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普洛药业药品研发再获进展 头孢泊肟酯片通过一致性评价
Zheng Quan Ri Bao Wang· 2025-09-30 06:42
Core Viewpoint - Prolo Pharmaceutical Co., Ltd. has received approval for its Cephalosporin antibiotic, which is expected to enhance its market competitiveness and operational development [1] Group 1: Product Approval - Prolo Pharmaceutical's wholly-owned subsidiary, Zhejiang Prolo Jutai Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration regarding the approval of the supplement application for Cephalosporin Poxacillin tablets [1] - Cephalosporin Poxacillin is an oral broad-spectrum third-generation cephalosporin that exhibits antibacterial activity against both Gram-positive and Gram-negative bacteria [1] Group 2: Indications and Efficacy - The indications for Cephalosporin Poxacillin include infections caused by sensitive bacteria, such as upper and lower respiratory tract infections, uncomplicated urinary tract infections, uncomplicated skin and soft tissue infections, acute uncomplicated gonococcal urethritis, cervicitis, and perianal infections caused by Neisseria gonorrhoeae [1] Group 3: R&D Investment and Market Impact - As of the announcement date, the total R&D investment for Cephalosporin Poxacillin tablets (0.1g specification) amounted to RMB 8.1768 million [1] - The product has passed the consistency evaluation of generic drug quality and efficacy, which is expected to expand its future market space and enhance Prolo Pharmaceutical's market competitiveness [1]
9月29日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-29 10:45
Group 1 - Yinglian Co., Ltd. expects a net profit increase of 1531.13% to 1672.97% year-on-year for the first three quarters of 2025, with projected revenue of 1.63 billion to 1.65 billion yuan, a growth of 9.49% to 10.83% [1] - Meixin Sheng plans to reduce its shareholding by no more than 1% through centralized bidding and block trading [1] - Huayin Technology signed two sales contracts totaling 402 million yuan, with one contract for special functional materials and another for research project materials [3] Group 2 - Shen Highways reported a total toll revenue of 114 million yuan for August [5] - Dash Smart signed a contract worth 113 million yuan for a smart hospital project [7] - Tianbang Food received an administrative regulatory measure decision from the China Securities Regulatory Commission for failing to disclose information in a timely manner [8] Group 3 - Fashilong plans to invest 250 million yuan to establish a wholly-owned subsidiary focused on AI applications and cloud computing [10] - Junpu Intelligent received a government subsidy of 20 million yuan, accounting for 243.97% of its audited net profit for 2024 [11] - Longyun Co. plans to apply for a bank credit limit of 32 million yuan [12] Group 4 - Yifan Pharmaceutical's subsidiary received acceptance for a drug registration application for a medication used to lower phenylalanine levels in patients [12] - Rundu Co. received a drug registration certificate for a hypertension medication [13] - Huahai Qingke elected a new employee director and appointed a new vice president [17] Group 5 - Wanyi Technology received a government subsidy of 173,000 yuan [19] - Haizheng Pharmaceutical's tacrolimus capsules passed the consistency evaluation for generic drugs [20] - Pulaike's new veterinary vaccine received registration certification [22] Group 6 - Boguang New Materials signed a major sales contract estimated at 4.3 billion to 5 billion yuan for nickel powder products [41] - Electric Soul Network announced plans for shareholders to reduce their holdings by up to 1.63% [42] - Jin Haitong's shareholders plan to reduce their holdings by up to 3% [44]
