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联邦制药:盐酸莫西沙星滴眼液通过国家药品监督管理局上市审批
Zhi Tong Cai Jing· 2025-12-09 10:04
Core Viewpoint - The approval of Moxifloxacin Hydrochloride Eye Drops by the National Medical Products Administration of China marks a significant advancement for the company in the ophthalmic product sector, enhancing its competitive position in the field of anti-infection treatments [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval for Moxifloxacin Hydrochloride Eye Drops in two specifications: 0.5% (3ml: 15mg) and 0.5% (5ml: 25mg) [1] - The drug approval numbers are: National Drug Approval Code H20256128 and H20256129 [1] Group 2: Product Characteristics - Moxifloxacin Hydrochloride is classified as a fourth-generation fluoroquinolone with broad-spectrum antibacterial activity [1] - The eye drops are indicated for the treatment of bacterial conjunctivitis caused by sensitive microorganisms such as Staphylococcus aureus, Haemophilus influenzae, and Chlamydia trachomatis [1] - The product is preservative-free, minimizing the toxic effects of preservatives on ocular tissues, making it suitable for a wide range of patients [1] Group 3: Market Position and Future Outlook - The eye drops are included in the National Medical Insurance Directory (2024 version) as a Class B drug, which may enhance market access and reimbursement potential [1] - This approval is expected to further expand the company's ophthalmic product portfolio and strengthen its position in the anti-infection treatment sector [1] - The company is committed to advancing new product development to provide comprehensive and high-quality medication solutions for clinical use, which is anticipated to generate greater returns for the company and its shareholders [1]
联邦制药:左氧氟沙星滴眼液通过中国国家药品监督管理局上市审批
Zhi Tong Cai Jing· 2025-12-09 09:57
Core Viewpoint - The approval of Levofloxacin eye drops by the National Medical Products Administration of China marks a significant advancement for the company in the ophthalmic product sector, enhancing its competitive position in the field of anti-infection treatments [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., received approval for Levofloxacin eye drops (0.488% concentration, 5ml: 24.4mg) from the National Medical Products Administration of China, with the approval number H20256135 [1] - Levofloxacin is a third-generation fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, effectively blocking bacterial DNA synthesis and demonstrating significant antibacterial activity against various Gram-positive and Gram-negative bacteria [1] Group 2: Clinical Applications - Levofloxacin eye drops are widely used in clinical settings for the treatment of conditions such as blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomianitis, and keratitis, as well as for sterile treatment during ophthalmic surgeries [1] Group 3: Market Impact - The approval of Levofloxacin eye drops will further expand the company's ophthalmic product portfolio and strengthen its leading position in the field of anti-infection treatments [1] - The product is classified as a Category A drug in the National Medical Insurance Directory (2024 edition), indicating its importance and potential for market success [1] - The company is committed to advancing new product development to provide comprehensive and high-quality medication solutions for clinical use, which is expected to generate greater returns for the company and its shareholders [1]
联邦制药(03933):左氧氟沙星滴眼液通过中国国家药品监督管理局上市审批
智通财经网· 2025-12-09 09:57
Core Viewpoint - Federal Pharmaceutical's subsidiary, Zhuhai Federal Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration of China for the launch of Levofloxacin Eye Drops, enhancing the company's position in the ophthalmic infection treatment market [1] Group 1: Product Approval - Levofloxacin Eye Drops (0.488% concentration, 5ml: 24.4mg) has been granted approval with the registration number H20256135 [1] - The drug is a third-generation fluoroquinolone antibiotic that inhibits bacterial DNA synthesis, showing significant antibacterial activity against various Gram-positive and Gram-negative bacteria [1] Group 2: Clinical Applications - Levofloxacin Eye Drops are widely used for treating conditions such as blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomianitis, and keratitis, as well as for sterile treatment during ophthalmic surgeries [1] Group 3: Market Impact - The approval of Levofloxacin Eye Drops will further expand Federal Pharmaceutical's ophthalmic product portfolio and strengthen its competitive position in the field of ophthalmic infection treatment [1] - The product is classified as a Category A drug in the National Medical Insurance Directory (2024 edition), indicating its importance in the healthcare market [1] Group 4: Future Outlook - The company is committed to advancing new product development to provide comprehensive and high-quality medication solutions for clinical use, which is expected to generate greater returns for the company and its shareholders [1]
联邦制药(03933) - 有关本集团產品盐酸莫西沙星滴眼液的最新情况
2025-12-09 09:55
有關本集團產品鹽酸莫西沙星滴眼液的最新情況 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的內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 ( 於開曼群島成立之有限公司 ) (股份代號: 3933) 本公告乃由聯邦制藥國際控股有限公司(「本公司」)自願發出。 本公司董事會(「董事會」)欣然公佈,本公司全資附屬公司珠海聯邦制藥股份有限公 司中山分公司申報的鹽酸莫西沙星滴眼液(規格:0.5%(3ml:15mg)、0.5%(5ml:25mg)) 通過中國國家藥品監督管理局上市審批,藥品批准文號分別為:國藥准字 H20256128、 國藥准字 H20256129。 鹽酸莫西沙星屬於第四代喹諾酮類藥物,具有廣譜的抗菌活性。鹽酸莫西沙星滴眼液 適用於治療金黃色葡萄球菌、流感嗜血桿菌、沙眼衣原體等敏感微生物引起的細菌性 結膜炎。該產品不含防腐劑,避免了抑菌劑對眼組織的毒性作用, ...
联邦制药(03933) - 有关本集团產品左氧氟沙星滴眼液的最新情况
2025-12-09 09:52
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的內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 香港,二零二五年十二月九日 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 於本公告日期,董事會成員包括:執行董事蔡海山先生、梁永康先生、蔡紹哲女士、 方煜平先生、鄒鮮紅女士及朱蘇燕女士;以及獨立非執行董事張品文先生、宋敏教授 及傅秋實博士。 ( 於開曼群島成立之有限公司 ) (股份代號: 3933) 有關本集團產品左氧氟沙星滴眼液的最新情況 本公告乃由聯邦制藥國際控股有限公司(「本公司」)自願發出。 本公司董事會(「董事會」)欣然公佈,本公司全資附屬公司珠海聯邦制藥股份有限公 司中山分公司申報的左氧氟沙星滴眼液(規格:0.488%(5ml: 24.4mg))通過中國國家 藥品監督管理局上市審批,藥品批准文號:國藥准字 H20256135。 左氧氟沙星為第三代喹諾酮類抗生素,通過抑制細菌 DNA 旋轉酶和拓撲異構酶 ...