Bovax Announces Clinical Trial Approval for Recombinant 15-Valent HPV Vaccine

Currently, the 15-Valent Recombinant Human Papillomavirus Vaccine (Hansenula polymorpha), jointly developed by Shanghai Bovax Biotechnology Co., Ltd. and its subsidiary company Chongqing Bovax Biopharmaceutical Co., Ltd., has received the Notification for Approval of Drug Clinical Trial (Notification No.: 2024LP00276) from the National Medical Products Administration. It is a recombinant HPV vaccine with the most valences produced by the eukaryotic expression system globally.

The 15-Valent Recombinant Human Papillomavirus Vaccine (Hansenula polymorpha) developed by Bovax covers all of the 12 high-risk HPV types of identified by the International Agency for Research on Cancer (IARC), a branch of the World Health Organization (WHO). Additionally, it also covers 1 possibly carcinogenic type and 2 low-risk types. This vaccine is able to prevent various types of cancers, including cervical, vulvar, vaginal, perineal, perianal, penile, anal, oropharyngeal, and head-neck cancers, as well as conditions such as CIN1/2/3, VIN1/2/3, ValN2/3, AIN1/2/3, and condyloma acuminata, etc., which are all caused by the infection of the HPV types included in the vaccine. Compared to the marketed 9-valent HPV vaccines, the 15-valent HPV vaccine is estimated to prevent 99% of cervical cancers, providing broader and more comprehensive protection.

Bovax is a high-tech biological company specializing in the R&D and industrialization of recombinant protein vaccines and drugs. The company was established in Zhangjiang Sci-tech City, Shanghai in December 2012 and has been certified as National High-tech Enterprise. In July 2017, Bovax invested in the construction of the "New Prophylactic Recombinant Protein Vaccine Industrial Park" in Chongqing BioPark. After the establishment, Bovax has completed a whole industry chain layout of the R&D and industrialization of recombinant vaccines centering in Shanghai and Chongqing.

Bovax holds independent intellectual property rights for its genetic engineering recombinant Virus-Like Particles technology (VLPs technology). Based on this technology platform, it has conducted several research pipelines. Among them, Bovax's 9-valent HPV vaccine is the core variety. This project obtained the first domestic clinical approval of 9-valent HPV vaccine in 2017 and also became the first domestic vaccine of its kind to enter Phase III clinical stage in 2020. Moreover, Bovax's 9-valent vaccine has aquiredsupport from the Ministry of Science and Technology of China as the The Science and Technology Major Project of "Significant New Drugs Development" during "The 13th Five-Year Plan". Furthermore, based on the research experiences of 9-valent HPV vaccine, Bovax developed the 15-valent HPV vaccine. Among all HPV vaccines in clinical trials, ithis vaccine covers the most valences of high-risk HPV types.