PG电子试玩平台

We completed the construction of our manufacturing facility for innovative vaccines (CHO cell) in Taizhou, Jiangsu province in November 2021 and obtained a vaccine manufacturing license issued by Jiangsu MPA. The manufacturing facility has a total GFA of approximately 17,000 sq.m., and can also be used for the manufacturing of a variety of innovative vaccines (CHO cell), including recombinant shingles vaccines. On April 9, 2022, the Company received the European Union (EU) Qualified Person Declaration issued by a Qualified Person (QP) for our innovative vaccines (CHO cell) manufacturing facility in Taizhou.

Pursuant to Eudralex Vol 4 regulations (EU Good Manufacturing Practice) and the guiding principles of International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE), etc., this EU QP audit mainly focused on the bulk and preparation of antigen and the novel adjuvant BFA03, covering manufacturing management system, quality management system, production equipment and facility management system, validation and computerized systems, material management systems, product testing and release management and other aspects of a comprehensive systematic and in-depth inspection. This signifies the Group’s manufacturing facility in Taizhou and its quality management system have met EU GMP standards, laying a solid foundation for the high-quality development and future international commercialisation of Innovation vaccine.

At present, the manufacturing facility is mainly used for the production of clinical samples of the new adjuvant recombinant shingles vaccine in China Phase 1 and Phase 3, and can support the production and supply of the vaccine at the future commercial level.