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...
Drug
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...
GenFleet’s GFH375 Wins CDE Breakthrough Therapy Designation – Oral KRAS G12D Inhibitor for NSCLC
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that GFH375, an oral KRAS G12D (ON/OFF) inhibitor, has...
InnoCare’s Zurletrectinib Wins Priority Review for Pediatric NTRK Tumors – Next‑Gen TRK Inhibitor Expands Label
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that the Center for Drug Evaluation (CDE) of China’s...
Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis
Sino Biopharmaceutical Limited (HKG: 1177) announced that the National Medical Products Administration (NMPA) has approved rovadicitinib...
Antengene’s XPOVIO Secures Second South Korea Reimbursement – Selinexor Combo Approved for Multiple Myeloma
Antengene Corporation Limited (HKG: 6996) announced that South Korea’s National Health Insurance Service (NHIS) has approved...
Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China
Zhejiang Hangyu Pharmaceutical Co., Ltd., a subsidiary of Jemincare, announced that China’s National Medical Products...