Beijing Health Guard Announces Enrollment of First Subject in Phase III Clinical Trial of the Nonavalent HPV Vaccine

Beijing Health Guard Biotechnology, Inc. (thereafter, the Company) recently initiated Phase III clinical trials of the Recombinant nonavalent HPV vaccine (targeting HPV 6/11/16/18/31/ 33/45/52/58 and expressed in E. coli) (nonavalent HPV vaccine), which is developed in-house by the Company. The first trial subject was enrolled on December 5, 2020 at the Center for Disease Control and Prevention in Sheyang County, Jiangsu Province.

The nonavalent HPV vaccine is intended for the prevention of cervical, vulvar, vaginal, and anal cancers caused by vaccine HPV types 16, 18, 31, 33, 45, 52, and 58, as well as genital warts caused by HPV types 6 and 11 in females ages 9-45.

The Company was approved to commence clinical trials of the nonavalent HPV vaccine by the NMPA in September 2018, and phase I/II clinical trials of the vaccine were initiated in September 2019. Clinical data from the double-blind, placebo-controlled Phase I study of the nonavalent HPV vaccine showed that 3 doses of the nonavalent HPV vaccine induced robust neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which are comparable to those elicited by Merck's nonavalent HPV vaccine Gardasil9. Phase I and II studies also indicated that the Company’s nonavalent HPV vaccine has a good safety profile.

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. In addition to clinical trials initiated for female indications, the Company has also submitted an IND application to the Center for Drug Evaluation for the nonavalent HPV vaccine for male indications, including but not limited to genital warts and anal cancer that are caused by vaccine HPV types.