Translation. Region: Russian Federal
Source: People’s Republic of China in Russian – People’s Republic of China in Russian –
Source: People’s Republic of China – State Council News
BEIJING, June 5 (Xinhua) — China’s medical device administration has approved the launch of the country’s first domestically produced 9-valent HPV (human papillomavirus) vaccine, ending a decade of foreign dominance in the Chinese market.
The new vaccine, called Cecolin 9, was included in a list of approved drugs released Wednesday by China’s National Medical Products Administration.
“The approval of Cecolin 9 not only opens up more opportunities for women to be vaccinated in China, but may also expand the availability and coverage of vaccination, helping to reduce the risk of cervical cancer,” said Zhang Jun, director of the Institute of Public Health at Xiamen University and a leading scientist on the vaccine development team.
HPV vaccines are commonly used to prevent cervical cancer in women, as well as genital cancers and warts in both men and women.
Cecolin 9, which targets nine HPV strains, was developed by Xiamen University, Xiang An Key Laboratory of Biomedicine and Xiamen Innovax Biotech Co., Ltd.
With the approval of Cecolin 9, China has become the second country in the world after the United States to have independent self-sufficiency in the production of highly valent HPV vaccine.
Compared with bivalent HPV vaccines, which are effective against two high-risk genotypes (HPV 16 and 18), 9-valent HPV vaccines additionally protect against five high-risk genotypes (HPV 31, 33, 45, 52, and 58) and two low-risk genotypes (HPV 6 and 11), and have been shown to be more effective in protecting against cervical cancer.
After 18 years of hard work, Chinese researchers have overcome major technical challenges in producing virus-like particles (VLPs) from several HPV types using the E. coli platform and completed key clinical trial processes.
Since 2019, five targeted clinical trials have been conducted in China, in which the new vaccine has demonstrated a favorable safety profile and a strong immune response comparable to similar international drugs on the market.
Statistics show that there are approximately 700,000 cases of HPV-related cancer worldwide each year, including about 530,000 cases of cervical cancer. At the same time, the vaccination method can effectively prevent HPV infection by 94 percent.
In 2020, the World Health Organization (WHO) launched a global programme to accelerate the elimination of cervical cancer, aiming to ensure that 90% of girls are fully vaccinated against HPV by age 15 by 2030.
In line with the WHO programme, China’s National Health Commission has launched an action plan to eliminate cervical cancer for the period 2022-2030, which urges expansion of HPV immunisation coverage across the country. -0-