Genocury’s In Vivo CAR-T JY231 Shows Early Promise in Refractory Neurologic Autoimmune Diseases
A Chinese research team has reported encouraging early clinical results for JY231, an investigational lentiviral in vivo CD19 CAR-T therapy that generates therapeutic CAR-T cells directly inside the patient’s body, potentially eliminating two of…
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…
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…
BRL Medicine’s BRL-101 Meets Primary Endpoint in Pivotal Trial for Transfusion-Dependent β-Thalassemia
BRL Medicine’s gene-edited stem cell therapy BRL-101 has met the prespecified primary efficacy endpoint in a pivotal Chinese study for transfusion-dependent β-thalassemia, with all 30 treated patients achieving transfusion independence and the…
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…
HUTCHMED’s Savolitinib-Tagrisso Combo Delivers Positive Phase 3 Results in MET-Driven EGFR-Mutated NSCLC
HUTCHMED has announced positive topline results from the global Phase 3 SAFFRON trial, showing that the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) delivered statistically significant and clinically meaningful improvements in both…