By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its trastuzumab rezetecan. The designation covers the treatment of gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) in combination with adebrelimab and chemotherapy.
Drug Profile
Trastuzumab rezetecan is an in-house developed HER2-targeted antibody drug conjugate (ADC) therapy. In May 2025, it was authorized by China’s National Medical Products Administration (NMPA) to treat adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations. These patients have previously received at least one systemic therapy.
Market Landscape
Globally, similar products already on the market include Roche’s Kadcyla (trastuzumab emtansine), Enhertu (trastuzumab deruxtecan) co-developed by AstraZeneca and Daiichi Sankyo, and RemeGen’s disitamab vedotin.-Fineline Info & Tech