CSPC PHARMA (01093): SYS6090 (JMT108) has been granted Fast Track designation by the U.S. FDA for the treatment of MSS/pMMR type mCRC patients.

CSPC PHARMA (01093) announced that its developed first-in-class PD-1/IL-15 bispecific fusion protein SYS6090 (JMT108) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) who have experienced disease progression after standard systemic therapy. In the United States, colorectal cancer (CRC) remains a significant public health challenge. It is the third most common cancer and the second leading cause of cancer-related deaths. According to statistics from the National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results) program, the five-year survival rate for patients with distant metastatic CRC is approximately 17%. Meanwhile, the median overall survival for MSS/pMMR mCRC patients who have undergone three or more lines of therapy is typically less than 12 months, indicating a substantial unmet clinical need. MSS/pMMR mCRC is considered a typical "cold" tumor with limited response to standard immunotherapy. This product is a bispecific fusion protein that simultaneously blocks PD-1 and activates the IL-15 signaling pathway. Its specially designed asymmetric structure precisely directs the activity of IL-15 in a PD-1 dependent manner, with the potential to selectively reshape the resistant or immune cold tumor microenvironment and activate exhausted effector cells while minimizing immunorelated toxicity. Data supporting this Fast Track designation include preclinical study results as well as ongoing Phase I clinical research data being conducted simultaneously in China and the United States. The FDA's granting of Fast Track designation is an acknowledgment of the product's potential for treating serious or life-threatening diseases and will facilitate accelerated development and review processes for it both in the United States and globally.