Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter
Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)...
Drug
Kexing Biopharma’s GB19 Wins NMPA Approval for Cutaneous Lupus – BDCA2‑Targeted Therapy Expands Autoimmune Pipeline
Kexing Biopharm Co., Ltd. (SHA: 688136) announced clinical trial approval from China’s National Medical Products Administration...
J&J’s Nipocalimab Wins FDA Fast Track for Lupus – FcRn Blocker Targets Autoantibody Diseases
Johnson & Johnson (J&J, NYSE: JNJ) announced that its investigational drug nipocalimab has received Fast Track...
Asieris Pharma’s Cevira Wins NMPA Approval – World’s First Non‑Surgical Photodynamic Therapy for Cervical Lesions
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176), a urogenital cancer specialist, announced marketing approval from China’s...
Antengene Licenses ATG-201 to UCB in $1.1B+ Deal – CD19/CD3 T‑Cell Engager Targets Autoimmune Diseases
Antengene Corp., Ltd (HKG: 6996) announced a licensing agreement with UCB (EBR: UCB), granting the Belgium‑based biopharma...
ImmuneOnco’s IMM0306S Wins NMPA Approval – Subcutaneous CD47×CD20 Bispecific for Lupus Enters Clinic
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) announced clinical approval from China’s National Medical Products Administration...
Huadong Medicine’s DR30206 Wins NMPA Approval – Triple‑Target Fusion Protein for NSCLC Enters Phase II
Huadong Medicine Co., Ltd (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has approved...
Hua Medicine’s Dorzagliatin Wins Hong Kong Approval – First‑in‑Class GKA Enters Market for Type 2 Diabetes
Hua Medicine (HKG: 2552) announced that the Department of Health in Hong Kong has approved HuaTangNing...
Lepu Medical’s siRNA MWX401 Wins NMPA Approval – RNAi Therapy Targets Primary Hypertension
Lepu Medical Technology (SHE: 300003), a cardiovascular disease solutions provider, announced clinical approval from China’s National...
Xellsmart’s iPSC Neural Therapy Cleared by NMPA and FDA – First “Off‑the‑Shelf” Cell Therapy for MSA‑P Enters Clinic
Xellsmart, a Suzhou‑based stem‑cell startup, announced regulatory clearance from both China’s NMPA and the US...
Lynk Pharma’s Zemprocitinib Hits Phase III Endpoints in Atopic Dermatitis – Best‑in‑Class JAK1 Inhibitor Shows Superior Efficacy
Lynk Pharmaceuticals Co., Ltd. announced positive topline results from a Phase III study for zemprocitinib...
ReviR Therapeutics Doses First Patient in RTX-117 Trial – China’s First “AI + RNA” Small Molecule Enters Clinic
ReviR Therapeutics, a clinical‑stage biotech incubated by XtalPi (HKG: 2228), announced first subject dosing in a...
Roche’s Fenebrutinib Hits Phase III Endpoint in MS – BTK Inhibitor Cuts Relapse Rate 51% vs. Standard of Care
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the pivotal Phase III FENhance 1 study for fenebrutinib in relapsing...
Sanofi’s Rilzabrutinib Wins Japan Orphan Designation for IgG4‑RD – BTK Inhibitor Expands Rare Disease Portfolio
Sanofi (NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted orphan...
CSPC Pharma’s SYHX2011G1 Wins FDA IND Approval – Instant‑Release Albumin‑Bound Paclitaxel for Metastatic Breast Cancer
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has...
Gan & Lee’s AR PROTAC GLR2037 Wins NMPA Approval – First‑in‑Class Prostate Cancer Therapy Enters Clinic
Gan & Lee Pharmaceuticals (SHA: 603087) announced that China’s National Medical Products Administration (NMPA) has approved...
Hotgen Biotech Doses First Patient in AA001 Phase Ib – Anti‑Aβ mAb Targets Early Alzheimer’s Disease
Hotgen Biotech Co., Ltd (SHA: 688068) announced first subject dosing in a Phase Ib clinical study...
Lynk Pharma’s Zemprocitinib Hits Phase III Endpoints in Atopic Dermatitis – Best‑in‑Class JAK1 Inhibitor Shows Superior Efficacy
Lynk Pharmaceuticals Co., Ltd. announced positive topline results from a Phase III study for zemprocitinib...
HealZen’s BTK Inhibitor HZ-A-018 Wins NMPA Approval for CSU Phase II – Expands Autoimmune Pipeline
Hangzhou HealZen Therapeutics Co., Ltd. announced that its self‑developed Category 1 innovative drug, HZ‑A‑018 capsules, has...
Ribo Life Science’s PCSK9 siRNA RBD7022 Enters Phase III – Qilu Pharma Advances Cholesterol‑Lowering Drug
Suzhou Ribo Life Science Co., Ltd. (HKG: 6938) announced that RBD7022 Injection, its independently developed siRNA...