Recently, Merck has announced that the US FDA has accepted the application for a supplemental biological product license for its 9-valent recombinant human papillomavirus (HPV) vaccine GARDASIL9, which seeks to extend the age-appropriate approval of GARDASIL9 for women aged 27 to 45 and Men, certain cancers and diseases caused by the prevention of nine HPV types covered by vaccines.
It is understood that the US FDA has approved the priority review of the drug's sBLA, and has established the prescription drug use fee method (PDUFA) and the time limit for approval. The estimated decision date is October 6, 2018.
At the end of last month, GlaxoSmithKline announced that according to the technical review of the Drug Evaluation Center of the State Drug Administration, the vaccination target of the bivalent HPV vaccine Cervarix has been approved to extend to 45 years old. This has become the only cervical cancer vaccine approved in China for all women aged 9 to 45 years old.
However, compared with Cervarix, Gardasil 9 is currently the largest number of HPV types on the market. In 2014, Gardasil 9 was approved for active immunization of 9-26 year old women and 9-15 year old men. Prevention is caused by 7 high risks. Cervical cancer, vulvar cancer, vaginal cancer, anal cancer caused by HPV (16, 18, 31, 33, 45, 52, 58), and prevention of genital warts caused by two low-risk HPV (6, 11) Condyloma acuminata). In addition, Gardasil9 can also be used to prevent precancerous lesions of the cervix, vulva, vagina and anus caused by these 9 genotypes of HPV. It is estimated that the seven high-risk HPVs covered by the Gardasil9 vaccine cause about 90% of cervical cancer cases and 80% of cervical lesions (cervical cancer precancerous lesions are defined as CIN2, CIN3 and AIS), and the other two low-risk types HPV causes about 90% of genital warts.
A large study involving 14,000 women (16-26 years old) in the United States showed that Gardasil 9 was associated with Gardasil [recombinant human papillomavirus tetravalent (4,11) when blocking four shared HPV types. Types 16 and 18) vaccines are equally effective; in addition, the researchers determined that Gardasil 9 is effective in preventing cancer caused by five additional HPV types as high as 97% in adolescents aged 9-15 (1200 males and 2800 females) The clinical trials conducted in Example) showed that the antibody response induced by Gardasil 9 in the 9-15 year old population was similar to that induced in women aged 16-26 years. The safety of Gardasil 9 was obtained in approximately 13,000 men and women. Confirmed.
Excellent effectiveness and safety result in eye-catching sales data. According to Merck's financial report, Gardasil/Gardasil 9 has maintained good sales in the past two years. In 2016 and 2017, the sales of the drug were 21 respectively. $7.3 billion and $2.308 billion, an annual increase of 6%. Among the various types of drugs sold by Merck in 2017, sales ranked third. As of now, Gardasil 9 has been approved for use in 71 countries around the world, and since 2015, more than 34 million doses of vaccine have been distributed worldwide.
On April 28, 2018, China's Drug Administration approved the Gardasil 9 market in mainland China. It is suitable for female vaccination for 16-26 years old and uses three doses of immunization program. On May 11, Hainan Province announced that the price was 1298 yuan / support, slightly higher than the previous price of about 1,200 yuan / support in Hong Kong. At the same time, a number of medical institutions in Hong Kong issued a notice saying that they have received official notice from Merck. Suspension of supply of nine-priced HPV vaccine to the territory.
This is the fastest drug ever approved in China. It took only 9 days from application to approval. After only 11 days, the first supplementary purchase was completed in Hainan. The listing process and the bidding price exceeded. The market is expected and will be listed in Beijing as soon as the end of this year.
On May 30, the first nine-price HPV vaccine in the Mainland was inoculated at the Bohe Super Health and Family Medical Center Hospital in Hainan. It is reported that the nine-priced HPV vaccine provided by Hainan Hejia Medical Center is mainly in the form of a package, including doctor consultation, health check, and three. A nine-price HPV vaccination service and a free and individual membership for a total of 5,800 yuan a year. The vaccine is suitable for women aged 16-26, and the immunization program is three times inoculated in 0, 2, and 6 months. He said that the first batch of nine-priced HPV vaccines totaled 6,000 and could be injected by 2,000 people. At present, there are about 1,800 women who have made an appointment for vaccination, and they are also in a tight supply situation.
According to industry analysts, the future market for cervical cancer vaccine market will be dominated by four-price and even nine-price. If domestic HPV vaccine developers can form a competitive price advantage in the 9th-order vaccine, the future market will be nine-priced. the Lord.
Therefore, in addition to Merck, many companies in China have placed a nine-price market. Up to now, including the three drugs of Xiamen Wantai Bohai Biotechnology Co., Ltd., Shanghai Bowei Biotechnology Co., Ltd. and Shanghai Zerun Biotechnology Co., Ltd. The clinical trial of the cervical cancer vaccine has been approved, and the clinical trial of the nine-valent cervical cancer vaccine of Jiangsu Ruike Biotechnology Co., Ltd. is still pending.
Some media have predicted that according to the current CDE approval rate for imported drugs and domestically developed new drugs, and the previous on-site instructions of Premier Li Keqiang, industry insiders expect that imported or domestic nine-priced HPV vaccines will be fully available by 2019 at the latest. Approving the listing and enriching the Chinese market.
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