FDA Approves Rocket Pharma’s Kresladi – First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
The U.S. Food and Drug Administration (FDA) this week approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel),...
Drug
Novo Nordisk’s Awiqli Wins FDA Approval – World’s First Once-Weekly Basal Insulin for Type 2 Diabetes
Novo Nordisk (NYSE: NVO) announced FDA approval for Awiqli (insulin icodec), becoming the world’s first...
Hengrui Pharma’s HRS9531 Wins NMPA Approval for Cardiovascular Outcomes Trial – Dual GIPR/GLP-1R Agonist Targets MACE Reduction
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) received National Medical Products Administration (NMPA)...
Chengdu Kanghong’s KHN922 Wins NMPA Approval – Dual-Payload HER3 ADC Targets Advanced Solid Tumors with Anti-Resistance Mechanism
Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced clinical trial approval from China’s National...
Huadong Medicine’s HDM2024 Wins NMPA Approval – EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors
Huadong Medicine Co., Ltd. (SHE: 000963) announced clinical trial approval from China’s National Medical Products...
Biocytogen’s NEOK002 Wins FDA Approval for Phase I – EGFR/MUC1 Bispecific ADC Targets Solid Tumors
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (SHA: 688796, HKG: 2315) announced that NEOK Bio, Inc., its...
Joincare Pharma’s JKN2404 Wins NMPA Approval for Asthma Trial – Next-Gen Inhaled Corticosteroid Targets Improved Safety Profile
Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that JKN2404 inhalation suspension, a Category...
Pulmongene’s PMG1015 Wins FDA Fast Track Designation – First-in-Class AREG Antibody Targets Idiopathic Pulmonary Fibrosis
Pulmongene (Beijing) Ltd. announced that PMG1015 received Fast Track Designation (FTD) from the U.S. Food...
Lee’s Pharma Wins NMPA Approval for Intrarosa – Estrogen-Free DHEA Pessary Targets Postmenopausal Vulvovaginal Atrophy
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) announced National Medical Products Administration (NMPA) marketing approval for...
United Laboratories Novo Nordisk Report Positive Phase II Data for UBT251 – Triple GLP-1/GIP/GCG Agonist Achieves 19.7% Weight Los
Partners United Laboratories International Holdings Ltd (HKG: 3933) and Novo Nordisk (NYSE: NVO) announced positive...
CStone’s Sugemalimab Wins ESMO [I, A] Recommendation – PD-L1 Inhibitor Targets Stage III NSCLC Consolidation Therapy in Europe
CStone Pharmaceuticals (HKG: 2616) announced that sugemalimab received a class recommendation in the...
SinoMab BioScience Reports Positive Phase I Bridging Data for SM17 – First-in-Class IL-25 Receptor Antibody Advances Route Conversion
SinoMab BioScience Ltd (HKG: 3681) announced positive readouts from a Phase I bridging study in...
Zhifei Bio Initiates Phase I Study for DTaP-Hib Quadrivalent Vaccine – Component Combination Targets Pediatric Immunization Compliance
Chongqing Zhifei Biological Co., Ltd. (SHE: 300122) announced the initiation of a Phase I clinical...
Changchun High-Tech Wins FDA Orphan Drug Designation for GenSci128 – TP53 Y220C Reactivator Targets Gastric Cancer
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that GenSci128 received Orphan...
Gan & Lee’s Bonfaglutide Wins NMPA Approval for OSA Study – Biweekly GLP‑1 Expands to Sleep Apnea Indication
Gan & Lee Pharmaceuticals (SHA: 603087) announced NMPA clinical trial approval to initiate a study...
Clover Bio Reports Positive SCB‑1019 Phase I Data – RSV PreF Vaccine Demonstrates Superior Booster Response vs. GSK’s Arexvy
Clover Biopharmaceuticals Ltd. (HKG: 2197) announced additional positive Phase I data from its US clinical...
Henlius Biotech Wins Health Canada Approval for Denosumab Biosimilars – Bildyos and Tuzemty Expand Organon Partnership to Canada
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced marketing approval from Health Canada for Bildyos (denosumab...
Qilu Pharma’s QLS31905 Wins FDA Orphan Drug Designation – First‑in‑Class Claudin18.2/CD3 Bispecific Enters Phase III for Pancreatic Cancer
Qilu Pharmaceutical Co., Ltd. announced that QLS31905, its Claudin18.2/CD3 bispecific T‑cell engager (BsAb), has received...
Bayer/Regeneron’s Eylea HD Wins Japan Approval for RVO – Third Indication Nod with Extended Dosing Demonstrates 3 Fewer Injections
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Eylea HD (aflibercept) injection 8...
Sanofi’s Dupixent Wins Japan Approval for Bullous Pemphigoid – Seventh Indication Expands IL‑4/IL‑13 Franchise
Sanofi S.A. (NASDAQ: SNY) announced that Dupixent (dupilumab) has received marketing approval from Japan’s Ministry...