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联邦制药(03933.HK)附属“左氧氟沙星滴眼液”通过药监局上市审批
Ge Long Hui· 2025-12-09 10:01
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 sector [1] Company Summary - The approved product is Levofloxacin Eye Drops (0.488% specification, 5ml: 24.4mg), a third-generation fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, effectively blocking bacterial DNA synthesis [1] - Levofloxacin exhibits significant antibacterial activity against various Gram-positive and Gram-negative bacteria, making it suitable for treating conditions such as blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, and keratitis, as well as for sterile treatment during ophthalmic surgeries [1] - The eye drops are classified as a Category A drug in the National Medical Insurance Directory (2024 edition), indicating strong market potential and support for the product's adoption [1] Industry Summary - The approval of Levofloxacin Eye Drops is expected to expand Federal Pharmaceutical's ophthalmic product portfolio and strengthen its competitive advantage in the field of ophthalmic infection treatment [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 ...
石四药集团(02005)取得国家药监局有关左氧氟沙星滴眼液的药品生产注册批件
Xin Lang Cai Jing· 2025-12-09 06:01
Group 1 - The company has obtained the drug production registration approval from the National Medical Products Administration (NMPA) for Levofloxacin Eye Drops (0.488% (5ml: 24.4mg)), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1][2] - Levofloxacin Eye Drops are primarily used for treating eyelid inflammation, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries, enriching the company's ophthalmic product portfolio [1][2] - The company has also announced the approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1][2] Group 2 - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing preparation before colonoscopy and X-ray examinations, and can also be used for bowel cleansing before surgical procedures [1][2] - The company's magnesium sulfate active pharmaceutical ingredient has been registered with the NMPA for use in marketed formulations, as noted in the announcement dated December 4, 2025 [1][2]
石四药集团(02005.HK)左氧氟沙星滴眼液取得药品生产注册批件
Jin Rong Jie· 2025-12-09 05:50
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company obtained a production registration for Levofloxacin Eye Drops (0.488% in 5ml, containing 24.4mg), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation. This product is primarily used for treating various eye conditions such as blepharitis, conjunctivitis, and for sterile chemotherapy during ophthalmic surgeries [1] - The company also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation. This product is mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, as well as for bowel preparation before surgical procedures [1] Group 2: Raw Material Approval - The company's magnesium sulfate raw material has been approved by the National Medical Products Administration for use in its registered formulations, indicating a solid foundation for its product offerings in the market [1]
石四药集团已取得国家药监局有关左氧氟沙星滴眼液(0.488% (5ml: 24.4mg))的药品生产注册批件
Zhi Tong Cai Jing· 2025-12-09 04:18
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company has obtained a production registration approval for Levofloxacin Eye Drops (0.488% concentration, 5ml: 24.4mg), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1] - Levofloxacin Eye Drops are primarily used for treating various eye conditions, including blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries [1] - The approval enriches the company's range of ophthalmic formulations [1] Group 2: Additional Product Approvals - The company has also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1] - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, and can also be utilized for bowel preparation before surgical procedures [1] - The company's magnesium sulfate active pharmaceutical ingredient has been approved for use in marketed formulations as of December 4, 2025 [1]
石四药集团(02005.HK)获左氧氟沙星滴眼液(0.488%(5ml:24.4mg))药品生产注册批件
Ge Long Hui· 2025-12-09 04:12
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company has obtained a production registration for Levofloxacin Eye Drops (0.488% (5ml: 24.4mg)), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1] - Levofloxacin Eye Drops are primarily used for treating various eye conditions, including blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries [1] - The approval increases the variety of ophthalmic formulations offered by the company [1] Group 2: Additional Product Approvals - The company has also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1] - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, and can also be used for bowel preparation before surgical procedures [1] - The company’s magnesium sulfate active pharmaceutical ingredient has been registered with the National Medical Products Administration for use in marketed formulations [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-12-09 04:01
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。 承董事局命 執行董事兼公司秘書 周興揚 香港,二零二五年十二月九日 於本公告日期,董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及 曲婉蓉女士,非執行董事劉文軍先生,以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策 先生。 - 2 - 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」)有關左氧氟沙星滴眼液(0.488%(5ml: 24.4mg))的藥品生產註冊批件,屬於化學藥品第4類,視同通過一致性評價。左氧氟沙星滴眼 液主要用於治療眼瞼炎、瞼腺炎、淚囊炎、結膜炎、瞼板腺炎、角膜炎以及用於眼科圍手術期 的無菌化療法。本次獲批使本集團眼用製劑的品種日漸豐富。 董事局亦欣然公告,本集團已取得國家藥監局有關複方匹可硫酸鈉顆粒(每袋含匹可硫酸鈉 10mg),屬於化學藥 ...
我国每年约3万儿童溺亡 溺水急救黄金4分钟家长必修
Yang Shi Xin Wen· 2025-07-13 03:19
Group 1 - Drowning is a significant cause of accidental death among children aged 1 to 14, with approximately 36 million deaths globally each year, of which children account for about 45% [1] - In China, around 30,000 children die from drowning annually, with rural children's mortality rate being five times higher than that of urban children [1] Group 2 - Many people mistakenly believe that drowning victims will call for help and struggle, but in reality, they often cannot make a sound, leading to the term "silent drowning" [2][3] - Signs of a child in danger of drowning include being quiet, having a vacant stare, or hair covering their face [5] Group 3 - The critical time for rescuing a drowning child is within four minutes, as loss of consciousness occurs after this period, increasing the risk of severe brain damage [6][7] - Proper rescue techniques include calling for help, clearing the airway, and performing CPR if necessary [9][11] Group 4 - Over 90% of child drowning incidents occur in seemingly safe and familiar environments, such as during brief parental absences during bath time or in unmonitored water containers [13][14] - High-risk scenarios include swimming pool accidents, natural water bodies, and unsafe behaviors like swimming without supervision [16][18] Group 5 - Children are also at risk of "pool-related illnesses," which can include skin infections, ear infections, and respiratory diseases due to poor water quality [18][19][27] - Parents should ensure proper hygiene and care after swimming to prevent infections, especially in young children [21][23] Group 6 - To assess pool water quality, individuals should look for health permits, staff health certifications, and water quality testing results [28][29] - The standard for residual chlorine in pool water is between 0.3 to 1.0 mg per liter, and visual clarity can also indicate water quality [31]