December 4th Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to  Roche 's Lunsumio VELO (mosunetuzumab; CD20 x CD3 BsAb), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. (Ref 1) ❓ What are the key pros and cons of this subcutaneous therapy?   Clinical Events 🔬 The Phase 3 LATIFY trial of  AstraZeneca 's ceralasertib (ATR kinase inhibitor) +

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

12/09/2025 The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC ( Ref )...

August 4th Week, 2025 Regulatory Events   🎯 Health Canada issued a NOC/c for  Iovance Biotherapeutics, Inc. 's lifileucel (autologous...

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US ( Ref ) Shanghai Henlius Biotech announced...

July 1st Week, 2025 Regulatory Updates 🎯 The US FDA granted accelerated approved for  Dizal Pharmaceutical ’s sunvozertinib (EGFR TKI)...