Zhitong Finance App News, Shiyao Group (01093) announced that a pioneering PD-1/IL-15 bispecific fusion protein SYS6090 (JMT108) (this product) has been granted fast-track status by the US Food and Drug Administration (FDA) to treat patients with microsatellite-stabilized (MSS) or complete mismatch repair (mCRC) disease progression after previous standard systematic treatment.
Colorectal cancer (CRC) remains a major public health challenge in the US. It is the third most common cancer and the second leading cause of cancer-related deaths. According to statistics from the US National Cancer Institute's SEER (Surveillance, Epidemiology, and Final Results) program, the 5-year survival rate of patients with distant metastatic CRC is about 17%; in MSS/PMMR mCRC patients treated with the 3rd line and above, the median overall survival time is usually less than 12 months, and there are large unmet clinical needs.
MSS/pMMR mCRC is considered a typical cold tumor and has limited response to standard immunotherapy. This product is a bispecific fusion protein that can simultaneously block PD-1 and activate the IL-15 signaling pathway. Its specifically designed asymmetric structure accurately guides IL-15 activity by relying on PD-1, and has the potential to selectively reshape the microenvironment of drug-resistant or immune cold tumors and activate depleted effector cells, while minimizing immune-related toxicity.
The data supporting this Fast Track qualification includes preclinical study results and data from phase I clinical studies currently being carried out simultaneously in China and the US. The FDA granted Fast Track status, which recognizes the product's potential to treat serious or life-threatening diseases, and will help speed up its development and approval process in the US and around the world.