On the evening of August 30, Merck and quietly released big news.
Merck China’s official Weibo said that the new indication of Merck’s nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) (hereinafter referred to as the “9-valent HPV vaccine”) has been approved by the China National Medical Products Administration. Merck’s nine-valent HPV vaccine The applicable group is extended to women aged 9 to 45 years old.
This expansion will undoubtedly greatly expand the market for the nine-valent HPV vaccine.
At present, the HPV vaccines that have been approved for marketing in my country include the imported Merck & Co. quadrivalent vaccine "Jadaxu" and the nine-valent vaccine "Jadaxu 9"; GlaxoSmithKline the bivalent vaccine "Cerris" ; and the bivalent vaccine " Xinconin " of domestic Wantai Biotechnology, and the bivalent vaccine "Wozehui" of Watson Biotechnology . Currently, the nine-valent HPV vaccine is the highest-priced vaccine on the market that can be used to protect against the HPV virus, and it is also the most popular vaccine among vaccinated people.
Previously, only the bivalent HPV vaccine was approved for use in women aged 9 to 45 years old in China, and the quadrivalent HPV vaccine was approved for women aged 20 to 45 years old. The age expansion of the nine-valent vaccine will obviously have an impact on the markets of the above two vaccines.
"One shot, one drug" in the Chinese market
Merck is a global vaccine production giant. In June 2006, its quadrivalent HPV vaccine was approved by the U.S. Food and Drug Administration, becoming the first HPV vaccine to be marketed in the world. In December 2014, the company launched a nine-valent HPV vaccine with a wider range of prevention.
China has now become a vital part of Merck's global growth strategy. Merck China is headquartered in Shanghai, with an R&D center in Beijing and a factory in Hangzhou, integrating R&D, manufacturing and commercial operations.
Merck mainly relies on "one shot, one drug" in the Chinese market, namely HPV vaccine and K drug (Keytruda, a type of anti-cancer drug). K drug insists on not being included in the medical insurance, and at the same time has been "attacked" by various types of PD-1. However, it relies on its many indications and unique curative effects to stand out and maintain high sales. In the first half of 2022, K drug became the "only" non-COVID-19 drug in the world with sales exceeding 10 billion.
Merck's quadrivalent HPV vaccine and nine-valent HPV vaccine received drug registration approvals from the State Food and Drug Administration in 2017 and 2018 respectively. Zhifei Biotech is its exclusive agent in China.
Zhifei Bio's latest disclosed semi-annual report for 2022 shows that during the reporting period, the company's four-valent HPV vaccine batch release volume was 4.8767 million, a year-on-year increase of 60.10%; the nine-valent HPV vaccine batch release volume was 9.2988 million, a year-on-year increase of 379.34 %.
Merck also disclosed in its 2022 semi-annual report that in the first six months of this year, sales in China increased by 87% year-on-year to US$2.57 billion. Merck specifically pointed out that in recent quarters, the demand for Jiadaxiu in the Chinese market has continued to be high, which has continued to promote the company's business expansion in China. How long will it continue that
is “hard to find”?
The nine-valent HPV vaccine has been in short supply since it was launched in China in April 2018. "Seedlings are hard to find" has even spawned rampant "scalpers" and the emergence of professional technical and business teams. The business involves robbing on behalf of others, existing seedlings, and smuggling seedlings from Hong Kong. Some scalpers bluntly stated that their monthly income is tens of thousands.
Since this year, the HPV vaccine industry has continued to be controversial. In April, the WHO Immunization Strategy Expert Group recommended that one dose of HPV vaccine is sufficient. This has caused great controversy in the two-dose and three-dose products advocated by most HPV vaccine companies. The approval of the indication for two-dose vaccination of the imported bivalent HPV vaccine in May has also intensified changes in market supply and vaccination procedures. .
Behind the long-term "unavailability" and "unavailability" of HPV vaccines, it directly points to the limited domestic supply of vaccines. But domestic vaccine manufacturers are catching up.
In May 2020, Wantai Biological's HPV bivalent vaccine was officially put on the market and began sales. In March this year, Watson Biotech’s bivalent HPV vaccine was also approved for marketing. Following closely behind, the nine-valent HPV from companies such as Kangleguard, Rico Biotech, and Bowie Biotech have entered Phase III clinical trials; the research and development of other companies' bivalent, quadrivalent, and even 14-valent products are also in full swing.
Not only that, in addition to the Chinese market, domestic HPV vaccine companies are also eager to try the global market. After passing the WHO's pre-certification (PQ certification), Wantai Biotech is in the process of registration applications in Morocco, Thailand, Indonesia, Malaysia and other countries. Leisure Guard has previously reached an agreement with Russian Pharmaceuticals and is expected to launch in 2024 In 2016, the nine-valent HPV vaccine was approved for sale in Russia.
Fighting for the "golden taels" in the vaccine production line
Merck is also "unable to sit still."
On April 4 this year, Merck announced a large investment in production. It recently expanded its vaccine production facility in Elkton, Virginia, USA. With regulatory approval, the construction area was 120,000 square feet. 150 jobs will further enhance the company’s HPV vaccine production and supply capabilities.
In 2019, Merck also invested more than US$1 billion to expand the capacity of existing production facilities and build new facilities to meet the unprecedented huge global demand for HPV vaccines.
Reporters noted that last year, Merck also launched a large-scale Phase 3 clinical trial with more than 8,000 people in China to evaluate the protective efficacy and immunogenicity of its nine-valent human papillomavirus (HPV) vaccine in men immunogenic and security. Previously, the HPV vaccine has been recommended by the US FDA and other agencies to extend its use to men of appropriate age.
At present, HPV vaccination in my country is not included in the national immunization plan and is vaccinated on a voluntary basis at one's own expense. The National Health and Medical Commission actively promotes the inclusion of HPV vaccination into local policies to benefit the people in places where conditions permit. Guangdong, Hainan, and Fujian provinces have successively launched the implementation of free vaccination of domestically produced bivalent HPV vaccines for school-age girls in the provinces, and included them in the 2022 provincial party committee and provincial government practical projects for the people.
The National Health Commission recently stated that it will vigorously promote the experience of Guangdong, Hainan, Fujian and other provinces, summarize the experience and practices of various localities in using government livelihood projects and medical insurance funds to raise funds through multiple channels, encourage local governments to take the lead in trials, and focus on promoting regions with mature conditions to take the lead. A free HPV vaccination policy has been introduced to continuously increase the HPV vaccination rate among girls of appropriate age. The
market is large enough and the competition is fierce enough.
Merck Global Senior Vice President and China President Anna Tian said that the expansion of the applicable age of the nine-valent HPV vaccine demonstrates the Chinese government’s determination to accelerate the elimination of cervical cancer . Merck will expand global production capacity and increase supply to the Chinese market. HPV vaccine accessibility.
In the future HPV vaccine market, it may be difficult to see a "single-out" one. The suspense of "who will get a larger market share" is getting bigger and bigger, but what is certain is that more and more Chinese women will be able to be protected.
