IMMUNEONCO-B (01541) has announced two significant clinical milestones for IMC-003/IMM72, a proprietary ActRIIA-Fc fusion protein developed by its subsidiary, Immuncare Biopharmaceutical Technology (Shanghai) Co., Ltd. The Ib/IIa clinical trial in patients with pulmonary arterial hypertension (PAH) has completed enrollment and dosing of the first subject, marking the official transition of IMC-003's clinical development into the patient validation stage.

In the Phase I single ascending dose (SAD) study conducted in postmenopausal healthy women, all seven dose cohorts have now completed enrollment and safety observation period assessments. IMC-003 demonstrated generally favorable tolerability at the 8 mg/kg dose level, with no dose-limiting toxicities (DLTs) reported. The vast majority of adverse events (AEs) related to the study drug (IMC-003 or placebo) were Grade 1, and no treatment-related Grade 3 or higher AEs were observed.

For the Phase I multiple ascending dose (MAD) study in postmenopausal healthy women, the fourth dose cohort (2 mg/kg) successfully completed enrollment of all eight subjects on August 17, 2026. With this, all dose cohorts specified in the protocol have now completed enrollment. Early safety data are encouraging: all AEs in the MAD phase were Grade 1 or 2, with no AEs of Grade 2 or higher related to hemoglobin elevation reported, and no DLT events occurred across the first three dose cohorts. The fourth dose cohort has not yet reached its scheduled safety observation assessment point.