Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML
Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance...
Clinical trial approval / initiation
Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases
Imviva Biotech announced it has received Investigational New Drug (IND) clearance from the U.S. Food...
Harbour BioMed’s TSLP Inhibitor HBM9378/WIN378 Doses First Patient in Phase II COPD Study with Windward Bio, Supporting Twice-Yearly Dosing Regimen
Harbour BioMed (HKG: 2142) announced that the first patient has been dosed in the Phase...
Hengrui Pharmaceuticals Advances Triple-Asset Breast Cancer Strategy with NMPA Approval for HRS-6209 Combination Study, Leveraging Selective CDK4 Inhibitor and Novel SERD
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received regulatory clearance...
Lynk Pharmaceuticals and Formation Bio Dose First Patient in Phase I BLKR201 Study for CNS-Penetrant TYK201 Inhibitor, Backed by $605M Partnership
Lynk Pharmaceuticals Co., Ltd. and its U.S. partner Formation Bio announced the dosing of the...
Antengene Launches Phase I ATTRACT Study for ATG-201 Bispecific Antibody in Autoimmune Diseases Following $1.18B UCB Licensing Deal
Antengene Corporation (HKG: 6996) announced it has received regulatory clearance from China’s National Medical Products...
CSPC Pharmaceutical Receives FDA Clearance for Once-Monthly Semaglutide SYH9017 in Weight Management, Challenging Weekly GLP-1 Standard
CSPC Pharmaceutical Group (HKG: 1093) announced today that its GLP-1 receptor agonist semaglutide long-acting injection...
Lepu Medical Receives TGA Approval for Phase I Trial of Dual-Targeting siRNA MWX205 Against PCSK9 and ANGPTL3 in Australia
Lepu Medical Technology (SHE: 300003), a leading provider of cardiovascular disease solutions, announced today that...
Sichuan Biokin Receives FDA Go-Ahead for Phase III Trial of DLL3-Targeting ADC BL-M14D1 in First-Line Extensive-Stage Small Cell Lung Cancer
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that the U.S. Food and Drug...
Adcentrx Therapeutics Receives NMPA IND Clearance for STEAP1-Targeting ADC ADRX-0405 in Advanced Solid Tumors
Adcentrx Therapeutics announced today that China’s National Medical Products Administration (NMPA) has cleared the company’s...
Oricell Therapeutics Receives NMPA Clearance for World’s First GPC3-Targeted CAR-T Therapy in Advanced Liver Cancer – Ori-C101 Enters Confirmatory Phase II
Oricell Therapeutics Co., Ltd. announced it has received clearance from China’s National Medical Products Administration...
Sichuan Biokin Receives NMPA Go-Ahead for BL-M08D1 Bispecific Antibody in DLBCL Combination Therapy – ADC Leverages Proven BL-B01D1 Platform
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced it has received regulatory approval from China’s...
Mabwell Bioscience Secures NMPA Clinical Approval for 9MW5211 in Inflammatory Bowel Disease – Highly Specific Depleting Antibody Targets Pathogenic Immune Cells
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced it has received clinical trial approval from...
Sichuan Biokin Enrolls First Patient in Phase III Trial of BL-M05D1 ADC for Claudin18.2-Positive Gastric Cancer
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced the enrollment of the first patient in...
Changchun High & New Tech Secures NMPA Clinical Trial Approval for GenSci155 in Dual Indications: Bronchopulmonary Dysplasia and Acute Ischemic Stroke
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced it has received clinical...
Huahai Pharmaceutical Receives NMPA Approval for Dual-Target IPF Therapy HB0056, Adding to Global Clinical Trial Authorizations
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced it has received clinical trial approval from...
Xtalpi-Backed Signet Therapeutics Secures FDA IND Approval for World’s First Pan-TEAD Inhibitor SIGX2649 Ahead of Schedule
Signet Therapeutics, an AI-driven biotechnology company incubated by Xtalpi Inc. (HKG: 2228), announced it has...
Changchun High & New Tech Secures FDA Approval for GenSci145, Mutation-Selective PI3Kα Inhibitor for PIK3CA-Mutant Solid Tumors
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced it has received clinical...
Changchun High & New Tech Secures FDA Clearance for GenSci136 Clinical Study in Generalized Myasthenia Gravis
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced it has received Investigational...
Lynk Pharmaceuticals Advances Pan-JAK Inhibitor LNK01004 into Phase II for Vitiligo and Hand Eczema with Skin-Restricted Design
Lynk Pharmaceuticals Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted clearance...