D3 Bio Secures Breakthrough Therapy Designation for Elisrasib – Next-Generation KRAS G12C Inhibitor for First-Line NSCLC
D3 Bio announced that China’s Center for Drug Evaluation (CDE) of the National Medical Products...
Cancer
Daiichi Sankyo, AstraZeneca Secure FDA Approval for Datroway in Triple-Negative Breast Cancer After Phase III TROPION-Breast02 Success
Daiichi Sankyo Company, Limited (TYO: 4568) and AstraZeneca PLC (NYSE: AZN) announced U.S. Food and...
Shanghai Henlius Biotech Secures Australian TGA Approval for Phase I Trial of HLX3902 Trispecific T-Cell Engager in Prostate Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that Australia’s Therapeutic Goods Administration (TGA) has granted...
Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX48 Bispecific ADC in Advanced Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Merck KGaA Launches Phase III PROCEADE-CRC-03 Trial for First-in-Class CEACAM5 ADC Precemtabart Tocentecan in Metastatic Colorectal Cancer
Merck KGaA (ETR: MRK) announced the initiation of the Phase III PROCEADE-CRC-03 study, evaluating the...
Novartis’ Pluvicto Demonstrates Significant PSA Response Improvement in PSMA-Positive mHSPC Patients in PSMAddition Study
Novartis AG (NYSE: NVS) announced today new data from the PSMAddition Phase III clinical trial...
Henlius Biotech Secures Exclusive China Rights to CTFH’s Third-Generation EGFR TKI FHND9041 for NSCLC
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced a strategic partnership with fellow Chinese biopharmaceutical company...
Leads Biolabs’ Opamtistomig Becomes World’s First 4-1BB Bispecific Antibody to Enter Pivotal Phase III for EP-NEC
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced it has received regulatory clearance in China...
CSPC Pharmaceutical Receives NMPA Clinical Trial Approval for SYH2095, World’s First KAT6 Inhibitor
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received clinical trial approval from China’s...
Full-Life Technologies Secures $150M Financing to Advance Radiopharmaceutical Pipeline and Establish Independent Actinium-225 Production
Full-Life Technologies announced the successful completion of a $150 million financing round, comprising $110 million...
Regeneron’s Fianlimab-Cemiplimab Combination Fails to Meet Primary Endpoint in Phase III Melanoma Trial – LAG-3/PD-1 Dual Therapy Shows No PFS Benefit Over Pembrolizumab Monotherapy
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that its Phase III clinical trial evaluating fianlimab (LAG-3...
AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer
AstraZeneca plc (NYSE: AZN) released high-level results from a prespecified interim analysis of the Phase...
Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced it has received regulatory approval from China’s...
Hengrui Pharma Launches Phase Ib/II Trial of Novel Triple Combination Therapy – SHR-3821 with Adebrelimab and Reltirafusp Alfa Targets Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received regulatory approval...
Huadong Medicine Receives NMPA Approval for HDM2017 ADC Trial in Colorectal Cancer – Cadherin 17-Targeting Therapy Shows Broad Solid Tumor Potential
Huadong Medicine Co., Ltd. (SHE: 000963) announced it has received clinical trial approval from China’s...
Shanghai Henlius Biotech Doses First Patient in Phase I Trial of HLX97 – Novel KAT6A/B Inhibitor for Advanced Solid Tumors
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the dosing of the first patient in a...
Merck & Co. Forges Four Strategic Partnerships with Chinese Biotechs to Advance Autoimmune and Oncology Pipeline Through MCICC Platform
Merck & Co., Inc. (MSD; NYSE: MRK) has established separate strategic partnerships with four leading...
Sichuan Kelun-Biotech Receives NMPA Approval for ITGB6-Targeted ADC SKB105 in Advanced Solid Tumors Following Crescent Biopharma Licensing Deal
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced it has received clinical approval from China’s...
Alphamab Oncology Initiates Phase II Trial of Subcutaneous Co-Formulation JSKN033 in First-Line Advanced Cervical Cancer
Alphamab Oncology (HKG: 9966) announced the initiation of a Phase II clinical study for its...
Sichuan Biokin’s Bispecific ADC Iza-Bren Receives NMPA Approval for NSCLC Clinical Study in China
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its bispecific antibody-drug conjugate (ADC) izalontamab...