Drug intelligence / Profile preview

quadrivalent human papillomavirus vaccine (types 6, 11, 16, 18) (hansenula polymorpha)

Development stage
Unknown
Lead developer
Chengdu Institute of Biological Products
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Intramuscular
01

Overview

The quadrivalent recombinant human papillomavirus vaccine (types 6, 11, 16, 18) produced in *Hansenula polymorpha* is a prophylactic vaccine developed by the Chengdu Institute of Biological Products (CDIBP), a subsidiary of China National Biotec Group (CNBG/Sinopharm). This vaccine is designed to prevent infections and associated diseases caused by HPV types 6, 11, 16, and 18, including cervical cancer, vulvar and vaginal cancers, and genital warts (condyloma acuminata). Unlike the first-generation quadrivalent vaccine (Gardasil), which utilizes *Saccharomyces cerevisiae*, this product employs the methylotrophic yeast *Hansenula polymorpha* as the expression system for the L1 major capsid proteins. These proteins self-assemble into non-infectious virus-like particles (VLPs) that mimic the structure of the native virus to induce a robust neutralizing antibody response. It was approved by China's National Medical Products Administration (NMPA) in early 2024 for use in females aged 9 to 45 years.

Brand names
Gengle
Other names
Recombinant Human Papillomavirus Quadrivalent (6, 11, 16, 18) Vaccine (Hansenula polymorpha)CDIBP HPV4Gengle HPV Vaccine
02

Targets

HPV11 L1HPV16 (Human papillomavirus type 16)HPV18 L1HPV6 L1 (Human papillomavirus type 6 major capsid protein L1)

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