登录新浪财经APP 搜索【信披】查看更多考评等级 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 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(以下简 称"万辉双鹤")收到了国家药品监督管理局(以下简称"国家药监局")颁发的阿法骨化醇软胶囊(以下简 称"该药品")《药品注册证书》。现将相关情况公告如下： 一、药品注册证书主要内容 ■ 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 ...

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which will enhance the company's product line and market competitiveness [1][5]. Drug Registration Certificate Details - The drug is a combination of Candesartan Cilexetil (16mg) and Hydrochlorothiazide (12.5mg) and is indicated for adults with primary hypertension who do not achieve adequate blood pressure control with either drug alone [1][2]. R&D Investment - The total R&D investment for this drug has reached RMB 4.8441 million (unaudited) as of the announcement date [3]. Market Status of Similar Drugs - In 2024, the sales revenue of Candesartan Cilexetil and Hydrochlorothiazide combination in China was approximately RMB 153.76 million, with significant contributions from urban public hospitals and community health centers [4].

Core Viewpoint - The company has received acceptance for the drug listing application of HRS9531 injection, which is aimed at long-term weight management for adults with obesity or overweight conditions [1] Group 1: Product Development - HRS9531 injection is intended for adults with an initial body mass index (BMI) of ≥28 kg/m² or those with a BMI of ≥24 kg/m² accompanied by at least one weight-related comorbidity [1] - The drug achieved all primary and key secondary endpoints in the Phase III clinical trial conducted in July 2025, demonstrating good safety and tolerability [1] - The total research and development investment for the HRS9531 project has reached approximately 452 million yuan [1] Group 2: Regulatory and Future Plans - The company will advance the project development in accordance with national regulations and will disclose progress in a timely manner [1]

Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 3%, currently at 77.75 HKD, following the acceptance of its drug application by the National Medical Products Administration (NMPA) for its drug, Haequibopamine Ethanolamine Tablets, aimed at treating immune thrombocytopenia (ITP) in adults and children aged 6 and above [1] Group 1 - The company received an acceptance notice from the NMPA for its drug application [1] - The drug is indicated for patients with persistent and chronic primary immune thrombocytopenia who have had poor responses to previous treatments such as corticosteroids and immunoglobulins [1] - The Phase III clinical trial (HR-TPO-ITP-III-PED) for Haequibopamine Ethanolamine Tablets achieved its primary endpoint as planned in March 2025 [1] Group 2 - The Phase III study was a multicenter, randomized, double-blind, and open-label trial evaluating the efficacy and safety of the drug in children and adolescents with primary immune thrombocytopenia [1] - The study was led by Professor Wang Tianyou from the Capital Medical University Affiliated Beijing Children's Hospital, enrolling 100 patients aged 6 and above [1] - The treatment group showed significant superiority over the control group in the primary endpoint, with good safety and efficacy observed during long-term treatment [1]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of its drug, HAIQUPOLPA Ethanolamine Tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2]. Drug Basic Information - Drug Name: HAIQUPOLPA Ethanolamine Tablets - Dosage Form: Tablets - Acceptance Number: CXHS2500092, CXHS2500093, CXHS2500094 - Application Stage: Marketing - Indication: For adults and children aged ≥6 years with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to corticosteroids and immunoglobulins [1][2]. Clinical Trial Information - The Phase III clinical trial (HR-TPO-ITP-III-PED) for HAIQUPOLPA Ethanolamine Tablets achieved its primary endpoint in March 2025. The study evaluated the efficacy and safety of the drug in children and adolescents with primary immune thrombocytopenia, involving 100 participants aged 6 and above. The treatment group showed significant improvement over the control group, with good long-term safety and efficacy [1][2]. Approved Indications - HAIQUPOLPA Ethanolamine Tablets have already been approved for two indications: 1. Treatment of chronic primary immune thrombocytopenia in adults with inadequate response to corticosteroids and immunoglobulins (approved in June 2021). 2. Treatment of severe aplastic anemia in adults with poor response to immunosuppressive therapy [2]. Disease Context - ITP is an acquired autoimmune bleeding disorder characterized by skin and mucosal bleeding, with severe cases leading to internal bleeding and even intracranial hemorrhage. It is the most common bleeding disorder in children and adolescents, with an annual incidence rate of 1.6-5.3 per 100,000 for primary ITP in children aged 1 month to 18 years. Approximately 80% of cases resolve within 12 months, but about 20% persist for over a year, indicating a significant clinical treatment demand [2][3]. Market Context - HAIQUPOLPA Ethanolamine Tablets are a non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production. Similar products available internationally include Eltrombopag, Avatrombopag, and Lusutrombopag. The global sales of these similar products are approximately $2.59 billion. In China, Eltrombopag was approved in 2017, Avatrombopag in 2020, and Lusutrombopag in 2023 [3][4].

Core Viewpoint - Jiangsu Hengrui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Hecuqipar Ethanolamine Tablets, targeting the treatment of persistent and chronic primary immune thrombocytopenia (ITP) in adults and children aged 6 and above [1] Group 1: Product Development - The drug has already been approved for two adult indications [1] - The Phase III clinical trial is expected to reach its primary endpoint by March 2025 [1] - The total research and development investment for this drug has reached approximately 44.587 million yuan [1] Group 2: Market Potential - ITP is a common bleeding disorder in children and adolescents, indicating a strong clinical treatment demand [1] - Similar products are already available in foreign markets, with an estimated global sales of approximately 2.59 billion dollars in 2024 [1]

Group 1 - The core point of the article is that China Resources Double Crane (华润双鹤) announced that its subsidiary, Xiangzhong Pharmaceutical, received a drug registration certificate from the National Medical Products Administration for Hydrobromide Vortioxetine Tablets, which are used to treat adult depression [1] - The drug has been under development since 2021 and is expected to be approved for market launch by May 27, 2025 [1] - The total research and development investment for the drug has reached 12.1484 million yuan [1] Group 2 - In 2023, the global sales revenue for the drug reached 1.999 billion USD, while the domestic market sales totaled 214 million yuan [1]

Group 1: Company Developments - Boya Bio's announcement to transfer 80% stake in its subsidiary, Jiangxi Boya Xinhao Pharmaceutical, for approximately 213 million yuan, aiming to optimize business structure and focus on core development [1] - Heng Rui Pharmaceutical received clinical trial approval for two drugs, HRS-9190 and SHR-3792, with total R&D investments of approximately 6.26 million yuan and 32.71 million yuan respectively, enhancing market confidence in future performance [2] - Boya Bio's approval for clinical trials of subcutaneous immunoglobulin, which is expected to boost R&D activity and provide new profit growth points in the blood products sector [3] - Novartis plans to invest 23 billion USD over the next five years in U.S. infrastructure to ensure local production of key drugs, reflecting confidence in long-term sales growth and core profit margin targets [4] - Argenx's FDA approval of Efgartigimod pre-filled subcutaneous injection for treating specific autoimmune diseases, enhancing market opportunities for Zai Lab through collaboration [5] Group 2: Market Implications - The stake transfer by Boya Bio is expected to generate cash flow and enhance sustainable development, aligning with the company's strategic goals [1] - The clinical trial approvals for Heng Rui's drugs are likely to attract more investors and improve the company's market valuation [2] - The approval of subcutaneous immunoglobulin by Boya Bio is anticipated to strengthen its competitive position in the blood products market [3] - Novartis's investment strategy aims to mitigate tariff risks and ensure supply chain stability, which is crucial in the current uncertain regulatory environment [4] - The approval of Efgartigimod's new formulation is expected to enhance patient convenience and solidify Argenx's leadership in the FcRn antagonist market [5]