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...
Drug
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...
Haixi Pharma Advances HXP056 to Phase II – Oral Multi‑Selective Therapy for Wet AMD and Hemorrhagic Retinal Diseases
Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced the initiation of a Phase II clinical...
IASO Bio Wins Japan PMDA Approval for Fucaso CAR‑T – BCMA Therapy Enters Phase III in Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics announced receiving tacit clinical approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)...
Hope Medicine Doses First Patient in HMI-115 Phase III – First-in-Class Non-Hormonal Endometriosis Therapy Advances in China
Hope Medicine Inc. announced first patient dosing in a Phase III clinical study evaluating HMI-115,...
Kelun‑Biotech’s SKB103 Wins NMPA Approval – Novel TAA‑PD‑L1 Bispecific ADC Enters Clinical Trials for Advanced Solid Tumors
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its SKB103, a novel TAA‑PD‑L1 bispecific...
Alphamab Oncology Doses First Patient in Phase III KN026 Study – Bispecific HER2 Antibody Targets Adjuvant Breast Cancer
Alphamab Oncology (HKG: 9966) announced first patient dosing in a Phase III clinical study of...
Shenzhen Salubris Wins NMPA Approval for SAL0150 – Oral Long-Acting Diabetes/Obesity Drug Targets Weekly Dosing Regimen
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced clinical trial approval from China’s National Medical...
GSK’s Risvutatug Rezetecan Wins Japan ODD – B7-H3 ADC Targets Small-Cell Lung Cancer with Phase 1 Durable Responses
GlaxoSmithKline (GSK; NYSE: GSK) announced that risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate (ADC), received...