CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has...
Market approval filings
HutchMed Completes NDA Submission to US FDA for Frquintinib in Metastatic CRC
Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of a rolling...
Chongqing Genrix’s Xeligekimab for Psoriasis Accepted for Market Approval Review
China-based Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) has announced that the market approval filing...
Henlius Biotech’s Serplulimab Accepted for EMA Review for ES-SCLC Treatment
Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted...
Hinova Pharmaceuticals’ HC-1119 NDA Accepted for Review by NMPA
Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the New Drug Application (NDA)...
Hengrui Pharmaceuticals’ SHR8028 Receives NMPA Review for Dry Eye Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing...
Luye Pharma’s BA1102 Biosimilar to Xgeva Accepted for CDE Review
China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing for its...
NMPA Accepts Market Filing for Guangdong Zhongsheng’s COVID-19 Drug RAY1216
China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that the market filing for...
MabPharm Files NDA for CMAB009, Biosimilar to Erbitux, Targeting Metastatic Colorectal Cancer
Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the filing of...
GSK’s Nucala Gains NMPA Approval for Severe Eosinophilic Asthma in China
UK-based GSK plc (NYSE: GSK) has announced that a market approval filing for Nucala (mepolizumab)...
Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced...
Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced...
CStone’s PD-L1 Inhibitor Sugemalimab Accepted for Review in Gastric Cancer
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has...
CStone’s Sugemalimab Accepted for EU Marketing Authorization by EMA
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the European Medicine Agency (EMA) has accepted...
Zai Lab’s SUL-DUR NDA Accepted for Review by NMPA
China-based Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has revealed that a New Drug Application...
Asieris’ Uro-G Bladder Endoscope Catheter Awaits NMPA Approval
China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that...
Luoxin’s Tegoprazan Gains NMPA Review for Duodenal Ulcer Treatment
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a leading China-based pharmaceutical company, has...
Shanghai Pharmaceuticals’ X842 Accepted for NMPA Review for Reflux Esophagitis
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products...
Junshi Biosciences Seeks UK MHRA Approval for PD-1 Inhibitor Tuoyi
Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biotech firm, has announced the submission...
Joincare’s Generic Seretide Accepted for NMPA Review
China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that the market filing...