J&J Files TECVAYLI Line Extension with EMA – BCMA Bispecific Seeks Earlier Use in Second-Line Multiple Myeloma
Johnson & Johnson (J&J, NYSE: JNJ) announced the submission of a Type II variation application...
Market approval filings
HighTide Therapeutics’ HTD1801 NDA Accepted by NMPA – First-in-Class AMPK/NLRP3 Dual-Target Drug for Type 2 Diabetes
HighTide Therapeutics Inc. (HKG: 2511) announced that China’s National Medical Products Administration (NMPA) has accepted...
Qyuns Therapeutics’ QX002N NDA Accepted by NMPA – IL-17A Antibody Targets Ankylosing Spondylitis Market
Qyuns Therapeutics (HKG: 2509) announced that the New Drug Application (NDA) for QX002N, its first...
Haisco’s HSK39297 NMPA Filing Accepted – Oral Factor B Inhibitor Targets Paroxysmal Nocturnal Hemoglobinuria Market
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Hansoh Pharma’s Mirdametinib Plus Almonertinib NDA Accepted by NMPA – Dual‑Target Combination for EGFR‑Mutant NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that China’s National Medical Products Administration (NMPA) has...
Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Shionogi Files CORECTIM Lotion for Japan Approval – Expands Topical JAK Inhibitor Franchise in Atopic Dermatitis
Shionogi & Co., Ltd. and subsidiary Torii Pharmaceutical Co., Ltd. announced the submission of a...
Asieris’ APL-1702 MAA Accepted by EMA – First Photodynamic Therapy for Cervical HSIL Nears EU Approval
Asieris Pharmaceuticals (SHA: 688176) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
Novartis’ Remibrutinib Wins CHMP Positive Opinion – Oral BTK Inhibitor Nears EU Approval for Chronic Urticaria
Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
Gan & Lee’s Insulin Biosimilars Win CHMP Positive Opinion – Bysumlog and Dazparda Near EU Market Entry
Gan & Lee Pharmaceuticals (SHA: 603087) and its European subsidiary Gan & Lee Europe announced that...
Akeso’s Manfidokimab NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Akeso, Inc. (HKG: 9926) announced that China’s National Medical Products Administration (NMPA) has formally accepted the...
3SBio’s SSGJ-611 NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Bio-Thera’s BAT4406F BLA Accepted by NMPA – Next‑Gen Anti‑CD20 mAb for Rare Disease NMOSD
Bio-Thera Solutions Inc. (SHA: 688177) announced that China’s National Medical Products Administration (NMPA) has accepted the...
Hengrui’s ANGPTL3 Antibody SHR-1918 NDA Accepted by NMPA – Priority Review for Rare Disease HoFH
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA)...
GSK Reports 7% Revenue Growth to $44.7 Billion in 2025; Oncology Surges 43%
GlaxoSmithKline plc (GSK, NYSE: GSK) delivered strong 2025 financial results, with total revenues rising 7% in...
SciClone’s Tasurgratinib NDA Accepted by NMPA for FGFR2+ Biliary Tract Cancer
SciClone Pharmaceuticals Inc. (HKG: 6600) announced that the National Medical Products Administration (NMPA) has accepted for...
Hengrui Pharma’s Trastuzumab Rezetecan Filing Accepted for HER2+ Colorectal Cancer Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
Takeda’s Oveporexton Wins FDA Priority Review for Narcolepsy Type 1, Potential First Orexin Agonist
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA)...
GSK’s RSV Vaccine Filing Accepted by NMPA for China Market Entry
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the Center for Drug Evaluation (CDE) of China’s NMPA...
Peijia Medical Files CE Mark for GeminiOne TEER System in European Mitral Regurgitation Market
Peijia Medical Ltd (HKG: 9996) announced it has submitted CE mark registration under the European...