Beijing Health Guard Biotechnology Inc. (thereafter, the Company) recently launched phase III clinical trials with its recombinant trivalent HPV vaccine (targeting HPV 16/18/58) developed in-house. The first subject was enrolled on October 17, 2020 at the Center for Disease Control and Prevention in Kaiyuan County, Yunnan Province. All 8,880 subjects are scheduled to be vaccinated with the first dose by mid-November, 2020.
The trivalent HPV vaccine is an innovative investigational vaccine designed based on cervical cancer epidemiology in East Asia. Compared with the bivalent and quadrivalent HPV vaccines on the market that afford protection against about 70% of cervical cancer, the Company’s trivalent HPV vaccine extends protection against cervical cancer to about 80% for females in China and East Asia.
The Company was approved to start clinical trials with the trivalent HPV vaccine by the NMPA in October 2017, and has concluded phase I/II trials in June 2019, in which the trivalent HPV demonstrated a good safety profile across three dosages (that is, high-, medium-, and low-dosage) of the vaccine, and generated robust neutralizing antibodies against HPV 16/18/58 following administration of three doses.
The Company has since inception been dedicated to the development of advanced and innovative vaccines to help improve public health and protect people from infectious diseases. It has developed a series of HPV vaccines for the prevention of diseases, such as cervical, anal, head and neck cancers, caused by HPV infections. Apart from the trivalent HPV vaccine, the Company is also scheduled to commence phase III clinical trials of the nonavalent HPV vaccine in November, 2020, and file an IND application for a 15-valent HPV vaccine in the first half of 2021.