市许可申请获得受理
Ge Long Hui A P P· 2025-12-18 09:25
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]
百奥泰:BAT5906上市许可申请获得受理
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]
百奥泰:维拉西塔单抗注射液(BAT5906)上市许可申请获得受理
Ge Long Hui· 2025-12-18 09:22
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]