Youcare Pharmaceutical Group (688658.SH): YKYY031 for injection has received approval to conduct clinical trials for advanced solid tumors.

Youcare Pharmaceutical Group (688658.SH) announced that its wholly-owned subsidiaries, Beijing Yuekang Science and Technology Pharmaceutical Technology Co., Ltd. and Hangzhou Tianlong Pharmaceutical Co., Ltd., recently obtained the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) approving the use of injection YKYY031 for late-stage solid tumors. Injection YKYY031 is a universal mRNA tumor vaccine intended for the treatment of late-stage solid tumors. The project uses a lipid nanoparticle (LNP) delivery system composed of a novel cationic lipid YK-009, based on the company's proprietary intellectual property. This system has high delivery efficiency and good safety characteristics. The mRNA sequence contained in injection YKYY031 encodes a peptide antigen sequence composed of multiple tumor-associated antigens (TAA) and tumor-specific antigens (TSA) that are highly expressed in solid tumor tissues. After the vaccine is delivered into the body, it can induce the production of specific cytotoxic T cells against these antigens, inhibiting tumor cell growth. The core sequence patent and delivery system patent have been granted by the National Intellectual Property Administration, and international patent applications have also been completed, granting the company global exclusive rights. Preclinical studies of injection YKYY031 have confirmed its significant efficacy and good safety profile. In terms of efficacy, injection YKYY031 can induce significant and long-lasting tumor antigen-specific T cell immune responses and show clear anti-tumor activity under multiple dosing regimens. When used in combination with anti-PD-1 antibodies, its efficacy can be further enhanced. Regarding safety, toxicological studies have shown good safety profiles and a wide therapeutic window, laying a solid foundation for clinical application. In terms of stability, the product uses an advanced LNP freeze-drying process, which can completely eliminate the dependence on ultra-low temperature cold chains for mRNA products, significantly reducing transportation and storage costs and improving accessibility.