Youcare Pharmaceutical Group Co., Ltd. (688658.SH) announced that its wholly-owned subsidiaries, Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. and Hangzhou Tianlong Pharmaceutical Co., Ltd., recently received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration (NMPA) for YKYY031 injection in the treatment of late-stage solid tumors.
YKYY031 injection is a universal mRNA tumor vaccine designed for late-stage solid tumor therapy. The project utilizes a lipid nanoparticle (LNP) delivery system based on the company's proprietary novel cationic lipid YK-009, which features high delivery efficiency and excellent safety.
The mRNA sequence in YKYY031 encodes a polypeptide antigen sequence composed of multiple tumor-associated antigens (TAA) highly expressed in solid tumor tissues and tumor-specific antigen (TSA) epitope peptides. Upon delivery into the body, the vaccine can induce the production of antigen-specific cytotoxic T cells to inhibit tumor cell growth.
The core sequence patent and delivery system patent for this project have been granted by the China National Intellectual Property Administration, with international patent applications also completed. The company holds exclusive global rights.
Preclinical studies of YKYY031 have fully demonstrated its significant efficacy and favorable safety profile. In terms of efficacy, YKYY031 induces robust and sustained tumor antigen-specific T-cell immune responses, exhibits clear anti-tumor activity under various dosing regimens, and shows enhanced therapeutic effects when combined with anti-PD-1 antibodies.
Toxicology studies confirm its safety with a wide therapeutic window, laying a solid foundation for clinical application. Regarding stability, the product employs an advanced LNP freeze-drying process, eliminating reliance on ultra-low temperature cold chain logistics, significantly reducing transportation and storage costs, and improving accessibility.
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