Last night, Zhifei Biological announced that the company's agreement to the Merck East nine-month HPV vaccine (cervical cancer vaccine) was approved. The nine-priced HPV vaccine was approved by the batch, marking the official entry of the nine-priced HPV vaccine into the Chinese market.
It is understood that there is no official sales of the nine-priced HPV vaccine in the Chinese market, and the sale of the product will fill the gap. Prior to this, Hainan has included the nine-priced HPV vaccine in the supplementary procurement catalogue, and other provinces have submitted or are ready to submit relevant bidding materials according to the progress of bidding in each province.
The fastest-listing drug in Chinese history
The speed at which the nine-priced HPV vaccine is marketed in China is called a "rocket."
In May 2015, the nine-price application for the first time in China was applied for clinically. In November 2017, the clinical approval was obtained. After submitting the application for listing on April 20, 2018, it was conditionally approved for listing on April 29 and officially obtained on May 23. Batch issuance certificate.
This is the fastest drug ever approved in China. It took only 9 days from the application to the approval of the listing, and then the first supplementary purchase was completed in Hainan in 11 days.
For a long time in the past, for safety reasons, the time for Chinese drug approval has generally been postponed in other countries. However, in recent years, HPV cancer vaccines are in short supply, and vaccine approvals are also accelerating. In order to meet the public demand for drugs, the State Drug Administration has included the nine-priced HPV vaccine in the priority review process, and has conditionally accepted overseas clinical trial data based on the approved data based on the four-valent HPV vaccine.
According to public information, Merck's nine-priced HPV vaccine was approved for marketing in the United States in 2014. In 2006, Hong Kong became the first region in China to open a vaccine for cervical cancer. Until last year, the bivalent and tetravalent HPV vaccines began to be officially listed in mainland China. Currently approved to enter China's HPV vaccine, the recommended age for bivalent vaccine is 9 to 25 years old, the recommended age for tetravalent vaccine is 20 to 45 years old, and the newly approved nine-valent HPV vaccine is suitable for women aged 16 to 26 .
The price represents the range of virus coverage. The higher the price, the more virus subspecies are covered, and the better the vaccine is. At present, cervical cancer is the second most common genital malignant tumor of the female genital tract, with nearly 600,000 new cases worldwide and about 300,000 deaths. China has an annual increase of about 135,000 new cases, of which 80,000 have died. 99.7% of cervical cancers are caused by HPV infection.
At present, the products listed on the mainland are the Shireshi bivalent vaccine produced by GlaxoSmithKline and the Qatar repair of Merck in the United Kingdom. The more popular in Hong Kong is Merck's nine-priced product. At this point, the bivalent, tetravalent, and nine-priced HPV vaccines have all entered the Chinese market.
The nine-priced HPV vaccine has landed in the Chinese market, and Merck has still handed it over to the "old partner" Zhifei Bio-Agent for many years, which enhances the influence and competitiveness of Zhifei Bio in the vaccine industry. The nine-valent HPV vaccine and the listed four-valent HPV vaccine form an effective complement, which will further expand the adaptation population.
According to CCTV news reports, the first needle of the nine-valent cervical cancer vaccine in the mainland will be inoculated in Boao Super Hospital in Hainan, the price is 1318 yuan / support. Sheng Guoping, executive vice president of Boao Super Hospital, said: The nine-valent vaccine is expected to be the earliest injection time in Boao Super Hospital from the end of May to the beginning of June. The vaccine is already on the way to purchase.
HPV vaccine, 30 billion market in short supply
A hard-to-find HPV vaccine has huge profit margins.
Previously, many women in the Mainland chose to go to Hong Kong to inject a nine-valent cervical cancer vaccine. According to statistics, nearly 2 million people in China go to Hong Kong to inject this vaccine every year. Hong Kong has already become the world's fourth largest market for the nine-valent HPV vaccine.
Not only the shortage of nine-priced HPV vaccines, but also the four-priced HPV vaccine in many cities in China has been exposed to tight supply.
“There are only about 800 places in the third- and fourth-tier cities, and they will soon be gone. At present, only the first two vaccines are paid, and the third one is still unknown.†Ms. Liu, who has already played the first four-price pair, Investing in the road, "It is really hot, Wuhan four prices have been reserved until next year."
Search online and you will find that there are many posts about how to make a prescription for cervical cancer vaccine. Behind the needs of many users, it is the huge profit margin of this industry.
According to the prediction of relevant agencies, according to the results of the sixth census in China, the number of young people aged 16 to 26 in China accounts for 17% of the country's total population, reaching 225 million, and the number of women is about 100 million. According to the current Hong Kong price of HPV vaccine 3000 Hong Kong dollars / three needles, according to the market penetration rate of 10%, HPV vaccine market space in the domestic market is at least 30 billion yuan.
According to the latest Merck's financial report, the total sales of four- and nine-priced HPV vaccines in 2017 was 2.308 billion US dollars.
The industry believes that with the official launch of the four-price, nine-priced HPV vaccine, the future performance of Zhifei Bio as a sales terminal is expected to maintain rapid growth. According to the data of Zhifei Bio in the third quarter of 2017, the total amount of the four-valent vaccine planned to be purchased in the four years is more than 6.5 billion yuan, of which about 542 million yuan in 2017 and about 1.372 billion yuan in 2018, 2019. About 1.784 billion yuan, about 2.230 billion yuan in 2020, and about 617 million yuan in 2021.
On May 11, the price announced by the Hainan Provincial Public Resource Trading Center, the price of the nine-price HOV vaccine pre-filled syringe and the vial bottle were both 1298 yuan/piece, higher than the previous price of about 1200 yuan/piece in Hong Kong. .
It is reported that the four-valent HPV vaccine has already won the bid in 27 provinces including Beijing, Shanghai, Guangdong, Jiangsu, Shandong, Sichuan, Hunan and Hubei. The number of batches issued in the first four months of this year has reached 1,282,200.
The battle is coming soon!
With the comprehensive listing of HPV vaccines, it not only led to the development of the industrial chain of Zhifei Biotech and other companies, but also led a large number of domestic enterprises to carry out research and development innovation in the HPV vaccine industry.
According to the information disclosed by the official website of the State Drug Administration, there are currently 14 domestic HPV vaccine varieties in different stages of research and development. For example, Shanghai Zerun Bio's bivalent HPV vaccine is already in the third phase of clinical trials, and its research and development of the nine-valent HPV vaccine clinical research application has also been accepted. According to market estimates, Shanghai Zerun's HPV vaccine will be available in 2019. Phase III clinical trials of the bivalent HPV vaccine conducted by Xiamen Wantai Bohai are also underway. In addition, the four-valent HPV vaccines from Chengdu Institute, Beijing Institute and Shanghai Bowei have entered Phase I clinical trials. In terms of the nine-valent HPV vaccine, Xiamen Wantai and Shanghai Bowei products have been approved for clinical use.
In addition to companies already in clinical trials, there are a large number of companies that are on the road to clinical approval of HPV vaccines. It is reported that the 11-valent HPV vaccine declared by Beijing Nuoning Biotechnology Co., Ltd. and the 11-valent HPV vaccine declared by Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd.; in addition, the nine-priced HPV vaccine and double heron declared by Jiangsu Ruike Biotechnology Co., Ltd. The four-valent HPV vaccine declared by the pharmaceutical industry...
Everyone wants to get a share in this market that is not yet fully competitive. It is foreseeable that the market competition for domestic cervical cancer vaccines is being fully rolled out.
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