RegeneBiotech's Lyophilized Omicron mRNA Vaccine RH109 Receives Clinical Approvals in New Zealand and the Philippines

On June 27, 2022, Shenzhen Ruiji Biotechnology Co., Ltd. (hereinafter referred to as “Ruiji Biotech”) announced that its developed lyophilized mRNA vaccine against the Omicron variant of SARS-CoV-2, RH109, had received clinical trial approvals in New Zealand and the Philippines through its joint venture subsidiaries.

This approval marks a milestone, as the world’s first lyophilized mRNA vaccine targeting the SARS-CoV-2 Omicron variant enters clinical trials.

Currently, the Omicron variant continues to rage globally, with recurring outbreaks imposing a substantial societal burden. RH109 utilizes Regentech’s proprietary lyophilization technology to effectively maintain the physicochemical properties and biological activity of mRNA-LNP, enabling long-term storage at 2–8°C. Preclinical studies have demonstrated that this product provides effective protection against the Omicron variant; when administered as a booster dose, it induces broad-spectrum cross-neutralizing responses, highlighting its favorable immunogenicity profile. Relevant findings have been posted on the preprint server bioRxiv.

Ruiji Biotechnology has completed the preclinical development of RH109 based on its proprietary mRNA drug development platform. The work primarily included antigen design and screening, mRNA sequence design and optimization, screening and optimization of delivery systems, development of lyophilized formulation processes, pilot-scale production of the mRNA vaccine, and research on manufacturing processes and quality standards.

Leveraging its comprehensive mRNA drug development platform, the company is rapidly advancing the product’s R&D and the production of clinical trial materials. In addition to New Zealand and the Philippines, it is currently engaging with regulatory authorities in multiple countries and regions to actively prepare for several clinical trials.

Rege Biotech, established in 2019, is a biotechnology company possessing globally leading mRNA technology. Headquartered in Shenzhen, the company has set up R&D, production, and clinical centers in Wuhan and Shanghai. Rege Biotech owns a comprehensive mRNA drug development platform with independent intellectual property rights. The company has applied multiple advanced technologies to fields with significant market prospects and clinical value, including vaccine development, protein replacement therapy, cancer immunotherapy, and rare disease treatment.