Luye Pharma’s Goserelin Acetate Injectable Accepted for Breast Cancer Review
China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate...
Market approval filings
Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for...
InnoCare Pharma’s Orelabrutinib sNDA Accepted for Marginal Zone Lymphoma
InnoCare Pharma (HKG: 9969) announced that a supplemental New Drug Application (sNDA) for its Bruton’s...
Everest Medicines’ Xerava NDA Accepted by Taiwan’s TFDA
Everest Medicines (HKG: 1952) announced that its New Drug Application (NDA) for Xerava (eravacycline) for...
NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review
The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted...
Eli Lilly Files for Baqsimi Approval in China to Treat Severe Hypoglycemia
Eli Lilly & Co. (NYSE: LLY) has submitted a market approval application to China’s Center...
Sihuan Pharma’s Xuanzhu Bio Files for Fulvestrant-Piroxetine Combo in Advanced Breast Cancer
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration...
InnoCare’s Tafasitamab Receives First Prescription in China’s Bo’Ao Lecheng Pilot Zone
China-based InnoCare (HKG: 9969) announced that the first prescription for its pipeline candidate tafasitamab (trade...
Sihuan Pharma’s Fourth-Gen Insulin Degludec NDA Accepted by NMPA for Review
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its New Drug Application (NDA)...
Huadong Medicine’s GFR Monitoring System Accepted by NMPA for Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a glomerular...
Luye Pharma’s Lurbinectedin Receives Hainan Approval for SCLC Treatment
China-based Luye Pharma Group (HKG: 2186) announced approval from the Hainan Medical Products Administration for...
Huadong Medicine’s Biosimilar Victoza (Liraglutide) Accepted for NMPA Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar...
Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA)...
Hengrui Medicine’s SHR8554 Accepted for NMPA Review in Postoperative Pain
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its market filing for SHR8554,...
Junshi Biosciences’ PD-1 Inhibitor Tuoyi Under FDA Review for NPC Treatment
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the Biologics License Application (BLA) for...
Shionogi Files NDA for S-217622 COVID-19 Antiviral Drug in China
Japan-based Shionogi & Co., Ltd has submitted a New Drug Application (NDA) to the National...
GenFleet Collaborates with BioLineRx to Develop Motixafortide for Pancreatic Cancer in China
China-based GenFleet Therapeutics has entered into a collaboration with Israel’s BioLineRx Ltd (NASDAQ: BLRX) to...
Sino Biopharmaceutical’s TQ-B3101 Accepted by NMPA for ROS1+ NSCLC Treatment
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the National Medical Products Administration (NMPA)...
BeiGene’s Tislelizumab Accepted for Review in Gastric Cancer Treatment
BeiGene (NASDAQ: BGNE) announced that a supplementary Biologic License Application (sBLA) for its programmed death-1...
CSPC’s JMT103 Accepted for Review in China, Targets RANKL-Related Deficiencies
The Center for Drug Evaluation (CDE) website indicates that a market filing by China-based CSPC...