Alphamab JSKN003 ADC FDA Breakthrough Therapy Targets Ovarian Cancer
Alphamab Oncology (HKG: 9966) announced that its independently developed HER2‑targeting biparatopic antibody‑drug conjugate (ADC), JSKN003,...
Drug
Jemincare JMX-2005 PAD Injection Secures NMPA Clinical Trial Approval
Jiangxi Jemincare Group (SHA: 603222) announced that its Class 2.2 and Class 2.4 new drug application for...
J&J TREMFYA Pediatric Psoriasis EC Approval Targets First IL-23 Indication
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has extended the...
Takeda Zasocitinib TYK2 Phase III Shows Positive Psoriasis Results
Takeda Pharmaceutical Company (TYO: 4502, NYSE: TAK) announced positive topline results from two pivotal Phase III...
Lilly Imlunestrant Breast-Cancer EMBER-3 Shows 38% Risk Reduction
Eli Lilly (NYSE: LLY) announced updated results from the Phase III EMBER‑3 clinical trial evaluating its...
IVIEW GVB-2001 Gene Therapy Treats First POAG Patient Successfully
IVIEW Therapeutics Inc. announced the successful treatment of the first patient with primary open-angle glaucoma...
Novabio’s Treg Therapy NP001 Doses First ALS Patient in China Trial
Novabio Therapeutics, a China‑based clinical‑stage biotech, announced the successful completion of first patient dosing in...
Grand Pharmaceutical’s TLX591‑CDx RDC Wins China Phase III for Prostate Cancer Diagnosis
Grand Pharmaceutical Group Limited (HKG: 0512) announced that its China‑based Phase III clinical trial for TLX591‑CDx...
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...
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)...