Workflow
SNSW(688117)
icon
Search documents
圣诺生物:关于自愿披露维培那肽原料药获得上市申请批准通知书的公告
Zheng Quan Ri Bao· 2025-11-19 09:45
Core Viewpoint - The announcement from Shengnuo Biopharmaceuticals indicates that its wholly-owned subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of the raw material drug, Weipena peptide [2] Group 1 - Shengnuo Biopharmaceuticals has a wholly-owned subsidiary named Chengdu Shengnuo Biopharmaceutical Co., Ltd. [2] - The company has received a marketing approval notification for Weipena peptide raw material from the National Medical Products Administration [2]
圣诺生物维培那肽原料药上市申请获批
Bei Jing Shang Bao· 2025-11-19 09:20
Core Viewpoint - Shengnuo Biopharmaceutical has received approval from the National Medical Products Administration for the production of its active pharmaceutical ingredient, Vepagliflozin, which is aimed at treating type 2 diabetes and obesity [1] Company Summary - Shengnuo Biopharmaceutical's wholly-owned subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd., has been granted a production approval notice for Vepagliflozin [1] - Vepagliflozin is a PEGylated form of Exenatide that activates GLP-1 receptors in the body, mimicking the physiological effects of natural human GLP-1 [1] Industry Summary - Vepagliflozin functions as a GLP-1 receptor agonist, enhancing insulin secretion in a glucose-dependent manner to lower blood sugar levels [1] - The drug is positioned to address the growing prevalence of type 2 diabetes and obesity, which are significant health concerns globally [1]
圣诺生物(688117.SH):维培那肽原料药获得上市申请批准通知书
Ge Long Hui A P P· 2025-11-19 08:17
Core Viewpoint - The approval of the raw material drug Visepegenatide by the National Medical Products Administration represents a significant milestone for the company, showcasing its comprehensive strengths in research, production, and quality management [1] Group 1: Product Approval - The company’s wholly-owned subsidiary, Chengdu Saintno Biological Pharmaceutical Co., Ltd., has received the approval notice for the listing application of Visepegenatide raw material drug [1] - The registration number for the approval is Y20230000631, and the chemical raw material drug registration standard number is YBY71372025 [1] Group 2: Product Description - Visepegenatide is a polyethylene glycol (PEG) modified exenatide that acts as a GLP-1 receptor agonist, mimicking the physiological effects of natural human GLP-1 [1] - It lowers blood sugar levels by enhancing insulin secretion in a glucose-dependent manner, making it suitable for the treatment of type 2 diabetes and obesity [1] Group 3: Implications for the Company - The approval of Visepegenatide is a testament to the company's capabilities in research and development, production, and quality management systems [1] - This achievement is expected to accumulate valuable experience for the company’s future drug research and has a positive impact on its operational development [1]
圣诺生物(688117) - 关于自愿披露维培那肽原料药获得上市申请批准通知书的公告
2025-11-19 08:15
证券代码:688117 证券简称:圣诺生物 公告编号:2025-033 包装规格:25g/瓶 申请事项:境内生产化学原料药上市申请 成都圣诺生物科技股份有限公司 关于自愿披露维培那肽原料药获得上市申请 批准通知书的公告 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。 成都圣诺生物科技股份有限公司(以下简称"公司")全资子公司成都圣诺 生物制药有限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") 签发的关于维培那肽原料药的《化学原料药上市申请批准通知书》,现将相关情 况公告如下: 一、药品基本情况 登记号:Y20230000631 化学原料药名称:Visepegenatide/维培那肽 化学原料药注册标准编号:YBY71372025 特此公告。 成都圣诺生物科技股份有限公司 董事会 生产企业:成都圣诺生物制药有限公司 审批结论:根据《中华人民共和国药品管理法及有关规定》,经审查,本品 符合药品注册的有关要求,批准本品注册生产。生产工艺、质量标准和包装标签 照所附执行。 二、药品的其他情况 维培那肽,是一种聚乙二醇( ...
圣诺生物:子公司维培那肽原料药上市申请获批
Core Viewpoint - The company, Shengnuo Biopharmaceutical (688117), has received approval from the National Medical Products Administration for the marketing application of its active pharmaceutical ingredient, Vepagliflozin, which is a PEGylated form of Exenatide, aimed at treating type 2 diabetes and obesity [1] Group 1 - Shengnuo Biopharmaceutical's subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd., has recently received a marketing approval notification for Vepagliflozin [1] - Vepagliflozin acts as a GLP-1 receptor agonist, mimicking the physiological effects of natural GLP-1 by enhancing insulin secretion in a glucose-dependent manner [1] - The drug is intended for the treatment of type 2 diabetes and obesity, indicating its potential market relevance in addressing these health issues [1]
圣诺生物:维培那肽原料药获得上市申请批准
Zhi Tong Cai Jing· 2025-11-19 08:11
Core Viewpoint - Shengnuo Biopharmaceutical (688117.SH) announced that its wholly-owned subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd., has received the approval notice for the marketing application of the active pharmaceutical ingredient, Vepagliflozin, from the National Medical Products Administration (NMPA) [1] Group 1 - The approved drug, Vepagliflozin, is a polyethylene glycol (PEG) modified version of Exenatide, which acts as a GLP-1 receptor agonist [1] - Vepagliflozin mimics the physiological effects of natural human GLP-1 by enhancing insulin secretion in a glucose-dependent manner, thereby lowering blood sugar levels [1] - The drug is intended for the treatment of type 2 diabetes and obesity [1]
圣诺生物(688117.SH):维培那肽原料药获得上市申请批准
智通财经网· 2025-11-19 08:11
Core Viewpoint - The company, Shengnuo Biopharmaceutical (688117.SH), has received approval from the National Medical Products Administration for the marketing application of its active pharmaceutical ingredient, Vepagliflozin [1] Group 1: Company Developments - Shengnuo Biopharmaceutical's wholly-owned subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd., has recently obtained the approval notice for Vepagliflozin from the National Medical Products Administration [1] - Vepagliflozin is a polyethylene glycol (PEG) modified version of Exenatide, which acts as a GLP-1 receptor agonist, mimicking the physiological effects of natural human GLP-1 [1] Group 2: Product Information - The drug enhances insulin secretion in a glucose-dependent manner, thereby lowering blood sugar levels, and is intended for the treatment of type 2 diabetes and obesity [1]
