Luye Pharma’s Parkinson’s Disease Treatment LY03003 Receives NMPA Review Acceptance
Luye Pharma Group (HKG: 2186) has announced that the National Medical Products Administration (NMPA) has...
Market approval filings
Astellas Pharma’s Zolbetuximab BLA Accepted by China’s CDE for Gastric Cancer Treatment
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE)...
Jiangsu Hengrui’s Camrelizumab and Apatinib Combo Accepted for FDA Review for HCC Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the US Food and Drug...
Novo Nordisk’s Turoctocog Alfa Pegol for Hemophilia A Accepted for Review by China’s CDE
The Center for Drug Evaluation (CDE) in China has indicated on its website that the...
BeiGene’s Tislelizumab Receives Positive CHMP Opinion for Esophageal Cancer Treatment
BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received a...
Hansoh Pharmaceutical’s Ibrexafungerp NDA Accepted for Review by China’s NMPA for VVC Treatment
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that the National Medical Products...
Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical...
Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical...
Zai Lab’s Vyvgart Receives NMPA Review for Subcutaneous Injection Form in gMG Treatment
China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products...
Shanghai Fosun Pharmaceutical Submits Daxibotulinumtoxin A (RT002) for NMPA Approval
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a...
Harbour BioMed’s Batoclimab for Generalized Myasthenia Gravis Accepted for NMPA Review
Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands,...
Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablets for AIS Accepted by NMPA for Review
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that the National Medical Products Administration...
CSPC Pharmaceutical’s Biosimilar Omalizumab Accepted for Review by China’s NMPA
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that the National Medical Products Administration...
Jiangsu Hengrui Pharmaceutials’ SHR-1209 for Hypercholesterolemia Accepted for NMPA Review
China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category...
Shanghai Pharmaceuticals’ SPH3127 for Hypertension Gets MNPA Review Acceptance
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products...
Takeda and HutchMed’s Elunate Study Results Published in The Lancet
Takeda (TYO: 4502) and HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) have announced that the...
Janssen Submits Additional Indication Application to FDA for Carvykti in Multiple Myeloma
The Janssen subsidiary of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an additional indication...
Hybio Pharmaceutical’s Semaglutide API Receives FDA Review Acceptance
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the US Food and Drug...
Genor Biopharma’s Geptanolimab NDA for PTCL Rejected by China’s NMPA
China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the National Medical Products Administration...
Reistone Biopharma’s Ivarmacitinib Accepted for Review by China’s CDE for Atopic Dermatitis
Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment...