ITELINE：2025年第三季度基因、细胞与RNA疗法领域报告（英文版）

Two gene therapy approvals: in China, the NMPA approved Hrain Biotechnology’s CAR-T therapy, Hicara, for relapsed or refractory large B-cell lymphoma; while in the US, the FDA approved Precigen’s Papzimeos, a gene therapy indicated for recurrent respiratory papillomatosis (RRP) • One RNA therapy approval: the US FDA granted marketing approval for Ionis Pharmaceuticals’ Dawnzera in hereditary angioedema • One non-genetically modified cell therapy approval: ExCellThera’s Zemcelpro was granted