Matters:
On April 11, 2022, the World Health Organization (who) announced on its official website that the strategic advisory group of experts on Immunization (SAGE) meeting was held from April 4 to 7 to review the evidence of immunogenicity and protective efficacy of single dose human papillomavirus (HPV) vaccination. The expert group believes that the single dose HPV vaccination program can effectively prevent cervical cancer caused by persistent HPV infection, and the effect is equivalent to that of the two or three dose program. It is suggested to modify the immunization program as follows: women aged 9-14 (the highest priority population) should be vaccinated once or twice; 15-20-year-old women were vaccinated once or twice; Women over 21 years old were vaccinated twice (with an interval of 6 months).
Guoxin pharmaceutical’s view: 1) who / sage has been discussing the change of single dose immunization procedure for many years. We believe that the formal proposal this time is more due to the slowdown of global HPV vaccine coverage under the background of covid-19 epidemic. Single dose vaccination can effectively improve the accessibility / affordability of HPV vaccine in low-income countries; 2) Most of the research results reviewed by SAGE take the persistent infection / immunogenicity of the young age group as the alternative end point. The advance of the standard may lead to the decline of the estimation accuracy of the final effective rate. At the same time, the peak value of single dose vaccination and long-term antibody titer are lower than the 2 / 3 dose immunization procedure. More data and longer-term continuous tracking are still needed for the long-term protective effect of cervical cancer; 3) At present, under the national drug administration policy, some clinical, data and registration procedures need to be changed for dosage change, with limited short-term impact. 4) Investment suggestion: China’s HPV vaccine products are fully promoted, consumers are willing to vaccinate, and the stock market space is broad; In 2020, many provinces and cities successively put forward HPV vaccine free vaccination programs. The short-term 2 import + 3 domestic pattern is stable, the purchase amount of MSD / Chongqing Zhifei Biological Products Co.Ltd(300122) agency agreement maintains a high growth rate, and Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) production capacity is gradually released, which is expected to quickly seize their respective target market share; In the medium and long term, five HPV products of four Chinese enterprises are in PH3 clinical stage and are expected to be listed successively around 2025, forming a pattern of 2 imports + 5-6 domestic products, 2 / 3 / 4 / 9 price product differentiation competition, product upgrading progress and international market expansion are the core driving forces. It is suggested to buy Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ( Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ), Chongqing Zhifei Biological Products Co.Ltd(300122) ( Chongqing Zhifei Biological Products Co.Ltd(300122) ), etc. 5) Risk warning: product sales are less than expected; Increased competition in China has led to a sharp decline in product prices; The construction of production capacity projects does not meet expectations; The progress of R & D pipeline does not meet expectations or fails; The contract cannot be renewed with the partner or the terms of the agreement do not meet the expectations; Risks such as major changes in national policies or vaccine recommended immunization procedures.
