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...
Cancer
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...
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...
AstraZeneca Joins ZERO Prostate Cancer’s Blitz the Barriers Initiative – Ambitious Program Aims to Save 100,000 Lives by 2035
ZERO Prostate Cancer, the leading prostate cancer organization in the United States, announced on June...
Shanghai Leadingtac Secures NMPA Approval for LT-010391 – China’s First Clinical-Stage Oral KRAS-G12D Degrader
Shanghai Leadingtac Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
Lannacheng Biotechnology Files HKEX Prospectus with 13-Candidate Radiopharmaceutical Pipeline
Yantai Lannacheng Biotechnology Co., Ltd. announced it has filed its prospectus for listing on the...
Sichuan Biokin’s Iza-Bren Becomes World’s First EGFR×HER3 Bispecific ADC with NDA Accepted by China’s NMPA
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that the new drug application (NDA) for...
Roche’s VENTANA PTEN Assay Receives FDA Approval as First Companion Diagnostic for AstraZeneca’s Truqap in Prostate Cancer
Roche Holding AG (SWX: ROP, OTCMKTS: RHHBY) announced that the VENTANA PTEN (SP218) RxDx Assay...
Merck Secures FDA Approval for Keytruda-Welireg Combination as Adjuvant Therapy in High-Risk Kidney Cancer
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
Shouyao Holdings Secures NMPA Approval for Second-Generation ALK Inhibitor CT-707 as First-Line Treatment for ALK-Positive NSCLC
Shouyao Holdings (Beijing) Co., Ltd. (SHA: 688197), a Beijing-based pharmaceutical company, announced it has received...
Novartis Secures Fourth China Approval for Tafinlar-Mekinist Combo in BRAF V600E-Mutated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Novartis AG (NYSE: NVS) announced that China’s National Medical Products Administration (NMPA) has granted approval...
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...
European Commission Approves Sanofi’s Subcutaneous Sarclisa (Isatuximab) Across All Multiple Myeloma Indications Based on Phase III IRAKLIA Data
The European Commission announced this week its approval of Sanofi’s (NASDAQ: SNY) Sarclisa (isatuximab) subcutaneous...
Henlius Biotech Doses First US Patient in Global Phase I Trial of HLX17 Pembrolizumab Biosimilar – Dual FDA/NMPA Approval Enables Simultaneous Development in China and United States
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the dosing of the first patient in the...
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...
Innovent Biologics Reports Positive Phase III Results for IBI343 in Advanced Gastric Cancer – CLDN18.2-Targeting ADC Files NDA with NMPA
Innovent Biologics (HKG: 1801) announced that the pre-specified first interim analysis from the global Phase...
Kadwise Biotech and Epiprobe Forge Strategic Partnership to Advance Pediatric Cancer Diagnostics in China
Wuhan Kadwise Biotechnology Co., Ltd., a China-based gynecologic oncology specialist with extensive expertise in genetic...
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...
AstraZeneca’s Next-Gen SERD Camizestrant Shows 55% Reduction in Progression Risk and Superior ctDNA Clearance in Phase III SERENA-6 Trial
AstraZeneca plc (NYSE: AZN) announced updated results from the Phase III SERENA-6 clinical trial, demonstrating...