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...
Product approvals
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)...
Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New...
BeiGene’s Brukinsa Receives Multiple Marketing Approvals in Latin America
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals...
AccuMedical’s Blood Flow-Guided Stent Wins NMPA Approval for Brain Aneurysms
AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its...
CSPC Receives CDE Approval for Generic Version of Pfizer’s Xeljanz
China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received market...
Henlius Biotech’s Hanbeitai Approved for Hepatocellular Carcinoma
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the...
Antengene’s Xpovio Receives Taiwan FDA Approval for Multiple Indications
China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan...
Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s...
China Approves GSK’s Juluca for HIV-1 Infection
The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE:...
Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from...
YiChang HEC ChangJiang Pharma’s Insulin Aspart Gains NMPA Approval
China-based firm YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that its in-house...
Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
Jemincare’s Sonidegib Receives First Prescriptions in China for Basal Cell Carcinoma
China-based Jiangxi Jemincare Group has announced the first prescriptions in China for its sonidegib, a...