On April 24th, it was found on the website of the Drug Evaluation Center of the State Food and Drug Administration that the application for the marketing of the nine-valent HPV vaccine submitted by Merck, an American pharmaceutical company, was accepted on April 20th, and the current processing status of the drug was "under review and approval".
Cervical cancer is a malignant tumor of female reproductive tract after ovarian cancer, with nearly 600,000 new cases and about 300,000 deaths worldwide every year. Every year, there are about135,000 new cases in China, among which 80,000 people die. 99.7% of cervical cancer is caused by HPV infection.
According to public information, Merck's Jiadaxiu nine-valent HPV vaccine was approved for marketing in the United States in 20 14, and its vaccinatable age is 9-26 years old. The vaccine can prevent 90% of cervical cancer virus. Merck's Jiadaxiu Jiujia was approved for clinical use in China on 20 1710/month, and it took less than half a year until the listing application was accepted.
In 2006, Hong Kong became the first region in China to open cervical cancer vaccination, and it was not until last year that cervical cancer vaccine was officially launched in mainland China. At present, the products listed in the Mainland are sirrah bivalent vaccine produced by GlaxoSmithKline in the United Kingdom and Jiadaxu tetravalent vaccine of Merck, while the nine-valent product of Merck is more popular in Hong Kong.
The valence represents the range of virus coverage. The higher the valence, the more virus subspecies it covers, and the better the preventive effect of the vaccine. Persistent infection of high-risk HPV is the main cause of cervical cancer. HPV is a DNA virus belonging to the family Papillomavirus, with human as the sole host, and the favorite place to settle down is skin and mucous membrane. Studies have shown that there are 15 high-risk HPV—— types, especially the two numbered 16 and 18, which will lead to precancerous lesions of cervical cancer and the occurrence of cervical cancer. HPV bivalent vaccine can prevent 16 and 18 HPV viruses; HPV tetravalent vaccine can be used to prevent four subtypes of HPV, namely, 6, 1 1, 16 and 18. The HPV9-valent vaccine added five subtypes of HPV virus, namely 3 1, 33, 45, 52 and 58, on the basis of the original tetravalent vaccine, and the virus coverage reached 90%.
This has led to an endless stream of mainland tourists who went to Hong Kong for vaccination for a long time.
According to the research report of Founder Securities, there is at least 10 billion markets to prevent cervical cancer. Before, nearly 2 million people went to Hong Kong for vaccination every year. Some experts predict that an annual increase of 8 million women out of a population of16 million, assuming that 50% of them are vaccinated against cervical cancer, will bring a market scale of 4 billion yuan every year after the market stabilizes.
However, the official listing of Jiadaxiu Jiujia in the Mainland has to wait for the final review and approval by the regulatory authorities.
Previously, Professor Wei Lihui, a well-known gynecologist from Peking University People's Hospital, said in an interview with The Paper that there is almost no difference between bivalent and tetravalent vaccines in terms of the preventive effect on cervical cancer. For the target vaccination population, it should be vaccinated as soon as possible when there are vaccination conditions, and don't miss the best vaccination time because of waiting.
From Fenghuang. com