On March 24, the official website of the State Food and Drug Administration showed that Watson Bio’s recombinant bivalent human papillomavirus (HPV) vaccine was officially approved for marketing, becoming the second domestic HPV vaccine. So far, the number of HPV vaccines approved for marketing in my country has increased to 5. Previously, Wantai Bio’s bivalent HPV vaccine became the first approved domestic HPV vaccine. The other three are the bivalent HPV vaccine produced by GlaxoSmithKline, the quadrivalent HPV vaccine and the nine-valent HPV vaccine produced by Merck & Co. From the perspective of industry insiders, as more pharmaceutical companies enter the bureau, the increase in domestic supply is expected to accelerate.
“2+3” pattern formed
The second domestic HPV vaccine was approved for marketing. On March 24, according to the official website of the State Food and Drug Administration, the recombinant human papillomavirus bivalent (type 16/18) vaccine (yeast) independently developed by Zerun Bio, a subsidiary of Watson Bio has been approved for marketing.
This is the second domestic HPV vaccine approved for marketing. In May 2020, Wantai Bio’s bivalent HPV vaccine officially opened for appointment vaccination, breaking the long-term monopoly of foreign companies in the domestic cervical cancer vaccine market.
It is reported that the new drug production application of Watson Bio bivalent HPV vaccine was accepted in June 2020. Watson Bio said in an article on official Weibo that the company has fully prepared hardware for the production of the HPV vaccine. The HPV vaccine production plant in Yuxi, Yunnan has been completed and obtained the drug production license issued by the Yunnan Provincial Food and Drug Administration in 2018. The annual output of vaccines can reach 15 million doses.
The relevant person in charge of Watson Bio told the Beijing Business Daily reporter that the company’s bivalent HPV vaccine immunization is suitable for women aged 9-30, and the immunization program is 3 injections (0, February, and June). Women aged 9-14 can also use the 2-needle schedule (0, 6 months), which can improve immunization coverage and reduce vaccination costs.
Before Watson Bio’s bivalent HPV vaccine was approved, there were 4 products on the market, namely GSK bivalent HPV vaccine Cervarix, Merck quadrivalent HPV vaccine Gardasil, and Merck 9-valent HPV vaccine. HPV vaccine Gardasil9 and Wantai Bio’s bivalent HPV vaccine. So far, the pattern of “2+3” (2 domestic models and 3 imported models) has been formally formed.
According to Liu Zhaohui, chief physician of Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University, sexual behavior is the main way of HPV transmission. Men and women who have sexual behaviors have an 85%-90% chance of being infected with HPV in their lifetime. . In China, “17-24 years old” and “40-44 years old” are the two peak ages of HPV infection among Chinese women. The management of these two groups has now become the focus of HPV prevention and treatment.
Driving performance growth
The approval of the bivalent HPV vaccine is expected to improve Watson’s performance. In 2021, Watson Bio achieved revenue of 3.463 billion yuan, a year-on-year increase of 17.82%; non-net profit deduction of 591 million yuan, a year-on-year decrease of 17.33%, increasing revenue without increasing profits.
According to public information, the price of GlaxoSmithKline’s (GSK) bivalent HPV vaccine Cervarix is 598 yuan/injection, the price of Merck’s quadrivalent HPV vaccine Gardasil is 798 yuan/injection, and the price of Merck’s nine-valent HPV vaccine is 798 yuan/injection. Gardasil9 is 1298 yuan/injection, and Wantai Bio’s bivalent HPV vaccine is 329 yuan/injection.
Benefiting from the continued production and sales of the company’s bivalent HPV vaccine, Wantai Bio’s operating income and attributable net profit in 2021 will both increase. The financial report shows that in 2021, Wantai Bio will achieve an operating income of about 5.75 billion yuan, a year-on-year increase of 144.25%; its net profit will be about 2.016 billion yuan, a year-on-year increase of 197.83%.
The HPV vaccine has also brought certain performance contributions to Merck. In 2021, Merck’s total revenue in China will reach US$4.262 billion, a year-on-year increase of 60%. MSD China will be the best performing region for MSD globally in 2021. According to Merck’s financial report, in the second quarter of 2021, the supply of cervical cancer vaccine Gardasil/Gardasil9 was resumed. In the fourth quarter, revenue from markets outside the United States (including China) increased by 177% year-on-year to $1.253 billion.
In response to issues such as product follow-up pricing, a reporter from Beijing Business Daily contacted the relevant person in charge of Watson Bio, and the other party said that there is no more information to share.
Domestic companies are making efforts
The domestic HPV vaccine is ushering in the harvest period. In addition to Watson Bio, Rico Bio, which has recently landed on the Hong Kong Stock Exchange, and Recreation Guard, which has sprinted to the Beijing Stock Exchange All have HPV vaccine research and development pipelines.
Judging from the research and development progress, Ruike Bio-aluminum adjuvant HPV nine-valent vaccine REC603 has entered the phase III clinical trial stage. The Phase III clinical trial of the nine-valent HPV vaccine independently developed by Recreation Guard has also been launched, and the first subject was successfully enrolled on December 5, 2020.
Wantai Bio revealed in its 2021 financial report that its plant for the production of nine-valent vaccines has entered the commissioning stage. Wantai Bio previously stated that the company’s nine-valent cervical cancer vaccine has entered the third phase of clinical trials, and the specific launch time depends on the clinical and approval progress.
Liu Zhaohui said that the bivalent HPV vaccine has a protective effect on two high-risk types of cancer (HPV16 and 18). The quadrivalent HPV vaccine can simultaneously protect against HPV6 and 11 infection on the basis of the bivalent vaccine, reducing the risk of genital warts. Currently, the quadrivalent HPV vaccine has been approved in China for women aged 9-45. The nine-valent HPV vaccine is currently the vaccine that covers the most types of HPV on the market and can prevent more than 90% of cervical cancers. Young girls should strive to get the HPV vaccine before sex for better protection. Women aged 40-44 should pay more attention to cervical cancer screening to reduce the incidence of precancerous lesions and cervical cancer. At the same time, women in this age group are also included in the scope of application of the HPV vaccine, and the HPV vaccine can also exert an immune effect at this time.
In the view of vaccine expert Tao Lina, with the successive launch of domestic HPV vaccines, consumers also have more choices.
The relevant person in charge of Watson Bio said that the company has built a modern production base with a production capacity of 30 million doses of HPV2 vaccine, which can effectively alleviate the dilemma of my country’s dependence on imported and expensive HPV vaccines.
Beijing Business Daily reporter Yao Qian