GAITHERSBURG, Maryland, November 15, 2022 /PRNewswire/ — YS Biopharma Co., Ltd. (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of next-generation vaccines and therapeutic biologics, today announced that its manufacturing the facility for the PIKA recombinant COVID-19 vaccine has successfully passed a European Union (“EU”) Qualified Person audit and received the QP declaration of its GMP equivalence to Union Good Manufacturing Practices European (“EU GMP”). The recombinant COVID-19 vaccine PIKA is currently undergoing a multi-country, multi-center phase III clinical trial in Southeast Asia and Middle East countries.
The audit was based on EU GMP guidelines and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The audit covered a comprehensive and in-depth audit focusing on the manufacturing quality of PIKA adjuvant and PIKA recombinant COVID-19 vaccine in the areas of pharmaceutical substance production, packaging system, management system of quality and other aspects. The statement demonstrates that YS Biopharma’s manufacturing facilities are compliant with European pharmaceutical GMPs and have the capability to supply high quality pharmaceutical products for clinical studies and commercialization in European and international markets.
About the PIKA recombinant COVID-19 vaccine
Boosted by PIKA immunomodulation technology, the PIKA recombinant COVID-19 vaccine is a combination of PIKA adjuvant and SARS-CoV-2 spike (S) subunit protein. The antigenic 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 triggers both Th1 and Th2 immune responses. PIKA adjuvant is able to promote dendritic cell activation and maturation, upregulate co-stimulatory molecules on dendritic cells, and induce B and NK cell activation and proliferation.
About YS Biopharma
YS Biopharma is a global biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulation technology platform and a series of prophylactic and therapeutic biologics targeting rabies, coronavirus, hepatitis B, shingles and influenza. YS Biopharma operates in China, Singapore, United States, in the United Arab Emirates and the Philippines, with more than 800 employees. For more information, please visit www.yishengbio.com.
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SOURCE YS Biopharma