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The World's First 14-valent HPV Vaccine Enters The Clinic

Recently, Shenzhou Cell announced that its self-developed 14-valent HPV vaccine SCT1000 has entered clinical phase I/II studies and completed the enrollment of all 80 subjects. It is worth noting that this is the world's first 14-valent HPV vaccine to enter the clinical research phase.


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SCT1000 is the world's first 14-valent HPV vaccine independently developed by Shenzhou Cell after more than ten years. It covers all 12 high-risk carcinogenic HPV virus types identified by the WHO and 2 HPV virus types that are the most important cause of condyloma acuminatum. It is intended to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, intraepithelial neoplasia and adenocarcinoma in situ caused by HPV infection, as well as genital warts caused by HPV6 and HPV11.


Cervical cancer is a female malignant tumor with a high incidence in recent years. Its incidence is second only to breast cancer, ranking second! HPV is clinically called human papillomavirus, and currently known HPV subtypes are one There are more than 100 kinds, divided into low-risk and high-risk two, and among them, high-risk HPV accounts for 14, such as high-risk HPV types 16 and 18, which are related to only 80% of cervical cancers!


On October 27, 2017, the list of carcinogens published by the International Agency for Research on Cancer of the World Health Organization was initially compiled for reference. Human papillomavirus types 6 and 11, human papillomavirus beta (except types 5 and 8) and gamma are in 3 In the list of carcinogens.


Human papillomavirus (HPV) is a genus of papilloma vacuolating virus A belonging to the family Papanoviridae. It is a spherical DNA virus that can cause the squamous epithelium of human skin and mucous membranes to proliferate. Manifested as common warts, genital warts and other symptoms. With the rapid increase in the incidence of condyloma acuminata in sexually transmitted diseases and the increase in cervical cancer and anal cancer, human papillomavirus infection has attracted more and more attention. The vaccine is the best way to prevent the disease.


The HPV vaccines currently popular in the world are mainly bivalent, quadrivalent and ninth valence. The reason why they are named after "valence" means that in terms of the number of types of virus subtypes targeted by this type of vaccine, the more valence, the greater the prevention. The more types of HPV.


Among the many types of HPV, HPV16 and 18 are the most common high-risk types of cervical cancer, so the most basic bivalent vaccine is for 16 and 18. As the name implies, quadrivalent and ninth-valent vaccines have added more preventable types on the basis of bivalent, and 14-valent has added several types of virus subtypes that can be targeted on the basis of many predecessors.


It is understood that the HPV vaccines on the market in China include: Merck’s quadrivalent vaccine and 9-valent vaccine, and GSK and Wantai Bio's bivalent vaccine. In addition, Watson Bio's bivalent vaccine has been applied for production, and it is expected to be available in the next 1-2 years.


The advantages of Shenzhou Cell's 14-valent HPV vaccine are mainly to increase the coverage of HPV virus types and the potential internationally differentiated competitive advantages such as manufacturing technology, production technology, capacity, and cost.


Data show that there is a huge clinical demand for HPV vaccines in the Chinese market. In 2017, a total of 1.455 million HPV vaccines entered the Chinese market and approximately 485,000 were vaccinated; in 2018, a total of 7.128 million HPV vaccines entered the market and approximately 2.376 million were vaccinated, a year-on-year growth rate of nearly 400%. Looking forward to the advent of the 14-valent vaccine of Shenzhou Cell, it will give everyone a choice in the prevention of hpv virus.