BioNTech and OncoC4’s Gotistobart Nearly Doubles Survival in Previously Treated Squamous NSCLC
Updated PRESERVE-003 data showed median overall survival of 18.5 months with the CTLA-4 antibody, compared with 10 months for docetaxel. The result is encouraging, but confirmation must come from the ongoing pivotal stage of the Phase 3 trial. BioNTech…
Forlong Biotech’s Pre-B Financing Reaches Nearly RMB 200 Million as It Prepares FL115 for Phase 3 Bladder Cancer Trial
Forlong Biotech has completed the second close of its Pre-B financing, bringing the round’s total to nearly RMB 200 million. Fosun Health Capital’s new drug fund led the latest close, which raised more than RMB 100 million, according to Chinese financing…
Roche and MediLink’s Tam-Peli Reduces Death Risk by 54% in Phase 3 Small-Cell Lung Cancer Trial
Roche and MediLink Therapeutics have reported a substantial survival benefit for tambotatug pelitecan, the experimental B7-H3-targeted antibody-drug conjugate known as Tam-Peli, in patients with relapsed small-cell lung cancer. In the Chinese Phase 3…
GSK and Hansoh’s Ris-Rez Cuts Risk of Death by 54% in Phase 3 Small-Cell Lung Cancer Trial
GSK and Hansoh Pharma’s B7-H3-directed antibody-drug conjugate risvutatug rezetecan delivered a striking survival benefit in relapsed small-cell lung cancer, potentially setting a new benchmark for a disease in which treatment progress has historically…
CTTQ’s HER2 Bispecific ADC TQB2102 Hits Phase 3 Endpoints in HER2-Low Breast Cancer, Setting Up China Filing
Chia Tai Tianqing Pharmaceutical Group (CTTQ), a core subsidiary of Sino Biopharmaceutical, has reported a major late-stage clinical win for TQB2102 (rolditamig deuderuxtecan), its internally developed HER2 bispecific antibody-drug conjugate (ADC). The…
Akeso’s Ivonescimab Outshines Pembrolizumab on Overall Survival in Phase 3 HARMONi-2 Trial
China’s Akeso has reported another major clinical milestone for ivonescimab (AK112), its first-in-class PD-1/VEGF bispecific antibody, announcing that the drug demonstrated a statistically significant and clinically meaningful overall survival (OS)…
ApicHope’s AR882 Beats Febuxostat in China Phase 3 Gout Trial, Meeting Primary Endpoint
China’s ApicHope Pharmaceutical Group has reported positive topline results from a Phase 3 clinical trial of AR882 (pozdeutinurad), its next-generation URAT1 inhibitor for gout, showing statistically significant superiority over febuxostat in lowering…
Ascletis Doses First Participant in Global Phase III Program of Oral GLP-1 Drug ASC30
Ascletis Pharma has dosed the first participant in its global Phase III AURORA clinical program evaluating ASC30, a once-daily oral small-molecule GLP-1 receptor agonist for chronic weight management, launching a roughly 4,600-patient registrational…
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’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…