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...
Drug
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),...
Beijing Sinotau Secures NMPA Approval for XTR021 Radiodrug Clinical Trial in mCRPC – Next-Generation PSMA-Targeted Therapy Shows Enhanced Efficacy Profile
Beijing Sinotau International Pharmaceutical Technology Co., Ltd. announced that China’s National Medical Products Administration (NMPA)...
Hybio Pharma’s Generic Tirzepatide ANDA Accepted by FDA – First-to-File Challenger Targets $20B+ Dual GLP-1/GIP Agonist Franchise with Paragraph IV Certification
Shenzhen Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced today that the U.S. Food and Drug...
Roche Receives FDA Priority Review for Enspryng in Thyroid Eye Disease – IL-6 Inhibitor Leverages Novel Recycling Technology for Second Indication
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced today that the U.S. Food and Drug...
Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence
Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced today that it has received clinical trial...
CSPC Innovation Launches Phase III Trial of SYS6010 ADC-PD-1 Combo in Resected NSCLC – Novel EGFR-Targeted Antibody-Drug Conjugate Enters Adjuvant Setting
CSPC Innovation Pharmaceutical Co., Ltd. (SHE: 300765) announced today the initiation and public registration of...
Sanofi Reports Positive Phase 3 Baby-COMET Results for Nexviazyme in Infantile-Onset Pompe Disease – ERT Shows 100% Survival and Ventilation-Free Outcomes at 52 Weeks
Sanofi S.A. (NASDAQ: SNY) announced today positive top-line results from the Baby-COMET Phase 3 study...
BeOne Medicines Reports 43% Reduction in Disease Progression with BRUKINSA-Rituximab Combo in Phase III MCL Study – Chemotherapy-Free Regimen Shows Significant PFS Benefit
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced today positive top-line results from...