SystImmune Announces First Approval of Iza-bren for the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma in China
The approval of iza‑bren represents the first regulatory approval for this bispecific ADC in China and marks a significant milestone for patients with recurrent or metastatic nasopharyngeal carcinoma.
SystImmune Inc. announced that its product iza-bren (BL-B01D1), a first‑in‑class EGFR×HER3 bispecific antibody‑drug conjugate (ADC), has received regulatory approval from the China National Medical Products Administration for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who progressed after platinum‑based chemotherapy and PD‑1/PD‑L1 inhibitor therapy. The approval was based on the pivotal Phase III BL‑B01D1‑303 study (NCT06118333), which demonstrated a confirmed objective response rate of 54.6% for iza‑bren versus 27.0% for chemotherapy, a median duration of response of 8.5 months versus 4.8 months, and a median progression‑free survival of 8.38 months versus 4.34 months.
ICH and NCCN consider nasopharyngeal carcinoma a rare, geographically concentrated malignancy with limited systemic options. The approval of a bispecific ADC targeting EGFR and HER3 provides a novel therapeutic pathway for patients who have exhausted standard Platinum‑based chemotherapy and immune checkpoint blockade.
Evidence level: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.
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