NMPA Accepts MediLink Therapeutics’ NDA for Tam‑Peli, Self‑Developed B7‑H3‑Targeting ADC for Relapsed Small Cell Lung Cancer
MediLink Therapeutics announced that the New Drug Application (NDA) for Tam‑Peli (tamatanmab pelidotin for injection;...
Market approval filings
Santen’s Atropine Eye Drops RYJUSEA Wins NDA Acceptance From China’s NMPA for Myopia Progression
Santen Pharmaceutical (TYO: 4536) announced that the New Drug Application (NDA) for its atropine sulfate...
Hengrui’s drotokibart BLA Accepted by NMPA for Moderate-to-Severe Atopic Dermatitis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...
Hengrui Pharmaceuticals’ Oral GLP‑1R Agonist HRS‑7535 NDA Accepted by NMPA for Type 2 Diabetes, Joining China’s Incretin Race
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its New Drug Application...
Cutia Therapeutics’ CU‑20101 BLA Accepted by NMPA for Moderate to Severe Glabellar Lines, Advancing a Safer Botulinum Toxin Type A
Cutia Therapeutics (HKG: 2487) announced that the Biologics License Application (BLA) for CU‑20101 has been...
Hansoh’s HS‑20093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7‑H3 ADC
Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS‑20093...
AbbVie Submits EMA Application for SKYRIZI Subcutaneous Induction in Crohn’s Disease
AbbVie (NYSE: ABBV) announced that it has submitted an application to the European Medicines Agency...
Hengrui’s NMPA Accepts NDA for HRG2010, a Novel Levodopa/Carbidopa Combination for Parkinson’s Disease
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
Leads Biolabs Files NDA for Opamtistomig in EP-NEC — World’s First 4-1BB Bispecific Nears Potential First Approval
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that it has submitted a New Drug...
LongBio Pharma’s LP‑003 BLA Accepted by NMPA for Seasonal Allergic Rhinitis, Advancing Novel Anti‑IgE Antibody Toward China Approval
LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that China’s National Medical Products Administration (NMPA)...
CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
CanSino Biologics Files NDA in China for Td5cp, a First-In-Nation Adolescent and Adult DTaP Booster Vaccine
CanSino Biologics (HKG: 6185) announced that it has submitted a New Drug Application (NDA) in...
Pfizer and Valneva See EMA Validate MAA for PF‑07307405, the First‑Potential Blockbuster Lyme Disease Vaccine
Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency...
Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms
Astellas Pharma Inc. (TYO: 4503) announced that it has submitted a New Drug Application (NDA)...
Alebund’s AP301 NDA Accepted by NMPA for Hyperphosphatemia in CKD Dialysis Patients
Alebund Pharmaceuticals (Jiangsu) Limited (HKG: 9637) announced that the New Drug Application (NDA) for its core...
Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application...
CSPC Pharmaceutical’s NDA for Anbenitamab-HB1801 Combination Accepted by China NMPA as Neoadjuvant Therapy for HER2+ Breast Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
Allergan Aesthetics’ BOTOX Cosmetic sBLA Accepted by FDA for Masseter Muscle Prominence, Poised to Become First Neurotoxin Indication
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), announced that the U.S. Food and Drug...
Sino Biopharmaceutical’s BCL-2 Inhibitor TQB3909 Tablet Receives CDE Acceptance for CLL/SLL Treatment in Relapsed/Refractory Patients
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ)‘s New...