Jacobio Pharmaceuticals’ JAB-8263 BET Inhibitor Proposed for NMPA’s Rare Disease “Caring Program” for Myelofibrosis Treatment
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced that...
Drug
Eisai and Biogen Secure FDA Approval for LEQEMBI Subcutaneous Autoinjector for Early Alzheimer’s Disease Initiation
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that the U.S....
CanSino Biologics Secures NMPA Acceptance for Menhycia Age Expansion to Adolescents, Extending China’s First Quadrivalent Meningococcal Conjugate Vaccine Coverage to Ages 3 Months–17 Years
CanSino Biologics Inc. (HKG: 6185) announced that the National Medical Products Administration (NMPA) has accepted...
Easton Pharmaceutical Secures NMPA Approval for China’s First Generic Remimazolam Besylate, Challenging Humanwell’s Ruima Monopoly in Procedural Sedation and General Anesthesia
Easton Pharmaceutical Co., Ltd (SHA: 688513) announced that its generic version of remimazolam besylate has...
Mabwell Secures NMPA IND Approval for 9MW5211 Injection in Vitiligo, Expanding Multi-Indication Autoimmune Pipeline with Highly Selective Depleting Antibody
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that its Investigational New Drug (IND) application...
Bio-Sincerity Secures NMPA Approval for Levetiracetam Extended-Release Granules – Pediatric-Friendly Epilepsy Treatment for Patients with Swallowing Difficulties
Hangzhou Bio-Sincerity Pharma-tech Corp., Ltd (SHE: 301096) announced that its Category 2.2 modified drug Levetiracetam...
Allergan Aesthetics Secures European Commission Approval for Boey (trenibotulinumtoxinE) – First Rapid-Onset, Short-Duration Botulinum Neurotoxin Serotype E for Glabellar Lines
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the European Commission has approved Boey...
GSK Reports Mixed Phase III Results for Camlipixant in Refractory Chronic Cough: CALM-1 Trial Meets Primary Endpoint While CALM-2 Falls Short
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced mixed results from the CALM-1 and CALM-2 Phase III...
Wepon Medical Secures FDA Clinical Approval for WP107 (Huperzine A Oral Solution) in Healthy Volunteers Following NMPA Clearance for Myasthenia Gravis
Wepon Medical Holding Group Co., Ltd. (SHE: 002082) announced that WP107 (Huperzine A Oral Solution)...
Jacobio Launches Phase Ib/III Trial of Pan-KRAS Inhibitor JAB-23E73 for KRAS-Mutated Pancreatic Cancer in Partnership with AstraZeneca
Jacobio Pharmaceuticals Group Co., Ltd. (HKG: 1167) announced that the first patient has been dosed...
CSPC Pharmaceutical Launches Phase III Trial of B7-H3-Targeting ADC SYS 6043 for Platinum-Resistant Ovarian Cancer
CSPC Pharmaceutical Group (HKG: 1093) announced the initiation of a randomized, multi-center, open-label Phase III...
CSPC Pharmaceutical Launches Phase II Trial of Albumin-Bound Sirolimus for Rare Vascular Tumor Epithelioid Hemangioendothelioma
CSPC Pharmaceutical Group (HKG: 1093) announced the initiation of a Phase II clinical trial of...
Hengrui’s HRS9531 Dual GIPR/GLP-1R Agonist Advances to Phase III for Obesity with Knee Osteoarthritis, Expanding Metabolic Disease Portfolio
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its HRS9531 injection has...
Sichuan Biokin’s Yizekang Receives NMPA Approval as World’s First EGFR×HER3 Bispecific ADC for Esophageal Squamous Cell Carcinoma
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...
Novartis’ Fabhalta Receives FDA Approval as First Oral Complement Factor B Inhibitor to Slow Renal Decline in Primary IgA Nephropathy
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted...
Shionogi’s Fetroja Receives FDA Acceptance for Pediatric sNDA Expanding Use to Gram-Negative Infections in Hospital-Acquired Pneumonia and Complicated UTIs
Shionogi & Co., Ltd. (TYO: 4507) announced that the U.S. Food and Drug Administration (FDA)...
Merck’s Lipfendra Receives FDA Approval as First Oral PCSK9 Inhibitor for LDL Cholesterol Reduction in Hypercholesterolemia Patients
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
InnoCare Pharma’s Soficitinib Meets Primary Endpoint in Phase III Atopic Dermatitis Trial as Highly Selective TYK2 Inhibitor
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced today that the Phase III registrational clinical...
Amoytop Biotech Secures NMPA Clinical Trial Approval for ACT201, Novel ASO Therapy for Chronic Hepatitis B
Amoytop Biotech (SHA: 688278) announced today that its investigational drug ACT201 has received clinical trial...
Harbour BioMed and Kelun-Biotech Secure NMPA IND Approval for HBM7575/SKB575, Long-Acting Bispecific Antibody for Asthma
Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990) announced today that the Investigational New Drug...