Weekly Digest – October 2025 Weekly Digest – October 2025 23 October 2025: Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma The US FDA has approved Blenrep (Belantamab mafodotin) in combination with bortezomib and dexamethasone […]
Weekly Digest – October 2025 Weekly Digest – October 2025 17 October 2025: Core product Trastuzumab botidotin approved for marketing by the NMPA for 2L+ HER2+ breast cancer Sichuan Kelun-Biotech’s core product trastuzumab botidotin (A166) received marketing approval from China’s […]
Weekly Digest – October 2025 Weekly Digest – October 2025 20 October 2025: JSKN003 granted another breakthrough therapy designation in China for the treatment of patients with HER2-positive advanced colorectal cancer JSKN003, a biparatopic HER2-targeting antibody-drug conjugate co-developed by CSPC’s […]
Weekly Digest – October 2025 Weekly Digest – October 2025 21 October 2025: Padcev (Enfortumab vedotin) plus Keytruda (Pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer The FDA has accepted a supplemental Biologics License […]
Weekly Digest – October 2025 Weekly Digest – October 2025 23 October 2025: Heidelberg Pharma’s lead ADC Candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma The US FDA granted fast track designation to […]
Weekly Digest – October 2025 Weekly Digest – October 2025 21 October 2025: Takeda enters global strategic partnership with Innovent Biologics to bolster oncology pipeline with next-generation investigational medicines for treatment of solid tumors Takeda entered a global strategic partnership […]
Weekly Digest – October 2025 Weekly Digest – October 2025 12 October 2025: Sacituzumab tirumotecan (Sac-TMT) approved for marketing for third indication by the National Medical Products Administration in EGFRm NSCLC following progresssion on EGFR-TKI therapy Sichuan Kelun-Biotech announced that its […]
Weekly Digest – October 2025 Weekly Digest – October 2025 13 October 2025: TQB2102 HER2 bispecific ADC included in the Breakthrough Therapeutic Designation process TQB2102, a HER2 bispecific antibody-drug conjugate (ADC) developed by Sino Biopharmaceutical, has been granted Breakthrough Therapeutic Designation (BTD) by China’s CDE for […]
Weekly Digest – October 2025 Weekly Digest – October 2025 13 October 2025: Mabwell’s CDH17-targeting ADC 7MW4911 Receives IND Clearance from NMPA Mabwell’s CDH17-targeting ADC, 7MW4911, received IND clearance from China’s NMPA to begin clinical trials in patients with advanced solid […]
Weekly Digest – October 2025 Weekly Digest – October 2025 14 October 2025: DualityBio DB-1324 project received clinical trial approval from HREC and TGA in Australia DualityBio announced that its DB-1324, a next-generation ADC developed using its Duality Immune Toxin Antibody […]
