Merck’s Pimicotinib Wins China Approval as First Class 1 Therapy for TGCT
Merck KGaA (ETR: MRK) announced that China’s National Medical Products Administration (NMPA) granted priority review approval...
Drug
GSK’s Nucala Wins China Approval as First IL‑5 Biologic for COPD
GlaxoSmithKline (GSK, NYSE: GSK) China announced that China’s National Medical Products Administration (NMPA) approved Nucala...
EPI-003 Wins FDA IND as First LNP Epigenetic Therapy for Hepatitis B
Epigenic Therapeutics (Shanghai) Biotechnology Co., Ltd., a clinical‑stage biotech focused on epigenetic modulation therapies, announced...
SanegeneBio’s INHBE siRNA Wins China IND for Obesity as First RNAi Target
SanegeneBio, a clinical‑stage RNAi therapeutics company, announced that China’s National Medical Products Administration (NMPA) approved...
BeOne Medicines Wins FDA Fast Track for GPC3 Bispecific in Liver Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. Food and Drug...
TransThera NDA Accepted for Tinengotinib in Cholangiocarcinoma After FGFR Inhibitor
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) formally...
Bio‑Thera NDA for VEGF‑A165 Antibody Targets $2B Wet AMD Market in China
Bio‑Thera Solutions (SHA: 688177) submitted a New Drug Application (NDA) to China’s National Medical Products...
Novo Nordisk Submits CagriSema NDA for 20% Weight Loss in Obesity
Novo Nordisk A/S (NYSE: NVO) submitted a New Drug Application (NDA) to the U.S. FDA...
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...
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...