CSPC’s EGFR ADC SYS6010 Beats Chemotherapy in Phase 3 NSCLC Trial, Setting Stage for Potential Regulatory Filing
CSPC Pharmaceutical Group’s experimental EGFR-targeting antibody-drug conjugate SYS6010 has met the primary endpoint in the pivotal Phase III SYNSTAR-01 trial, significantly improving progression-free survival over platinum-based chemotherapy in…
DualityBio Partners with Genentech in $1B-Plus Next-Generation ADC Collaboration Built Around Novel Payload Platform
China’s Duality Biotherapeutics has signed a global research, development and licensing agreement with Roche’s Genentech to develop a new generation of antibody-drug conjugates designed to overcome resistance to payloads used in today’s…
Biokin Pharmaceutical
Building a Global Oncology Franchise Around Bispecific ADCs
Akeso, Inc.
Building a Global Bispecific Antibody and Next-Generation Oncology Franchise
Biokin’s Iza-Bren Hits Phase 3 PFS Endpoint in HR+/HER2− Breast Cancer, Marking 5th Phase 3 Success
Biokin Pharmaceutical’s first-in-class EGFR×HER3 bispecific antibody-drug conjugate izalontamab brengitecan (iza-bren; BL-B01D1) has delivered another positive Phase 3 readout, meeting the progression-free survival endpoint in previously treated…
Akeso’s Ivonescimab Beats Durvalumab Standard in Phase 3 Biliary Tract Cancer Trial
Akeso’s PD-1/VEGF bispecific antibody ivonescimab has delivered another major Phase 3 victory, this time outside lung cancer, demonstrating a statistically significant overall survival advantage over durvalumab plus chemotherapy in first-line advanced…
China’s NMPA Conditionally Approves GenrixBio’s Velinotamig for Heavily Pretreated Multiple Myeloma
China’s National Medical Products Administration (NMPA) has granted conditional approval to velinotamig (GR1803), a BCMA×CD3 bispecific antibody developed by Genrix Bio and partnered with Fosun Pharma’s YaoPharma, for adults with heavily pretreated…
LaNova Medicines’ Next-Generation Nectin-4 ADC LM-364 Wins China IND Clearance for Advanced Solid Tumors
LaNova Medicines has received clearance from China’s National Medical Products Administration (NMPA) to advance LM-364, its next-generation tumor microenvironment-responsive Nectin-4 antibody-drug conjugate (ADC), into clinical development for patients…
Leads Biolabs’ Opamtistomig NDA Accepted in China, Setting Up Potential World-First 4-1BB Therapy
Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the company’s internally developed…
Kelun-Biotech’s TROP2 ADC Sac-TMT Shows Durable Activity Across Genomically Altered NSCLC in a Phase 2 Study
Sichuan Kelun-Biotech has reported new Phase 2 data for its TROP2-directed antibody-drug conjugate sacituzumab tirumotecan (sac-TMT; SKB264/MK-2870) in heavily pretreated non-small cell lung cancer (NSCLC), showing durable antitumor activity across…