Chengdu Olymvax Biopharmaceuticals Inc(688319) (688319)
Event: the company issued an announcement on receiving the summary report of phase II clinical trial of recombinant Staphylococcus aureus vaccine (E. coli), which showed that the product had good safety and immunogenicity in the target population.
comment:
The safety and immunogenicity are good. It is expected to enter phase III clinical stage next year. According to the summary report of phase II clinical trial, the company's product recombinant Staphylococcus aureus vaccine (E. coli) has good safety in the target population of Orthopaedic Surgery aged 18-70 in China; In addition, the specific antibody level of each immunization program group reached the peak 10-14 days after the first injection, and the immunogenicity was good. The specific antibody level was still at a plateau relative to the baseline 42 days after the first injection, and there was still a high level 180 days after the first injection. At present, the company is actively preparing for follow-up clinical research, and phase III clinical trial is expected to be carried out next year. This product is the national exclusive class 1 innovative vaccine developed by the company in cooperation with the Army Medical University. Compared with overseas competitive products, it has obvious improvements in antigen design, vaccination procedures and indications. Considering only 3 million fracture surgery patients in China every year, according to the calculation of 20% vaccination rate, the sales volume is expected to reach 1.2 billion yuan; If the indications are expanded to other departments through bridging test, the growth space will be expanded by at least 10 times, and it is expected to develop into a super heavy product of nearly 10 billion.
Multiple factors drive the continuous high-volume tetanus vaccine. 1) In terms of disease control system, the national animal injury diagnosis and treatment specification issued by the health commission is conducive to the promotion and vaccination of tetanus vaccine in dog injury vaccination clinic together with rabies vaccine, accelerating the vaccination and promotion of tetanus vaccine and improving the understanding of the preventive effect of tetanus vaccine in the emergency department of the hospital; 2) In terms of blood products enterprises, there is a strong demand for tetanus immunoglobulin, which is expected to drive the rapid growth of tetanus vaccine directly sold to blood products enterprises.
Heavy products are gradually entering the harvest period, which is expected to thicken the company's performance. AC conjugate vaccine was approved and issued for the first time at the end of March this year. With the advantage of less vaccination for infants over 6 months old, it is expected to usher in a large-scale stage, and will seize part of the market share in the future; AC Hib triple vaccine has completed phase III clinical site work and is about to be applied for production. It is expected to be approved for listing by the end of 2022 or the beginning of 2023; The two products are expected to increase the company's performance.
Profit forecast: it is estimated that the operating revenue from 2021 to 2023 will be RMB 530 / 1009 / 1802 million respectively, with a year-on-year increase of 66% / 90% / 79%. The net profit attributable to the parent company was 124 / 304 / 612 million yuan respectively, with a year-on-year increase of 243% / 145% / 101%, corresponding to 120 / 49 / 24 times of PE from 2021 to 2023.
Risk factors: risk of failure in research and development of new products; The risk that the product sales volume is less than expected; Product quality risk.
