News Room

On August 2, 2024, Shanghai Zerun’s wholly-owned subsidiary, Yuxi Zerun Biotechnology Co., Ltd. (hereinafter referred to as “Zerun Biotech”), received official notification from the World Health Organization (WHO) that its bivalent human papillomavirus (HPV) vaccine (Pichia pastoris) (Walrinvax^®) (hereinafter referred to as the “HPV-2 vaccine”) has passed WHO Prequalification (hereinafter referred to as “WHO PQ”). This milestone signifies that the HPV-2 vaccine, independently developed by Shanghai Zerun and manufactured by Yuxi Zerun, has met WHO’s stringent standards for safety, efficacy, and quality control, and that its production quality management system complies with WHO's GMP requirements.

The development of the HPV-2 vaccine received funding from various national and local government sources, as well as guidance and $5 million in funding from the Bill and Melinda Gates Foundation (BMGF), along with technical support from the PATH organization, which accelerated the WHO PQ process.

Currently, there are five HPV vaccines available on the domestic market, including Zerun Biotech's HPV-2 vaccine, Wantai Biopharms’ HPV-2 vaccine, GSK’s HPV-2 vaccine, Merck’s HPV-4 vaccine, and the HPV-9 vaccine. Zerun Biotech has become the fourth HPV vaccine company globally to receive WHO prequalification.

WHO PQ is a qualification assessment and verification of vaccine products and suppliers conducted by WHO. A vaccine that passes WHO PQ signifies that it is eligible for procurement by UNICEF and other UN agencies, facilitating its entry into more countries and regions. According to the WHO's global strategy for the accelerated elimination of cervical cancer, the routine vaccination demand for HPV vaccines is expected to reach 100 million doses per year by 2024, increasing annually to 120 million doses per year. Currently, there remains a significant supply gap in the global HPV vaccine market. The achievement of WHO PQ certification for Zerun Biotech’s HPV-2 vaccine will greatly help fill this supply gap and make an important contribution to global cervical cancer prevention and control.

Shanghai Zerun will continue to focus on the research and development of high-quality vaccine products, contributing to global public health efforts.