Overview
Suzhou, China – On December 4, 2024, RinuaGene Biotechnology Co., Ltd. (hereinafter referred to as "RinuaGene") announced that it has received Investigational New Drug (IND) approval from China NMPA CDE for RG002 Injection, a Class 1 new drug fully developed by RinuaGene.
This approval follows the FDA's clinical trial clearance for RG002 Injection, making it the first mRNA product globally to receive clinical approval for this indication. The back-to-back approvals from both the U.S. and China validate RinuaGene's advanced capabilities in core mRNA technologies, including antigen design, delivery vectors, and CMC (Chemistry, Manufacturing, and Controls). RinuaGene will now accelerate the global development of RG002.
RG002 encodes multiple key early protein antigens of HPV16 and 18. The innovative antigen design not only targets the two most clinically significant high-risk HPV types but also moves beyond the traditional approach of using only E6/E7 as antigens. By addressing both E6/E7-driven and non-E6/E7-driven tumors, RG002 offers a potentially superior solution for the treatment of HPV16/18-related precancerous lesions and tumors. RG002 uses RinuaGene's proprietary mRNA sequence and Lipid Nanoparticle (LNP) delivery system, optimized through multiple patented technologies covering antigen design, sequence optimization, regulatory elements, and formulation. The company's delivery system is highly efficient and has an excellent in vivo safety profile. The outstanding preclinical data provides a solid foundation for using RG002 to treat persistent HPV infections, precancerous lesions, and malignant tumors.
RinuaGene is committed to efficiently advancing the clinical development of RG002 and actively exploring its value at different stages of HPV infection. The company is strategically planning to expand its indications globally to include cervical precancerous lesions, cervical cancer, head and neck squamous cell carcinoma, and rare tumors, addressing the significant unmet clinical need in treating HPV-related diseases and benefiting patients worldwide.
About RinuaGene
RinuaGene is dedicated to developing innovative mRNA-based drugs to meet major global unmet clinical needs. Its therapeutic products for HPV16 and 18-related infections have received IND approvals in both the U.S. and China, and several other products, such as infectious disease vaccines, are currently in the IND stage. The company has full-chain R&D and clinical production capabilities for mRNA drugs and vaccines, with four core technology platforms: linear mRNA, circular RNA, LNP delivery, and CMC. In 2024, RinuaGene filed over 90 patent applications and was granted 10 patents, continuously building a robust global patent portfolio. With its deep foundational research, the company aims to be a leader in mRNA drug development.
RinuaGene will continue to uphold its corporate culture of innovation, openness, collaboration, and win-win partnerships. The company welcomes multi-faceted collaborations in product development, combination therapies, technology platforms, and novel delivery systems to jointly advance the development and application of RNA technology in various fields. (bd@rinuagene.com)