3D MEDICINES (01244): ENVAFOLIMAB® Granted Orphan Drug Designation for Gastric and Gastroesophageal Junction Cancer

Stock News2025-12-22

3D MEDICINES (01244) announced that its commercialized product ENVAFOLIMAB® (generic name: Envafolimab Injection, R&D code: KN035) has officially received orphan drug designation for gastric cancer and gastroesophageal junction cancer. This marks the third orphan drug indication approved for ENVAFOLIMAB®, following previous approvals for bile duct cancer and soft tissue sarcoma. The approval was based on the company's Phase II clinical study of ENVAFOLIMAB® in advanced gastric/gastroesophageal junction adenocarcinoma, which demonstrated clear antitumor efficacy. When combined with the FOLFOX regimen, the objective response rate reached 60%, with a disease control rate of 100%. The treatment also showed favorable safety and tolerability, with no adverse events leading to treatment discontinuation or death.

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