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西格列汀二甲双胍片(II)
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中关村:西格列汀二甲双胍片(II)收到《受理通知书》
Ge Long Hui· 2025-10-14 07:54
格隆汇10月14日丨中关村(000931.SZ)公布,下属公司多多药业有限公司(简称:多多药业)于近日收 到国家药品监督管理局签发的《受理通知书》,西格列汀二甲双胍片(II)(规格:每片含磷酸西格列 汀50mg(以西格列汀计)和盐酸二甲双胍850mg)上市许可申请获得受理。多多药业西格列汀二甲双 胍片(II)(规格:每片含磷酸西格列汀50mg(以西格列汀计)和盐酸二甲双胍850mg)于2023年立项 开发,其适应症为:本品配合饮食和运动治疗,用于经二甲双胍单药治疗血糖仍控制不佳或正在接受二 者联合治疗的2型糖尿病患者。 ...
中关村:下属公司西格列汀二甲双胍片(II)上市许可申请获受理
Core Viewpoint - The company Zhongguancun (000931) has received acceptance for the marketing authorization application of its drug, Sitagliptin Metformin Tablets, from the National Medical Products Administration, indicating a significant step in expanding its product portfolio in the diabetes treatment market [1] Company Summary - Zhongguancun's subsidiary, Duoduo Pharmaceutical Co., Ltd., has recently received the acceptance notice for the marketing authorization application of Sitagliptin Metformin Tablets [1] - The drug is indicated for the treatment of type 2 diabetes patients who have inadequate blood sugar control with metformin monotherapy or are currently receiving a combination of both treatments [1] Industry Summary - The acceptance of the drug application highlights the ongoing demand and market potential for diabetes medications, particularly for combination therapies that enhance blood sugar control [1] - The drug contains 50mg of Sitagliptin and 850mg of Metformin per tablet, which aligns with current treatment protocols for managing type 2 diabetes [1]
中关村:多多药业西格列汀二甲双胍片获受理
Xin Lang Cai Jing· 2025-10-14 07:49
Core Viewpoint - The announcement indicates that Duoduo Pharmaceutical, a subsidiary of Zhongguancun, has received an acceptance notice from the National Medical Products Administration for the marketing authorization application of Sitagliptin Metformin Tablets (II) [1] Group 1: Product Details - The drug is formulated to contain 50mg of Sitagliptin (as Sitagliptin phosphate) and 850mg of Metformin hydrochloride per tablet [1] - It is indicated for type 2 diabetes patients whose blood sugar is not adequately controlled by Metformin monotherapy or who are currently receiving a combination of both medications [1] Group 2: Financial Implications - As of the date of the announcement, the total research and development expenses for this project have reached 6.8755 million yuan [1] - If the drug is successfully approved, it is expected to enhance the market competitiveness of the company's antidiabetic products and positively impact the company's operating performance [1]