Protect Human Health with Best−in−Class Vaccines
Protect Human Health with Best−in−Class Vaccines
Protect Human Health with Best−in−Class Vaccines
Protect Human Health with Best−in−Class Vaccines
Protect Human Health with Best−in−Class Vaccines
Jiangsu Recbio
Biotechnology Co., LTD.
Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereafter referred to as Recbio or the Company; stock code: 2179.HK) is an innovative vaccine company propelled by internally developed technologies. Committed to our mission of " Protect human health with best-in-class vaccines", we have cultivated a robust portfolio of vaccine products with exclusive rights, addressing the substantial unmet needs in the realm of high-impact infectious diseases. Over the course of more than two decades, Recbio has meticulously built three pioneering platforms: a novel adjuvant platform, a protein engineering platform, and an immunological evaluation platform, making us one of the few global companies capable of both developing and manufacturing the complete range of novel adjuvants.
Leveraging the close integration of our three platforms, we are consistently creating promising vaccine candidates. Fueled by these innovative platforms, the Company has forged a high-value portfolio of innovative vaccines, encompassing over ten potential blockbuster varieties. These encompass areas such as cervical cancer, shingles, RSV infection, and other prevalent high-burden diseases, and have emerged as leading products in terms of development and clinical progress in China.
Having been honed and refined over the course of a decade, Recbio is poised to reap the benefits as several products are nearing commercialization.
Press Release
Acceptance Of The Application For Clinical Trial Of The Company’s Novel Adjuvanted Recombinant HPV 9-Valent Vaccine REC604c In China
2025-02-12
Completion Of Enrollment Of Phase III Clinical Trial Of The Company’s Novel Adjuvanted Recombinant Shingles Vaccine REC610
2025-01-01
Manufacturing Facility
HPV Vaccine Manufacturing Facility
Innovation Vaccine (CHO cell) Manufacturing Facility
HPV Vaccine Manufacturing Facility
At present, the company is building an HPV vaccine production facility in Taizhou, Jiangsu Province, with an annual production potential of up to 20 million doses of HPV nine-valent vaccine in the first phase. The Company's new manufacturing facility is designed and built to produce vaccines in compliance, which meets the WHO Prequalification (WHO PQ) Standards with full production capacity and ready for commercial production.
The production base covers a total area of 122.92 mu, with a total construction area of 103,068.80 m2. The main construction contents include HPV vaccine building, comprehensive warehouse, quality inspection and development building, animal room, power center and other newly built production plants. Through the purchase of fermentation equipment, purification equipment, pre-potting production line and other production equipment, the project adopts fermentation, purification, preparation and other production technologies to build a number of stock liquid production lines and potting production lines.
HPV Vaccine Manufacturing Facility Address: No.888, Yaocheng Avenue, China Medical City, Taizhou City.
Innovation Vaccine (CHO cell) Manufacturing Facility
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.
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