Core Viewpoint - The global plant alkaloid market is experiencing stable growth, with projections indicating an increase from $8.72 billion in 2015 to $14.49 billion in 2024, and further to $15.94 billion by 2025. The Chinese market is expected to grow from 37.27 billion yuan in 2015 to 60.32 billion yuan in 2024, reaching 62.6 billion yuan by 2025 [1][4]. Group 1: Industry Definition and Extraction Process - Plant alkaloids are nitrogen-containing organic compounds primarily found in plants, often existing as salts with organic acids. They are predominantly located in the roots, stems, leaves, and fruits of higher plants, especially in dicotyledons [2][3]. - The extraction methods for plant alkaloids include reflux extraction, ultrasonic-assisted extraction, and supercritical fluid extraction, with advancements in technology leading to the discovery of more alkaloids and their physiological activities [3]. Group 2: Current Industry Status - The plant alkaloid market is gaining attention due to its wide availability and excellent properties such as antioxidant, anti-tumor, and anti-inflammatory activities. The market is projected to grow steadily, with significant applications in healthcare and animal husbandry [4]. - The core product, paclitaxel, is experiencing a trend of increasing sales but decreasing prices, with new formulations being adopted rapidly. Key players in the market include Jiangsu Hengrui Medicine and Shijiazhuang Yiling Pharmaceutical [4]. Group 3: Industry Chain - The upstream of the plant alkaloid industry chain includes natural plant resources, with various plant families providing different alkaloids. The midstream involves extraction, processing, and formulation development, while the downstream focuses on applications in pharmaceuticals and health products [5]. Group 4: Development Environment and Policies - The biopharmaceutical industry is a key area for national strategic development, with policies introduced to promote high-quality growth in the pharmaceutical sector. The government is focusing on innovative drug development and improving clinical evaluation and approval processes [6]. Group 5: Competitive Landscape - Major companies in the plant alkaloid sector include Nanjing Green Leaf Pharmaceutical, Jiangsu Hengrui Medicine, and Shijiazhuang Yiling Pharmaceutical, among others. These companies are involved in the development and production of various alkaloid-based drugs [5][7]. Group 6: Industry Development Trends - The plant alkaloid industry is undergoing a transformation driven by technological innovation and market changes, with trends towards upgrading technology, green practices, and precision medicine. The demand for effective and accessible plant alkaloid drugs is rapidly increasing in emerging markets [12][13].

Core Viewpoint - The company announced that its wholly-owned subsidiary, Huaren Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (NMPA) [1][2]. Group 1: Drug Registration and Development - The drug Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older, as well as for adult patients classified as WHO functional class II to IV [1][2]. - The development of this generic drug began in 2022, with the application for marketing authorization submitted on June 14, 2024, and approval granted on September 23, 2025 [2]. Group 2: Market Situation - Bosentan dispersible tablets were developed by Actelion Pharmaceuticals Ltd and were approved for sale in the EU in 2009 under the brand name "Tracleer." The drug was imported into China in September 2019 under the brand name "Quankeli" [3]. - In 2024, the global sales of Bosentan dispersible tablets reached approximately $35.9 million, with "Tracleer" accounting for about $31.3 million of that total [3]. - In the Chinese market, the total sales of Bosentan dispersible tablets were approximately 2.126 million yuan in 2024, with Johnson & Johnson holding a 100% market share [3]. Group 3: Impact on the Company - The acquisition of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].

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]