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浙江康恩贝制药股份有限公司 关于子公司盐酸丙卡特罗吸入溶液获得药品注册证书的公告
Core Viewpoint - Zhejiang Kang En Bei Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for two specifications of the drug "Bromhexine Hydrochloride Inhalation Solution," indicating a significant step in expanding its product portfolio and potential market presence [1][2]. Drug Basic Information - The drug is named Bromhexine Hydrochloride Inhalation Solution, available in two specifications: (1) 0.3ml:30μg and (2) 0.5ml:50μg [1]. - It is classified as a Class 3 chemical drug, with the registration numbers H20256396 and H20256397 [1]. - The approval confirms that the drug meets the registration requirements under the Drug Administration Law of the People's Republic of China [1]. Market Context - Bromhexine Hydrochloride was first launched in Japan in 2002 under the brand name "Meptin," and it has not been marketed in the US, UK, or EU [2]. - The drug is primarily used to relieve symptoms of bronchial asthma, chronic bronchitis, and emphysema [2]. - In 2024, the total sales amount for Bromhexine Hydrochloride Inhalation Solution in domestic retail and medical terminals is projected to be 130 million yuan [4]. R&D Investment - The company has invested approximately 6.85 million yuan in the research and development of Bromhexine Hydrochloride Inhalation Solution [3]. Competitive Landscape - As of the announcement date, there are 16 domestic manufacturers, including Kang En Bei, that have received approval for the Class 3 chemical drug registration of Bromhexine Hydrochloride [4]. - The drug is listed as a Class B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 edition) [4].
12月29日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-29 11:51
Group 1 - Nan Mining Group signed a procurement contract for iron ore equipment worth 3 billion yuan with Lanyan Weiye Mineral Processing Co., Ltd., for a project processing over 4.6 million tons of ore annually, with an estimated operational cost of 3 billion yuan over 10 years [1] - Guangdong Yuedian A's Dapu Power Plant Phase II Project's Unit 4 has commenced commercial operation, with a total investment of 8.122 billion yuan and an expected annual power generation of 9 billion kilowatt-hours [2] - China Energy Engineering's subsidiary won an EPC general contracting project in Shaanxi Province with a bid amount of approximately 6.864 billion yuan, covering ecological governance, infrastructure, urban renewal, and water conservancy projects, with a total construction period of 36 months [3] Group 2 - ST Dongtong's stock will resume trading on December 30, 2025, entering a delisting arrangement period of 15 trading days, with the last trading date expected to be January 21, 2026 [4] - Roman Co.'s subsidiary signed a contract for a computing power service project worth approximately 156 million yuan with Tianjin Maoyuan Equipment Leasing Co., Ltd. and China Merchants Intelligent Supply Chain Service Co., Ltd. [5] - Hangzhou Thermal Power plans to sign a three-year coal purchase contract with Shanghai Yitai Shenpu for a total of 9 million tons, ensuring stable coal supply from 2026 to 2028 [6] Group 3 - Caitong Securities received approval from the China Securities Regulatory Commission to publicly issue bonds totaling no more than 15 billion yuan [7] - Qipai Technology's application for a stock issuance to specific investors has been approved by the Shanghai Stock Exchange [8] - China Software plans to sell 555 units of X86 servers and two properties to optimize idle assets, with a total estimated value of approximately 6.758 million yuan [10] Group 4 - Xinhua Medical received medical device registration certificates for two products, including an interleukin-6 test kit and a dual test kit for procalcitonin/interleukin-6 [11] - Shandong Haohua announced the resignation of Deputy General Manager Yuan Falin due to personal reasons [12] - Haixiang Pharmaceutical's invested company NWRD06 injection has completed the enrollment of the first subject in its Phase II clinical trial [13] Group 5 - Tiantong Co. terminated the absorption merger of its wholly-owned subsidiary Tiantong Rijing Precision Technology Co., Ltd., retaining its independent legal status [14] - Ruima Precision's subsidiary received a project designation for automotive air suspension systems, with an estimated sales revenue of approximately 1.342 billion yuan over a six-year lifecycle [15] - Ningbo Huaxiang's subsidiary signed a strategic cooperation agreement with Qianxing Future to enhance collaboration in the development and manufacturing of quadruped robots [16] Group 6 - Huali Co. terminated the acquisition of a 51% stake in Zhongke Huilian due to failure to reach consensus on key transaction terms [17] - Acolyte's olefin copolymer has passed customer verification and is now in bulk supply for the