Press Release 2024. 01. 12

Innorna Receives IND Clearance by FDA Enabling Phase I Initiation for Bivalent Respiratory Syncytial Virus mRNA Vaccine

United States, January 12, 2024 - Innorna, a clinical-stage biotech company pioneering its proprietary lipid nanoparticle (LNP) technology to develop novel RNA therapeutics, announces that its first-in-class bivalent Respiratory Syncytial Virus (RSV) mRNA Vaccine has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to initiate a Phase I clinical trial.  This is Innorna’s third IND approval granted by the FDA.


IN006, the first bivalent mRNA vaccination that targets both Types A and B, subtypes of RSV, comprises two mRNAs utilizing Innorna's proprietary pre-fusion F protein design.


RSV is a highly contagious virus and a common pathogen causing lower respiratory tract infections in adults over age 60, children under age 5, and the immuno-compromised population, leading to significant health and economic burden on society. "We are thrilled to have received IND approval of IN006 by the FDA. We will accelerate the clinical development of IN006 to provide more effective measures to prevent and control RSV-related diseases worldwide," said Linxian Li, Ph.D., CEO and Founder of Innorna.


About Respiratory Syncytial Virus (RSV) and IN006


Respiratory syncytial virus (RSV) is a common respiratory virus with two major subtypes, A and B. It is highly contagious and can lead to outbreaks in communities and hospitals. There is still the possibility of re-infection with RSV in people who have been infected, especially in adults over age 60, children under age 5, and the immuno-compromised population. There is a substantial unmet medical need for RSV-specific therapy, as the current therapy remains primarily supportive care and symptomatic treatment. Therefore, active immunization through vaccination is crucial to avoid severe RSV infection and reduce death.


After decades of research and development, two RSV vaccines were approved for market in 2023, AREXVY® from GlaxoSmithKline and ABRYSVO® from Pfizer; both are recombinant protein vaccines. There is no RSV vaccine approved in China.


IN006 is a first-in-class bivalent mRNA RSV vaccine independently developed by Innorna, utilizing a proprietary LNP delivery system and mRNA technology platform, as well as independently designed and screened pre-fusion F protein. In preclinical studies, IN006 has demonstrated high efficacy in animal models with a well-tolerated safety profile.


About Innorna


Founded in 2019, Innorna focuses on developing best-in-class LNP delivery technology and advancing innovative RNA therapies to address unmet medical needs globally. Innorna has built a diversity-oriented lipid library (DOLL) of over 5,000 ionizable lipids, which can be applied in various modalities or scenarios, including mRNA vaccines and therapeutics, cell therapies (CAR-T, CAR-NK, etc.), and genome editing therapies. Innorna’s comprehensive R&D capability fully supports the end-to-end process development of innovative therapies for internal development and external collaboration partners, from discovery to clinical development.  Innorna has developed an extensive global patent portfolio and filed over 40 patent applications regarding the innovation of LNP and mRNA technology.


Based on its proprietary technology platform, Innorna has built extensive internal R&D pipelines for infectious and rare diseases. In addition, the company has established partnerships with pharma and biotech companies to explore the potential of the technology in broader therapeutic areas. Since its establishment four years ago, Innorna has been widely recognized by the investment community and industry. It has won many awards, including MIT Technology Review's Global 50 Smartest Companies and Fortune China's Most Socially Influential Startups.


At Innorna, we value INNOVATION, INTEGRITY, EFFICIENCY, and OPENNESS. Innorna is committed to exploring the frontier of mRNA application based on platform technologies and leading the revolutionary step toward expanding the clinical application of mRNA in various therapeutic approaches to fulfill the unmet medical needs of patients worldwide!


Please visit the Innorna website at for more information.