YS Biopharma Received Qualified Person Declaration for Its PIKA COVID-19 Vaccine Facility from European Union GMP

Media OutReach – 25 November 2022 – YS Biopharma Co., Ltd. (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics, today announced that its manufacturing facility for PIKA recombinant COVID-19 vaccine successfully passed an audit by a European Union (“EU”) Qualified Person (“QP”) and received QP declaration of its GMP equivalence to European Union Good Manufacturing Practice (“EU GMP”). PIKA recombinant COVID-19 vaccine is currently in a multi-country, multi-center, Phase III clinical trial in Southeast Asian and Middle East countries.
The audit was based on the guidance of EU GMP and the guiding principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The audit covered a comprehensive and in-depth audit focused on the manufacturing quality of PIKA adjuvant and PIKA recombinantCOVID-19 vaccine in the areas of pharmaceutical substance production, packaging system, quality management system and other aspects. The declaration demonstrates that the manufacturing facilities at YS Biopharma complies with European pharmaceutical GMP and has the ability to provide high quality pharmaceutical products for clinical studies and commercialization in European and international markets.
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