Hengrui’s Bispecific Fusion Protein Relafusp Alfa Approved, Setting New First‑Line Standard for Gastric Cancer

In April 2026, relafusp alfa injection (Aizeli), a Class 1 innovative drug independently developed by Hengrui Medicine, was approved by the China NMPA. It is indicated in combination with fluoropyrimidine and platinum‑based chemotherapy for first‑line treatment of locally advanced unresectable, recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma with PD‑L1 positivity (CPS≥1).

It is the world’s first approved anti‑PD‑L1/TGF‑βRII bispecific antibody fusion protein, dual‑blocking the PD‑L1 immune checkpoint and TGF‑β tumor microenvironment pathways to achieve “immune activation + microenvironment remodeling” with superior efficacy vs single checkpoint inhibitors.

Phase III data showed significant mOS prolongation and 24% reduced death risk vs chemotherapy, with manageable safety. As a China‑originated First‑in‑class asset, its approval solidifies China’s global leadership in bispecific/fusion protein therapeutics.