Aiweijia: China’s First Domestic Quadrivalent HPV Vaccine Completes Full Homegrown HPV Lineup
NMPA has approved China’s first domestic quadrivalent HPV vaccine (Aiweijia) from Sinopharm’s CNBG. Following the launch of domestic bivalent and nine-valent vaccines, and after Merck’s Gardasil, it is the second quadrivalent on the Chinese market, targeting HPV 6/11/16/18 for women aged 18–45.
The National Medical Products Administration (NMPA) has granted market approval for China’s first domestically developed quadrivalent recombinant human papillomavirus (HPV) vaccine (produced using Hansen’s yeast, brand name:Aiweijia). The product was jointly developed by the Chengdu Institute of Biological Products and the National Vaccine & Serum Institute, both under Sinopharm’s China National Biotec Group (CNBG). The approval (CXSS2400063) was announced today on CNBG’s official Weibo account.
This milestone comes after the successful launch of domestic bivalent and nine-valent HPV vaccines, and marks the second quadrivalent HPV vaccine approved in China, following Merck’s imported Gardasil.
Development Journey and Clinical Data
- Clinical application filed: January 2014
- Clinical approval received: December 2015
- Phase III trial initiated: 2018 (CTR20171662), with ~10,000 participants
- Interim analysis: Demonstrated statistically significant efficacy and safety, meeting prespecified criteria
The vaccine targets HPV types 6, 11, 16, and 18, covering both high-risk oncogenic types (16, 18) associated with cervical cancer, CIN 2/3, adenocarcinoma in situ (AIS), CIN 1, and low-risk types (6, 11) responsible for genital warts. It is approved for preventive use in females aged 18–45 years.
Expanding CNBG’s HPV Vaccine Portfolio
Alongside this milestone, CNBG and its Chengdu subsidiary are advancing an 11-valent HPV vaccine, currently in Phase III clinical trials. This candidate places China among the global leaders in the high-valent HPV vaccine race.
HPV Vaccine Landscape in China
According to the Insight database, six HPV vaccines were already available in China prior to today’s approval:
- Nine-valent (2): Merck’s Gardasil 9 and Wantai Biological’s domestic version
- Quadrivalent (1): Merck’s Gardasil (imported)
- Bivalent (3): GSK’s Cervarix (imported), plus domestic vaccines from Watson Biological and Wantai Biological
Merck’s quadrivalent and nine-valent products also hold male indications in China. Gardasil was expanded to males aged 9–26 in January 2025, followed by Gardasil 9’s approval in April 2025 for males 16–26.
Policy Context: National HPV Vaccination Program
On September 11, 2025, at a State Council press briefing, Shen Hongbing, Director of the National Disease Control and Prevention Administration, announced that China will launch HPV vaccination services for school-aged girls and integrate HPV vaccines into the National Immunization Program. This policy move is expected to accelerate coverage and reduce the burden of HPV-related diseases.
Outlook
The approval of China’s first domestic quadrivalent HPV vaccine strengthens the nation’s vaccine self-sufficiency, lowers reliance on imports, and enhances affordability. With both quadrivalent and upcoming 11-valent products in development, China is rapidly building a competitive HPV prevention portfolio.
Source: CNBG official weibo announcement
Disclaimer: This article is intended for informational purposes only. It summarizes publicly available data and official announcements. It does not constitute medical advice. Please consult a qualified healthcare professional for individual diagnosis, treatment, or vaccination decisions.