Simcere Pharmaceutical Secures NMPA Approval for SIM0689 Bispecific Antibody Targeting PD-1 and VEGF in Solid Tumors
Simcere Pharmaceutical Group (HKG: 2096) announced that SIM0689, a novel bispecific antibody (BsAb) targeting both...
PD-1/L1
Henlius Biotech’s Serplulimab Becomes World’s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
MSD and Gilead Discontinue Phase 3 KEYNOTE-D46/EVOKE-03 Study of Trodelvy-KEYTRUDA Combination in First-Line NSCLC
Merck & Co., Inc. (MSD; NYSE: MRK) and Gilead Sciences, Inc. (NASDAQ: GILD) announced today...
BMS Secures EC Approval for Opdivo-AVD Combination in Advanced Classical Hodgkin Lymphoma
Bristol-Myers Squibb Co. (BMS, NYSE: BMY) announced that the European Commission (EC) has granted marketing...
AstraZeneca’s IMFINZI-BCG Combination Approved for High-Risk Non-Muscle-Invasive Bladder Cancer in US
AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved IMFINZI...
Shanghai Yizhong Pharma’s Trifunctional Antibody Fusion Protein YXC-001 Receives IND Acceptance in China – Novel Approach Targets Advanced Solid Tumors with Precision IL-2 Delivery
Shanghai Yizhong Pharmaceutical Co., Ltd. (SHA: 688091) announced that China’s National Medical Products Administration (NMPA)...
Junshi Biosciences Completes Phase III NEOTORCH Study of Toripalimab in Perioperative NSCLC, Plans Regulatory Filing
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced the completion of analysis from...
Astellas and MSD’s PADCEV-Keytruda Combination Receives Positive CHMP Opinion for Muscle-Invasive Bladder Cancer in EU
Astellas Pharma Inc. (TYO: 4503) announced that the Committee for Medicinal Products for Human Use...
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...
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...
Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
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...
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...
Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from...
Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS/pMMR Colorectal Cancer
Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein,...
Hengrui Pharmaceuticals Secures NMPA Clinical Approval for KRAS G12D Inhibitor HRS-6093 and Multiple Combination Regimens in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical trial...
Senhwa Biosciences Launches Global Phase I/II Trial of First-in-Class Pidnarulex Combined with BeOne’s Tislelizumab in Solid Tumors Including Pancreatic Cancer
Senhwa Biosciences, Inc. (TPE: 6492) announced on May 5, 2026, the initiation of a global,...
BeOne Medicines’ Tislelizumab-Zanidatamab Combo Receives FDA Priority Review for HER2-Positive Gastric Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), formerly BeiGene, announced that the U.S....
Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the Center for Drug Evaluation (CDE)...
Henlius Biotech Launches Phase II/III Trial in Australia for Triple Combination Therapy in Squamous NSCLC Featuring Novel Anti-EGFR Antibody Pimurutamab and Approved PD-1 Inhibitor HanSiZhuang
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced regulatory clearance from Australia’s Therapeutic Goods Administration (TGA)...