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...
Product approvals
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...
BeiGene’s Brukinsa Receives EU Marketing Approval for Marginal Zone Lymphoma
China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from...
Sino Medical Sciences’ Non-Compliant Balloon Catheter Approved by NMPA
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the...
NMPA Approves Luye Pharma’s LY03005 for Depression Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that its Category 1 chemical drug LY03005...
BGI Genomics Receives NMPA Approval for Chromosome Aneuploidy Detection Kit
China-based genomics firm BGI Genomics Co., Ltd (SHE: 300676), the Shenzhen-listed subsidiary of BGI Group,...
Novartis’ Cosentyx Gains Approval for New Doses in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval for two new specifications...
NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4)...
NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab),...
Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY)...