Leads Biolabs’ Opamtistomig Becomes World’s First 4-1BB Bispecific Antibody to Enter Pivotal Phase III for EP-NEC
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced it has received regulatory clearance in China...
Drug
CSPC Pharmaceutical Receives NMPA Clinical Trial Approval for SYH2095, World’s First KAT6 Inhibitor
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received clinical trial approval from China’s...
Boehringer Ingelheim’s JASCAYD (Nerandomilast) Approved in Japan for IPF and Progressive Pulmonary Fibrosis
Boehringer Ingelheim (BI) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted...
Bayer’s HYRNUO Receives FDA Priority Review for First-Line HER2-Mutated NSCLC Treatment
Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has granted...
Sanegene Bio’s C3-Targeted siRNA SGB-9768 Expands to Hematological Disorders Following NMPA Clinical Trial Approval
Suzhou Sanegene Bio Inc., an RNAi specialist with R&D centers in the U.S. and China,...
Hengrui’s HER3-Targeting ADC SHR-A2009 Achieves Phase III Success in EGFR-Mutated NSCLC After TKI Failure
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the Phase III SHR-A2009-301...
Merck’s Sacituzumab Tirumotecan Demonstrates First-Ever OS and PFS Benefit in Phase 3 Endometrial Cancer Trial
Merck & Co., Inc. (MSD) (NYSE: MRK) announced that the pivotal Phase 3 TroFuse-005 trial...
GSK’s Arexvy RSV Vaccine Receives Expanded Japanese Approval for Adults 18-49 at Increased Risk
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW)...
Taiji Industry Secures NMPA Clinical Trial Approval for DSC158A, Next-Generation Influenza RNA Polymerase Inhibitor
Chongqing Taiji Industry (Group) Co., Ltd. (SHA: 600129) announced that China’s National Medical Products Administration...
Viatris Submits Fast-Acting Meloxicam NDA to FDA for Moderate-to-Severe Acute Pain; Decision Expected December 2026
Viatris Inc. (NASDAQ: VTRS) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Regeneron’s Fianlimab-Cemiplimab Combination Fails to Meet Primary Endpoint in Phase III Melanoma Trial – LAG-3/PD-1 Dual Therapy Shows No PFS Benefit Over Pembrolizumab Monotherapy
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that its Phase III clinical trial evaluating fianlimab (LAG-3...
AstraZeneca’s Baxfendy Secures FDA Approval for Uncontrolled Hypertension – First-in-Class Aldosterone Synthase Inhibitor with Selective CYP11B2 Targeting
AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has granted marketing...
Harbour BioMed Unveils Preclinical Data for LET003 – AI-Discovered ACVR2A/2B Antibody Shows Best-in-Class Potential in Obesity Combination Therapy with GLP-1 Drugs
Harbour BioMed (HKG: 2142) has published preclinical data for LET003, an ACVR2A/2B-targeted monoclonal antibody (mAb)...
AstraZeneca and Daiichi Sankyo’s ENHERTU Secures Dual FDA Approval for HER2-Positive Early Breast Cancer – Neoadjuvant and Adjuvant Indications Supported by Landmark Phase 3 Data
AstraZeneca (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug...
Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy
Biogen Inc. (NASDAQ: BIIB) announced that zorevunersen, an investigational antisense oligonucleotide (ASO) for Dravet syndrome,...
Shanghai CureGene’s CG-0255 Receives NMPA Clearance for Ischemic Stroke Clinical Trial – First Thiol-Based P2Y12 Inhibitor Overcoming Clopidogrel Resistance
Shanghai CureGene Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced market approval from China’s National Medical Products...
Changchun GeneScience’s GenSci161 Receives FDA Clearance for Hidradenitis Suppurativa Clinical Trial – Novel Bispecific Antibody Targeting IL-1α/IL-1β
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun...
Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration
Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has accepted for...