盐酸吡格列酮分散片
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华润双鹤药业股份有限公司关于控股子公司双鹤天安药业(贵州)股份有限公司 盐酸吡格列酮分散片获得药品补充申请批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-01 23:27
Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Pioglitazone Hydrochloride Dispersible Tablets, which is expected to enhance market competitiveness and sales potential in the future [1][2]. Group 1: Drug Approval and Development - The company’s subsidiary, Shuanghe Tianan Pharmaceutical, received the approval notice for Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1]. - The consistency evaluation for this drug began in 2017, with the application submitted in December 2024 and approval received in November 2025 [2]. - The total R&D investment for this drug's consistency evaluation has reached RMB 8.8227 million (unaudited) [2]. Group 2: Market Situation of Similar Drugs - Pioglitazone tablets, developed by Takeda Pharmaceutical, were approved in the U.S. in July 1999 and in China in 2004, but have since been withdrawn from the market [3]. - The global sales of Pioglitazone tablets are projected to be USD 254 million in 2024, with "ACTOS" contributing USD 41.6958 million [3]. - In China, the total sales of Pioglitazone tablets in the medical and retail markets are estimated at RMB 349 million in 2024, with Shuanghe Tianan holding a market share of 10.46% [3].
华润双鹤:盐酸吡格列酮分散片获得药品补充申请批准通知书
Zhi Tong Cai Jing· 2025-12-01 09:27
Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its subsidiary, Double Crane Tianan Pharmaceutical (Guizhou) Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets, which is considered to have passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approved drug, Pioglitazone Hydrochloride Dispersible Tablets, is used for the treatment of type 2 diabetes [1] - The successful consistency evaluation is expected to enhance future market sales and competitiveness for the company [1] - This achievement will also provide valuable experience for the company in conducting future evaluations of generic drug consistency [1]
华润双鹤(600062.SH):盐酸吡格列酮分散片获得药品补充申请批准通知书
智通财经网· 2025-12-01 09:25
Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its subsidiary, Double Crane Tianan Pharmaceutical (Guizhou) Co., Ltd., received the approval notice for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration, indicating that the drug has passed the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The approved drug, Pioglitazone Hydrochloride Dispersible Tablets, is used for the treatment of type 2 diabetes [1] - The successful consistency evaluation is expected to enhance future market sales and competitiveness for the company [1] - This achievement will also provide valuable experience for the company in conducting future evaluations of generic drug consistency [1]
华润双鹤:盐酸吡格列酮分散片获得药品补充申请批准
Ge Long Hui A P P· 2025-12-01 09:17
Core Viewpoint - China Resources Double Crane announced that its subsidiary, Double Crane Tianan Pharmaceutical Co., Ltd., received the approval notice for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1] Summary by Categories - **Regulatory Approval** - The company has received a supplementary application approval for Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1] - **Research and Development Investment** - As of the date of the announcement, the total R&D investment for this drug's consistency evaluation amounts to RMB 8.8227 million (unaudited) [1]