Report summary
This week, we discussed the impact of the who’s recommendation on the single dose immunization procedure of HPV vaccine. On April 11, the World Health Organization (who) announced on its official website that the who held an immunization strategy expert group (SAGE) meeting from April 4 to 7 to review the evidence of one dose of human papillomavirus (HPV) vaccine inoculation. The expert group considered that only one dose of HPV vaccine can produce the same immune effect as 2-3 doses, and can effectively prevent cervical cancer caused by HPV infection.
Our views on the above events are as follows:
1. The who proposed that the single needle vaccination procedure is of the nature of recommendation, and the impact is expected to be limited. The document proposed by the who is of the nature of recommendation, which aims to suggest that vaccine manufacturers can adopt the single needle immunization procedure as much as possible, and the single needle vaccine will be more likely to pass the WHO certification and enter the WHO procurement market. However, there is no mandatory ban on the two needle and three needle vaccines from entering the market. In recent years, who has put forward a number of suggestions on HPV vaccine in order to speed up the listing of HPV vaccine. The appeal behind it is that who purchases the vaccine through the foundation and puts it into the third world countries in order to improve the popularity of HPV vaccine in the third world. Therefore, it is highly sensitive to the price and cost of the vaccine.
Before entering the who market, the vaccine needs to be approved by the National Drug Administration. According to the promotion history of GSK two needle method, the change of vaccination mode often needs to be actively promoted by enterprises. Only after obtaining the proof data of good effect can it be adopted by the national level (such as the U.S. vaccination Commission), and the national level takes less initiative to promote.
2. According to the relevant clinical data published by who, the long-term protection ability of single needle vaccination remains to be discussed, and the support of replacing two needle method and three needle method is insufficient.
Most of the single needle clinical trials conducted by who in India, Africa and other countries take persistent infection as the alternative endpoint. By comparing the data of persistent infection, we can explain the protective effect of single needle method compared with the negative control group, but through the comparison of the proportion of infected people in different vaccination procedures, we do not fully explain the protective ability of the vaccine.
Refer to the clinical trial of two needle method in the low-age group. Because there is almost no way of HPV infection in the low-age group, the antibody titer is investigated clinically. The protective effectiveness of the vaccine was evaluated by comparing the antibody titer after two needle vaccination in the low-age group and the antibody titer data of three needle vaccination in the adult group. From the data published by two who clinical trials (Doris and CVT), we noticed that the antibody titer of single needle method did not meet the expected performance.
According to the test data published by Doris, compared with the two needle method and the three needle method, the HPV16 antibody titer level can reach the non inferior level after 24 months of inoculation with the single needle method, but the HPV18 antibody titer level cannot reach the non inferior level. According to the data published in CVT test, the antibody levels of two needle method and three needle method are the same in the long term, including the peak level, and are much higher than those of single needle method. Therefore, judging from the current clinical data, the single needle method is insufficient to replace the two needle method and the three needle method.
3. We believe that the Chinese HPV single injection method is less likely to be accepted by the drug administration, and the enterprise has insufficient driving force.
From the historical adoption of who’s recommendations on HPV by China’s State Drug Administration, we believe that the possibility of single needle method being accepted is low, mainly because its protective power has not been fully proved. From a historical point of view, after the two HPV vaccines listed by GSK and MSD, who has suggested that the data of persistent infection should be used to replace the precancerous lesion grade II (CIN II) of cervical cancer as the clinical endpoint. The purpose of the proposal is to reduce the time of clinical trial of HPV vaccine. However, in consideration of safety and protection, the China food and drug administration insists on CIN Ⅱ as the clinical endpoint, so as to effectively ensure the protective effect of the vaccine. From this point of view, the possibility of single needle method being accepted is low.
If enterprises want to compete in the who market by changing vaccination procedures, they must first obtain approval from the National Drug Administration. According to China’s approval process, the enterprise must first make the clinical protective data of the adult group (with CIN Ⅱ as the clinical end point), and then it is possible to obtain the approval by changing the vaccination method. However, at the same time, due to the submission of new vaccination procedures, there will be more data to be approved during the review, resulting in a longer overall approval time, and the enterprise will pay higher time and cost. From the perspective of input-output ratio, enterprises have insufficient motivation to actively promote the single needle method.
Overall, we believe that the impact of the who’s recommendation on the single dose immunization procedure of HPV vaccine is very limited. At present, the penetration rate of HPV vaccine in China is low, and there is great room for growth.
Related objects: Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Chongqing Zhifei Biological Products Co.Ltd(300122) and Walvax Biotechnology Co.Ltd(300142) .
Risk warning: policy uncertainty, R & D uncertainty, competition intensifies price risk.
Market review: this week (from April 11 to April 15), the biomedical sector fell 1.33%, underperforming the CSI 300 index by 0.34pct and outperforming the gem index by 2.93pct, ranking 22nd among 30 CITIC primary industries. This week, medical services and medical devices rose by 3.45% and 2.53%, and medical circulation was 0.10%; Chemical raw materials, prepared pieces of traditional Chinese medicine, proprietary Chinese medicine, chemical preparations and biomedicine decreased by 5.29%, 4.91%, 4.05%, 3.19% and 1.33% respectively.
