Stemirna receives Emergency Use Authorization from Laos for its proprietary mRNA vaccine

SHANGHAI, Dec. 14, 2022 /PRNewswire/ -- On December 8, 2022, Stemirna Therapeutics Co., Ltd. (Stemirna), a Chinese biotech startup specialized in mRNA technology-based drug development, received an Emergency Use Authorization (EUA) from the Food and Drug Department under the Ministry of Health of the Lao People's Democratic Republic for its proprietary Covid-19 mRNA vaccine which prevents infection from the coronavirus through active immunization and is available to individuals aged 18 years and above. This is China's first such vaccine of its kind to be approved in Laos and the country's first mRNA vaccine against Covid-19 variants to be granted an EUA.

Stemirna's Covid-19 mRNA vaccine was developed and designed to provide protection against several Covid-19 variants that contain the D614G mutation and that are currently prevalent worldwide, including Delta and Omicron. The vaccine is stable when kept at a temperature of minus 20(±5) degrees Celsius and remains effective for up to 24 months from the date of manufacture.

Data from a clinical study conducted in Laos confirms the safety of the vaccine with no serious adverse events or adverse events of special interest. Immunogenicity-related data shows a 100% seroconversion rate of the Wild type strain and the delta strain as well as a 95.8% seroconversion rate of the Omicron strain within 14 days after a second immunization.

Furthermore, the results of the clinical studies conducted in China on the safety of the vaccine have also demonstrated its safety and immunogenicity. Compared to inactivated vaccines with homologous boosters, the vaccine showed a 28.4-fold increase in neutralizing antibodies against the Omicron strain within 14 days after sequential boosting. The solution also maintained significant cross-neutralizing activity against multiple variant strains as well as persistent immunity at day 180 after sequential vaccination.

Stemirna's EUA from the Laos Food and Drug Department for its Covid-19 mRNA vaccine demonstrates that the Chinese mRNA vaccine manufacturer has gained access to the international market. At the same time, to further promote the economic growth of the two countries in tandem with facilitating technology exchanges and collaborations, Stemirna has purchased some land in Laos and started the construction of a vaccine manufacturing facility on the parcel with a planned annual capacity of 20 million doses. This is not only the firm's first vaccine production facility outside of the home market in China but also the first of its kind in Laos. With the facility, the company expects to deepen the cooperation between both countries in the area of healthcare by supporting the local government's efforts in improving public health as well as in preventing and controlling the spread of Covid-19. In addition, to support the Lao government in dealing with the pandemic while facilitating a return to normalcy in terms of both work and daily life, Stemirna will donate a certain number of Covid-19 mRNA vaccines.  

The messenger RNA (mRNA) vaccine, a new technology that stimulates the body's own immune response to specific antigens, has multiple advantages, including the ability to rapidly develop new vaccines and bring them to market, a high level of safety and a short production cycle. In addition to aiding in the prevention and control of infectious diseases, the technology provides another type of immunotherapy for oncology patients, ushering in a new era of biomedical technology.

Relying on its proprietary LPP nanotechnology-based delivery technology platform and extensive experience in the R&D of mRNA drugs, Stemirna, an innovative pharmaceutical company focusing on the R&D and industrialization of mRNA products, has successfully built a technology platform across the whole industry chain for mRNA drugs from AI design, synthesis, preparation and quality control to mass production. Stemirna's EUA from the Lao  has also validated the safety and efficacy of its proprietary LPP mRNA platform technology that overcomes several patent barriers and technical challenges, laying a solid foundation for the development of additional mRNA vaccines and drugs.  The patent has been formally licensed in Europe, Hong Kong, China, Japan and the US in addition to being registered in several European countries. Most notably, the vaccine is China's only mRNA delivery system that has been licensed internationally as well as the world's first validated, non-lipid nanoparticle (LNP) mRNA delivery system.

To date, Stemirna has built a comprehensive business portfolio across the biopharmaceutical industry chain with over 20 pipelines in six major areas under development. The company has also established a nearly 50,000 square-meter mRNA vaccine production facility split between sites in Shanghai's Zhoupu Town and Fengxian District. By using domestically-produced equipment and the firm's proprietary mass production technology, the facility, with an annual capacity of 2 billion vaccine solutions and an annual filling capacity of 400 million doses, has become one of the largest mRNA vaccine plants to have been completed in Asia.

Stemirna plans to continue its commitment to R&D and innovation in a move to make a meaningful contribution to the health and wellness for all by developing quality mRNA vaccines and drugs!

Source: Stemirna Therapeutics Co. ,Ltd