CSPC Pharmaceutical Group Ltd. has announced FDA approval of an IND application for JMT-106, a bispecific fusion protein drug, for glypican-3 (GPC3)-positive solid tumors.

Corbus Pharmaceuticals Holdings Inc. has obtained FDA clearance of its IND application for CRB-601, a TGF-β-blocking monoclonal antibody targeting the integrin αvβ8. Enrollment in a first-in-human phase I study will open in the first half of this year.

Sana Biotechnology Inc. has obtained FDA clearance of its IND application to conduct a study of SC-262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed chimeric antigen receptor (CAR) T therapy.

Onquality Pharmaceuticals LLC has obtained IND clearance from the FDA for OQL-025 to treat epidermal growth factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy for various cancers.

Obi Pharma Inc. has received FDA clearance for its IND application to conduct a phase I/II study of OBI-992, a novel antibody-drug conjugate (ADC) cancer therapy targeting TROP2. The trial will open shortly and aims to enroll patients with advanced solid tumors, including non-small-cell lung cancer, small-cell lung cancer and gastric cancer, although several other cancers are also potential targets.