Yuekang Pharmaceutical (688658.SH): YKYY031 for injection was approved for advanced solid tumors clinical trials

Zhitong Finance App News, Yuekang Pharmaceutical (688658.SH) announced that its wholly-owned subsidiaries, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. were recently approved and issued by the National Drug Administration (“NMPA”) to approve the “Drug Clinical Trial Approval Notice” for injecting YKYY031 for advanced solid tumors.

Injectable YKYY031 is a general-purpose mRNA tumor vaccine intended for the treatment of advanced solid tumors. The project uses a lipid nanoparticle (LNP) delivery system composed of a novel cationic lipid YK-009 based on the company's independent intellectual property rights. The system has the characteristics of high delivery efficiency and good safety. The mRNA sequence contained in YKYY031 for injection encodes a polypeptide antigen sequence composed of multiple highly expressed tumor-associated antigens (TAA) and specifically expressed tumor-specific antigen (TSA) epitopeptides in solid tumor tissue. When delivered to the body, the vaccine can induce the body to produce T-cells specific to these antigens and inhibit tumor cell growth. The core serial patent and delivery system patent of the project have been authorized by the State Intellectual Property Office for invention patents, and international patent applications have been completed simultaneously, and the company enjoys exclusive global rights.

Pre-clinical studies of YKYY031 for injection have fully proved that it has remarkable efficacy and good safety, and has outstanding advantages. In terms of efficacy, injectable YKYY031 can induce a significant and long-lasting tumor antigen-specific T-cell immune response, and shows clear anti-tumor activity under various administration regimens, and can be used in combination with anti-PD-1 antibodies to further enhance the curative effect. In terms of safety, toxicological studies have shown good safety, and there is a broad treatment window, laying a solid foundation for clinical application. In terms of stability, this product uses an advanced LNP freeze-drying process, which can completely break through the dependence of mRNA products on the ultra-low temperature cold chain, greatly reduce transportation and storage costs, and improve the accessibility of this product.