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不良事件/反應報告

https://www.walvax.com/public_information/?type=5&id=1

不良事件/反應報告

Shanghai Zerun Biotechnology Co., Ltd. is dedicated to the development of new recombinant vaccines. Zerun Biotech possesses platforms for Preparation of Virus-Like Particles, Recombinant Protein Expression and Innovative Adjuvant Evaluation. Based on yeast expression system, the company has developed bivalent and nine-valent preventive Human Papillomavirus Vaccine (HPV vaccine), and other vaccines, among which the bivalent HPV vaccine has been approved for marketing in China on March 22, 2022 and the 9-valent HPV vaccine has entered Phase III clinical trials. Grounded in CHO cell expression system, Zerun Biotech has progressed in two SARS-CoV-2 vaccines and Varicella-Zoster Virus vaccine, of which the SARS-CoV-2 prototype vaccine has completed Phase II clinical trials, and the SARS-CoV-2 variant vaccine has completed Phase I clinical trials at home and abroad.

Zerun Biotech’s research focus is on four technology Platforms: Virus-Like Particle Technology Platform, Recombinant Protein Expression Technology Platform, Innovative Adjuvant Evaluation Platform and Innovative Vaccine Technology Platform(mRNA).

To achieve its product development goal, Zerun Biotech established its first manufacturing facility in 2016 for its HPV vaccine production. The site named Yuxi Zerun Biotechnology Co., Ltd. (“Yuxi Zerun”) and located in Yuxi City, Yunnan Province, is an innovation-driven biopharmaceutical company focusing on the industrialization, production and operation of new recombinant vaccines for human use. With the support from Bill & Melinda Gates Foundation, Yuxi premise was designed and constructed to meet both current Chinese and WHO prequalification (WHO-PQ) requirements. The premise is a modern four-story building covering an area of over 4,000 square meters (~40,000 sf) and the premise area is about 20,000 square meters (~200,000 sf), with a capacity producing an initial 15 million doses of bivalent HPV vaccine a year. The state-of-art premise is furnished with top international brand manufacturing equipment to ensure production continuity and process stability. In early 2018, Yuxi Zerun was granted a “Drug Manufacturing License” by the provincial branch of CFDA (now the National Medical Products Administration), signifying the readiness of the plant for production.

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