The board of directors of the Company (the “Board”) is pleased to announce that the clinical trial approval for the mRNA respiratory syncytial virus (RSV) vaccine developed by a controlled subsidiary of the Group, Liverna Therapeutics Inc., has been recently obtained from the National Medical Products Administration, which marks a new progress of the research and development of the vaccine.

RSV, a common respiratory tract infection pathogen, is highly contagious and widely prevalent worldwide. RSV infection is an important cause of death in infants under one year old and also an important factor in the death of respiratory tract infections in the elderly. Meanwhile, people who have been infected with RSV previously are still at risk of being reinfected with RSV. At present, there is no approved antiviral drug specifically for RSV that is available for clinical use worldwide. Therefore, the prevention of RSV has become an important strategy to resist the health threat from RSV, and vaccination for active immune prophylaxis is an effective means to avoid severe RSV infection. No RSV vaccine has been approved for marketing in China, and now there are two RSV vaccines from GlaxoSmithKline and Pfizer on the global market. In 2023, the global sales of RSV vaccines reached US$2.46 billion. According to the forecast of China Insights Industry Consultancy Limited, an industry consultant, it is expected that the global market size of RSV vaccines will reach approximately US$16.7 billion by 2030 with great market potential.

The Group is one of the enterprises that take the lead in developing mRNA vaccine products in China, and also one of the first batch of domestic vaccine enterprises that have obtained an independent patent for mRNA technology. The Group has a mature mRNA vaccine research and development system and has developed several mRNA vaccine candidates (including but not limited to mRNA rabies vaccine, mRNA RSV vaccine and mRNA shingles/herpes zoster vaccine, etc.). The Group has also established a sound quality management system for mRNA vaccines and a commercial-scale production workshop in line with GMP standards, and vaccines produced on the mRNA technology platform have also been verified by clinical trials. The Group has now smoothened the whole life cycle process such as the research, development and production of mRNA vaccines, allowing for rapid achievement of the industrialization of mRNA vaccine products after the completion of the clinical trials as well as the acceleration of the commercialization process of vaccine products.

The Group will rapidly advance the clinical trials of the mRNA respiratory syncytial virus (RSV) vaccine. As a new and globally heavyweight key vaccine product, this product is expected to become a new growth driver of the Group after its launch.