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")全资子公司华润赛科药业有限责任公司(以下简 称"华润赛科")收到了国家药品监督管理局(以下简称"国家药监局")颁发的比索洛尔氨氯地平片(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 ■ 三、同类药品的市场状况 比索洛尔氨氯地平片由默克(Merck Kft)公司研制开发，于2017年11月在欧盟获批上市，商品名 为"Concor AMLO?"，于2021年5月在中国获批上市。根据全球71国家药品销售数据库显示，2024年比索 洛尔氨氯地平片全球销售额为7,404.93万美元，其中"Concor AMLO?"的销售额为4,429.46万美元。 国内市场，根据国家药监局网站信息显示，中国大陆境内已批准上市的比索洛尔氨氯地平片生产企业有 14家(含华润赛科)，其中视同通过一致性评价的生产企业13家(含华润赛科)。根据米内网数据显示， 2024年国内医疗市场和零售市场比索洛尔氨氯地平片销售总额(终 ...

近日，华润双鹤药业股份有限公司(以下简称"公司")全资子公司华润赛科药业有限责任公司(以下简 称"华润赛科")收到了国家药品监督管理局(以下简称"国家药监局")颁发的比索洛尔氨氯地平片(以下简 称"该药品")《药品注册证书》。现将相关情况公告如下： 证券代码：600062 证券简称：华润双鹤 公告编号：临2025－099 华润双鹤药业股份有限公司 关于全资子公司华润赛科药业有限责任公司 比索洛尔氨氯地平片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。 一、药品注册证书主要内容 ■ 二、药品相关情况 比索洛尔氨氯地平片作为高血压治疗的替代疗法，用于目前同时服用与复方制剂剂量相同的单药且血压 控制良好的患者。 华润赛科于2022年11月启动该药品的仿制药研发工作，于2024年6月14日向国家药监局提交上市许可申 请，于2024年6月19日获得受理通知书，并于2025年11月18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 ...

Core Viewpoint - The approval of the drug registration application for Dextroamphetamine Sulfate Capsules by the National Medical Products Administration marks a significant step for the company, indicating the product is entering the review phase, which could enhance the company's product line and market competitiveness [1] Group 1 - The company's subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received the acceptance notice for the drug registration application of Dextroamphetamine Sulfate Capsules from the National Medical Products Administration [1] - Currently, there are no Dextroamphetamine Sulfate Capsules available in the domestic market, nor have any related products been approved for import [1] - The total R&D investment by Yichang Renfu in this project has reached approximately 90 million RMB [1]

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the injection of Nicorandil, which is classified as a Class 3 chemical drug for unstable angina, indicating a significant development in its product portfolio [1] Group 1: Product Approval - The injection of Nicorandil is approved with a specification of 12mg [1] - This drug was first launched in Japan in September 1993 and has not been imported as an original research product in China [1] Group 2: Market Potential - According to Mi Nei Network, the projected domestic market sales for Nicorandil in 2024 are approximately 620 million yuan [1] Group 3: R&D Investment - The company has invested around 6.78 million yuan in the research and development of this product [1] Group 4: Competitive Advantage - The approval of this product is seen as a means to enhance the company's product line and competitiveness, as it is considered to have passed the consistency evaluation [1] Group 5: Market Challenges - The production and sales of the drug may be influenced by various factors, indicating potential challenges in the market [1]

Financial Data and Key Metrics Changes - In Q3 2025, BRINSUPRI achieved $28 million in net sales, reflecting a strong early launch performance [32] - ARIKAYCE posted its largest quarter of revenue ever, up 22% year-over-year, with U.S. growth of 11% and international growth exceeding 50% [39][40] - The company raised its full-year global ARIKAYCE net revenue guidance to $420 million-$430 million, up from $405 million-$425 million previously [41] Business Line Data and Key Metrics Changes - BRINSUPRI's launch saw approximately 2,550 new patients starting treatment and about 1,700 physicians prescribing it within the first six weeks [32] - ARIKAYCE continues to perform strongly, with double-digit growth across all geographic regions [39] Market Data and Key Metrics Changes - The early days of BRINSUPRI's launch have shown broad prescribing patterns, with physicians testing the medicine on a small number of patients before wider adoption [33] - The U.S. market access for BRINSUPRI has been encouraging, with most prescriptions approved for coverage without formal contracts [36] Company Strategy and Development Direction - The company aims to position BRINSUPRI alongside leading respiratory launches like DUPIXENT and OFEV, targeting significant commercial opportunities [9] - Insmed is focused on executing multiple late-stage and commercial programs, including brensocatib and ARIKAYCE, while expanding its pipeline of earlier-stage programs [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the BRINSUPRI launch, emphasizing the need for more data from the first full quarter to assess long-term trends [51] - The company is well-capitalized with approximately $1.7 billion in cash, allowing it to support the launch of BRINSUPRI and other portfolio programs [41][43] Other Important Information - The company received a positive opinion from Europe's CHMP for brensocatib, anticipating a potential EU launch in early 2026 [12][13] - Insmed was awarded the number one ranking on Science Magazine's Top Employers list for the fifth consecutive year, highlighting its strong company culture [31] Q&A Session Summary Question: Early feedback on physician experience with BRINSUPRI - Management noted positive feedback from physicians, with enthusiasm for the medicine and manageable reimbursement processes during the early launch phase [47][49] Question: Thresholds for payer coverage and prior authorization - The company aims for clear and non-burdensome criteria for approval, focusing on patients with two or more exacerbations and confirmed diagnoses [54][56] Question: Dynamics of patient journey and DTC impact - There is clear enthusiasm from patients, with social media activity reflecting excitement about the new medicine [66] Question: Investment needed for European launch - The strategy involves cautious investment in Europe, ensuring reimbursement aligns before significant additional investments [70] Question: Phase III design considerations for TPIP - Management is confident in overcoming orphan drug exclusivity and plans to leverage insights from previous studies to inform the design of upcoming trials [75][78]

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 - 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].