On July 16, Rec-Biotechnology submitted its prospectus to HKEX and was accepted. Rec-Biotechnology is an innovative vaccine company, and its core product, Human Papillomavirus 9-valent Vaccine, Recombinant, is in Phase III clinical trial stage. According to the prospectus, the co-sponsors of this IPO are Morgan Stanley, CMB International and CITIC Securities, and the funds raised will be mainly used for the research and development of vaccine.
Rec-Biotechnology has developed a comprehensive vaccine innovation engine, including a new adjuvant platform, a protein engineering platform and an immune evaluation platform. The company is one of the few companies capable of developing new adjuvants, and is able to benchmark all new adjuvants currently approved by the FDA. The company's technology platform has formed an "iron triangle", which has created synergistic effects in antigen design and optimization, adjuvant development and production, and determination of the best combination of antigen and adjuvant.
The company has established a product pipeline including 11 innovative vaccines under research, which are used to treat diseases such as cervical cancer, COVID-19, adult tuberculosis, herpes zoster, hand-foot-mouth disease and influenza. However, the core product is REC603, a Human Papillomavirus 9-valent Vaccine, Recombinant, which is currently in Phase III clinical trial stage and is also the company's vaccine closest to commercialization. Let's take a closer look.
Research and Development Pipeline of Rec-Biotechnology (Source: Rec-Biotechnology Prospectus)
HPV vaccine -- REC603
REC603 is a Human Papillomavirus 9-valent Vaccine, Recombinant, which aims to provide protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. REC603 adopts hansenula expression system, and the methanol utilization pathway of hansenula has strong and adjustable promoter, high secretion, low glycosylation level and other characteristics, which is suitable for the production of medical recombinant protein.
The Phase I clinical trial of REC603 has proved that it has good immunogenicity and safety. At present, the product is in the Phase III clinical trial stage, and it is expected to submit BLA to the State Food and Drug Administration in 2025. In addition to REC603, Human Papillomavirus 2-valent Vaccine, Recombinant candidate vaccines developed by the company -- REC601 and REC602 for HPV 16/18 and HPV 6/11 respectively, have entered Phase I clinical trials.
As far as HPV market is concerned, it has great potential. Since the first HPV vaccine has been approved in 2017, the market volume has increased to RMB 13.1 billion in 2020, and it is expected to grow to RMB 69 billion in 2030 at a compound annual growth rate of 18%. At present, among the four HPV vaccines listed in China, the only approved Human Papillomavirus 9-valent Vaccine, Recombinant, has a market share of over 48.5%.
COVID-19 vaccine - ReCOV
In addition to HPV vaccine, COVID-19 vaccine (ReCOV), a product of Rec-Biotechnology, is one of the most concerned products at present, and is undergoing Phase I clinical trial in New Zealand. It is worth mentioning that the actual research and development of this project is carried out by Jiangsu Provincial ...
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