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广西梧州中恒集团股份有限公司关于控股子公司获得药品补充申请批准通知书的公告
Core Viewpoint - The announcement highlights that Chongqing Laimei Pharmaceutical Co., Ltd., a subsidiary of Guangxi Wuzhou Zhongheng Group Co., Ltd., has received approval for a supplementary application for the injectable drug Aztreonam, which is expected to enhance its market competitiveness and future expansion opportunities [1][3]. Group 1: Drug Information - Aztreonam is indicated for the treatment of infections caused by sensitive Gram-negative bacteria, including urinary tract infections, lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]. - The drug was developed by the French company Bristol-Myers Squibb and was first launched in France in 1983, followed by Italy in 1984, and subsequently in other European and American countries, with its introduction to China occurring in 1997 [1]. Group 2: Market Data - According to MoShang data, the sales revenue of Aztreonam in Chinese hospitals for the years 2023 to the first half of 2025 is projected to be 259 million yuan, 220 million yuan, and 40 million yuan, respectively [2]. - As of the date of the announcement, Laimei Pharmaceutical has invested a total of 6.3781 million yuan in the research and development of Aztreonam (unaudited data) [2]. Group 3: Impact on the Company - The approval of the supplementary application for Aztreonam is expected to improve the product's market competitiveness and facilitate future market expansion for the company [3]. - The pharmaceutical production and sales are subject to uncertainties due to factors such as changes in national policies, bidding procurement, and market environment fluctuations [3].
中恒集团:控股子公司获得药品补充申请批准通知书
Ge Long Hui· 2025-11-27 09:43
Core Viewpoint - Zhongheng Group's subsidiary, Chongqing Laimei Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Amikacin (0.5g), which is expected to enhance the product's market competitiveness and future market expansion [1] Group 1: Product Approval - The approval notification for Amikacin injection is a significant milestone for Laimei Pharmaceutical, as it allows the company to strengthen its position in the market [1] - Amikacin is indicated for treating infections caused by sensitive Gram-negative bacteria, including urinary tract infections, lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1] Group 2: Market Data - According to MoShang data, the sales revenue of Amikacin in Chinese hospitals is projected to be CNY 259 million, CNY 220 million, and CNY 40 million for the years 2023, 2024, and the first half of 2025, respectively [1] - As of the date of the announcement, Laimei Pharmaceutical has invested a total of CNY 6.3781 million in the research and development of Amikacin (unaudited data) [1] Group 3: Competitive Landscape - The approval is expected to improve the market competitiveness of Amikacin, which has been produced by 12 manufacturers that have passed the consistency evaluation [1]
莱美药业(300006.SZ):注射用氨曲南获得药品补充申请批准通知书
Ge Long Hui A P P· 2025-11-27 08:07
Core Viewpoint - Lai Mei Pharmaceutical has received approval from the National Medical Products Administration for the injection of Aztreonam (0.5g), which is indicated for the treatment of infections caused by sensitive Gram-negative bacteria [1] Group 1 - The approved drug, Aztreonam, is suitable for treating various infections, including urinary tract infections (both uncomplicated and complicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]
莱美药业:注射用氨曲南获得药品补充申请批准通知书
Ge Long Hui· 2025-11-27 07:59
Core Viewpoint - Lai Mei Pharmaceutical has received approval from the National Medical Products Administration for the injection of Aztreonam (0.5g), which is indicated for the treatment of infections caused by sensitive Gram-negative bacteria [1] Group 1 - The approved drug, Aztreonam, is suitable for treating various infections, including urinary tract infections (both uncomplicated and complicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]
上海医药:两款药品通过仿制药一致性评价
Cai Jing Wang· 2025-11-11 05:24
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Shiyuan New Asia Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for its injectable drugs, Cefuroxime Sodium and Aztreonam, which passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Drug Approvals - The injectable Cefuroxime Sodium is indicated for infections caused by specific sensitive strains of microorganisms, including respiratory, ENT, urinary tract, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, and postpartum and gynecological infections [1] - Cefuroxime Sodium was originally developed by GSK and launched in countries like the UK and Italy in 1978 [1] - The projected procurement amount for Cefuroxime Sodium injection in Chinese hospitals for 2024 is RMB 2.62 billion [1] Group 2: Aztreonam Details - Injectable Aztreonam is indicated for infections caused by sensitive Gram-negative bacteria, including urinary tract infections (both complicated and uncomplicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1] - Aztreonam was developed by BMS and first launched in Italy in 1984 [1] - The projected procurement amount for Aztreonam injection in Chinese hospitals for 2024 is RMB 163 million [1]
