Hengrui Pharma’s HER2 ADC SHR-A1811 Wins NMPA Approval for Breast Cancer – Second Indication Expands Trastuzumab Rezetecan Franchise
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its self-developed Category 1...
Cancer
Haihe Biopharma Wins Japan Approval for Risovalisib – First PI3Kα Inhibitor for Ovarian Clear Cell Carcinoma
Haihe Biopharma Co., Ltd. announced that its independently developed selective PI3Kα inhibitor, Risovalisib Mesylate Tablets,...
Huahai Pharmaceutical Initiates Phase III Trial for HB0025 – PD-L1/VEGF Bispecific Targets First-Line Endometrial Cancer
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced the initiation of a Phase III clinical...
Konruns Pharma Wins NMPA Phase III Approval for KC1036 – Multi-Target VEGFR2/AXL Inhibitor Targets Thymic Carcinoma
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) received National Medical Products Administration (NMPA) approval to initiate...
Pfizer Reports Positive FOURLIGHT-1 Results for Atirmociclib – CDK4 Inhibitor Shows PFS Benefit in Post-CDK4/6 Breast Cancer
Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase II FOURLIGHT-1 study, demonstrating...
AstraZeneca Secures EU Approval for Imfinzi in Gastric Cancer – Perioperative Regimen Cuts Death Risk 22% in MATTERHORN Trial
AstraZeneca PLC (NASDAQ: AZN) announced European Union marketing approval for Imfinzi (durvalumab) in combination with...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
Hengrui’s Irinotecan Liposome (II) Wins NMPA Phase II Approval – Adjuvant Pancreatic Cancer Study vs. Gemcitabine/Capecitabine
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
Chipscreen Biosciences’ CS08399 Wins NMPA Approval – PRMT5-MTA Inhibitor Targets MTAP-Deficient Solid Tumors and Lymphomas
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced NMPA clearance to initiate a clinical study...
J&J’s Erda-iDRS Shows 89% Complete Response in NMIBC – Intravesical Erdafitinib System Advances to Phase II/III
Johnson & Johnson (J&J, NYSE: JNJ) announced positive Phase I results for Erda-iDRS, an investigational...
Sino Biopharm’s TQB3454 Hits Phase III Endpoints in IDH1+ Biliary Tract Cancer – China’s First IDH1 Inhibitor Poised for NDA Filing
Sino Biopharmaceutical (HKG: 1177) announced that TQB3454 Tablets, a Category 1 innovative drug developed by...
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...
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...