On March 15, Liaoning Chengda Biotechnology Co.Ltd(688739) ( Liaoning Chengda Biotechnology Co.Ltd(688739) ) announced that the recombinant fifteen valent human papillomavirus vaccine (Escherichia coli) (hereinafter referred to as fifteen valent HPV vaccine) jointly developed by the listed company had received the notice of approval for drug clinical trials approved and issued by the State Drug Administration, approving the fifteen valent HPV vaccine to carry out clinical trials.
It is understood that apart from Liaoning Chengda Biotechnology Co.Ltd(688739) the applicant for the fifteen price HPV vaccine, there are also recreational guards. This is a product jointly developed by the two companies. It is the first domestic fifteen valent HPV vaccine approved for clinical trial.
According to the approval results of the State Food and drug administration, after review, the fifteen valent HPV vaccine accepted on December 15, 2021 meets the relevant requirements of drug registration, and agrees to carry out clinical trials to prevent genital warts, cervical cancer, vulvar cancer, vaginal cancer, anal cancer and corresponding precancerous lesions caused by HPV type infection contained in the vaccine.
Cervical cancer is the second largest malignant tumor in women. Human papillomavirus (HPV) is directly related to cervical cancer. HPV vaccine is the first vaccine used to prevent tumor in the world. Human beings try to eliminate a kind of cancer through vaccine for the first time.
At present, the products listed in the Chinese market are mainly the nine price and four price vaccines imported from MSD, and some domestic four price and two price vaccines. Among them, the nine valent vaccine has been in a state of “difficult to obtain one shot”.
The “price” in HPV vaccine represents the types of virus that can be prevented by the vaccine. The higher the number, the more types can be prevented. It is understood that among the high-risk strains of HPV virus, types 16 and 18 are subtypes that cause most HPV related cancers, and bivalent vaccine is to prevent the infection of these two viruses; On this basis, tetravalent vaccine adds two kinds of virus prevention, and the scope of nine valent vaccine prevention is wider.
Research in China shows that more than 84.5% of cervical cancer is infected by HPV16 and HPV18 viruses. At present, bivalent and tetravalent vaccines listed in China can prevent and control 84.5% of the risk of cervical cancer, while bivalent vaccines can prevent and control 92.1% of cervical cancer.
According to Liaoning Chengda Biotechnology Co.Ltd(688739) introduction, the fifteen valent HPV vaccine it participated in the research and development can prevent all high-risk HPV viruses and HPV6 / 11 vaccines highly related to condyloma acuminatum by screening the dominant gene sequence of the target serotype, constructing the engineering strain of the target serotype, developing the detection kit and optimizing the protein purification process.
Specifically, it can be used to prevent the corresponding types of persistent infection and the resulting cervical cancer, vulvar cancer, vaginal cancer, anal cancer and condyloma acuminatum, as well as cin1 / 2 / 3, cervical adenocarcinoma in situ, vin2 / 3, vain2 / 3, ain1 / 2 / 3 and other related diseases, and the prevention effect of cervical cancer is more than 96%.
At present, there are 15 HPV vaccine products in clinical trials, including bivalent, tetravalent, jiuvalent, 11valent, 14valent, 15valent, etc. Among them, only the products cooperated by Liaoning Chengda Biotechnology Co.Ltd(688739) and Kangle guard have been approved, and its listing process has attracted wide attention.
There is still a large gap in the supply of HPV vaccine in China. According to frost Sullivan, the overall vaccination rate of HPV vaccine in China is low, less than 1%. If the expected increase of HPV vaccination rate is included, it is estimated that 234 million women aged 9 to 45 in China will not be vaccinated with HPV vaccine by 2050. Assuming 3 doses per person, an additional 702 million doses may be required.
At present, China’s HPV vaccine market is mainly divided by four vaccines, including Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) Xinkening (bivalent), GlaxoSmithKline’s Cervarix (bivalent), MSD’s Gardasil (tetravalent) and gardasil9 (bivalent).
In terms of output value, the four price and nine price of MSD account for about 91% of the total market scale of HPV vaccine in China in 2020, and it is difficult to obtain one injection of imported HPV vaccine from MSD.
Huaan Securities Co.Ltd(600909) research report shows that in the field of nine valent vaccine, in addition to Kangle guardian and rec biology, Bowei biology and Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) have also entered the phase III clinical stage. In the field of tetravalent vaccine, there are three clinical products. At present, the fastest progress is Bowei biology and China biology, both of which have entered phase III. In the field of bivalent vaccine, Walvax Biotechnology Co.Ltd(300142) has made the fastest progress and has entered the stage of listing application.
In terms of demand, people have a high demand for high priced HPV vaccine. If the fifteen valent HPV vaccine jointly developed by Liaoning Chengda Biotechnology Co.Ltd(688739) and Kangle guard goes on the market, it may alleviate the tension between supply and demand of nine valent HPV vaccine in China, and is expected to become a popular product after the nine valent vaccine.
Liaoning Chengda Biotechnology Co.Ltd(688739) said in the announcement that after obtaining the notice of clinical trial approval, the vaccine still needs to carry out a series of clinical trials and can be produced and listed only after being approved by the State Drug Administration, which will not have a great impact on the company’s business in the short term.
