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阿法骨化醇软胶囊
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华润双鹤药业股份有限公司关于全资子公司北京万辉双鹤药业有限责任公司阿法骨化醇软胶囊获得药品注册证书的公告
Core Viewpoint - The company announced that its wholly-owned subsidiary, Beijing Wanhui Shuanghe Pharmaceutical Co., Ltd., has received a drug registration certificate for Alfacalcidol soft capsules from the National Medical Products Administration, which is expected to enhance the company's product line and market competitiveness [1][2]. Drug Registration Certificate Details - The drug is indicated for treating calcium metabolism disorders caused by insufficient endogenous 1,25-dihydroxyvitamin D3, including conditions such as renal osteodystrophy and osteoporosis [1][2]. - The company initiated the drug's generic research and development in August 2022, submitted the marketing authorization application in June 2024, and received approval on October 14, 2025 [2]. Market Situation - Alfacalcidol soft capsules were developed by LEO Pharma A/S and were approved for sale in the Netherlands in 1978 under the brand name "Etalpha," which was also approved in China in May 2023 [2]. - The global sales of Alfacalcidol capsules are projected to reach $182 million in 2024, with "Etalpha" contributing $14.13 million [2]. - In the Chinese market, there are nine approved manufacturers of Alfacalcidol soft capsules, with three having passed the consistency evaluation, including Wanhui Shuanghe [3]. - The total sales in the domestic medical and retail market for Alfacalcidol soft capsules are estimated at 659 million RMB in 2024, with the top three companies holding market shares of 36.53%, 17.65%, and 17.27% respectively [3].
华润双鹤:关于全资子公司北京万辉双鹤药业有限责任公司阿法骨化醇软胶囊获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-10-20 13:14
Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, Beijing Wanhui Double Crane Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Alfacalcidol Soft Capsules from the National Medical Products Administration [2] Group 1 - The announcement was made on the evening of October 20 [2] - The Drug Registration Certificate is a significant regulatory milestone for the company [2] - Alfacalcidol is a medication used to treat conditions related to calcium metabolism [2]
华润双鹤(600062.SH):阿法骨化醇软胶囊获得药品注册证
Ge Long Hui A P P· 2025-10-20 10:34
Core Viewpoint - China Resources Double Crane Pharmaceutical (华润双鹤) announced that its wholly-owned subsidiary, Beijing Wanhui Double Crane Pharmaceutical Co., Ltd. (万辉双鹤), has received the Drug Registration Certificate for Alfacalcidol Soft Capsules from the National Medical Products Administration (国家药品监督管理局) [1] Group 1: Product Information - Alfacalcidol Soft Capsules are indicated for the treatment of calcium metabolism disorders caused by insufficient endogenous 1,25-dihydroxyvitamin D3 production [1] - The drug is applicable for various conditions, including renal osteodystrophy, postoperative or idiopathic hypoparathyroidism, pseudohypoparathyroidism, as an adjunct therapy for tertiary hyperparathyroidism, vitamin D-resistant rickets or osteomalacia, vitamin D-dependent rickets, neonatal hypocalcemia or rickets, malabsorption of calcium, osteoporosis, malabsorption-related and nutritional rickets, and osteomalacia [1]
华润双鹤子公司阿法骨化醇软胶囊获得药品注册证书
Zhi Tong Cai Jing· 2025-10-20 09:37
Core Viewpoint - China Resources Double Crane Pharmaceutical Co., Ltd. has received a drug registration certificate for Alfacalcidol soft capsules from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Company Summary - The company's wholly-owned subsidiary, Beijing Wanhui Double Crane Pharmaceutical Co., Ltd., is responsible for the registration of Alfacalcidol soft capsules [1] - Alfacalcidol is indicated for the treatment of calcium metabolism disorders caused by insufficient endogenous 1,25-dihydroxyvitamin D3 production, which includes various conditions such as renal osteodystrophy and vitamin D-dependent rickets [1] Industry Summary - The approval of Alfacalcidol soft capsules highlights the growing demand for treatments addressing calcium metabolism disorders in the pharmaceutical industry [1] - The product is positioned to cater to a range of diseases, including osteoporosis and malabsorption-related conditions, reflecting the industry's focus on specialized therapeutic areas [1]
