XLifeSc's TCR-T Therapy XLS-103 Receives IND Approval for Two Indications: Advanced NSCLC and Pancreatic Cancer with KRAS G12V Mutation

Dec 25, 2025 11:06 CST Updated 11:06

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On December 22, 2025, Xiangxue Life Sciences Technology (Guangdong) Co., Ltd. (hereinafter referred to as "Xiangxue Life Sciences") received the "Clinical Trial Approval Notice" issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Investigational New Drug (IND) application for Xiangxue Life Sciences' self-developed high-affinity TCR-T cell therapy product "XLS-103 Injection" (application numbers: CXSL2500856 and CXSL2500857) has officially been granted clinical trial approval by the CDE.This cell therapy product has been approved for two indications this time.：

Approved Indication 1: For the treatment of advanced non-small cell lung cancer with HLA-A*11:01 genotype and positive KRAS G12V mutation in tumor neoantigen.

Approved Indication 2: For the treatment of patients with genotype HLA-A*11:01 and positive for the tumor neoantigen KRAS G12V mutation in advanced pancreatic cancer.

"XLS-103 Injection" is the third high-affinity TCR-T cell therapy product developed by GuangDong XIANGXUE LIFE SCIENCES LTD, targeting the pHLA complex composed of HLA-A*1101 and its presented KRAS G12V mutant peptide.

As a target for TCR-T, the KRAS G12V mutant peptide epitope "VVGAVGVGK" can be presented on the cell surface by multiple HLA-I molecules (including HLA-A*11:01, A*03:01, etc.). Among these, A*11:01 is the most widely distributed in the Chinese population, with over 40% of the population carrying this allele (including homozygotes and heterozygotes). Therefore, the HLA-A*11:01-restricted KRAS G12V epitope represents an ideal target suitable for the Chinese population. This is precisely the target of the TCR-T cell product "XLS-103 Injection," which has recently received IND approval.In addition to the two approved indications this time, the KRAS G12V mutation is also expressed in other tumors, such as colorectal cancer, endometrial cancer, and cholangiocarcinoma. GuangDong XIANGXUE LIFE SCIENCES LTD will further expand the indications for XLS-103 in the future.According to statistical analysis, the number of new cases annually in China that meet the treatment criteria for XLS-103's representative cancer types will exceed 50,000.

Source of the article: XIANGXUE LIFE SCIENCES LTD

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