optical lens sector [18] - Tianjian Technology signed a supplementary agreement for military product price adjustments, expecting a revenue reduction of approximately 256 million yuan [19] Group 7 - Southeast Network Framework won an EPC project bid for the "China Vision Valley Industrial Base" with a total bid amount of 888 million yuan [20] - Baodi Mining plans to acquire 87% of Congling Energy for a total of 685 million yuan through a combination of cash and share issuance [21] - Heng Rui Pharmaceutical received clinical trial approval for multiple drugs, including HRS-6257 tablets for treating acute and chronic pain [22] Group 8 - Zhongxin Saike received a dividend of 60 million yuan from its wholly-owned subsidiary [23] - ST Songfa's subsidiary signed a contract for the construction of an oil tanker with a total contract value of approximately 80 to 100 million USD [24] - China Resources Double Crane received clinical trial approval for hydroxocobalamin injection, aimed at treating metabolic disorders in children [25][26]
康恩贝子公司盐酸丙卡特罗吸入溶液获得药品注册证书
Bei Jing Shang Bao· 2025-12-29 11:21
Core Viewpoint - Kang En Bei (600572) has received approval from the National Medical Products Administration for two specifications of the inhalation solution of Salbutamol Hydrochloride, indicating a significant advancement in its product portfolio and potential market opportunities in the respiratory medication sector [1] Group 1: Company Developments - Kang En Bei's wholly-owned subsidiary, Zhejiang Jinhua Kang En Bei Biopharmaceutical Co., Ltd., has been granted drug registration certificates for Salbutamol Hydrochloride inhalation solution with approval numbers H20256396 and H20256397 [1] - The inhalation solution was first launched in Japan in 2002 under the brand name "Meptin" [1] Group 2: Product Information - The approved specifications for the inhalation solution are 0.5ml:50μg and 0.3ml:30μg, which are set to be marketed in China in 2023 and 2024 respectively [1] - The primary indications for the inhalation solution include alleviating symptoms of bronchial asthma, chronic bronchitis, and emphysema, which are diseases characterized by airflow limitation [1]
康恩贝(600572.SH):子公司盐酸丙卡特罗吸入溶液获得药品注册证书
Ge Long Hui A P P· 2025-12-29 09:13
Core Viewpoint - Kang En Bei (600572.SH) has received approval from the National Medical Products Administration for two specifications of the inhalation solution of salbutamol, which is primarily used to alleviate symptoms of bronchial asthma, chronic bronchitis, and emphysema, among other airflow-restricted diseases [1] Group 1 - The company’s wholly-owned subsidiary, Zhejiang Jinhua Kang En Bei Biopharmaceutical Co., Ltd., is responsible for the newly approved medication [1] - The inhalation solution is aimed at treating respiratory conditions that involve airflow limitation [1]
康恩贝:盐酸丙卡特罗吸入溶液获得药品注册证书
Core Viewpoint - Kang En Bei (600572) announced the approval of two specifications of hydrochloride pirbuterol inhalation solution by the National Medical Products Administration, which is primarily used to relieve symptoms of bronchial asthma, chronic bronchitis, and emphysema based on airflow limitation [1] Group 1 - The product received a drug registration certificate from the National Medical Products Administration [1] - The inhalation solution is intended for the treatment of respiratory diseases [1]
康恩贝:子公司盐酸丙卡特罗吸入溶液获得药品注册证书
Xin Lang Cai Jing· 2025-12-29 09:01
Core Viewpoint - The company has received approval from the National Medical Products Administration for two specifications of the drug, Salbutamol Hydrochloride Inhalation Solution, which is primarily used to alleviate symptoms of bronchial asthma, chronic bronchitis, and emphysema [1] Group 1 - The company's wholly-owned subsidiary, Zhejiang Jinhua Kang En Bei Biopharmaceutical Co., Ltd., has been granted a drug registration certificate for Salbutamol Hydrochloride Inhalation Solution [1] - The drug is indicated for diseases characterized by airflow limitation, including bronchial asthma, chronic bronchitis, and emphysema [1] - The company has invested approximately 6.85 million RMB in the research and development of Salbutamol Hydrochloride Inhalation Solution to date [1]
石四药集团已取得国家药监局有关氨茶硷片的药品生产注册批件
Zhi Tong Cai Jing· 2025-11-24 09:01
