疫苗生产许可变更

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7月21日午间公告一览:康华生物ACYW135群疫苗生产许可证变更获批
news flash· 2025-07-21 04:17
Core Viewpoint - The company, Kanghua Biological (300841), has received an updated drug production license from the Sichuan Provincial Drug Administration, allowing the resumption of production for the ACYW135 group meningococcal polysaccharide vaccine, which is now compliant with GMP standards [1] Group 1: Regulatory Approval - The production workshop for the ACYW135 group meningococcal polysaccharide vaccine has passed the GMP compliance inspection, indicating readiness for production [1] - The vaccine will be available for market sale after obtaining the qualified certificate from the China Food and Drug Inspection Institute [1] Group 2: Product and Market Impact - The vaccine is primarily used to prevent epidemic meningitis caused by various strains of meningococci and has already been exported to 10 countries [1] - The recent changes will help the company improve its product structure, although there is no significant short-term impact on financial performance [1]