Neurodawn’s Y-4 Wins FDA Fast Track for First‑in‑Class Neuropathic Pain Combo
Neurodawn Pharmaceutical Co., Ltd. announced that its Y‑4 tablet received Fast Track Designation (FTD) from...
Drug
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...
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...