03/08/2026 US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer FDA Grants Orphan Drug Designation to DLL3-Targeting ADC Zoci, for Neuroendocrine Carcinomas US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer (Ref) Eli Lilly announced that the US FDA has granted Breakthrough Therapy designation to olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant a

11/05/2026 FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs Hansoh Pharma’s HS-20093 B7-H3 ADC wins NMPA Breakthrough Therapy nod in ESCC Innovent’s IBI363 secures third Breakthrough Therapy Designation in China, advancing to Phase III for MSS/pMMR colorectal cancer with Takeda partnership FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs (Ref) Zai Lab's : Zocilurtatug pelitecan (Zoci,

14/01/2026 Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma (Ref) The US FDA granted fast track designation to Nanjing Leads Biolabs' opamtistomig (LBL-024; PD-L1 x 4-1BB bispecific antibody) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC). Dr. Charles Cai, CMO,