Investment suggestions:
Recent view: high-quality companies have become more and more cost-effective. In the short term, continue to suggest two ideas, preferably:
1. Rapid growth, continuous improvement of performance and reasonable valuation range.
1) vaccines: Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Chongqing Zhifei Biological Products Co.Ltd(300122) and Shenzhen Kangtai Biological Products Co.Ltd(300601) ;
2) oral consumables: Yantai Zhenghai Bio-Tech Co.Ltd(300653) (active biological bone will be approved soon); Angel of the times (local invisible orthodontic leader)
3) life related upstream: Jenkem Technology Co.Ltd(688356) (PEG derivative), Nanjing Vazyme Biotech Co.Ltd(688105) (molecular enzyme), Acrobiosystems Co.Ltd(301080) (recombinant protein reagent).
2. Downside risk is limited, waiting for Fundamentals to catalyze.
The number of leading enterprises (including the number of planned blood pulp;
2) pharmacy sector ( Yifeng Pharmacy Chain Co.Ltd(603939) , Yixintang Pharmaceutical Group Co.Ltd(002727) , Lbx Pharmacy Chain Joint Stock Company(603883) , Dashenlin Pharmaceutical Group Co.Ltd(603233) , Shenzhen Mindray Bio-Medical Electronics Co.Ltd(300760) (short-term policy disturbance does not change long-term development logic),
3) private service leaders: haijiya medical and Jinxin reproductive;
4) China sublingual desensitization faucet Zhejiang Wolwo Bio-Pharmaceutical Co.Ltd(300357) ;
5) China’s leading pharmaceutical glass enterprise Shandong Pharmaceutical Glass Co.Ltd(600529) ;
6) angel of the times (local invisible orthodontic leader).
3. Continue to pay attention to covid-19 antigen detection.
1) recommendation: Guangzhou Wondfo Biotech Co.Ltd(300482) , Nanjing Vazyme Biotech Co.Ltd(688105) , Sino Biological Inc(301047)
Medium and long term perspective: pay attention to the invariance in change and look for opportunities with relative certainty. The impact of centralized mining continues to expand. The opportunity at the investment level lies in that the establishment of centralized mining is based on “multiple enterprises supply mutually replaceable varieties, and the production capacity can be supplied indefinitely in theory”. The basis for enterprises to maintain product price and profit space is the competition pattern, and the dynamic excellent competition pattern lies in the ability to continuously develop products and product iteration, which remains unchanged.
Start DRG / Dip reform in 2022. As a means of payment, the core role of DRGs is to achieve a balance between improving the efficiency and quality of diagnosis and treatment and ensuring the sustainability of medical insurance through refined medical insurance management. Hospitals that cannot actively adapt to the rules of the game will be eliminated. The opportunity at the investment level lies in that excellent private medical institutions have paid more attention to cost control for a long time, with higher operation efficiency and competitive advantage.
The general trend of industrial development is: China Meheco Group Co.Ltd(600056) industrial manufacturing is upgraded, the competitiveness is continuously improved, and moves upstream in the global production value chain.
The competitiveness of upstream raw materials is prominent:
1) biological “core” – life science support industrial chain: domestic enterprises have developed rapidly, reagent quality has reached the international leading level, and their competitiveness has been continuously improved. Entering the overseas market through global comparative advantage, China benefits from domestic alternative logic, with high growth and great development potential.
2) IVD raw materials and consumables: the covid-19 epidemic has opened a window for the transfer of the global IVD raw materials and consumables production supply chain to China.
Accelerated internationalization process: with the breakthrough of key technologies of Chinese enterprises, not only the localization rate of the Chinese market is accelerating, but also some high-quality enterprises have the strength to compete with international giants.
1. Manufacturing upgrading of pharmaceutical industry and continuous improvement of Competitiveness:
Upstream: life science support industry chain, IVD raw materials and consumables, related targets: Nanjing Vazyme Biotech Co.Ltd(688105) , Sino Biological Inc(301047) , Acrobiosystems Co.Ltd(301080) , Suzhou Nanomicro Technology Co.Ltd(688690) ;
High end medical devices: endoscope and sequencer, related subjects: Shenzhen Mindray Bio-Medical Electronics Co.Ltd(300760) , Qingdao Novelbeam Technology Co.Ltd(688677) , Sonoscape Medical Corp(300633) , Aohua endoscope, Micro-Tech (Nanjing) Co.Ltd(688029) ; Huada Zhizao (IPO application in progress); International layout of medical devices, related subjects: Shenzhen Mindray Bio-Medical Electronics Co.Ltd(300760) ;
Others: Jenkem Technology Co.Ltd(688356) , Shandong Pharmaceutical Glass Co.Ltd(600529) .
; Desensitization preparation, related subject matter: Zhejiang Wolwo Bio-Pharmaceutical Co.Ltd(300357) .
3. Private medical service sector with differentiated competition. Ophthalmology, Aier Eye Hospital Group Co.Ltd(300015) ; Dentistry, Topchoice Medical Co.Inc(600763) ; Assisted reproduction, Jinxin reproduction; Cancer treatment services, Hagia.
4. Pharmacy sector. Related objects: Yifeng Pharmacy Chain Co.Ltd(603939) , Dashenlin Pharmaceutical Group Co.Ltd(603233) , Lbx Pharmacy Chain Joint Stock Company(603883) and Yixintang Pharmaceutical Group Co.Ltd(002727) .
5. Aging and consumption upgrading. Class II vaccine, related targets: Chongqing Zhifei Biological Products Co.Ltd(300122) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) and Changchun Bcht Biotechnology Co(688276) ; Invisible orthodontics, related subjects: Angel of the times;
Risk tips: policy risk, price risk, performance risk less than expected, product R & D risk, expansion progress risk less than expected, medical accident risk, uncertainty of overseas covid-19 virus epidemic, M & A integration risk less than expected, etc.
