Onco-Summaries: Daily Oncology Updates at a Glance

23/12/2025

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• Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC

• SN Bioscience's SNB-101 received the FDA orphan drug designation for GC/GEJC

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Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC (Ref)

The US FDA granted the orphan drug designation to Alphamab Oncology and 3D (Beijing) Medicines' envafolimab (KN035; subcutaneously injectable PD-L1 inhibitor) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ).

• The ODD was granted based on the efficacy demonstrated in a previous Phase 2 clinical study for advanced GC/GEJ

  
  

  • Envafolimab + FOLFOX achieved an ORR of 60.0% and DCR of 100.0%, with a favorable safety and tolerability profile

SN Bioscience's SNB-101 received the FDA orphan drug designation for GC/GEJC (Ref)

The US FDA granted the orphan drug designation to SN Bioscience's SNB-101 (polymer nanoparticle drug) for gastric cancer (including gastroesophageal junction cancer).

• SNB-101 previously received ODDs from the US FDA for small cell lung cancer in July 2023 and pancreatic cancer in February 2024

• By receiving an ODD for gastric cancer, SN Bioscience expects to gain momentum in indication expansion and clinical development