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太极集团:子公司获司美格鲁肽注射液药物临床试验批准
Cai Jing Wang· 2025-09-10 15:51
Core Viewpoint - Taiji Group's subsidiary has received clinical trial approval for Semaglutide injection, a GLP-1 receptor agonist for type 2 diabetes management and weight control [1][2]. Group 1: Company Developments - Taiji Group's subsidiary, Chongqing Fuling Pharmaceutical Factory, has obtained the clinical trial approval notice from the National Medical Products Administration for Semaglutide injection [1]. - The approved indication for the clinical trial is for blood sugar control in adult patients with type 2 diabetes who have inadequate control despite treatment with metformin and/or sulfonylureas [1]. - The company has invested approximately RMB 44.1834 million in the research and development of this project [2]. Group 2: Industry Context - Semaglutide is a long-acting GLP-1 receptor agonist that stimulates insulin production, suppresses glucagon secretion, and reduces appetite, playing a significant role in treating type 2 diabetes and aiding weight management [1]. - The original product of Semaglutide injection was developed by Novo Nordisk, which reported total revenue of USD 29.296 billion for the product in 2024 [2]. - Currently, Novo Nordisk is the only company with the Semaglutide injection product approved for market in China [1].
太平洋医药日报(20250909):BMS在研双抗PUMITAMIG二期临床成功 用于治疗ES-SCLC
Xin Lang Cai Jing· 2025-09-10 10:33
Market Performance - The pharmaceutical sector experienced a decline of -1.91% on September 9, 2025, underperforming the CSI 300 index by 1.21 percentage points, ranking 28th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, pharmaceutical distribution (-0.52%), blood products (-0.62%), and in vitro diagnostics (-0.73%) performed relatively better, while medical R&D outsourcing (-3.63%), medical devices (-2.47%), and medical consumables (-2.06%) lagged behind [1] - Top three gainers included Rongchang Bio (+11.92%), Hehua Co. (+10.07%), and Zhend Medical (+10.00%), while the largest decliners were Yifang Bio (-11.74%), Huahai Pharmaceutical (-10.00%), and Chenxin Pharmaceutical (-8.42%) [1] Industry News - BMS announced positive results from the Phase II clinical trial of Pumitamig, a bispecific antibody developed in collaboration with BioNTech for the treatment of extensive-stage small cell lung cancer (ES-SCLC), showing a confirmed objective response rate (cORR) of 76.3% and a disease control rate (DCR) of 100% [2] - Pumitamig targets PD-L1 and VEGF-A, designed to restore the function of effector T cells in the tumor microenvironment while locally neutralizing the effects of VEGF-A [2] Company News - Heng Rui Medicine (600276) announced that its subsidiary Chengdu Shengdi Pharmaceutical received approval from the National Medical Products Administration for its product, Eicosapentaenoic Acid Ethyl Ester Soft Capsules, to lower triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) [3] - Taiji Group (600129) reported that its subsidiary Fuling Pharmaceutical Factory received a clinical trial approval notice for Semaglutide injection for the treatment of type 2 diabetes [3] - Huahai Pharmaceutical (600521) disclosed that its subsidiary Huahai Jiancheng underwent a pre-approval inspection by the FDA from July 14 to 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin, which met the CGMP requirements [3] - Dongfang Bio (688298) announced that its subsidiary Laihe Bio obtained a Class III medical device registration certificate for its influenza virus antigen detection kit (colloidal gold method), enhancing the company's product portfolio in the respiratory joint detection field [3]
太极集团:全资子公司收到药物临床试验批准通知书
Zheng Quan Ri Bao Wang· 2025-09-09 13:45
Core Viewpoint - Taiji Group's wholly-owned subsidiary has received approval for clinical trials of Semaglutide injection from the National Medical Products Administration [1] Group 1 - Taiji Group announced on the evening of September 9 that its subsidiary, Taiji Group Chongqing Fuling Pharmaceutical Factory Co., Ltd., has received the "Drug Clinical Trial Approval Notice" for Semaglutide injection [1]
9月9日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-09 10:10
Group 1 - Matrix Co., Ltd. announced that its wholly-owned subsidiary, Anke Technology, introduced a strategic investor, Shenzhen Jifu New Industry Venture Capital Fund, which invested 5 million yuan for a 10% stake [1] - Heng Rui Medicine received approval from the National Medical Products Administration for its Eicosapentaenoic Acid Ethyl Ester Soft Capsule, aimed at reducing triglyceride levels in patients with severe hypertriglyceridemia [1] - Mo Gao Co., Ltd. announced the resignation of its Vice President Jin Baoshan due to job transfer [1] Group 2 - Yao Wang Technology decided to terminate two fundraising projects and will permanently supplement the remaining funds into working capital [2] - Minhe Livestock reported sales of 25.53 million chicklings in August, generating revenue of 86.41 million yuan, with year-on-year growth of 27.60% [2] - Sichuan Jinding announced the resignation of its Director and General Manager Xiong Jifeng due to personal reasons [3] Group 3 - Taiji Group received approval for clinical trials of its Semaglutide Injection, aimed at blood sugar control in type 2 diabetes patients [5] - Jieput announced plans to increase capital in its affiliate, Suidong Intelligent