Workflow
奥洛格列净胶囊
icon
Search documents
东阳光药:核心产品奥洛格列净胶囊获得国家药品监督管理局批准上市
Zhi Tong Cai Jing· 2026-01-16 12:10
Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its SGLT-2 inhibitor, Ologliptin capsules, which are intended for improving blood glucose control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also showed additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes is now the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in diabetes treatment, including five insulin products that have been approved and are consistent in effectiveness, safety, and quality with original formulations [2] - The new product approval will enhance the company's diabetes product portfolio, and the company plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]
东阳光药(06887):核心产品奥洛格列净胶囊获得国家药品监督管理局批准上市
智通财经网· 2026-01-16 11:44
Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its innovative drug, Ologliptin capsules, which are designed to improve blood sugar control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also offers additional metabolic benefits such as weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood sugar, weight, and blood pressure [1] Group 2 - Diabetes has become the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in the diabetes treatment field, including five insulin products that have been approved and are consistent in efficacy, safety, and quality with original formulations [2] - The approval of the new product will enhance the company's diabetes product portfolio, and it plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]
东阳光药(06887.HK):核心产品“奥洛格列净胶囊”获国家药监局批准上市
Ge Long Hui· 2026-01-16 11:43
Group 1 - Dongyangguang Pharmaceutical (06887.HK) announced that its self-developed SGLT-2 inhibitor, Oloklignet capsules (brand name: Dongzean, specifications: 20mg, 50mg), received approval from the National Medical Products Administration of China for marketing, aimed at improving blood glucose control in adult patients with type 2 diabetes, either as monotherapy or in combination with metformin [1] - The registration approval was based on two multicenter, randomized, double-blind, placebo-controlled Phase III clinical studies, which showed statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with significant improvements in fasting blood glucose and postprandial blood glucose [1] - The product also demonstrated additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes has become the third most serious chronic non-communicable disease globally, following cancer and cardiovascular diseases, with the International Diabetes Federation reporting a diabetes prevalence rate of 13.79% among adults (ages 20-79) in China, translating to approximately 148 million patients, the highest in the world [2] - Over 90% of these cases are type 2 diabetes, with a poor medication adherence rate and an effective blood glucose control rate of only 50.1% [2] - The company has a comprehensive product line in the diabetes treatment field, having developed five insulin products that have been approved for marketing, all of which are consistent in efficacy, safety, and quality with original formulations and have been included in the national drug centralized procurement [2] - The approval of the new product will further enrich the company's diabetes product line, leveraging its established production system and marketing network for rapid commercialization, while also exploring clinical applications in diabetes complications to expand the range of indications [2]
东阳光药(06887) - 自愿性公告核心產品奥洛格列净胶囊获得国家药品监督管理局批准上市
2026-01-16 11:35
香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責,對其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部 或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 SUNSHINE LAKE PHARMA CO., LTD. 廣 東 東 陽 光 藥 業 股 份 有 限 公 司 (在中華人民共和國註冊成立之股份有限公司) (股份代號:6887) 自願性公告 – 1 – 目前,糖尿病已成為全球範圍內繼腫瘤、心腦血管病之後,第三位嚴重危害人類 健康的慢性非傳染性疾病。國際糖尿病聯盟(IDF)第11版《糖尿病地圖》數據顯示, 中 國 成 人( 20 – 79 歲 )糖 尿 病 患 病 率 達 13.79 % , 患 者 數 量 達 1.48 億 , 位 居 全 球 首 位 。 其 中 2 型 糖 尿 病 佔 比 超 90 % , 患 者 臨 床 用 藥 依 從 性 普 遍 不 佳 , 血 糖 有 效 控 制 率僅有50.1 %。 本集團長期深耕糖尿病治療領域,擁有全面的產品規劃,佈局了完整的產品線。 本集團 ...
东阳光药1类创新药奥洛格列净获批上市:控糖效果更优
人民财讯1月16日电,近日,东阳光(600673)药自主研发的1类创新药奥洛格列净胶囊已获国家药监局 批准上市,用于单药或联合二甲双胍改善成人2型糖尿病患者的血糖控制,为中国糖尿病患者提供了兼 具精准疗效与综合获益的"中国创新"治疗方案。从目前披露的临床数据来看,奥洛格列净的空腹血糖和 餐后2小时血糖降低幅度更优。空腹血糖的波动往往是糖尿病并发症的早期信号,能够更稳健地平抑全 天血糖基准线,意味着该药在精细化控糖方面具有较强的竞争力,可实现"空腹+餐后"全周期血糖覆 盖。 ...