华润双鹤(600062.SH)子公司阿法骨化醇软胶囊获得药品注册证书
智通财经网· 2025-10-20 09:36
Core Viewpoint - China Resources Double Crane Pharmaceutical Co., Ltd. has received a drug registration certificate for Alfacalcidol soft capsules from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Group 1: Company Developments - The wholly-owned subsidiary, Beijing Wanhui Double Crane Pharmaceutical Co., Ltd., is responsible for the new product, Alfacalcidol soft capsules [1] - Alfacalcidol is indicated for the treatment of calcium metabolism disorders caused by insufficient endogenous 1,25-dihydroxyvitamin D3 production [1] Group 2: Product Applications - The product is applicable for various conditions, including renal osteodystrophy, postoperative or idiopathic hypoparathyroidism, pseudohypoparathyroidism, and as an adjunct therapy for tertiary hyperparathyroidism [1] - Other indications include vitamin D-resistant rickets, osteomalacia, vitamin D-dependent rickets, neonatal hypocalcemia or rickets, malabsorption syndromes, osteoporosis, and nutritional rickets or osteomalacia [1]
华润双鹤:全资子公司北京万辉双鹤药业阿法骨化醇软胶囊获药品注册证书
Xin Lang Cai Jing· 2025-10-20 09:26
Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, Beijing Wanhui Double Crane Pharmaceutical Co., Ltd., received the drug registration certificate for Alfacalcidol soft capsules from the National Medical Products Administration, indicating a significant advancement in the company's product portfolio [1] Group 1: Product Development - The drug is indicated for the treatment of calcium metabolism disorders caused by insufficient endogenous 125-dihydroxyvitamin D3, including conditions such as renal osteodystrophy and vitamin D-dependent rickets [1] - The company initiated the development of this generic drug in August 2022 and submitted the marketing authorization application on June 18, 2024, which was accepted on June 25, 2024, and approved for market launch on October 14, 2025 [1] - Cumulative R&D investment for this drug reached 4.9302 million RMB as of the announcement date [1]
昆药集团Q1“开门黑”,华润三九入主第三年靠什么兑现双位数增长? | 直击业绩会
Tai Mei Ti A P P· 2025-05-30 13:28
Core Viewpoint - Kunming Pharmaceutical Group's stock price has experienced significant volatility, with a sharp decline following a brief rise, raising concerns among investors regarding its performance and future growth plans [2][3]. Financial Performance - In 2024, Kunming Pharmaceutical Group reported revenue of 8.401 billion yuan, a slight decrease of 0.34% year-on-year, while net profit attributable to shareholders increased by 19.86% to 648 million yuan [3]. - However, in Q1 2025, the company faced a substantial decline in performance, with revenue dropping by 16.53% to 1.608 billion yuan and net profit falling by 31.06% to approximately 90.48 million yuan [3][7]. - The company aims for double-digit revenue growth in 2025, despite the challenges faced in the first quarter [5][7]. Strategic Transition - The company is undergoing a significant transformation in its sales and channel management, moving from a decentralized distribution model to a more integrated and structured approach [4][5]. - The new channel system aims to enhance brand recognition and operational efficiency, focusing on long-term brand building and better collaboration with distributors [5][7]. Market Focus - Kunming Pharmaceutical Group is targeting the aging population and chronic disease management, positioning itself as a leader in the "silver health industry" [7][8]. - The company’s product portfolio includes treatments for cardiovascular diseases, with a noted decline in revenue from this segment, which fell by 17.45% to 2.195 billion yuan in 2024 [8]. Product Performance - Sales of key products, such as the blood stasis series and Tianma injection, have shown mixed results, with significant declines in some areas, such as a 54.66% drop in sales volume for the freeze-dried blood stasis injection [9]. - The company is actively working to improve its market presence and sales channels, particularly in retail and smaller medical institutions [9].