圣诺生物:维培那肽原料药获上市批准
Xin Lang Cai Jing· 2025-11-19 08:08
Core Viewpoint - The approval of the raw material drug Weipinatin by the National Medical Products Administration represents a significant achievement for the company, showcasing its comprehensive strengths in research, production, and quality management systems [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd., has received the approval notice for the marketing application of Weipinatin raw material drug [1] - Weipinatin is a polyethylene glycol-conjugated exenatide that acts as a GLP-1 receptor agonist, mimicking the physiological effects of natural human GLP-1 [1] Group 2: Therapeutic Use - The drug is designed to enhance insulin secretion in a glucose-dependent manner, thereby lowering blood sugar levels, which is beneficial for the treatment of type 2 diabetes and obesity [1] Group 3: Strategic Implications - The approval is expected to accumulate valuable experience for the company's future drug research and development, positively impacting its operational growth [1]
避开药明,这些CDMO靠多肽突围
3 6 Ke· 2025-11-17 03:34
Core Insights - The CDMO industry is experiencing a competitive landscape characterized by "head concentration, niche breakthroughs, and increasing differentiation" with leading companies like WuXi AppTec dominating the market share [1] - The growth of the peptide CDMO sector is significantly driven by the expansion of GLP-1 drugs, which has led to substantial revenue increases for several companies [4][14] - The competition is shifting from cost advantages to technological depth, with companies focusing on specialized areas like peptide CDMO to carve out their niches [1][6] Industry Overview - WuXi AppTec services 8 out of 40 small molecule drugs approved by the FDA from 2024 to the first half of 2025, indicating its irreplaceable value in the global market [1] - Other CDMO companies, such as Kelaiying and Saintno Bio, are focusing on peptide CDMO and achieving above-average growth rates, forming a "high-growth camp" within the industry [1][4] - The CXO sector saw a 12% revenue growth year-on-year in Q1 to Q3 of 2025, with net profit increasing by 58%, highlighting a positive growth trend across the industry [2] Company Performance - Kelaiying reported a total revenue of 4.63 billion yuan in the first three quarters of 2025, with peptide and oligonucleotide segments growing by 72% year-on-year, and peptide revenue increasing by over 150% [4] - Saintno Bio's revenue grew by 54% year-on-year, with net profit increasing by 123%, primarily driven by its peptide business [4] - Notably, the combined sales of GLP-1 drugs from Novo Nordisk and Eli Lilly reached approximately $50.2 billion in the first three quarters of 2025, underscoring the market's potential [4] Technological Advancements - The shift from scale advantages to technological premiums is evident, as companies must innovate to meet the complex demands of new therapies [6] - Kelaiying is leveraging its expertise in small molecule CDMO to expand into peptide and other large molecule areas, enhancing its production capabilities [8] - Companies like Nuotai Bio and Saintno Bio are developing specialized technologies for peptide synthesis, which allows them to maintain competitive advantages in the market [10][11] Market Dynamics - The entry of numerous pharmaceutical companies into the GLP-1 market has rapidly expanded the global peptide market, benefiting the peptide CDMO sector [5] - The competition is expected to evolve as the market transitions from a shortage to an oversupply, necessitating a focus on technological innovation and ecosystem building [16] - Future growth in the peptide sector may be driven by innovations in multi-target peptide drugs and the application of AI in drug design [14][15]
分红早知道|最近24小时内,圣诺生物、江苏国泰、大北农、戎美股份、凯盛新材、桂林三金、隆华新材、明泰铝业等8家A股上市公司发布分红派息实施公告!
Mei Ri Jing Ji Xin Wen· 2025-11-11 02:14
分组1 - Shengnuo Biotech announced a cash dividend of RMB 0.03176 per share, with the record date on November 14, 2025, and the ex-dividend date on November 17, 2025 [1] - Jiangsu Guotai declared a cash dividend of RMB 1.70 per 10 shares (including tax), with the record date on November 17, 2025, and the ex-dividend date on November 18, 2025 [1] - Dabeinong issued a cash dividend of RMB 0.30 per 10 shares (including tax), with the record date on November 17, 2025, and the ex-dividend date on November 18, 2025 [1] 分组2 - Rongmei Co. announced a cash dividend of RMB 1.32 per 10 shares (including tax), with the record date on November 17, 2025, and the ex-dividend date on November 18, 2025 [2] - Kaisheng New Materials declared a cash dividend of RMB 0.50 per 10 shares (including tax), with the record date on November 17, 2025, and the ex-dividend date on November 18, 2025 [2] - Guilin Sanjin issued a cash dividend of RMB 2.00 per 10 shares (including tax), with the record date on November 18, 2025, and the ex-dividend date on November 19, 2025 [2] 分组3 - Longhua New Materials announced a cash dividend of RMB 0.70 per 10 shares (including tax), with the record date on November 18, 2025, and the ex-dividend date on November 19, 2025 [3] - Mingtai Aluminum declared a cash dividend of RMB 0.10 per share (including tax), with the record date on November 18, 2025, and the ex-dividend date on November 19, 2025 [3]