23/12/2025 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 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 t

26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL (Ref) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D,

25/11/2025 CStone Pharmaceuticals' sugemalimab received the EC approval for unresectable stage III NSCLC (Ref) The European Commission granted approval to CStone Pharmaceuticals' sugemalimab (anti-PD-L1) as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 ≥1% and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy. Dr. Jason Yang, CEO, President of R&D, an

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer (Ref) The US FDA granted the Orphan Drug Designation to Invion's INV043 (photodynamic therapy) for the treatment of anal cancer. Invion is working with Peter Mac to conduct an trial of INV043 in combination with ICIs in anogenital cancer including anal, vulvar and penile cancers Prof Thian Chew, Executive Chairman and CEO, Invion: “This regulatory milestone enhances our ability to bring INV0