Lately, Beijing Health Guard Biotechnology, Inc. (hereafter, the Company) received a letter (No.: 2022LP00449) from the NMPA acknowledging that clinical trials of the recombinant 15-valent HPV vaccine (expressed in E. Coli) may commence. The 15-valent HPV vaccine co-developed by the Company and Liaoning Chengda Biotechnology Co., Ltd. (hereafter, Chengda Bio) is by far of the highest valency among the HPV vaccines that are commercially available or have been cleared to start clinical trials by global regulatory authorities.
According to data published by the WHO, cervical cancer is the second most common malignant tumor in women ages 15–44. The International Agency for Research on Cancer (IARC) has identified 13 HPV types as carcinogenic or probably carcinogenic (HPV 16/18/31/33/35/39/45/51/52/56/58/59/68). Epidemiology studies indicated that almost all cervical cancer cases can be attributed to persistent infections with carcinogenic HPV types. Cervical cancer and pre-cancerous lesions are preventable by quality and safe HPV vaccines.
The recombinant 15-valent HPV vaccine (expressed in E. Coli) targets all the carcinogenic HPV types identified by the IARC, and would protect against persistent infections with vaccine HPV types, associated cancers and lesions, including cervical cancer, vulvar cancer, vaginal cancer, anal cancer, CIN1/2/3, cervical adenocarcinoma in situ, VIN2/3, VaIN2/3, AIN1/2/3, and condyloma acuminata. Theoretically, the 15-valent HPV vaccine may afford protection against over 96% of cervical cancer.
In addition to the 15-valent HPV vaccine, the Company has also developed a recombinant trivalent HPV vaccine (targeting HPV 16/18/58) and a nonavalent HPV vaccine (targeting HPV 6/11/16/18/31/33/45/52/58), both of which are in phase III clinical trials for female indications. Moreover, a phase I clinical trial in male indications of the nonavalent HPV vaccine has been initiated, making the Company a pioneer in clinical development of HPV vaccines with respect to male indications.
The Company has now built a holistic HPV vaccine pipeline, which upon commercialization, will benefit all market segments by providing valuable solutions to relieving global communities from disease burden caused by HPV, therefore contributing to the attainment of WHO’s strategic goal of accelerating the elimination of cervical cancer worldwide.