普洛药业(000739.SZ):头孢泊肟酯片获得药品补充申请批准通知书
Ge Long Hui A P P· 2025-09-29 08:06
Core Viewpoint - Prolo Pharmaceutical (000739.SZ) announced that its wholly-owned subsidiary, Zhejiang Prolo Jutai Pharmaceutical Co., Ltd., received the approval notice for the supplementary application of Cefoperazone Ester Tablets from the National Medical Products Administration [1] Group 1: Product Information - Cefoperazone Ester is an oral broad-spectrum third-generation cephalosporin that exerts antibacterial effects after being hydrolyzed by non-specific esterases in the body [1] - The drug is effective against both Gram-positive and Gram-negative bacteria [1] - It is indicated for infections caused by sensitive bacteria, including upper respiratory tract infections, lower respiratory tract infections, uncomplicated urinary tract infections, uncomplicated skin and soft tissue infections, acute uncomplicated gonococcal urethritis, cervicitis, and perianal infections caused by Neisseria gonorrhoeae [1]
普洛药业:头孢泊肟酯片获得药品补充申请批准通知书
Ge Long Hui· 2025-09-29 08:05
Core Viewpoint - Prolo Pharmaceutical (000739.SZ) announced that its wholly-owned subsidiary, Zhejiang Prolo Jutai Pharmaceutical Co., Ltd., received the approval notice for the supplementary application of Cefoperazone Tablets from the National Medical Products Administration [1] Group 1: Product Information - Cefoperazone is an oral broad-spectrum third-generation cephalosporin that exerts antibacterial effects after being hydrolyzed by non-specific esterases in the body [1] - The drug is effective against both Gram-positive and Gram-negative bacteria [1] - It is indicated for infections caused by sensitive bacteria, including upper respiratory tract infections, lower respiratory tract infections, uncomplicated urinary tract infections, uncomplicated skin and soft tissue infections, acute uncomplicated gonococcal urethritis, cervicitis, and perianal infections caused by Neisseria gonorrhoeae [1]
普洛药业:头孢泊肟酯片通过仿制药质量和疗效一致性评价
Xin Lang Cai Jing· 2025-09-29 07:47
Core Viewpoint - The announcement indicates that the company's wholly-owned subsidiary, Zhejiang Pro Pharmaceutical Co., Ltd., has received approval for the drug Cefoperazone Ester Tablets from the National Medical Products Administration, which is expected to enhance market competitiveness and positively impact future development [1] Group 1: Product Approval - The drug Cefoperazone Ester Tablets is an oral broad-spectrum third-generation cephalosporin, suitable for treating infections caused by sensitive bacteria, including upper and lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, and gonococcal infections [1] - The approval is expected to facilitate market expansion and sales through consistency evaluation, thereby enhancing the product's market competitiveness [1] Group 2: Market Potential - The projected domestic sales for the year 2024 are estimated to reach 128 million yuan, with clinical hospital sales amounting to 108 million yuan and retail pharmacy sales reaching 20 million yuan [1] - Cumulative R&D investment up to the date of the announcement is 8.1768 million yuan, indicating a commitment to product development [1]
康芝药业(300086) - 关于头孢泊肟酯片通过仿制药一致性评价的公告
2025-02-27 12:08
证券代码:300086 证券简称:康芝药业 公告编号:2025-005 康芝药业股份有限公司 关于头孢泊肟酯片通过仿制药一致性评价的公告 本公司及董事会全体成员保证公告内容真实、准确、完整,没有虚假记 载、误导性陈述或重大遗漏。 康芝药业股份有限公司(以下简称"公司")近日收到国家药品监督管理局下 发的头孢泊肟酯片《药品补充申请批件》,公司头孢泊肟酯片通过仿制药质量和疗 效一致性评价(以下简称"仿制药一致性评价"),现将相关情况公告如下: 一、药品基本情况 产品:头孢泊肟酯片 英文名/拉丁名:Cefpodoxime Proxetil Tablets 商品名称:西博特欣 剂型:片剂 规格:100mg 注册分类:化学药品 原药品批准文号:国药准字 H20030591 药品注册标准编号:YBH03772025 上市许可持有人及生产企业:康芝药业股份有限公司 相关审批结论:根据《中华人民共和国药品管理法》《国务院关于改革药品医 疗器械审评审批制度的意见》(国发〔2015〕44 号)和《关于仿制药质量和疗效一 致性评价工作有关事项的公告》(2017 年第 100 号)的规定,经审查,本品通过 仿制药质量和疗效一致性评价 ...