Breakthrough After a Decade: Cervical Cancer Vaccine Approved for Launch in China

After a decade, the HPV (Human Papillomavirus) vaccine, which has been widely administered in over 100 countries worldwide, has finally entered the Chinese market.

On the morning of July 18, GlaxoSmithKline (GSK) exclusively confirmed to Yicai that,Its “Cervarix®” (Human Papillomavirus Vaccine [Types 16 and 18]) received marketing approval from the China Food and Drug Administration (CFDA), becoming the first HPV vaccine approved in China for the prevention of cervical cancer.

This means that, since the launch of the world’s first HPV vaccine in 2006, women in China can finally protect themselves against cervical cancer through vaccination, shielding them from what is currently the most lethal and aggressive cancer affecting women.

Cervical cancer is the second most common cancer among women aged 15 to 44 in China, with approximately 130,000 new cases diagnosed annually. Each year, China accounts for more than 28% of global cervical cancer cases. Worldwide, a new case is diagnosed every minute on average, and one woman dies from cervical cancer every two minutes.

According to information released by the WHO, cervical cancer is the second most common cancer among women in developing countries and one of the deadliest cancers. In 2012, there were 445,000 new cases of cervical cancer worldwide; nearly 270,000 women died from this disease, with more than 85% of these deaths occurring in low- and middle-income countries.

At the same time, cervical cancer is currently the only cancer with a clearly identified cause that allows for early detection and prevention. As early as 1999, a study published in The Journal of Pathology showed that high-risk human papillomavirus (HPV) infection was detectable in 99.7% of cervical cancer patients. The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) have also confirmed that persistent infection with high-risk HPV is the primary cause of cervical cancer.

Experience from prevention and control efforts in multiple countries worldwide demonstrates that combining cervical cancer screening with HPV vaccination significantly reduces the incidence of cervical cancer and precancerous lesions, thereby lowering the disease burden. In countries such as Australia and Germany, not only have adolescent girls—the optimal target population for this vaccine—been included in nationally funded immunization programs, but boys of the same age group have also begun receiving the HPV vaccine to protect a broader population from cervical cancer.

In recent years, public awareness of cervical cancer has risen significantly, driven by news of the deaths of several prominent actresses, including Anita Mui and Li Yuanyuan, from the disease.

Yicai has learned that,GSK’s Cervarix® has been approved in China for vaccination in females aged 9 to 25 years, administered as a three-dose series, and is expected to be commercially launched in early next year. Together with cervical cancer screening, HPV vaccination will provide Chinese women with enhanced means of preventing cervical cancer.

Previously, there was much speculation in the market about why the Chinese government had been slow to approve HPV vaccines, one of which concerned their efficacy in Asian populations.

Data from GSK indicate that a six-year clinical trial of Cervarix® conducted in China enrolled more than 6,000 participants who received either the vaccine or a control. The results demonstrated that the vaccine provides high protective efficacy against certain oncogenic HPV-related cervical diseases and exhibits a favorable benefit–risk profile. These findings are consistent with global clinical study data. The approval of Cervarix® means that girls and young women in China will have the opportunity to prevent this life-threatening disease through vaccination.

Further good news is that GSK’s HPV vaccine, scheduled for official market launch early next year, will offer greater “flexibility” in pricing.

Mr. Ji Haiwei, Senior Vice President and General Manager of the Prescription Drugs and Vaccines Division for China/Hong Kong at GSK, stated, “Enhancing the accessibility of our innovative medicines and vaccines is a clear strategic priority for GSK China. We believe that through collaboration with relevant government authorities, we will improve access for the Chinese population to innovative vaccines such as Cervarix®. To achieve this goal, we will explore innovative pricing models to support the inclusion of Cervarix® in the National Immunization Program.”

“HPV vaccines have been on the global market for ten years. We are also considering how to enable a larger segment of the Chinese public to benefit from vaccine protection,” Zhang Yingwei, Head of Corporate Communications and Government Affairs at GSK China, revealed in an exclusive interview with Yicai (First Financial Daily). He stated that GSK is currently in discussions with relevant authorities regarding matters such as inclusion in the National Immunization Program.

Data show that in recent years, approximately 2 million mainland Chinese tourists have traveled to Hong Kong annually to receive HPV vaccinations. Based on the current price of HKD 3,000 per dose in Hong Kong, the potential market size in mainland China could reach tens of billions of yuan if the vaccine were launched domestically.

Public information indicates that HPV vaccines from Chinese pharmaceutical companies, including Wantai BioPharmaceutical Co., Ltd. under Yangshengtang and Shanghai Zerun Biotechnology Co., Ltd. under Walvax Biotechnology, have all entered Phase III clinical trials.

Reprinted from: Yicai