EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
HER2
Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of...
AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the...
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug...
Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB,...
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi...
MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD;...
Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has...
Amoy Diagnostics and AstraZeneca Expand Collaboration on Companion Diagnostic Development
China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has announced a new cooperation agreement with...
Sino Biopharmaceutical Receives NMPA Approval for Biosimilar Herceptin for HER2+ Cancers
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the...
Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from...
Transcenta Holding Ltd Secures Global Clinical Trial Approvals for Osemitamab in Gastric Cancer
China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug...
BioNTech’s DB-1303 ADC Shows Promising Results in Solid Tumor Phase I/IIa Trial
Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303,...
Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has...
Alphamab Oncology and CSPC Pharma Get Green Light for KN026 Phase III Study in Breast Cancer
China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced receiving...
Sihuan Pharmaceutical’s Birociclib Meets Primary Endpoint in Phase III Breast Cancer Study
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its Phase III clinical...
Jiangsu Hengrui Pharmaceuticals’ Pyrotinib Gains NMPA Approval for HER2+ Breast Cancer Treatment
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced receiving another indication...
RemeGen’s Disitamab Vedotin (RC48) Clears for Phase I Study in HER2-Positive Tumors
RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from...
Shanghai Fosun Pharma Commences Phase III Trial for HER2-Targeted FS-1502
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent Chinese pharmaceutical company,...
RemeGen’s RC48 Receives Two Clinical Trial Approvals for Breast Cancer Treatments
RemeGen Ltd (HKG: 9995) has announced the receipt of two clinical trial approvals for its...