Recently, the prequalification (PQ) application for Cecolin 9, the HPV 9-valent vaccine, was formally submitted to the World Health Organization (WHO). In accordance with relevant procedures, WHO will subsequently conduct dossier screening, technical assessment and manufacturing site inspection before making a final decision on whether to grant prequalification.

The submission marks an important step forward in the internationalization of Cecolin 9 and reflects the accelerated efforts to bring this Chinese innovative vaccine closer to broader global public health needs.

Cecolin 9 was approved in China in 2025 and is China's first domestically developed and the world's second HPV 9-valent vaccine. As a high-valency HPV vaccine with proprietary intellectual property, Cecolin 9 is expected to provide an additional high-quality option for the international market and further diversify the global HPV vaccine supply.

Cervical cancer is a major public health challenge that can be accelerated toward elimination through vaccination, screening and treatment. In 2020, WHO launched the Global Strategy to Accelerate the Elimination of Cervical Cancer, setting the 90-70-90 targets to be achieved by 2030.¹ In recent years, access to HPV vaccines has continued to improve through a major push by Gavi, the Vaccine Alliance, lower-income countries and global health partners, including WHO, UNICEF and the Gates Foundation. These efforts have helped protect an estimated 86 million girls in the world's highest-risk countries from cervical cancer and are expected to avert an estimated 1.4 million future deaths.² This demonstrates the significant public health value and social importance of improving global access to HPV vaccines for cervical cancer prevention and control.

At the same time, many countries and regions continue to face challenges in stable HPV vaccine supply and equitable access.

IX will continue to enhance its product quality system in alignment with international standards, actively support the subsequent WHO assessment process, and leverage its continuously expanding large-scale manufacturing capacity and global supply readiness to accelerate efforts to enable Cecolin 9 to serve public health needs in more countries and regions. Looking ahead to the global fight against cervical cancer, IX aims to contribute a more diversified and sustainable Chinese solution through the international development of innovative vaccines from China, helping improve HPV vaccine access and accelerate the elimination of cervical cancer.

About WHO Prequalification³

References：

1.https://www.who.int/zh/news-room/events/detail/2020/11/17/default-calendar/launch-of-the-global-strategy-to-accelerate-the-elimination-of-cervical-cancer

2.https://www.gavi.org/news/media-room/cervical-cancer-vaccines-save-over-1-million-lives-lower-income-countries

3.https://extranet.who.int/prequal/vaccines/welcome-vaccines-prequalification