Press Release 2025. 09. 10
BOSTON, MA and HONG KONG, September 10, 2025 — Innorna today announced the completion of enrollment and vaccination in its Phase II clinical trial for IN006, the world’s first bivalent respiratory syncytial virus (RSV) mRNA vaccine currently in development by the company.
IN006 is also China's first domestically developed RSV vaccine to enter clinical trials, following IND approval in June 2024. The Phase I trial began with the first subject vaccinated in November 2024. Completion of enrollment and dosing in the Phase II trial marks a milestone toward dose optimization and sets the stage for Phase III efficacy studies.
The Phase II study is a randomized, double-blind, placebo-controlled trial conducted in China among healthy adults aged 60 and above. Key objectives include:
“This Phase II clinical trial marks a critical step in validating IN006’s scientific hypothesis—delivering broad-spectrum, durable protection against RSV,” said Dr. Linxian Li, Founder and CEO of Innorna. “We remain committed to advancing the clinical development of this vaccine candidate efficiently. Our goal is to deliver safer, more effective RNA medicines to meet global public health needs.”
About RSV
Respiratory syncytial virus (RSV) is a highly contagious respiratory pathogen that can cause recurrent infections throughout life. While RSV typically presents as mild, cold-like symptoms in the general population, certain groups— including older adults, infants and young children, immunocompromised individuals, and those with chronic underlying conditions—face a significantly higher risk of developing severe illness and complications. These may include pneumonia, respiratory failure, and, in some cases, death.
Despite its global impact, there are currently no approved antiviral treatments for RSV infection, and no RSV vaccine has been authorized in China. This underscores a critical unmet need in the prevention and management of RSV, particularly among vulnerable populations in the region.
About IN006
IN006 leverages Innorna’s proprietary pre-fusion F protein design, mRNA technology, and lipid nanoparticle (LNP) delivery system. It encodes stabilized pre-fusion F proteins from both RSV-A and RSV-B, making it a bivalent mRNA vaccine candidate designed to target both major subtypes. RSV-A and RSV-B frequently circulate in alternating or overlapping seasonal patterns. While monovalent RSV vaccines generally offer cross-protection against both subtypes, a bivalent vaccine has the potential to deliver broader-spectrum efficacy.
Preclinical studies suggested favorable safety profile and strong humoral and cellular immune responses. In challenge models, IN006 provided effective protection against both RSV-A and RSV-B.
As China’s first domestically developed RSV vaccine—and the country’s first non-COVID mRNA vaccine to enter clinical trials—IN006 represents a meaningful advancement in public health innovation. Furthermore, IN006’s bivalent design positions it as a potential global solution for seasonal RSV prevention across diverse populations.
About INNORNA
Founded in 2019, Innorna is dedicated to advancing next-generation LNP delivery platforms and RNA medicines to address unmet global health needs. Its proprietary, rationally designed lipid library—comprising over 6,000 chemically diverse ionizable lipids—enables breakthroughs in mRNA vaccines and therapeutics.
Powered by its mRNA-LNP platform, Innorna has built a robust pipeline targeting infectious diseases, rare diseases, metabolic disorders, and cancer immunotherapy. In addition to its internal R&D programs, the company collaborates with leading biotechnology and biopharma innovators worldwide to expand the reach and impact of its transformative technology.
Innorna’s achievements have been recognized by both investors and industry leaders, earning accolades such as Forbes China Industry Leaders, MIT Technology Review’s 50 Smartest Companies, and Fortune China Impact Startups.
Learn more at www.innorna.com.
