Grand Pharmaceutical RDC GPN01530 Wins FDA Phase I/II Nod for FAP Tumor Diagnosis
Grand Pharmaceutical Group Limited (HKG: 0512) announced that its self‑developed, globally innovative Radionuclide Drug Conjugate...
Drug
DualityBio’s DB-1310 Wins FTD as First HER3‑ADC for HR+/HER2‑ Breast Cancer
Duality Biotherapeutics, Inc. (HKG: 9606) announced that the U.S. FDA granted Fast Track Designation (FTD)...
Yabao’s GLX002 Wins NMPA Approval for PAH Clinical Trial, First Modified Bosentan
Yabao Pharmaceutical Group Co., Ltd. (SHA: 600351) announced that China’s National Medical Products Administration (NMPA)...
Biostar Technologies Doses First Patient in US Pivotal Trial for Utedelone in Breast Cancer Brain Mets
Beijing Biostar Technologies Ltd (HKG: 2563) announced that its wholly‑owned U.S. subsidiary, Biostar Pharma, Inc.,...
Asieris’ APL-2401 FGFR2/3 Inhibitor Wins NMPA Nod for Phase 1 Solid Tumor Trial
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that China’s National Medical Products Administration (NMPA)...
InnoCare’s Soficitinib Wins NMPA Approval for Phase 2/3 TYK2 Urticaria Study
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that China’s National Medical Products Administration (NMPA)...
Hutchmed’s HMPL-A251 ATTC Dosed in Global Phase 1 for HER2 Tumors
Chinese pharmaceutical company HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a...
Antengene Xpovio sNDA Malaysia Approval Expands DLBCL Indication
Antengene Corporation Limited (HKG: 6996) announced that the Malaysian National Pharmaceutical Regulatory Agency has approved...
Everest lerodalcibep PCSK9 FDA Approval Targets China Launch
Everest Medicines Limited (HKG: 1952) announced that the U.S. FDA has approved the Biologics License...
GSK’s Exdensur Wins FDA Approval as First Twice‑Yearly Asthma Biologic
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) approved...
Adagene’s Muzastotug Wins FDA Fast Track for CTLA-4 Cancer Combo
Adagene Inc. (NASDAQ: ADAG) announced that the U.S. Food and Drug Administration (FDA) granted Fast...
Aficamten Wins China Approval as HCM Drug in Global First for Sanofi
Sanofi (NASDAQ: SNY) announced that aficamten, a second‑generation cardiac myosin inhibitor, received marketing approval from...
Haisco Wins NMPA Clinical Approval for Four Category 1 Drugs, Advancing Pipeline
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Orelabrutinib First BTK Inhibitor to Hit Phase 3 in Lupus as InnoCare NMPA Filing Cleared
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self‑developed novel BTK inhibitor orelabrutinib...
ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) in...
Sanofi’s Tolebrutinib Fails Phase 3 PPMS Endpoint, Halting Registration Plans
Sanofi (NASDAQ: SNY) announced that the Phase 3 PERSEUS study (NCT04458051) of tolebrutinib in primary progressive...
Konruns Doses First Patient in Phase 2 Esophageal Cancer Trial for KC1036
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) announced first patient dosing in the Phase 2 KC1036‑COM‑01...
Johnson & Johnson’s TECVAYLI Gets FDA Priority Review for Myeloma Combo
Johnson & Johnson (NYSE: JNJ) announced that the U.S. FDA selected the teclistamab MajesTEC‑3 supplemental...
Hengrui NMPA Approves Four Clinical Trials Advancing Oncology and Metabolic Pipeline
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) announced that China’s National Medical Products...
GSK’s Nucala Wins CHMP Nod for COPD in Europe
UK biopharma GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency’s Committee for...