On March 4, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the Investigational New Drug (IND) application for the freeze-dried Respiratory Syncytial Virus (RSV) mRNA vaccine submitted by Abogen (Acceptance Nos.: CXSL2400848, CXSL2400849, CXSL2400850) has received clinical tacit approval.This is Abogen's first application of its proprietary intellectual property.BaseThe approval of修饰技术 for clinical use marks a milestone.
Respiratory Syncytial Virus (RSV) is the most common viral pathogen causing acute lower respiratory tract infections, aside from influenza viruses. It frequently occurs in susceptible populations such as the elderly and infants, leading to a significant number of complications and deaths annually, imposing a substantial economic burden. To date, only three RSV vaccines have been approved globally, and there are currently no related products available in China, indicating a huge clinical demand.The RSV mRNA vaccine approved this time has many highlights:1. Using Abogen's proprietary intellectual property baseModificationTechnology, for the first time, successfully broke through the key modification patent barriers of overseas enterprises (m1Ψ fully modified mRNA). Overseas companies had previously established extremely high technical barriers in China through core patent layouts, with a protection period of 20 years, greatly restricting the development of Chinese companies in this field. This breakthrough by Abogen has opened up a new path for independent development.
2. Using Abogen's proprietary lipid nanoparticle delivery system (LNP), the core component of which is the only ionizable lipid in China that has been validated in large-scale Phase III clinical trials and possesses independent intellectual property rights, demonstrating good safety and efficacy. It has currently been granted patents in multiple major countries including China, the United States, Australia, and Europe.3. Using the company's mature freeze-dried formulation platform technology, this process allows the product to be stably stored for more than two years under mild conditions of 2-8°C, offering significant advantages in terms of storage, transportation, accessibility, and convenience.。Following the development of China's first COVID-19 mRNA vaccine using its own delivery system, this approval marks another breakthrough for Abogen achieved through the application of its self-developed nucleic acid modification technology. It also represents a successful implementation of the company’s freeze-drying process, highlighting Abogen's outstanding innovation platform.About Us
Abogen Biosciences (referred to as "Abogen") is an innovative biopharmaceutical company specializing in the research and development of messenger ribonucleic acid (mRNA) drugs. The company owns industry-leading, proprietary intellectual property rights over its mRNA and nanodelivery technology platforms. It is one of the few mRNA drug research and development enterprises in China with complete value chain capabilities, covering all aspects from mRNA design, formulation development, to large-scale production. The company has established a rich product pipeline, spanning multiple fields including infectious disease prevention and control (such as mRNA COVID-19 vaccines), tumor immunology, and protein replacement therapies.
