FDA Approves Revolution Medicines’ Rasonque (daraxonrasib), an Oral Multi‑Selective RAS(ON) Inhibitor, for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ Rasonque (daraxonrasib) for the...
Potential first-in-class
Shanghai Yizhong’s First‑in‑Class Tri‑Specific Biologic YXC‑001 Wins NMPA Clinical Trial Approval for Advanced Solid Tumors
Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that its Category 1 therapeutic biologic YXC‑001,...
Haixi Pharma Launches Phase III Trial of C019199 – First-in-Class Multi-Targeted Immunomodulator for Refractory Osteosarcoma
Haixi Pharmaceutical announced it has officially initiated its Phase III clinical trial (CTR20261818) evaluating C019199,...
LTZ Therapeutics Secures FDA IND Approval for LTZ-232, First-in-Class Myeloid Engager Targeting EpCAM-High Solid Tumors
LTZ Therapeutics announced that its second drug candidate, LTZ-232, has received Investigational New Drug (IND)...
Bayer AG Completes $2.45 Billion Acquisition of Perfuse Therapeutics for PER-001 Glaucoma Implant
Bayer AG (ETR: BAYN) announced the completion of its acquisition of Perfuse Therapeutics, Inc., securing...
Shanghai Yizhong Pharma’s Trifunctional Antibody Fusion Protein YXC-001 Receives IND Acceptance in China – Novel Approach Targets Advanced Solid Tumors with Precision IL-2 Delivery
Shanghai Yizhong Pharmaceutical Co., Ltd. (SHA: 688091) announced that China’s National Medical Products Administration (NMPA)...
AstraZeneca’s Tozorakimab Reduces COPD Exacerbations in Phase III Trials, Targeting IL-33 in First-in-Class Approach
AstraZeneca plc (NYSE: AZN) announced positive top-line results from two pivotal Phase III trials—OBERON and...
Chipscreen Biosciences Licenses Epidaza to Nizhpharm – $29M Deal Expands HDAC Inhibitor into Central Asia and Eastern Europe
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced a licensing agreement with Nizhny Novgorod Chemical...
Super Vision Technology Wins NMPA Approval for Ocular Neurostimulator – First-in-Class Implantable Device Treats Congenital Nystagmus
Super Vision Technology, Inc. announced National Medical Products Administration (NMPA) approval for its implantable ocular...
Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic
Shanghai Essight Biotechnology Co., Ltd. announced that ES502 Injection has received FDA approval to proceed...
Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel...
HutchMed Initiates Phase I/IIa Trial for HMPL-A580 – Second Antibody-Targeted Triggered Conjugate Targets EGFR+ Solid Tumors
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I/IIa clinical...
Asieris’ APL-1702 MAA Accepted by EMA – First Photodynamic Therapy for Cervical HSIL Nears EU Approval
Asieris Pharmaceuticals (SHA: 688176) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
Everest Medicines Licenses Micot’s MT1013 for Secondary Hyperparathyroidism in $178M Deal
Everest Medicines Limited (HKG: 1952) announced a licensing agreement with Micot, a polypeptide NME drug...
Huadong Medicine DR10624 Gets NMPA Nod for Hypertriglyceridemia Study
Huadong Medicine Co., Ltd (SHE: 000963) announced that its subsidiary Doer Biologics has received National...
Ascletis ASC40 Phase III Success in Acne Vulgaris
Ascletis Pharma Inc (HKG: 1672) announced positive top‑line results from the open‑label Phase III study (NCT06248008)...
Biogen’s Litifilimab Secures FDA Breakthrough Therapy Designation for Lupus
Biogen Inc. (NASDAQ: BIIB) announced that its investigational litifilimab has received Breakthrough Therapy Designation (BTD) from...
Biokin’s iza-bren NDA Accepted for Nasopharyngeal Carcinoma, Advancing Bispecific ADC
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its New Drug Application (NDA) for...
Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a...
GSK Secures Worldwide Exclusive Rights to Empirico’s EMP‑012, a First‑in‑Class siRNA for COPD
GlaxoSmithKline plc (GSK, NYSE: GSK) and Empirico Ltd. today announced a global exclusive licence agreement...