HUTCHMED’s Fanregratinib Wins China NMPA Approval for FGFR2+ Intrahepatic Cholangiocarcinoma (ICC)
HUTCHMED has secured conditional approval from China’s National Medical Products Administration (NMPA) for fanregratinib (HMPL-453), providing a new targeted treatment option for patients with FGFR2-altered intrahepatic cholangiocarcinoma (ICC). The NMPA…
TYK Medicines Wins China Approval for Asandeutertinib in EGFR-Mutant NSCLC With Brain Metastases
China’s NMPA has granted conditional approval to asandeutertinib (TY-9591), TYK Medicines’ brain-penetrant, deuterated EGFR inhibitor, for the first-line treatment of patients with EGFR-mutated non-small cell lung cancer with central nervous…
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…
Biokin Pharmaceutical
Building a Global Oncology Franchise Around Bispecific ADCs
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…
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…
Biokin’s Iza-bren hits Phase 3 PFS endpoint in EGFR-Mutant NSCLC, marking 4th positive Phase 3 trial
Sichuan Biokin Pharmaceutical’s izalontamab brengitecan (iza-bren, BL-B01D1) has achieved another major clinical milestone, with the company reporting that its Phase 3 BL-B01D1-301 study in previously treated EGFR-mutant non-small cell lung cancer…