Group 1 - The core point of the article is that China Resources Double Crane has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration [2] Group 2 - The announcement was made by China Resources Double Crane on the evening of September 29 [2] - The certificate was issued to the company's wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. [2]

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (济南) Co., Ltd., has received the drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (国家药监局) [1] Group 1: Product Information - Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) classified as WHO Group 1 [1] - The drug is intended to improve pulmonary vascular resistance (PVR) in pediatric patients aged 3 years and older with idiopathic or congenital PAH [1] - It is also used for the treatment of adult patients with WHO functional class II to IV pulmonary arterial hypertension (PAH) [1]

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (济南) Co., Ltd. (referred to as "Double Crane Limin"), has received the Drug Registration Certificate for Bosentan Dispersible Tablets from the National Medical Products Administration (国家药监局) [1] Group 1 - The indication for Bosentan Dispersible Tablets is for pulmonary arterial hypertension (PAH) (WHO Group 1) [1] - The drug is intended to improve pulmonary vascular resistance (PVR) in pediatric patients aged 3 years and older with idiopathic or congenital PAH [1] - It is also used for the treatment of adult patients with WHO functional class II to IV pulmonary arterial hypertension (PAH) [1]

| 药品名称 | 药品通用名称：波生坦分散片 英文名/拉丁名：Bosentan Dispersible Tablets | | --- | --- | | 剂型 | 片剂 | | 注册分类 | 化学药品 类 4 | | 规格 | 32mg(以 计) C27H29N5O6S | | 证书编号 | 2025S02969 | | 药品批准文号 | 国药准字 H20255550 | | 申请事项 | 药品注册(境内生产) | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定， 经审查，本品符合药品注册的有关要求，批准注册， | | | 发给药品注册证书。 | 一、注册证书主要内容 证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－083 华润双鹤药业股份有限公司 关于全资子公司华润双鹤利民药业(济南)有限公司 波生坦分散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。 近日，华润双鹤药业股份有限公司(以下简称"公司")全资子公 司华润双鹤利民药业(济南)有限公司(以下简称"双鹤利 ...

Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd., has received the drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration [1] Group 1: Product Development - Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged ≥3 years and adult patients classified as WHO functional class II to IV [1] - The company initiated the development of this generic drug in 2022, receiving the acceptance notice on June 20, 2024, and obtaining approval for market launch on September 23, 2025 [1] - As of the announcement date, the total R&D investment for this drug has reached 8.4359 million RMB [1]

Company Overview - China Resources Double Crane Pharmaceutical Co., Ltd. is located in Beijing and was established on May 16, 1997, with its listing date on May 22, 1997. The company is primarily engaged in the development, manufacturing, and sales of pharmaceuticals [1]. Financial Performance - For the first half of 2025, the company reported operating revenue of 5.742 billion yuan, a year-on-year decrease of 3.16%, and a net profit attributable to shareholders of 975 million yuan, down 6.79% year-on-year [2]. - The company has cumulatively distributed 4.356 billion yuan in dividends since its A-share listing, with 1.057 billion yuan distributed over the past three years [3]. Stock Performance - As of September 23, the stock price of China Resources Double Crane fell by 2.01%, trading at 18.52 yuan per share, with a total market capitalization of 19.238 billion yuan. The stock has decreased by 4.68% year-to-date and by 2.83% over the last five trading days [1]. - The stock's trading volume showed a net outflow of 17.2454 million yuan from main funds, with significant selling pressure observed [1]. Shareholder Structure - As of June 30, 2025, the number of shareholders decreased to 57,400, a reduction of 2.78%. The average circulating shares per person increased by 3.41% to 17,980 shares [2]. - The second-largest circulating shareholder is Hong Kong Central Clearing Limited, holding 12.2414 million shares, an increase of 550,200 shares compared to the previous period [3].

Group 1 - The core point of the article is that China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, Anhui Double Crane Pharmaceutical Co., Ltd. (安徽双鹤), has received a drug registration certificate for the injection of Rivaroxaban Sodium Chloride from the National Medical Products Administration [1] Group 2 - The drug registration certificate is a significant regulatory approval that allows the company to market and sell the Rivaroxaban Sodium Chloride injection in China [1] - This approval may enhance the company's product portfolio and potentially increase its market share in the pharmaceutical industry [1] - The development reflects the company's ongoing efforts to expand its offerings in the healthcare sector [1]

Core Viewpoint - China Resources Double Crane's subsidiary, Anhui Double Crane Pharmaceutical, has received approval for its sodium chloride injection of tirofiban hydrochloride, marking a significant addition to its product line [1] Company Summary - The drug received its registration certificate from the National Medical Products Administration on September 9, 2025, and is now officially approved for market launch [1] - The total R&D investment for this drug amounts to approximately 3.7558 million yuan [1] Market Summary - The estimated domestic market sales for the drug in 2024 are around 106 million yuan [1] - There are currently 18 companies approved to produce this drug, indicating a highly competitive market environment [1]

证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－082 华润双鹤药业股份有限公司 关于全资子公司安徽双鹤药业有限责任公司 盐酸替罗非班氯化钠注射液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 安徽双鹤药业有限责任公司(以下简称"安徽双鹤")收到了国家药品监 督管理局(以下简称"国家药监局")颁发的盐酸替罗非班氯化钠注射液 (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 | 药品名称 | 药品通用名称：盐酸替罗非班氯化钠注射液 英文名/拉丁名：Tirofiban Hydrochloride and Sodium | | --- | --- | | | Chloride Injection | | 剂型 | 注射剂 | | 注册分类 | 化学药品 类 3 | | | 100ml:盐酸替罗非班(按C22H36N2O5S计)5mg与氯化 钠0.9g； | | 规格 | 250ml:盐酸 ...

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, Anhui Double Crane, received a drug registration certificate from the National Medical Products Administration for the sodium chloride injection of Ticagrelor, which is an antiplatelet aggregation drug used for preventing early myocardial infarction in adult patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) [1] Company Summary - The drug is specifically indicated for adult patients experiencing chest pain within 12 hours and accompanied by ECG changes and/or elevated myocardial enzymes [1]