Core Viewpoint - The company Shijiazhuang Pharmaceutical Group has received production registration approvals from the National Medical Products Administration of China for several pharmaceutical products, indicating significant progress in its product portfolio and market positioning [1] Group 1: Product Approvals - The company has obtained production registration for Aminophylline Tablets (100mg), classified as a Class 3 chemical drug, making it the third domestic company to receive such approval [1] - Aminophylline Tablets are primarily used for alleviating symptoms of bronchial asthma, asthmatic bronchitis, and obstructive pulmonary emphysema, and can also treat asthma caused by cardiogenic pulmonary edema [1] - The company's raw material for Aminophylline has also been approved for use in marketed formulations by the National Medical Products Administration [1] Group 2: Additional Product Approvals - The company has also secured production registration for Hydrochloride of Picarbital Inhalation Solution (0.5ml: 50μg) and Injection of Dihydrosodium Adenosine Triphosphate (0.5g), classified as Class 3 and Class 4 chemical drugs respectively [1] - Hydrochloride of Picarbital Inhalation Solution is mainly used to relieve symptoms associated with bronchial asthma, chronic bronchitis, and emphysema with airflow limitation [1] - Injection of Dihydrosodium Adenosine Triphosphate is primarily used for treating intrahepatic cholestasis caused by liver cirrhosis and cholestasis during pregnancy [1]
石四药集团(02005.HK):氨茶碱片等三药品获注册批件
Ge Long Hui· 2025-11-24 08:35
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration for several pharmaceutical products, indicating a significant advancement in its product portfolio and market position in the pharmaceutical industry [1] Group 1: Product Approvals - The company has obtained the production registration approval for Aminophylline Tablets (100mg), classified as a Class 3 chemical drug, making it the third domestic company to receive such approval [1] - Aminophylline Tablets are primarily used for alleviating symptoms of bronchial asthma, asthmatic bronchitis, and obstructive pulmonary emphysema, and can also be used to treat asthma caused by cardiogenic pulmonary edema [1] - The company’s Aminophylline raw material has also been approved for use in marketed formulations by the National Medical Products Administration [1] Group 2: Additional Product Approvals - The company has secured production registration approvals for Salbutamol Inhalation Solution (0.5ml: 50μg) and Injection Adenosine Methionine (0.5g), classified as Class 3 and Class 4 chemical drugs, respectively [1] - Salbutamol Inhalation Solution is mainly used to relieve symptoms associated with bronchial asthma, chronic bronchitis, and emphysema based on airflow limitation [1] - Injection Adenosine Methionine is primarily used for treating intrahepatic cholestasis caused by liver cirrhosis and cholestasis during pregnancy [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-11-24 08:31
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示,概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 自願公告 產品開發的最新進展 石四藥集團有限公司(「本公司」,連同其附屬公司,「本集團」)董事局(「董事局」)欣然公告, 本集團已取得中國國家藥品監督管理局(「國家藥監局」)有關氨茶鹼片(100mg)的藥品生產 註冊批件,屬於化學藥品第3類,視同通過一致性評價,是國內企業第三家獲批。氨茶鹼片主要 用於支氣管哮喘、喘息型支氣管炎、阻塞性肺氣腫等緩解喘息症狀,也可用於治療心源性肺水 腫引起的哮喘。本集團的氨茶鹼原料藥已獲國家藥監局批准登記成為在上市製劑使用的原料藥。 董事局亦欣然公告,本集團已取得國家藥監局有關鹽酸丙卡特羅吸入溶液(0.5ml:50μg)及注射 用丁二磺酸腺苷蛋氨酸(0.5g)的藥品生產註冊批件,分別屬於化學藥品第3類及第4類,視同通 過一致性評價。鹽酸丙卡特羅吸入溶液主要用於緩解支氣管哮喘、慢性支氣管炎及肺氣腫以氣 流受限為基礎的各種症狀。注射用丁二磺酸腺苷蛋氨酸主要用於治療肝硬化前和肝 ...
浏阳经开区4家药企8个药品拟纳入第十一批国家集采
Chang Sha Wan Bao· 2025-10-31 12:11
Core Insights - The 11th batch of national organized drug centralized procurement results has been announced, with 55 drugs selected, covering various therapeutic areas such as anti-infection, anti-allergy, anti-tumor, and more [1][2] - A total of 272 companies with 453 products have been proposed for selection, indicating a significant participation from the pharmaceutical industry [1] - The procurement aims to stabilize clinical use, ensure quality, counteract price wars, and prevent collusion in bidding processes [1] Group 1: Selected Companies and Products - Hunan Jiutian Pharmaceutical Co., Ltd. has 11 products selected in total, including Dapagliflozin tablets and Nicorandil tablets [1] - Hunan Warner Pharmaceutical Co., Ltd. has 22 products selected for national or regional procurement, including Benidipine Hydrochloride tablets [2] - Hunan Xianshi Pharmaceutical Co., Ltd. has three drugs selected, including inhalation solutions and capsules for treating various conditions [2] Group 2: Pricing and Market Impact - The centralized procurement process has significantly reduced drug prices, alleviating the financial burden on patients [2] - For instance, the price of imported Malatoparib tablets was previously between 4000 to 5000 yuan, while the locally produced version is priced under 40 yuan [2] - This pricing strategy aims to break the monopoly of imported drugs and enhance patient accessibility [2] Group 3: Company Innovations and Investments - Mingrui Pharmaceutical has invested over 400 million yuan in new drug research and development, successfully launching numerous new products [3] - The company’s selected product, Rosasthit capsules, is aimed at treating anemia caused by chronic kidney disease [3] - Mingrui's commitment to innovation is evident through its continuous product development and market introduction [3]