Everest Medicines’ Nefecon Gains Accelerated Approval in Taiwan and South Korea
China-based Everest Medicines (HKG: 1952) has announced receiving Accelerated Approval Designation (AAD) from the Taiwan...
Market approval filings
Junshi Biosciences Files for UK Approval of PD-1 Inhibitor Tuoyi
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has filed for market...
Bio-Heart Bio Receives Ethical Approval for Iberis RDN System in Hainan
China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced receiving ethical approval from...
CSPC Pharma’s rhTNK-tPA Accepted for Review by NMPA for Stroke Indication
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that a supplementary market filing for...
Everest Medicines’ Nefecon NDA Accepted for IgA Nephropathy in China
China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has...
3SBio Receives NMPA Review for Pediatric ITP Thrombopoietin Filing
China-based 3SBio Inc. (HKG: 1530) has announced that the National Medical Products Administration (NMPA) has...
Haisco’s HSK16149 Accepted for Review by NMPA for Diabetic Neuropathic Pain
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that a market approval filing...
Ji Xing Pharmaceuticals’ Omecamtiv Mecarbil Accepted for Review by CDE
Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that a market filing for its...
Santhera and ReveraGen Submit NDA for Vamorolone in Duchenne Muscular Dystrophy
Swiss firm Santhera Pharmaceuticals and US-based ReveraGen BioPharma, Inc have announced the rolling submission of...
Hengrui Medicine Files for Dalpiciclib as Initial Therapy for Breast Cancer
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for...
Bio-Thera’s BAT1806 Biosimilar Accepted for Review by European Medicine Agency
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for...
LianBio Cancels Phase III Trial for Truseltiq in China Amid Global Halt
China-based LianBio (OTCMKTS: LIANY) revealed in an SEC filing that it is canceling work on...
Aosaikang’s Neratinib Maleate API Market Filing Accepted by NMPA
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its...
Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing...
Zelgen Files NDA for Jacktinib to Treat Myelofibrosis in China
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has filed a New...
Daehwa Pharmaceutical Files NDA for Liporaxel in China for Gastric Cancer Treatment
South Korea’s Daehwa Pharmaceutical (KOSDAQ: 067080) has announced the filing of a New Drug Application...
BeiGene’s Tislelizumab Receives 11th NMPA Filing for First-Line Esophageal Cancer
BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the National Medical Products Administration (NMPA)...
Daiichi Sankyo’s Enhertu Accepted for Review in China for HER2-Low Breast Cancer
Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced that its market approval filing for Enhertu (T-DXd,...
Junshi Biosciences’ JunMaiKang Biosimilar Gets NMPA Approval Filing
China-based Junshi Biosciiences (HKG: 1877, SHA: 688180) has announced that another market approval filing for...