Main points of investment
The technology platform forms the "iron triangle", and the R & D pipeline covers all aspects. The company has developed a comprehensive vaccine innovation engine including a new adjuvant platform, a protein engineering platform and an immune evaluation platform, and the technology platform has formed an "iron triangle". There is a synergistic effect in antigen design and optimization, adjuvant development and production, and determining the best combination of antigens and adjuvants. The company's 12 vaccine candidates strategically cover six high burden disease areas around the world, including HPV, COVID-19, Herpes Zoster, Adult Tuberculosis, Influenza and HFMD.
Establish production capacity at the early stage to ensure the smooth transformation of candidate vaccines. The company is building a HPV vaccine production base in Taizhou City, Jiangsu Province, with a design capacity of 5 million doses of HPV 9-valent vaccine or 30 million doses of HPV bivalent vaccine per year, and is expected to expand to more than 1000 million doses of HPV 9-valent vaccine per year. The company's GMP standard production base of COVID-19 vaccine ReCOV has obtained the production license issued by Jiangsu Provincial Drug Administration in November 2021 and the compliance declaration issued by the EU quality authorized person in April 2022; the production base is expected to support an annual capacity of 300 million doses of ReCOV and can also be used to produce recombinant herpes zoster vaccine.
In the orderly development of the pipeline, REC603 is expected to become the first batch of commercial domestic HPV nine-valent vaccine. The core product, recombinant HPV nine-valent vaccine REC603, is in phase III clinical trials. In August 2022, the company has completed the young age group immune bridging of REC603 and the first dose vaccination of all subjects in two studies comparing the immunogenicity of REC603 with Gardasil 9; the subjects of the REC603 primary efficacy test are following up according to the clinical plan; and the BLA application of REC603 is planned to be submitted to NMPA in 2025.
Based on New Zealand Phase I clinical data, COVID-19 candidate vaccine ReCOV has successively conducted multicenter II/III phase trials for basic immunization and sequential enhancement in the Philippines and the United Arab Emirates; in May 2022, ReCOV was approved by NMPA clinical trials; in August 2022, ReCOV conducted a head-to-head II phase clinical trial with Pfizer Inc mRNA vaccine in the Philippines; and plans to submit EUA/BLA applications in 2022.
Profit forecast: the company is based on independent advantage technology, differentiation layout has not been met by the market demand. With the orderly development of graded vaccine R & D pipeline and the rapid construction of domestic and foreign commercial networks, the company can grow in the future. We expect the company's first product, ReCOV, to submit an EUA/BLA application in 2022, which will bring an increase in performance for the company. In the follow-up, the expected approval of blockbuster products such as recombinant herpes zoster vaccine and HPV series vaccine will further accelerate the steady growth of the company's performance. We have adjusted our profit forecasts to forecast operating income of RMB0.00,2.00 and RMB 150 million and net profit of-RMB7.06,5.66 and-564 million in 2022-2024, maintaining a "prudent overweight" rating.
Risk tips: the risk of persistent loss, the risk of R & D failure, the risk related to additional financing, the risk of less than expected vaccine production and commercialization, the risk of change in policy and regulatory environment, the risk of change in industry competition pattern, etc.