超颖电子14.68亿加码PCB;*ST元成触及交易类强制退市丨公告精选
Group 1: Company Announcements - ChaoYing Electronics' wholly-owned subsidiary plans to invest 1.468 billion RMB in an AI computing high-end printed circuit board expansion project in Thailand, aiming to enhance its product layout in high-end PCB applications such as routers and AI servers [1] - DeMingLi is in the process of planning a refinancing matter, which is still in the internal communication stage without a clear plan or determined financing amount [1] - *ST YuanCheng's stock has triggered mandatory delisting due to a market capitalization below 500 million RMB for 20 consecutive trading days, leading to a suspension of trading starting November 11, 2025 [1] Group 2: Investment and Cooperation - ZhongBei Communication signed a framework agreement for comprehensive computing services worth 1 billion RMB with Hongxin Electronics, with a service period of 60 months [2] - ShangTai Technology plans to invest approximately 4.07 billion RMB in a project to produce 200,000 tons of lithium-ion battery anode materials in Shanxi Province [3] Group 3: Clinical Trials and Approvals - Maiwei Bio's innovative drug 9MW3811 injection for pathological scars has received approval for a Phase II clinical trial, with plans to start by the end of 2025, positioning it as the first IL-11 targeted drug in this indication [3]
上海医药两款药品通过仿制药一致性评价
Bei Jing Shang Bao· 2025-11-10 10:19
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for its generic drugs, injectable Cefuroxime Sodium and injectable Aztreonam, confirming their quality and efficacy consistency [1] Group 1: Company Developments - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyuan New Asia Pharmaceutical Co., Ltd., has been granted a Supplementary Drug Application Approval Notice [1] - The injectable Cefuroxime Sodium is indicated for treating infections caused by specific strains of microorganisms in respiratory, ENT, and urinary tract infections, first launched in 1978 in countries like the UK and Italy [1] - The injectable Aztreonam is used for treating urinary tract infections (both complex and uncomplicated) and lower respiratory tract infections caused by sensitive Gram-negative bacteria, first launched in Italy in 1984 [1]
上海医药(02607.HK):注射用头孢呋辛钠及注射用氨曲南通过仿制药一致性评价
Ge Long Hui· 2025-11-10 09:41
Core Insights - Shanghai Pharmaceuticals' subsidiary, Shanghai Shenyang Pharmaceutical Co., has received approval from the National Medical Products Administration for its injectable drugs, Cefuroxime Sodium and Aztreonam, which have passed the consistency evaluation for generic drug quality and efficacy [1][2] Group 1: Cefuroxime Sodium - Cefuroxime Sodium is indicated for infections caused by specific sensitive strains of microorganisms, including respiratory, ENT, urinary, skin, and soft tissue infections, among others [1] - The drug was originally developed by GSK and launched in the UK and Italy in 1978 [1] - As of the announcement date, the company has invested approximately RMB 3.5343 million in the research and development of this drug [1] - The total procurement amount for Cefuroxime Sodium injection in mainland China hospitals in 2024 is projected to be RMB 2,621.73 million [1] Group 2: Aztreonam - Aztreonam is used to treat infections caused by sensitive Gram-negative bacteria, including urinary tract infections, lower respiratory tract infections, and skin infections [2] - The drug was developed by BMS and first launched in Italy in 1984 [2] - The company has invested approximately RMB 6.6794 million in the research and development of Aztreonam [2] - The total procurement amount for Aztreonam injection in mainland China hospitals in 2024 is projected to be RMB 162.7 million [2]
上海医药:关于注射用头孢呋辛钠及注射用氨曲南通过仿制药一致性评价的公告
Core Viewpoint - Shanghai Pharmaceuticals announced the approval of its injectable drugs, Cefuroxime Sodium and Aztreonam, by the National Medical Products Administration, indicating successful consistency evaluation of generic drug quality and efficacy [1] Group 1 - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyuan New Asia Pharmaceutical Co., Ltd., received approval for injectable Cefuroxime Sodium and Aztreonam [1] - The approval was granted through the issuance of Supplementary Application Approval Notices with specific notification numbers [1] - The approved drugs have passed the consistency evaluation for generic drug quality and efficacy [1]
上海医药:注射用头孢呋辛钠及注射用氨曲南通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-11-10 07:45
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shenyang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for its injectable drugs, Cefuroxime Sodium and Aztreonam, which passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Drug Approvals - The injectable Cefuroxime Sodium is indicated for infections caused by specific sensitive strains of microorganisms, including respiratory infections, ENT infections, urinary tract infections, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, as well as postpartum and gynecological infections [1] - The injectable Aztreonam is indicated for infections caused by sensitive Gram-negative bacteria, including urinary tract infections (both complicated and uncomplicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]