不良事件/反应报告

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不良事件/反应报告

Shanghai Zerun Biotechnology Co., Ltd. Started Phase III Clinical Trial of Nonavalent HPV Vaccine

2022.09.15

Recently, the "recombinant human papillomavirus nonavalent virus-like particle vaccine (hereinafter referred to as "9-valent HPV vaccine") (6, 11, 16, 18, 31, 33, 45, 52, 58 type L1 protein) (Pichia pastoris), developed by Shanghai Zerun Biotechnology Co., Ltd. (hereinafter referred to as "Shanghai Zerun"), has officially launched the "Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9". The inclusion of test subjects marks the official start of Phase III clinical research.

IND application for the 9-valent HPV vaccine was accepted in November 2016, and approved in January 2018. Phase I clinical trials have demonstrated good safety and immunogenicity results. The 9-valent HPV vaccine is primarily used for the prevention of cervical cancer, vulvar cancer, vaginal cancer, anal cancer and genital cancer caused by HPV16, 18, 31, 33, 45, 52, 58 infections and genital warts caused by HPV types 6 and 11 among women, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 infections and genital warts caused by HPV types 6 and 11 among men.

The launch of the clinical phase III trial of the 9-valent HPV vaccine is an important milestone for Shanghai Zerun’s HPV vaccine project. Shanghai Zerun is dedicated to its mission of making life better by promoting health and delivering high-quality vaccines made in China. We will make unremitting efforts to safeguard the health of people both in China and around the world.