On the same day, Merck also released a message confirming that the new indication of the nine-valent HPV vaccine was approved by the State Administration of Pharmaceutical Products. Subsequently, "Nine-valent vaccine of human papillomavirus expanded to 9-45 years old" quickly topped the hot search list in Weibo.
Nine-valent HPV vaccine extended to 45 years old.
Cervical cancer is one of the common gynecological malignant tumors. ICO/IARC China 202 1 Report on Human Papillomavirus and Related Diseases shows that in 2020, the incidence and mortality of cervical cancer among women aged 5-44 in China will be the third among female tumors.
According to the virus subtypes covered by the vaccine, human papillomavirus vaccines are divided into bivalent, tetravalent and nonavalent, and the age range of each vaccine is slightly different. Among them, bivalent HPV vaccine is suitable for people aged 9 to 45, covering HPV 16 and HPV 18. The applicable age of tetravalent HPV vaccine is 20 to 45 years old, covering HPV6, HPV 1 1, HPV 16 and HPV 18. The nine-valent HPV vaccine covers HPV6, HPV 1 1, HPV 16, HPV 18, HPV3 1, HPV33, HPV45, HPV52 and HPV58. The previous applicable age was 16 to 26 years old. Previously, many women were forced to give up the nine-valent HPV vaccine because they were over age.
After this approval, the four-valent and nine-valent human papillomavirus vaccines of Merck in China are all women aged 9 to 45. In 20 18, Merck's nine-valent HPV vaccine was approved for marketing in China, but it was only approved for women aged 16 to 26.
Tian Anna, senior vice president of Merck and president of China District, said that the expansion of the applicable age of the nine-valent HPV vaccine shows the determination of the China government to accelerate the elimination of cervical cancer, and Merck will improve the accessibility of HPV vaccine by expanding global production capacity and increasing supply to the China market.
Nine-valent HPV vaccine is still "a needle is hard to find"
At present, the human papillomavirus vaccines approved for marketing in China include imported Merck tetravalent vaccine "Jiadaxiu" and nine-valent vaccine "Jiadaxiu 9"; GlaxoSmithKline's bivalent vaccine "Sirrah"; As well as bivalent vaccine "Xinkening" produced in Wan Tai and bivalent vaccine "Wozehui" produced in watson biological. At present, the nine-valent HPV vaccine is the highest-priced vaccine that can be used to protect human papillomavirus in the market, and it is also the most sought after vaccine by the vaccinated population.
However, the penetration rate of nine-valent HPV vaccine still cannot meet the huge market demand, showing that "one needle is hard to find". Since 20 18 was approved to be listed in China, Merck has been increasing the supply of nine-valent HPV vaccine every year. Zhifei Bio is the domestic agent of Merck HPV vaccine. Its 2022 semi-annual report shows that from June to June 2022, the number of nine-valent human papillomavirus vaccines issued reached 9,298,700, a year-on-year increase of 379.34%.
Merck also disclosed in the 2022 semi-annual report that in the first six months of this year, China's sales increased by 87% year-on-year to US$ 2.57 billion. In particular, Merck said that in recent quarters, the market demand of Jiadaxiu in China has remained at a high level, which has continuously promoted the company's business expansion in China.
A batch of domestic nine-valent human papillomavirus vaccines entered the third phase of clinical practice.
In addition to Merck, the platform of drug clinical trial registration and information publicity shows that at present, five companies, including Recreation Guardian Wan Tai Bio, Weber Bio, Ruike Bio and Zerun Bio (watson biological subsidiary), are conducting phase III clinical trials of nine-valent HPV vaccine in China. Except Zerun Bio, the upper limit of the registered clinical trial age group of the other four companies is 45 years old.
On the morning of August 3 1, Wan Tai Bio told reporters that the head-to-head clinical trial of the company's nine-valent HPV vaccine and Merck's nine-valent HPV vaccine has completed the clinical trial site and specimen detection, and the data is being statistically analyzed, and the recruitment of the young-age bypass clinical trial has been completed.
Liu Jun, deputy chief physician of the Department of Obstetrics and Gynecology of Beichao Hospital affiliated to Capital Medical University, said that it is not recommended to blindly pursue the nine-valent HPV vaccine, and it is recommended to vaccinate in time at the right age. Liu Jun said that bivalent and tetravalent HP vaccines can also have a good preventive effect, and it is not recommended to wait for higher-priced vaccines to increase the scope of protection and miss the best preventive opportunity.