Enveda Therapeutics secured FDA IND clearance and initiated a phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease. The move starts human testing for a pipeline aimed at ulcerative colitis and Crohn’s disease. In China, Simcere Zaiming received NMPA approval to begin clinical trials of SIM‑0610 in locally advanced or metastatic solid tumors. Both clearances expand the global pipeline of novel small molecules and highlight parallel early‑stage activity in GI immunology and oncology.