On May 13, Sedate Biological jointly held a strategic meeting with its partner CRO to discuss the Phase II clinical strategy for its core pipeline asset, SDTM001 Injection. Currently, the Phase I clinical trial is progressing steadily, with the Safety Review Committee (SRC) meetings for the low- and medium-dose groups completed and the high-dose administration phase underway. The program has preliminarily met the conditions to transition into Phase II, marking an acceleration of the development process.

During the meeting, key design elements of the Phase II clinical protocol were discussed in depth. Both parties reached a consensus and formed a clear implementation strategy on critical issues including patient enrollment and exclusion criteria, selection of primary clinical efficacy endpoints, and collaborative operational mechanisms.

SDTM001 Injection is a novel cell therapy independently developed by Sedate Biological. It is intended for the prevention of postoperative recurrence of non-small cell lung cancer (NSCLC). Leveraging its differentiated mechanism of action, the product has demonstrated excellent anti-tumor activity in preclinical and early clinical studies, along with a generally manageable safety profile.

The successful optimization of the clinical development strategy further highlights Sedate Biological’s scientific innovation strength and efficient clinical execution capabilities in the field of cell therapy. This milestone solidifies the foundation for accelerating the clinical program and ultimately bringing benefits to patients in need.