普洛药业股份有限公司 关于获得药品注册证书的公告

Core Viewpoint - The company has received a drug registration certificate for Cefdinir Dry Suspension, marking it as the first domestic generic drug approved and deemed to have passed the consistency evaluation of quality and efficacy, which will enhance its market competitiveness and eligibility for national medical insurance negotiations [1][5]. Group 1: Drug Registration Approval - Product Name: Cefdinir Dry Suspension [8] - Dosage Form: Oral Suspension [8] - Specifications: 1.5g (125mg/5ml); 3.0g (250mg/5ml) [8] - Registration Classification: Chemical Drug Class 3 [8] - License Holder: Zhejiang Pro Pharmaceutical Co., Ltd. [8] - Production Company: Zhejiang Pro Pharmaceutical Co., Ltd. [8] - Certificate Numbers: 2025S03414; 2025S03415 [8] - Drug Approval Numbers: National Drug Standard H20255948; H20255949 [8] Group 2: Drug Information - Cefdinir Dry Suspension is a third-generation oral cephalosporin antibiotic, suitable for treating mild to moderate infections in children caused by specified sensitive strains of microorganisms [2]. - Indications include acute bacterial otitis media, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections [2]. Group 3: Market Impact - The estimated market size for Cefdinir oral dosage forms in China's hospital market for 2024 is 530 million tablets, with a sales value of 760 million yuan [3]. - The total R&D investment for Cefdinir Dry Suspension as of the announcement date is 10.2427 million yuan [4]. - The approval of Cefdinir Dry Suspension will facilitate participation in national medical insurance negotiations, thereby expanding market sales and enhancing competitiveness [5].