Wantai HPV Vaccine Prequalified by World Health Organization
【China, October 15th 2021】 Xiamen Innovax Biotech Co., Ltd.（Innovax）, the subsidiary of Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (Wantai) received an official letter from the World Health Organization (WHO), confirming that its bivalent human papillomavirus vaccine Cecolin® has been accepted by WHO for Prequalification. It is the first China-manufactured HPV vaccine receiving WHO Prequalification.
(WHO website: https://extranet.who.int/pqweb/content/cecolin%C2%AE )
Cecolin is an innovative vaccine product with independent intellectual property rights jointly developed by Wantai and Xiamen University. It was approved by the National Medical Products Administration of China on December 30, 2019, and officially launched in China (excluding Hong Kong, Macao and Taiwan) in May 2020. It is the first domestically manufactured vaccine against cervical cancer in China. Since 2016, Wantai has received support from PATH in areas including quality systems improvement, clinical and regulatory compliance and pharmacovigilance (safety) systems set up. This support was funded by the Bill & Melinda Gates Foundation.
“The approval of WHO Prequalification is of great significance.” Said Mr. Li Shicheng, the chairman of Innovax, “Going through the reviewing process of WHO is a remark and ensure Wantai’s vaccine development, manufacturing process, and product quality meets strict international standard. Paving a broad way for Wantai towards global market.
“For too many women, cervical cancer is a death sentence. But it doesn’t have to be. Fortunately, HPV vaccines can dramatically cut cases and put the world on track to eliminate this deadly disease,” said Trevor Mundel, president of the Global Health division at the Bill & Melinda Gates Foundation. “World Health Organization prequalification of new products is an important step toward making safe and effective HPV vaccines accessible to all, especially women and girls in lower-income countries who are disproportionately impacted by cervical cancer and can have limited access to health care. Achieving this milestone is a reflection of China's growing efforts to advance global health.”
Cervical cancer is the second most common cancer among women living in less developed regions, with 85% of cases occurring in low- and middle-income countries, and the highest rates in sub-Saharan Africa and Asia. In May 2018, the WHO Director-General called on all countries to take action to eliminate cervical cancer globally by 2030. On 17 November 2020, WHO initiated a global strategy to accelerate the elimination of cervical cancer, highlighting three key measures, including vaccination. However, the supply of HPV vaccines is insufficient to meet the current demand, which is one of the major obstacles to eliminating cervical cancer.
The Prequalification of Wantai’s bivalent cervical cancer vaccine is an important milestone that will not only help HPV vaccine enter a broader international market, but also enable more women to get HPV vaccination and improve the health and wellbeing of women around the world.
About WHO Prequalification
WHO vaccines prequalification is a service provided to UNICEF and other UN agencies that procure vaccines. The goal of WHO vaccines prequalification is to ensure that vaccines used in immunization programmes are safe and effective. Prequalification also supports the specific needs of national immunization programmes with regards to vaccine characteristic such as potency, thermostability, presentation, labelling and shipping conditions. As a result, more people can be vaccinated with safe, effective and quality vaccines because immunization programme managers can plan, select and procure appropriate products. For more information, please visit: https://extranet.who.int/pqweb/
About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of Bill Gates and Melinda French Gates. For more information, please visit: https://www.gatesfoundation.org/zh
About PATH
PATH is a global nonprofit dedicated to ending health inequity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing public health challenges. Learn more at www.path.org.
About Xiamen University
Xiamen University (XMU) was established in 1921 and is well-known in biomedical field. XMU owned two well-established institutions– National Institute of Diagnostic and Vaccine Development in Infectious Diseases (NIDVD) and Key Laboratory of Molecular Vaccinology and Molecular Diagnostics (SKLVD). XMU and Wantai co-developed the only licensed hepatitis E vaccine in the world and the first licensed domestic human papillomavirus vaccine in China. For more information, please visit: https://www.xmu.edu.cn/
About Wantai
Established in 1991, Beijing Wantai Biological Pharmaceutical Co., LTD. (Wantai) is a high-tech enterprise engaged in the R&D, production and sales of in vitro diagnostic reagents, medical instruments and vaccines. Xiamen Innovax Biotech Co., Ltd. (Innovax) is a wholly-owned subsidiary of Wantai. It is an innovative vaccine branch dedicated for vaccine R&D, production and commercialization.
Cooperation with the National Institute of Diagnostics and Vaccine Development in Infectious Disease (NIDVD) of Xiamen University, Innovax has established a core-platform using recombinant technology to express protein in E. coli for vaccine production. Based on this platform, the world’s first Hepatitis E Vaccine, Hecolin® was launched in China in October 2012. Cecolin®, the HPV vaccine, was been licensed in China in December 2019. Furthermore, Innovax has initiated a Phase III clinical trial with its 9-valent HPV candidate vaccine.
For more information, please visit: https://www.ystwt.com/
