SGLT - 2抑制剂
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赛升药业:达格列净二甲双胍缓释片注册上市许可申请获受理
Zheng Quan Shi Bao Wang· 2025-12-04 09:03
人民财讯12月4日电,赛升药业(300485)12月4日公告,子公司赛而生物近日收到国家药监局下发的达 格列净二甲双胍缓释片境内生产药品注册上市许可申请的受理通知书。 SGLT-2抑制药达格列净和盐酸二甲双胍的复方片剂由英国阿斯利康制药公司研发,于2014年FDA批准 上市。2023年6月,该品种在我国批准上市。SGLT-2抑制剂是通过非胰岛素依赖机制发挥作用,通过减 少葡萄糖在肾脏的重吸,从尿中直接排糖来降低血糖,SGLT-2联用二甲双胍表现了更好的降糖效果和 更低的副作用。 ...
赛升药业:达格列净二甲双胍缓释片药品注册上市许可申请获受理
Zhi Tong Cai Jing· 2025-12-04 08:16
SGLT-2抑制药达格列净和盐酸二甲双胍的复方片剂由英国阿斯利康制药公司研发,于2014年FDA批准 上市。2023年6月,该品种在我国批准上市。SGLT-2抑制剂是通过非胰岛素依赖机制发挥作用,通过减 少葡萄糖在肾脏的重吸,从尿中直接排糖来降低血糖,SGLT-2联用二甲双胍表现了更好的降糖效果和 更低的副作用。 赛升药业(300485)(300485.SZ)发布公告,公司子公司北京赛而生物药业有限公司(以下简称"赛而生 物")近日收到了国家药品监督管理局下发的达格列净二甲双胍缓释片境内生产药品注册上市许可申请的 《受理通知书》。 ...
赛升药业(300485.SZ):达格列净二甲双胍缓释片药品注册上市许可申请获受理
智通财经网· 2025-12-04 08:10
智通财经APP讯,赛升药业(300485.SZ)发布公告,公司子公司北京赛而生物药业有限公司(以下简称"赛 而生物")近日收到了国家药品监督管理局下发的达格列净二甲双胍缓释片境内生产药品注册上市许可申 请的《受理通知书》。 SGLT-2抑制药达格列净和盐酸二甲双胍的复方片剂由英国阿斯利康制药公司研发,于2014年FDA批准 上市。2023年6月,该品种在我国批准上市。SGLT-2 抑制剂是通过非胰岛素依赖机制发挥作用,通过减 少葡萄糖在肾脏的重吸,从尿中直接排糖来降低血糖,SGLT-2联用二甲双胍表现了更好的降糖效果和 更低的副作用。 ...
赛升药业(300485.SZ):子公司收到药品注册上市许可申请受理通知书
Ge Long Hui A P P· 2025-12-04 07:59
格隆汇12月4日丨赛升药业(300485.SZ)公布,子公司北京赛而生物药业有限公司近日收到了国家药品监 督管理局下发的达格列净二甲双胍缓释片境内生产药品注册上市许可申请的《受理通知书》。SGLT-2 抑制药达格列净和盐酸二甲双胍的复方片剂由英国阿斯利康制药公司研发,于2014年FDA批准上市。 2023年6月,该品种在我国批准上市。SGLT-2抑制剂是通过非胰岛素依赖机制发挥作用,通过减少葡萄 糖在肾脏的重吸,从尿中直接排糖来降低血糖,SGLT-2联用二甲双胍表现了更好的降糖效果和更低的 副作用。 ...
联环药业创新药LH-1801片有望于2026年申报上市
Zheng Quan Ri Bao Wang· 2025-06-23 01:50
Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. is advancing its innovative drug LH-1801, which is expected to enter the market in 2026 if clinical trials proceed smoothly [1][2]. Company Summary - LH-1801 is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor designed to lower blood sugar by preventing glucose reabsorption in the kidneys, thus reducing the risk of hypoglycemia [1]. - The drug has successfully completed Phase I clinical trials and has been granted exemption from Phase II trials, moving directly to Phase III due to its favorable pharmacokinetic properties and safety profile [2]. - The Phase III clinical study is being conducted across over 70 top hospitals in China, led by a prominent endocrinology expert, ensuring scientific rigor [2]. Industry Summary - Diabetes has become a significant health threat, with a large and growing patient base in China [3]. - The Chinese type 2 diabetes pharmaceutical market is projected to grow at a compound annual growth rate (CAGR) of 10.18% from 2025 to 2030, reaching a market size of 151.8 billion yuan by 2025 and potentially expanding to 259.2 billion yuan by 2030 [3]. - SGLT-2 inhibitors represent a shift in diabetes treatment from merely controlling blood sugar to providing comprehensive cardiovascular and renal protection, making them a core recommendation in global treatment guidelines [3].
通化东宝:Q1实现约20万支利拉鲁肽注射液销售,目前研发管线中没有口服胰岛素
Cai Jing Wang· 2025-05-27 09:18
Group 1 - The company is actively expanding its international market presence, particularly in the U.S. insulin market through strategic partnerships and ongoing clinical trials for three types of insulin [1] - The company has achieved sales of approximately 200,000 units of liraglutide injection in Q1 2025, with a strong foundation for annual sales growth due to successful procurement results [2] - The company is focusing on the sales of insulin analog products and expanding its market presence for GLP-1 receptor agonists and SGLT-2 inhibitors to meet diverse patient needs [2] Group 2 - The company has received approvals for insulin products in several developing countries, including Nicaragua and Uzbekistan, and is working on expanding registrations for insulin products in these markets [1] - The company is advancing its clinical trials for new products, including THDBH120 for weight loss, which has completed its Phase II clinical trial [2][3] - The company is not currently developing oral insulin products due to technical challenges but will monitor industry advancements for potential future adjustments in R&D strategy [3] Group 3 - The company’s parent group, Dongbao Group, is working to reduce its share pledge ratio, which is currently high due to long project cycles and financial pressures [3] - The long-term outlook for Dongbao Group is positive, with ongoing projects and products expected to enter a recovery phase, improving operational capabilities [4]