Beijing Health Guard Initiates Phase I Clinical Trial of the Recombinant Nonavalent HPV Vaccine

Beijing Health Guard Biotechnology Inc. (thereafter, the Company) recently commenced a Phase I clinical trial of the Recombinant nonavalent HPV vaccine (targeting HPV 6/11/16/18/31/33/45/52/58 and expressed in E.coli) developed in-house at Sheyang Center for Disease Control and Prevention in Jiangsu Province, with the first participant enrolled at 6:00 a.m. on September 1.

The investigational Recombinant nonavalent HPV vaccine is the second Category I prophylactic biologics developed by the Company. Previously, the Company has concluded a Phase II clinical trial of the Recombinant trivalent HPV vaccine and will soon start Phase III clinical trials of the trivalent HPV vaccine. In addition, smooth progress has been made in the development of a Recombinant 15-valent HPV vaccine on which the Company is collaborating with Liaoning Chengda Biotechnology Co., Ltd. An IND application is expected to be filed for the 15-valent HPV vaccine next year.

Merck’s GARDASIL9, a Recombinant nonavalent HPV vaccine that received conditional approval from China's National Medical Products Administration (NMPA) in 2018, offers broader protection against lesions and diseases caused by HPV than other HPV vaccines on the market and is among the vaccines that are most urgently needed. However, as its demand always outruns supply, who can get vaccinated with Gardasil9 is determined by a vaccination-lottery system in certain provinces and cities.

GARDASIL9 is indicated in girls and women for the prevention of infections with HPV types 16/18/31/33/45/52/58 and associated diseases caused by vaccine HPV types, including cervical, vaginal, vulvar and anal cancers, precancerous lesions in the cervix, vagina, vulva and anus, and condyloma acuminata. In addition, GARDASIL9 also protects men of certain age against anal, penile and oropharyngeal cancers, precancerous lesions in the anus and condyloma acuminata caused by vaccine HPV types.

The Company’s Recombinant nonavalent HPV vaccine targets the same HPV types as Gardasil9, and thus shall offer comparable protection for the same indications. HPV vaccine supply shortage will be eased with licensure of the Company’s nonavalent HPV vaccine pending a successful phase III efficacy trial. High HPV vaccination coverage will effectively block HPV transmission, thereby reducing incidence of serious diseases caused by HPV infection and benefiting a much broader chunk of the population.