HLB Acquires Rights to 'Nanocobox'... Growing Expectations for Strengthening Vaccine Sovereignty

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma has acquired the global rights to the COVID-19 vaccine ‘Nanocovax,’ which is currently in Phase 3 clinical trials in Vietnam. This is the first case of a domestic company acquiring the rights to a COVID vaccine nearing the final stages of clinical trials overseas.

According to industry sources on the 19th, HL Biopharma acquired the global rights to the COVID-19 vaccine 'Nanocovax,' which is in Phase 3 clinical trials in Vietnam, from Nanogen the day before. Through this agreement, the two companies have agreed on technology transfer for the production, sales, and global marketing of ‘Nanocovax.’ Over the next three months, three lead scientists from each side will be appointed to review the vaccine data and finalize the technology transfer negotiations.

Currently, the global supply of vaccines is absolutely insufficient compared to demand, and this situation is prolonged. As a result, a ‘rich get richer, poor get poorer’ phenomenon is occurring in vaccine distribution. This has intensified the power struggle in the international community surrounding vaccines. This is why governments worldwide, including our own, are putting great effort into ‘vaccine diplomacy’ to secure vaccine supplies while also striving to secure vaccine sovereignty through domestic development.

Among domestic pharmaceutical companies, SK Bioscience, Genexine, and GeneOne Life Science are developing protein recombinant and DNA vaccines, while recently Celltrion has also started developing an mRNA vaccine, entering the domestic COVID vaccine development race. The domestic vaccine market grew rapidly, recording a growth rate of 30.3% in 2020 compared to 2019. It is expected that this growth trend will continue as the importance of vaccinations against COVID-19 and other diseases increases.

Globally, various vaccine platform technologies such as RNA vaccines, viral vector vaccines, inactivated vaccines, and recombinant vaccines are actively being developed. ‘Nanocovax,’ whose rights were acquired by HL Biopharma, is a recombinant protein vaccine that uses genetic recombination technology to produce the COVID-19 virus surface spike protein, which is injected into the body to induce an immune response. It generally has fewer side effects, higher safety, consistent production quality, and cost competitiveness. Unlike mRNA vaccines that require ultra-low temperature freezing storage, it can be stored refrigerated, which is also considered a major advantage.

Novavax, a COVID-19 vaccine based on the same recombinant protein platform, produces the COVID-19 spike protein in insect cells and adds a saponin-based adjuvant to create a nanoparticle-form vaccine. Nanocovax is produced in CHO (Chinese Hamster Ovary) cells, a mammalian cell line widely used for recombinant protein production. It differs by using aluminum salts, which are commonly used as vaccine adjuvants and have proven safety and efficacy, as the immune enhancer.

‘Nanocovax’ is being developed by Nanogen, established in Ho Chi Minh City, Vietnam. Nanogen is Vietnam’s only biosimilar company, founded in 1997 by Chairman Ho Nhan, who studied pharmacy at the University of Arizona and clinical and pathology sciences at Boston University, and worked for major pharmaceutical companies such as Sanofi before returning to Vietnam. In 2012, Nanogen succeeded in producing generic hepatitis treatment drugs, significantly contributing to the reduction of hepatitis patients in Vietnam. The company also holds the U.S. patent for pegylation, a protein drug technology.

COVID vaccine development is led by economic powers such as the U.S. and Europe. However, Vietnam is also considered one of the leading countries in the vaccine field. Since the Pasteur Institute was established during French colonial rule, Vietnam has a 126-year history of vaccine development and is the fourth Asian country after Japan, India, and China to produce finished vaccine products. It has succeeded in developing vaccines for Southeast Asian endemic diseases such as diphtheria and dengue fever, as well as interferon B and hepatitis C treatments. In 2015, the World Health Organization (WHO) announced that “Vietnamese vaccines guarantee safety and efficacy.”

Nanogen applied for emergency use authorization for ‘Nanocovax,’ which is in Phase 3 clinical trials, to the Vietnamese Ministry of Health on the 13th and plans to apply for WHO approval as well. Phase 2 results showed an antibody production rate exceeding 90% fourteen days after the second dose, already demonstrating high efficacy. German Siemens Healthineers participated in the analysis of Nanocovax clinical results, enhancing the credibility of the data.

Considering the tight schedule, HL Biopharma and Nanogen plan to jointly pursue the rapid commercialization and market development of ‘Nanocovax.’ In particular, under the comprehensive cooperation of HL Biopharma Group affiliates including HL Biopharma, DandiBio, HL Biopharma Cell, and Next Science, production plans will also be established. They also announced that they will continue to collaborate in various areas, including the development of a nasal spray antibody-based COVID treatment.