The association revealed Tuesday that 53 trials received approval between January and March, averaging about 17.7 approvals per month. Multinational trials dominated the period, comprising about 87 percent of the total, or 46 cases.
Late-stage trials — including phase 3, phase 3b and phase 2/3 — numbered 28, accounting for about 53 percent of all approvals, pointing to a pipeline clustered around near-term commercialization.
Antibody-based therapies led by modality, with monoclonal antibodies, bispecific and trispecific antibodies, polyclonal antibodies and antibody-drug conjugates (ADCs) making up more than 80 percent of approvals at 43 cases. Monoclonal antibodies and bispecific antibodies anchored the field, with 19 and 14 cases respectively, both concentrated in late-stage development.
ADCs, with seven cases across seven products, spanned early- and late-stage trials, reflecting their emergence as a next-generation antibody-based therapeutic class. Oncology was the dominant indication, accounting for about 49 percent of approvals.
However, domestic developers accounted for only about 19 percent of approvals, with foreign-led trials making up the remainder. BioNTech's bispecific antibody pumitamig led individual investigational drugs with five approvals, spanning indications including non-small cell lung cancer, triple-negative breast cancer, and gastroesophageal cancer.
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