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...
Clinical trial approval / initiation
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...
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...
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...
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...
Kanghong Pharma’s Orexin Antagonist KHN707 Cleared for Insomnia Trials – First-in-Class Sleep Disorder Candidate
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced receiving clinical trial approval from China’s National...
Fosun Pharma’s Luvometinib Cleared for Phase II NSCLC Combination Trial – MEK Inhibitor Plus Anlotinib Targets KRAS Mutations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced NMPA approval to initiate a Phase...
Kexing Biopharma’s GB19 Wins NMPA IND Approval – Novel BDCA2 Targeted Therapy for Lupus Enters Clinic
Kexing Biopharma (SHA: 688136) announced that China’s National Medical Products Administration (NMPA) has cleared GB19 Injection...
Lepu Biopharma’s GPC3 ADC MRG006A Wins NMPA Approval for HCC Combination Trials – First‑in‑Class Asset Advances
Lepu Biopharma Co., Ltd (HKG: 2157) announced that China’s National Medical Products Administration (NMPA) has approved...
SinoMab’s First‑in‑Class IL‑25R Antibody SM17 Wins NMPA IND Approval – Novel IBD Therapy Enters Clinic
SinoMab BioScience Limited (HKG: 3681) announced that China’s National Medical Products Administration (NMPA) has approved the...
Pharscin Pharma’s PARP7 Inhibitor HSN002066C1 Wins NMPA IND Approval – First Class 1.1 Innovative Drug Enters Clinic
Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) announced that China’s National Medical Products Administration (NMPA) has...
CSPC Pharmaceutical Wins NMPA Approval for Phase II Study of SYS6023 HER3 ADC in Metastatic Breast Cancer
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has granted...
Innovent Biologics Initiates Phase 3 HeriCare-Breast01 Study for IBI354 in HER2+ Breast Cancer
Innovent Biologics, Inc. (HKG: 1801) announced first patient dosing in the pivotal Phase 3 HeriCare-Breast01 study...
Henlius Biotech Initiates Phase Ib/II Study for HLX43 ADC Combinations in Colorectal Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced first patient dosing in a Phase Ib/II clinical study...
Changchun High-Tech’s GenSci136 Wins NMPA Approval for IgA Nephropathy Clinical Trial
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun GeneScience...
Delonix Bioworks’ DX-104 Becomes First China-Approved Engineered OMV Vaccine, Targets $1.3 Billion MenB Market
Delonix Bioworks announced that DX-104, its Group B meningococcal (MenB) vaccine candidate, has received clinical...
Sino Biopharm Completes Phase III Enrollment for LM-302 ADC in Gastric Cancer
Sino Biopharmaceutical Ltd (HKG: 1177) announced completion of patient enrollment for the registrational Phase III...