Table 1.
Prophylactic HPV vaccine development in China, 2023
| Manufacturer | Vaccine | Expression system | Current phase of R&D |
|---|---|---|---|
| GSK | HPV-2 (16, 18) | Insect cell | Approved in 2016 |
| Merck | HPV-4 (6,11,16,18) | Yeast (Saccharomyces cerevisiae) | Approved in 2017 |
| Merck* | HPV-9 (6,11,16,18,31,33,45,52,58) | Yeast (Saccharomyces cerevisiae) | Approved in 2018 |
| Xiamen Innovax | HPV-2 (16,18) | Escherichia coli | Approved in 2019 |
| Shanghai Zerun (Walvax) | HPV-2 (16,18) | Yeast (Pichia pastoris) | Approved in 2022 |
| CNBG/CDIBP (Chengdu/Beijing) | HPV-4 (6,11,16,18) | Yeast (Hansenula polymorpha) | Phase III |
| Shanghai Bovax | HPV-4 (6,11,16,18) | Yeast (Hansenula polymorpha) | Phase III |
| Shanghai Bovax | HPV-9 (6,11,16,18,31,33,45,52,58) | Yeast (Hansenula polymorpha) | Phase III |
| Xiamen Innovax | HPV-9 (6,11,16,18,31,33,45,52,58) | Escherichia coli | Phase III |
| Beijing Health Guard | HPV-3 (16,18, 58) | Escherichia coli | Phase III |
| Beijing Health Guard | HPV-9 (6,11,16,18,31,33,45,52,58) | Escherichia coli | Phase III |
| CNBG/SIBP (Shanghai) | HPV-4 (16,18,52,58) | Yeast (Pichia pastoris) | Phase II |
| CNBG/CDIBP (Chengdu/Beijing) | HPV-11 (6,11,16,18,31,33,45,52,58,59,62) | Yeast (Hansenula polymorpha) | Phase II |
| Beijing Nuoning / Beijing SinoCellTech | HPV-14 (6,11,16,18,31,33,35,39,45,51,52,56,58,59) | Insect cell | Phase II |
| Jiangsu RecBio | HPV-9 (6,11,16,18,31,33,45,52,58) | Yeast (Hansenula polymorpha) | Phase I |
| Jiangsu RecBio | HPV-2 (16,18) | Yeast (Hansenula polymorpha) | Phase I |
| Shanghai Zerun (Walvax) | HPV-9 (6,11,16,18,31,33,45,52,58) | Yeast (Pichia pastoris) | Phase I |
| Jiangsu RecBio | HPV-2 (6,11) | Yeast (Hansenula polymorpha) | Phase I |
BLA Biologics License Application; GSK GlaxoSmithKline; HPV Human Papillomavirus; CNBG China National Biotec Group; CDIBP Chengdu Institute of Biological Products; SIBP Shanghai Institute of Biological Products, R&D Research and Development
*Conditionally approved by NMPA in 2018, the phase III clinical trial was initiated in June 2019 in China