Technology, with an investment of 5 million yuan for a 5% stake [7] - GeLing Deep Vision's controlling shareholders committed not to reduce their shareholdings for six months starting from September 17, 2025 [8] Group 4 - Huafeng Superfiber reported the resignation of its Vice President Liu Cong due to personal reasons [9] - Xiaoming Co., Ltd. reported sales revenue of 79.90 million yuan from chicken products in August, with year-on-year growth of 11.73% [11] - Lion Head Co., Ltd. announced that its application for issuing shares and cash to acquire assets has been accepted by the Shanghai Stock Exchange [12] Group 5 - Jinlong Automobile reported a bus sales volume of 4,074 units in August, a year-on-year increase of 23.6% [43] - Metro Design signed a contract for the Ho Chi Minh City urban rail transit project in Vietnam, with a total amount of 1.754 trillion VND [45] - North New Road and Bridge announced winning a mining construction project worth 504 million yuan [28]
太极集团子公司司美格鲁肽注射液获临床试验批件
Bei Ke Cai Jing· 2025-09-09 09:16
Core Viewpoint - Taiji Group's subsidiary Fuling Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of Semaglutide injection for type 2 diabetes [1] Group 1: Company Developments - Fuling Pharmaceutical, a wholly-owned subsidiary of Taiji Group, has been granted a Clinical Trial Approval Notice for Semaglutide injection [1] - The clinical trials will focus on the indication of type 2 diabetes, specifically for blood sugar control in adult patients [1] - The total research and development investment in this project amounts to approximately 44.1834 million yuan [1] Group 2: Product Information - Semaglutide injection is classified as a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist [1] - It is intended for use in adult patients with type 2 diabetes to manage blood sugar levels and reduce the risk of major cardiovascular adverse events in those with cardiovascular disease [1]
太极集团:获得司美格鲁肽注射液药物临床试验批准通知书
Core Viewpoint - Taiji Group's subsidiary has received approval for clinical trials of Semaglutide injection, indicating a significant step in diabetes treatment and weight management [1] Company Summary - Taiji Group's wholly-owned subsidiary, Taiji Group Chongqing Fuling Pharmaceutical Factory, has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for Semaglutide injection [1] - Semaglutide is a long-acting GLP-1 receptor agonist that stimulates insulin production, suppresses glucagon secretion, and reduces appetite and food intake [1] Industry Summary - Semaglutide plays a crucial role in the treatment of type 2 diabetes and assists in weight management, highlighting its importance in the pharmaceutical industry [1]
太极集团(600129) - 太极集团关于获得司美格鲁肽注射液药物临床试验批准通知书的公告
2025-09-09 09:00
证券代码:600129 证券简称:太极集团 公告编号:2025-071 重庆太极实业(集团)股份有限公司 关于获得司美格鲁肽注射液药物临床试 验批准通知书的公告 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。 近日,重庆太极实业(集团)股份有限公司(以下简称:公司) 全资子公司太极集团重庆涪陵制药厂有限公司(以下简称:涪陵制药 厂)收到国家药品监督管理局关于司美格鲁肽注射液的《药物临床试 验批准通知书》,现将相关情况公告如下: 一、药物基本情况 药品名称:司美格鲁肽注射液 剂型:注射剂 申请事项:境内生产药品注册临床试验 本次涪陵制药厂获批临床的适应症为适用于成人 2 型糖尿病患 者的血糖控制:在饮食控制和运动基础上,接受二甲双胍和/或磺脲 类药物治疗血糖仍控制不佳的成人 2 型糖尿病患者;适用于降低伴有 1 心血管疾病的 2 型糖尿病成人患者的主要心血管不良事件(心血管死 亡、非致死性心肌梗死或非致死性卒中)风险。 截至本公告日,经查询国家药品监督管理局数据库,国内仅有原 研企业诺和诺德(Novo Nordisk In ...
太极集团:司美格鲁肽注射液药物临床试验批准
Ge Long Hui A P P· 2025-09-09 08:52
Core Viewpoint - Taiji Group's wholly-owned subsidiary, Taiji Group Chongqing Fuling Pharmaceutical Factory, has received approval from the National Medical Products Administration for the clinical trial of Semaglutide injection for type 2 diabetes, indicating progress in the company's drug development pipeline [1] Group 1 - The clinical trial application for Semaglutide injection was accepted on July 4, 2025, and meets the requirements for drug registration [1] - The company has invested approximately RMB 44.1834 million in the research and development of this project to date [1]
太极集团(600129.SH)获得司美格鲁肽注射液药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-09 08:52
Core Viewpoint - Taiji Group's subsidiary, Fuling Pharmaceutical, has received approval from the National Medical Products Administration for clinical trials of Semaglutide injection, which is significant for treating type 2 diabetes and weight management [1] Group 1: Company Developments - Fuling Pharmaceutical has been granted a clinical trial approval for Semaglutide injection, a GLP-1 receptor agonist [1] - The approved indication is for blood sugar control in adult patients with type 2 diabetes who have inadequate control despite treatment with metformin and/or sulfonylureas [1] - The drug is also indicated for reducing the risk of major cardiovascular adverse events in adult patients with type 2 diabetes and cardiovascular disease [1]
太极集团:子公司司美格鲁肽注射液临床试验获批
Xin Lang Cai Jing· 2025-09-09 08:52
Core Viewpoint - Taiji Group's subsidiary, Chongqing Fuling Pharmaceutical Factory, has received approval from the National Medical Products Administration for clinical trials of Semaglutide injection for type 2 diabetes treatment [1] Group 1: Clinical Trial Approval - The approved clinical trial is aimed at adult patients with type 2 diabetes for blood sugar control [1] - The indication is for adults whose blood sugar remains uncontrolled despite treatment with Metformin and/or Sulfonylureas [1] - The trial also targets reducing the risk of major cardiovascular adverse events in adults with type 2 diabetes and cardiovascular diseases [1]