证券代码：600062 证券简称：华润双鹤 公告编号：临2026－003 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 通过GMP符合性检查的公告 被检查单位名称：北京万辉双鹤药业有限责任公司 检查地址：北京市门头沟区石龙经济开发区上园路1号 检查范围及相关车间、生产线： 委托华润双鹤药业股份有限公司(北京市朝阳区双桥东路2号)综合制造车间软胶囊剂生产线生产软胶囊 剂阿法骨化醇软胶囊(国药准字H20255672)。 检查时间：2025年11月26日至2025年11月28日 结论：依据本次检查情况，经审查，该企业此次检查范围符合《药品生产质量管理规范(2010年修订)》 和附录要求。 本次检查是阿法骨化醇软胶囊上市前的首次药品GMP符合性检查。该检查项目是在原有厂房、设备情 况下的检查，未投入资金。 二、本次检查所涉生产线及产品情况 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。 近日，华润双鹤药业股份有限公司(以下简称"公司")全资子公司北京万辉双鹤药业有限责任公司收到北 京市药品监督管理局颁发的《药品 ...

本次检查是阿法骨化醇软胶囊上市前的首次药品GMP符合性检查。该检查项目是在原有厂房、设备情 况下的检查，未投入资金。 华润双鹤（600062）(600062.SH)发布公告，近日，公司全资子公司北京万辉双鹤药业有限责任公司收 到北京市药品监督管理局颁发的《药品GMP符合性检查告知书》(编号：京药监药GMP[2025]020140)。 ...

本次检查是阿法骨化醇软胶囊上市前的首次药品GMP符合性检查。该检查项目是在原有厂房、设备情 况下的检查，未投入资金。 智通财经APP讯，华润双鹤(600062.SH)发布公告，近日，公司全资子公司北京万辉双鹤药业有限责任 公司收到北京市药品监督管理局颁发的《药品GMP符合性检查告知书》(编号：京药监药 GMP[2025]020140)。 ...

华润双鹤公告，全资子公司北京万辉双鹤药业有限责任公司收到北京市药品监督管理局颁发的《药品 GMP符合性检查告知书》。检查范围为华润双鹤药业股份有限公司综合制造车间软胶囊剂生产线生产 软胶囊剂阿法骨化醇软胶囊。检查时间2025年11月26日至2025年11月28日，结论为符合《药品生产质量 管理规范(2010年修订)》和附录要求。该检查项目是在原有厂房、设备情况下的检查，未投入资金。 ...

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]

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]