Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic
Shanghai Essight Biotechnology Co., Ltd. announced that ES502 Injection has received FDA approval to proceed...
Cancer
WuXi Biologics Partners with Earendil Labs – Integrated CDMO Services for Bispecific Antibodies and ADCs Targeting Autoimmune and Oncology Indications
WuXi Biologics (HKG: 2269) announced a strategic cooperation agreement with Earendil Labs, the overseas subsidiary...
Changchun GeneScience’s GenSci128 Wins FDA Orphan Drug Designation – TP53 Y220C Reactivator Targets Pancreatic Cancer
Changchun GeneScience Pharmaceutical Inc. announced that GenSci128 tablets, its independently developed selective TP53 Y220C mutation...
Huadong Medicine’s HDM2017 Wins FDA Orphan Drug Designation – CDH17 ADC Targets Three Gastrointestinal Cancers
Huadong Medicine Co., Ltd (SHE: 000963) announced that HDM2017, its independently developed CDH17-targeting antibody-drug conjugate...
J&J’s AKEEGA Wins EU Approval for mHSPC – PARP/Abiraterone Combo Expands to Earlier-Line Prostate Cancer
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved a...
FDA Accepts ENHERTU sBLA with Priority Review – HER2 ADC Seeks Early Breast Cancer Approval with 53% Recurrence Risk Reduction
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. FDA has...
Astellas’ XOSPATA Fails Phase III Primary Endpoint in Frontline AML – FLT3 Inhibitor Misses OS Benefit vs. Midostaurin
Astellas Pharma Inc. (TYO: 4503) and the HOVON Foundation announced that the Phase III HOVON...
Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel...
Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase...
Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors
Bio-Thera Solutions Ltd (SHA: 688177) announced NMPA clearance to initiate a clinical study evaluating BAT8008...
J&J’s TECVAYLI Wins FDA Approval in Earlier-Line Myeloma – BCMA BiTE Plus Daratumumab Combo Expands Addressable Market
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...
Fosun Pharma’s HLX97 Wins NMPA Phase I Approval – First-in-Class KAT6A/B Inhibitor Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97,...
HutchMed Initiates Phase I/IIa Trial for HMPL-A580 – Second Antibody-Targeted Triggered Conjugate Targets EGFR+ Solid Tumors
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I/IIa clinical...
Konruns Pharma’s KC1036 Wins NMPA Approval – Dual‑Target VEGFR2/AXL Inhibitor Enters IO Combination Trials
Beijing Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced that China’s National Medical Products Administration (NMPA) has...
Sihuan Pharma’s Bireociclib Wins NMPA Approval for First‑Line HR+/HER2‑ Breast Cancer – CDK2/4/6 Inhibitor Expands Label
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that Xuanyuening (bireociclib), a Category 1 CDK2/4/6 inhibitor developed...
Leman Biotech Raises RMB 200M Series A+ – Advances Ultra‑Low‑Dose Metabolically Armored CAR‑T
Leman Biotech Co., Ltd. announced the completion of a Series A+ financing round totaling nearly...
Huadong Medicine’s DR30206 Wins NMPA Approval – Triple‑Target Fusion Protein for NSCLC Enters Phase II
Huadong Medicine Co., Ltd (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has approved...
GenFleet’s GFH375 Wins CDE Breakthrough Therapy Designation – Oral KRAS G12D Inhibitor for NSCLC
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that GFH375, an oral KRAS G12D (ON/OFF) inhibitor, has...
InnoCare’s Zurletrectinib Wins Priority Review for Pediatric NTRK Tumors – Next‑Gen TRK Inhibitor Expands Label
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that the Center for Drug Evaluation (CDE) of China’s...
Antengene’s XPOVIO Secures Second South Korea Reimbursement – Selinexor Combo Approved for Multiple Myeloma
Antengene Corporation Limited (HKG: 6996) announced that South Korea’s National Health Insurance Service (NHIS) has approved...