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].

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]

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]

证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－085 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 二、药品相关情况 阿法骨化醇软胶囊适用于治疗内源性 1,25-二羟基维生素 D3产生 不足所致的钙代谢紊乱性疾病。例如肾性骨营养不良、术后性或特发 性甲状旁腺功能低下症、假性甲状旁腺功能低下症、作为第三性甲状 旁腺功能亢进的辅助治疗、抗维生素 D 性佝偻病或骨软化症、维生 素 D 依赖型佝偻病、新生儿低钙血症或佝偻病、钙吸收不良症、骨 质疏松症、吸收不良性及营养性佝偻病及骨软化症。 公司于2022年8月启动该药品的仿制药研发工作，于2024年6月18 日向国家药监局提交上市许可申请，于2024年6月25日获得受理通知 书，并于2025年10月14日获得国家药监局批准上市。根据国家相关政 策规定，本次获得《药品注册证书》视同通过一致性评价。 截至本公告日，公司针对该药品累计研发投入为 493.02 万元人 民币(未经审计)。 阿法骨化醇软胶囊获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记 载、误导性陈述或者重大遗漏，并对其内容的真实性、准 ...

关于召开 2025 年第三季度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、 误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承 担法律责任。 证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－084 华润双鹤药业股份有限公司 重要内容提示： 会议召开时间：2025 年 10 月 28 日(星期二)上午 10:00—11:30 会议召开方式：现场结合网络、电话会议 现场会议地点：北京市朝阳区望京东路 8 号锐创国际中心 A 座 9 层会议室 问题征集方式：公司邮箱 mss@dcpc.com 华润双鹤药业股份有限公司(以下简称"公司")于 2025 年 10 月 25 日发布 2025 年第三季度报告，为便于广大投资者更全面深入地了解 公司 2025 年第三季度经营成果、财务状况，公司计划于 2025 年 10 月 28 日(星期二) 上午 10:00—11:30 举行 2025 年第三季度业绩说明 会，就投资者普遍关注的问题进行交流。 一、说明会类型和安排 (一)会议召开时间：2025 年 10 月 28 日(星期二)上午 10:00—11:30 (二) ...

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]

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]

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]

Core Insights - The appointment of Cheng Jie as the new president of China Resources Pharmaceutical signifies a strategic shift as the company faces challenges in traditional business growth and profitability amidst industry transformation [1][2][11] - The company reported a "revenue growth without profit increase" in its recent half-year report, with total revenue reaching 131.87 billion yuan, a 2.5% year-on-year increase, while net profit dropped by 20.3% to 2.08 billion yuan [2][7] - Cheng Jie, who has a strong background within the company, is expected to leverage his experience to navigate the current challenges and drive innovation and growth [4][19] Company Performance - China Resources Pharmaceutical's revenue has shown steady growth, increasing from 232.20 billion yuan in 2022 to 257.67 billion yuan in 2024, with an average annual growth rate of over 5% [7] - However, net profit has fluctuated, with a 13.06% decline in 2024 to 3.35 billion yuan and a further drop of 20.25% in the first half of 2025 [7][8] - The decline in profit is attributed to one-time impairment losses and rigid expense growth, with a net loss of 1.09 billion yuan in other income and losses reported for the first half of 2025 [7][8] Strategic Initiatives - The company has been actively pursuing mergers and acquisitions, with significant transactions including the acquisition of 100% of Green Cross Hong Kong for 1.82 billion yuan and a 28% stake in Tian Shi Li Pharmaceutical for 6.21 billion yuan [9][10] - Despite the expansion through acquisitions, the company is now shifting focus towards optimizing its asset structure by divesting non-core and loss-making businesses to enhance operational efficiency and profitability [10][15] - Cheng Jie is tasked with balancing the expansion from acquisitions with the need for profit growth, as well as addressing potential impairment risks associated with goodwill from these acquisitions [11][19] Industry Context - The Chinese pharmaceutical distribution market is experiencing maturation and differentiation, presenting structural opportunities for leading companies like China Resources Pharmaceutical [12] - Collaborations with multinational pharmaceutical companies are increasing, as these companies seek to focus on core products and leverage local distribution expertise [12][13] - The industry is transitioning from a phase of scale expansion to one of high-quality development, emphasizing the need for new products, channels, and innovative service models [14][15] Innovation and R&D - China Resources Pharmaceutical is enhancing its pharmaceutical business through initiatives such as establishing a 1 billion yuan investment fund focused on innovative drugs and high-end medical devices [17] - The company is also pursuing partnerships for innovative drug development, such as a collaboration with Nanjing Ai Er Pu for a heart failure treatment [17][19] - However, the company faces challenges in its R&D efforts, with a significant portion of its pipeline still focused on generic drugs rather than innovative products, which may hinder its competitive edge in a rapidly evolving market [18][19]

Core Insights - The report analyzes the current status and future trends of the global and Chinese management industry for respiratory distress syndrome from 2025 to 2031 [1][3]. Market Overview - The management market for respiratory distress syndrome is categorized into different product types, including Alfacalcidol, Belactam, and Calfactant, with growth trends projected from 2020 to 2031 [4][5]. - The market is segmented by application, focusing on extremely premature infants and moderate to late preterm infants, with growth trends also forecasted for the same period [4][5]. Industry Development Status - The report provides an overview of the development of the respiratory distress syndrome management industry during the 14th Five-Year Plan period, highlighting key characteristics and barriers to entry [4][5]. - It discusses the overall scale and forecast of the global respiratory distress syndrome management industry from 2020 to 2031, including the Chinese market's share of the global market [4][5]. Competitive Landscape - The report analyzes the revenue of major global manufacturers in the respiratory distress syndrome management market from 2020 to 2025, including market share and rankings for 2024 [4][5]. - It provides insights into the competitive landscape, including the concentration of the industry and the distribution of major companies [4][5]. Product and Application Analysis - The report details the overall scale and market share of different product types and applications in both global and Chinese markets from 2020 to 2031 [4][5]. - It includes forecasts for the growth of these segments, emphasizing the importance of understanding market dynamics for investment opportunities [4][5]. Industry Opportunities and Challenges - The report identifies key drivers and opportunities for the respiratory distress syndrome management industry, as well as potential risks and policy analysis [4][5]. - It discusses the supply chain dynamics, including procurement, production, and sales models within the industry [4][5].