On March 24, Walvax Biotechnology Co.Ltd(300142) announced that the State Food and Drug Administration had issued the drug approval certificate of Yuxi Zerun bivalent human papillomavirus vaccine (Pichia pastoris) (hereinafter referred to as “bivalent HPV vaccine”), a wholly-owned subsidiary of Shanghai Zerun, the holding subsidiary of the company. The vaccine became the second domestic bivalent HPV vaccine.
Cervical cancer is the second most common female malignant tumor in developing countries. On November 17, 2020, the World Health Organization (who) released the global strategy for accelerating the elimination of cervical cancer. 194 countries committed to the elimination of cervical cancer for the first time, and proposed that three key measures are indispensable to achieve this goal: vaccination, screening and treatment. According to the report, the scale of HPV vaccine in China will reach RMB 13.5 billion by 2020, and the compound growth rate of HPV vaccine in China will increase to 69.7% by 2030.
The bivalent HPV vaccine developed by Shanghai Zerun is used to prevent cervical cancer caused by HPV (human papillomavirus) 16 and 18 virus infection. International research data show that 99.7% of cervical cancer is caused by HPV infection. Earlier, min ruoqian, director of the physical examination and rehabilitation center of the Civil Aviation General Hospital, pointed out in an interview with the Beijing news that 84.5% of cervical cancer in China is caused by high-risk HPV16 and HPV18 viruses. Therefore, the risk of cervical cancer can be reduced by 84.5% by effectively preventing the continuous infection of HPV16 and HPV18 viruses.
According to the insight database of dingxiangyuan, the bivalent HPV vaccine of Shanghai Zerun obtained the clinical trial approval as early as June 1, 2011. From February 2012 to September 2015, phase I and phase II clinical studies were completed. In September 2014, Watson started the phase III clinical study and did not complete the phase III clinical trial data Unblinding until January 2020. In June of the same year, Watson submitted a listing application to the State Food and Drug Administration and was included in the priority review in July 2021.
Previously, HPV vaccines approved for marketing in China include bivalent HPV vaccine of GSK, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) bivalent HPV vaccine, tetravalent HPV vaccine and jiuvalent HPV vaccine of MSD. Among them, tetravalent HPV and jiuvalent HPV still need to be imported from abroad, and they are often out of stock, especially jiuvalent HPV vaccine. The pain point of “difficult to get a needle” and low vaccination rate has been persistent.
On December 30, 2019, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) the bivalent HPV vaccine (trade name “Xinkening”) was approved, becoming the first domestic bivalent HPV vaccine. In 2020, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) achieved revenue of 2.354 billion yuan, of which Xinkening achieved sales revenue of 693 million yuan. In 2021, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) achieved a revenue of 5.75 billion yuan, of which the vaccine sector contributed 3.363 billion yuan. Although the specific sales data of Xinkening is not disclosed, according to the published bid winning data, the actual procurement volume of medical institutions of bivalent HPV vaccine in 2021 is about 1009918 million, and the bid winning price range is 329 yuan / bottle – 344 yuan / bottle. Even based on the lowest bid price of 329 yuan / bottle, the actual purchase amount of Xinkening has exceeded 3.3 billion yuan.
Compared with tetravalent HPV vaccine and nine valent HPV vaccine, bivalent HPV vaccine has the advantages of economy and production capacity. In terms of economy, domestic bivalent HPV vaccine is better than imported bivalent HPV vaccine. Therefore, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) Xinkening quickly seized the market after its listing. By the end of 2020, Xinkening’s share in the bivalent HPV vaccine market had exceeded 85%. The sales volume in 2021 will exceed 10 million doses. After the bivalent HPV vaccine of Shanghai Zerun is approved for listing, it will form a competitive trend with Xinkening. How to win more market share remains to be determined by Walvax Biotechnology Co.Ltd(300142) and the commercialization strategy of Shanghai Zerun.
At present, many companies in China have disclosed the research and development or clinical progress of HPV vaccine Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ‘s nine valent HPV vaccine, Shanghai Zerun nine valent HPV vaccine, 11 valent recombinant human papillomavirus vaccine (Hansen’s yeast) jointly developed by Sinopharm Zhongsheng biology, Beijing Institute of biological products and Chengdu Institute of biological products, recombinant nine valent HPV vaccine of Beijing Kangle Weishi biology, four valent HVP vaccine of Shanghai Institute of biological products, recombinant HPV nine valent vaccine jointly developed by Jiangsu Ruike biology and Beijing anbaisheng biology, etc, They have entered different clinical research stages.
At the policy level, the state is also vigorously promoting the popularization of HPV vaccination. In February this year, the National Health Commission mentioned that HPV vaccination should be integrated into the national immunization plan for overall research. According to the National Health Commission, the next step will be to strengthen the monitoring of suspected abnormal vaccination reactions of HPV vaccine, promote the pilot first, encourage conditional areas to explore more flexible vaccination financing methods and vaccination policies, and gradually promote free vaccination for HPV vaccine age groups.
