Hengrui Pharmaceuticals Expands Dalpiciclib Label with NMPA Approval for Early Breast Cancer Adjuvant Therapy
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received additional indication...
WuXi XDC Partners with BioDlink International for Monoclonal Antibody Intermediate Manufacturing in RMB 19.0 Million CRDMO Agreement
WuXi XDC (HKG: 2268), a leading global end-to-end CRDMO (Contract Research, Development and Manufacturing Organization),...
Hengrui Pharmaceuticals Receives NMPA Clinical Approvals for Two Novel Anti-Tumor Candidates SHR-6914 and HRS-7525, Addressing Unmet Needs in Prostate Cancer and Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received separate clinical...
Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan Receives EMA Orphan Drug Designation for Pulmonary Neuroendocrine Carcinomas
Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) announced that the European Medicines Agency (EMA) has...
Luye Pharma’s Dual-Target Candidate LY03015 Achieves Breakthrough Phase II Results in Tardive Dyskinesia with 76.5% Response Rate
Luye Pharma Group Limited (HKG: 2186) announced that its Category 1 candidate drug LY03015 has...
GSK’s Momelotinib Receives Orphan Drug Designation from FDA and EMA for VEXAS Syndrome, Addressing Critical Unmet Need in Rare Myeloid Disorder
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced that momelotinib has received Orphan Drug Designation (ODD) from...
Regent Pacific’s Senstend Receives NMPA Approval with Four-Year Data Protection, Triggering $5M Milestone Payment from Wanbang
Regent Pacific Group Limited (HKG: 0575) announced that the New Drug Application (NDA) for its...
Bayer AG Inaugurates Second Consumer Health Innovation Center in China, Expanding Skin and Digestive Health Partnerships
Bayer AG (ETR: BAYN) announced the inauguration of its second Bayer Consumer Health China Center...
Shanghai Henlius Biotech Receives Australian Clearance for Phase II Study of PD-L1 ADC HLX43 Combined with Hansizhuang in NSCLC Neoadjuvant Therapy
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory clearance in Australia to...
Shanghai Henlius Biotech’s HLX04-O Meets Primary Endpoints in Phase III Trial for Wet AMD, Demonstrating Non-Inferiority to Ranibizumab
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Phase III international multicenter clinical study...
NMPA Releases 106th Batch of Reference Drugs for Generic Quality Consistency Evaluation, Including BeOne Medicines’ Brukinsa (zanubrutinib)
The National Medical Products Administration (NMPA) announced the 106th batch of reference drugs designated for...
China’s CDE Proposes Framework for Reference Listed Drug Selection Following Marketing Authorization Holder Changes for Foreign-Originator Drugs Manufactured Locally
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released two...
China’s National Health Commission Revises Physician Practice Regulations to Align with Physicians Law and Enhance Multi-Site Practice Framework
The National Health Commission (NHC) announced comprehensive revisions to five key regulatory frameworks governing physician...
Servier Group Partners with n-Lorem Foundation to Develop ASO Therapies for Rare Neurodevelopmental Disorders
Servier Group announced a multi-target research collaboration with the n-Lorem Foundation, a non-profit research organization...
Shanghai Juncell Therapeutics Files for HKEX Listing with Breakthrough TIL Therapy GC101 for Solid Tumors
Shanghai Juncell Therapeutics Co., Ltd. announced it has published its prospectus and filed for listing...
Everest Medicines Licenses DMX-200 from Dimerix – CCR2 Inhibitor for FSGS Targets Asia-Pacific Markets
Everest Medicines (HKG: 1952) announced it has struck a licensing agreement with U.S. firm Dimerix...
Zelgen Biopharmaceuticals Secures NMPA Approval for Zepuping in Severe Alopecia Areata – First Immuno-Inflammatory Indication for Pan-JAK Inhibitor
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that the National Medical Products Administration (NMPA)...
Hinova Pharmaceuticals Reports Positive Phase IIa Data for HP515 in MASH – THR-β Agonist Achieves >50% Liver Fat Reduction
Hinova Pharmaceuticals Inc. (SHA: 688302) announced that final analysis results from the Phase IIa clinical...
Chia Tai Tianqing Presents Positive Phase II Data for TQC2938 in Allergic Rhinitis – Novel ST2-Targeting mAb Shows Efficacy Across Inflammatory Pathways
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG:...
Harbour BioMed and BioMap Launch MegaStream TechBio – Next-Generation AI Drug Discovery Company Targeting Global Markets
Harbour BioMed (HKG: 2142) announced it will co-establish, together with U.S. biotechnology company BioMap, a...