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

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]