Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Included in China’s Emergency Use Program
China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced the inclusion of its COVID-19 vaccine...
Product approvals
Microport EP Medtech’s Pressure Monitoring Catheter Approved by NMPA
Shanghai Microport EP Medtech Co., Ltd’s disposable pressure monitoring magnetic positioning radiofrequency catheter has been...
NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer
The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696)...
Sansure Biotech’s Pertussis Detection Kit Approved by NMPA
China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) announced that it has obtained medical...
Assure Tech Wins Japanese PDMA Approval for Pen-Type COVID-19 Antigen Test
China-based Assure Tech (Hangzhou) Co., Ltd (SHA: 688075) has announced receiving marketing approval from Japan’s...
Fosun Pharma’s Human Interferon Gamma Approved for New Indication by NMPA
Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced receiving another indication approval from the...
InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore
China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health...
Hengrui Pharmaceuticals Receives FDA ANDA Approval for Gadobutrol Generic
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving Abbreviated New Drug Application (ANDA) status...
Hotgen Biotech Receives FDA EUA for COVID-19 Antigen Home Test
China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving Emergency Use Authorization (EUA) from...
Hainan Poly Pharm Wins Finland Approval for Generic Cytovene-IV
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the...
China’s Jiangsu Bioda Gains NMPA Approval for Innovative Artificial Blood Vessel
The National Medical Products Administration (NMPA) has granted marketing approval to China-based Jiangsu Bioda Life...
BeiGene’s Brukinsa Receives EC Approval for CLL Treatment
China-based biotech BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving marketing approval...
Hotgen Receives NMPA Approval for HBV RNA Assay Kit
China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced that it has received marketing approval...
Yabao Receives FDA Clearance for Generic Nexavar
China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated...
Acotec Scientific Secures FDA 510(k) Approval for Vericor Catheter
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received a 510(k)...
Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from...
BeiGene’s Brukinsa Receives Marketing Approval in Brazil
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has...
Merck’s Keytruda Receives 10th Indication Approval in China for TNBC
US-based Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has...
Sinovac’s Varicella Vaccine Receives WHO Pre-Qualification
China-based Sinovac has announced receiving pre-qualification (PQ) status from the World Health Organization (WHO) for...