On Dec. 15, 2021, Beijing Health Guard Biotechnology, Inc. (thereafter, the Company) received a letter (NO: CXSL2101487国) from the NMPA acknowledging that the IND application for the Recombinant 15-valent HPV vaccine (expressed in E.coli) codeveloped by the Company and Liaoning Chengda Biotechnology Co., Ltd. (thereafter, Chengda Bio) has been accepted for review by the agency. This 15-valent HPV vaccine is by far of the highest valency among the HPV vaccines that are commercially available or with an IND application accepted for review by global regulatory agency.
HPV infection can cause Human reproductive system diseases. HPV is a group of more than 200 related viruses, 13 of which (that is, HPV 16/18/31/33/35/39/45/51/52/56/58/59/68) have been identified by International Agency for Research on Cancer (IRAC) as high-risk oncogenic HPV types that cause human cancers. Epidemiology studies indicate that almost all cervical cancer cases can be attributed to persistent infections with high-risk HPV types. Cervical cancer and pre-cancerous lesions are preventable by quality and safe HPV vaccines.
In January, 2019, the Company and Chengda Bio entered into a collaboration agreement on the development of the Recombinant 15-valent HPV vaccine (targeting HPV 6/11/16/18/31/33/35/39/45/51/52/56/58/59/68), a potential best-in-class solution for the prevention of HPV infection, which targets all the 13 IRAC-designated high-risk HPV types. The nonavalent HPV vaccine can afford protection against 90% of cervical cancer; the 15-valent HPV vaccine, however, theoretically can extend protection against cervical cancer to over 96%, thus further reducing disease burden associated with HPV infection.
Both the Recombinant trivalent HPV vaccine (targeting HPV 16/18/58 and expressed in E.coli) and nonavalent HPV vaccine (targeting HPV 6/11/16/18/31/33/45/52/58 and expressed in E.coli) developed by the Company are in phase III clinical trials for female indications. Moreover, a phase I clinical trial in male indications of the Recombinant nonavalent HPV vaccine has commenced in August, 2021.
Acceptance for review of the IND application for the 15-valent vaccine indicates that the Company’s HPV vaccine pipeline gets more competitive. Among the HPV vaccine developers across the globe, the Company sports an outstanding pipeline of HPV vaccines that covers all market niches and can satisfy diverse customer needs.