Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML
Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance...
Drug
CSPC Pharmaceutical’s Phase III Trial of Anbenitamab-Docetaxel Combination Meets Primary Endpoint in First-Line HER2-Positive Advanced Breast Cancer
CSPC Pharmaceutical Group (HKG: 1093) announced that its Phase III clinical trial evaluating Ennituo (anbenitamab)...
Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases
Imviva Biotech announced it has received Investigational New Drug (IND) clearance from the U.S. Food...
Akeso Biopharma Secures NMPA Approval for Gumokimab, IL-17A Monoclonal Antibody for Moderate-to-Severe Plaque Psoriasis
Akeso Biopharma (HKG: 9926) announced it has received marketing approval from China’s National Medical Products...
Hansoh Pharmaceutical’s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China’s NMPA for Secondary Hyperparathyroidism in Dialysis Patients
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...
Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications
Bio-Thera Solutions Ltd. (SHA: 688177) announced it has received marketing approval from Singapore’s Health Sciences...
PKU Hi-Tech Huatai Pharmaceuticals Blacklisted from China’s Volume-Based Procurement Following Quality Compliance Failures
PKU Hi-Tech Huatai Pharmaceuticals Co., Ltd. has been blacklisted from China’s national volume-based procurement (VBP)...
Sanofi Halts Phase 3 MOBILIZE Trial for Riliprubart in Refractory CIDP Patients Following Interim Analysis
Sanofi (NASDAQ: SNY) announced the discontinuation of its MOBILIZE phase 3 clinical trial evaluating riliprubart...
NeuroGen Pharma Secures NMPA Approval for Ajovy (Fremanezumab) in China, Launching First Quarterly CGRP Migraine Prevention Therapy
NeuroGen Pharma announced it has received marketing approval from China’s National Medical Products Administration (NMPA)...
Harbour BioMed’s TSLP Inhibitor HBM9378/WIN378 Doses First Patient in Phase II COPD Study with Windward Bio, Supporting Twice-Yearly Dosing Regimen
Harbour BioMed (HKG: 2142) announced that the first patient has been dosed in the Phase...
Haisco Pharmaceutical Files Nav1.8 Inhibitor HSK51155 with NMPA Following $700M+ AbbVie Licensing Deal for Novel Pain Therapeutic
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced it has submitted a clinical filing for...
Henlius Biotech’s Serplulimab Becomes World’s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Hengrui Pharmaceuticals Advances Triple-Asset Breast Cancer Strategy with NMPA Approval for HRS-6209 Combination Study, Leveraging Selective CDK4 Inhibitor and Novel SERD
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received regulatory clearance...
Takeda’s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn’s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...
Lynk Pharmaceuticals and Formation Bio Dose First Patient in Phase I BLKR201 Study for CNS-Penetrant TYK201 Inhibitor, Backed by $605M Partnership
Lynk Pharmaceuticals Co., Ltd. and its U.S. partner Formation Bio announced the dosing of the...
Zai Lab Launches Commercial Rollout of Cobenfy in China Following First Nationwide Prescription for Schizophrenia Treatment
Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) announced the initiation of commercial launch for Cobenfy™...
Eli Lilly Secures FDA Approval for Every-Eight-Week EBGLYSS Regimen in Atopic Dermatitis, Offering Just Six Annual Injections
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA)...
Antengene Launches Phase I ATTRACT Study for ATG-201 Bispecific Antibody in Autoimmune Diseases Following $1.18B UCB Licensing Deal
Antengene Corporation (HKG: 6996) announced it has received regulatory clearance from China’s National Medical Products...
Jikeshu (Sebaloxavir Marboxil) Receives NMPA Approval for Adolescent Influenza Treatment, Expanding Single-Dose Category 1 Antiviral Franchise
Jikeshu (sebaloxavir marboxil), a Category 1 anti-influenza drug jointly developed by Jumpcan Pharmaceutical (SHA: 600566)...
CSPC Pharmaceutical Receives FDA Clearance for Once-Monthly Semaglutide SYH9017 in Weight Management, Challenging Weekly GLP-1 Standard
CSPC Pharmaceutical Group (HKG: 1093) announced today that its GLP-1 receptor agonist semaglutide long-acting injection...