Qihan Biotech Secures NMPA Approval for Dual-Target Allogeneic CAR-T Therapy QT-019C in Refractory Lupus
Hangzhou Qihan Biotech Engineering Life (“Qihan Biotech”) announced that its QT-019C cell injection has received...
Drug
Insilico Medicine Launches Phase 3 Trial for AI-Discovered Rentosertib in Idiopathic Pulmonary Fibrosis
Insilico Medicine (HKG: 3696) announced the initiation of a Phase 3 clinical trial (CTR20262475, NCT07687459)...
LTZ Therapeutics Secures FDA IND Approval for LTZ-232, First-in-Class Myeloid Engager Targeting EpCAM-High Solid Tumors
LTZ Therapeutics announced that its second drug candidate, LTZ-232, has received Investigational New Drug (IND)...
Shanghai Stexo Biotechnology Secures NMPA Clinical Approval for STX11101 Extracellular Vesicle Therapy in Acute Liver Failure
Shanghai Stexo Biotechnology Co., Ltd. announced that its proprietary extracellular vesicle drug STX11101 injection, derived...
China NMPA Launches PIONEER Program to Accelerate NAMs Adoption in Drug Development
China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) unveiled the “PIONEER” (Propel...
Sino Biopharmaceutical Submits China Marketing Application for World’s First Intra-Incisional Long-Acting Ropivacaine Analgesic
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary, Beijing Tide Pharmaceutical, has submitted a...
Shaanxi Micot Enrolls First Patient in Phase Ib/II Clinical Trial of MT1002 for Acute Ischemic Stroke Treatment
Shaanxi Micot Pharmaceutical Technology Co., Ltd. (HKG: 2335) announced the successful enrollment of the first...
Changchun High & New Tech Secures NMPA Clinical Approval for GenSci164 PTH1R Agonist in Hypoparathyroidism Treatment
Changchun High & New Tech (SHE: 000661) announced it has received clinical trial approval from...
Hengrui Pharmaceuticals Secures NMPA Priority Review for Trastuzumab Rezetecan in HER2-Low Breast Cancer, Expanding Third Indication in China
Hengrui Pharmaceuticals (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has...
Edding Genor’s Trispecific Antibody GB268 Secures NMPA IND Approval for Phase Ib/II Breast Cancer Trial, Targeting TNBC and HR+/HER2- Subtypes
Edding Genor Group Holdings Limited (HKG: 6998) announced that China’s National Medical Products Administration (NMPA)...
Hengrui Pharmaceuticals Secures NMPA Priority Review for Trastuzumab Rezetecan in HER2-Low Breast Cancer, Expanding Third Indication in China
Hengrui Pharmaceuticals (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has...
Shandong Boan Biotechnology Secures NMPA Approval for Phase II Trial of BA1106/BA1104 Combination in NSCLC, China’s First Non-IL-2-Blocking Anti-CD25 Antibody
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that China’s National Medical Products Administration (NMPA)...
Bio-sincerity Secures NMPA Clinical Trial Approval for BIOS0629-109, Novel XPO1 Inhibitor for Advanced Malignant Tumors
Bio-sincerity (SHE: 301096) announced that China’s National Medical Products Administration (NMPA) has approved its investigational...
Novartis Secures EU Approval for Itvisma, First Gene Replacement Therapy for Broad SMA Population Including Patients Two Years and Older
Novartis AG (NYSE: NVS) announced that the European Commission (EC) has granted marketing authorization for...
Ocumension Therapeutics Secures NMPA Approval for OT-502, China’s First Single-Dose Sustained-Release Intraocular Steroid for Postoperative Inflammation
Ocumension Therapeutics (HKG: 1477) announced that China’s National Medical Products Administration (NMPA) has approved the...
Hangzhou Adamerck’s Aom0498 Receives NMPA Approval as China’s First Homegrown Neuromuscular Blockade Reversal Agent – Completing Decade-Long National Innovation Program
Hangzhou Adamerck Pharmlabs Inc. announced that its independently developed Class 1 innovative drug Aom0498 has...
Jingxin Pharmaceutical Secures NMPA Approval for China’s First Generic Cariprazine in Schizophrenia – Capturing Market Opportunity as Reference Product Remains Unlaunched
Jingxin Pharmaceutical (SHE: 002020) announced that China’s National Medical Products Administration (NMPA) has approved the...
TransThera Completes Patient Enrollment in Global Phase III Trial of Tinengotinib for Advanced Cholangiocarcinoma – Multi-Kinase Inhibitor Backed by Multiple Regulatory Designations
TransThera (Nanjing) Technology Co., Ltd. (HKG: 2617) announced the completion of patient enrollment in the...
TransThera Advances Phase II Trial of Selective BTK Inhibitor TT-01488 with Anti-CD20 Antibodies for Mantle Cell Lymphoma – Novel Non-Covalent Approach Shows Enhanced Safety Profile
TransThera (Nanjing) Technology Co., Ltd. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA)...
Juventas Cell Therapy’s CAR-T Therapy Yuanruida Receives HSA Filing Acceptance for r/r B-ALL – Expanding Global Regulatory Footprint Following NMPA Approval
Juventas Cell Therapy Ltd. announced that the New Drug Application (NDA) for Yuanruida (inaticabtagene autoleucel),...