YS Biopharma Co., Ltd., a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics, 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 recombinant COVID-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.
Empowered by PIKA immunomodulating technology, PIKA recombinant COVID-19 vaccine is combination of the PIKA adjuvant and the SARS-CoV-2 spike (S) subunit protein. The antigen component of this candidate vaccine is based on the recombinant SARS-CoV-2 spike protein subunit with a stable prefusion S trimeric protein structure. PIKA adjuvant is a synthetic chemical analogue of double-stranded RNA (dsRNA) acting as a TLR3 agonist, which elicits both Th1 and Th2 immune responses. PIKA adjuvant is able to promote the activation and maturation of dendritic cells, upregulate the co-stimulatory molecules on dendritic cells and induce the activation and proliferation of both B and NK cells.
YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of prophylactic and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Shingles, and influenza.