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Yabao Receives FDA Clearance for Generic Nexavar
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence…
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Acotec Scientific Secures FDA 510(k) Approval for Vericor Catheter
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received a 510(k) license from the US FDA for its Vericor, a peripheral support catheter designed to improve peripheral vascular pathways. This approval marks a significant milestone for Acotec in expanding its presence in the US medical device…
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Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of…
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BeiGene’s Brukinsa Receives Marketing Approval in Brazil
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL)…
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Merck’s Keytruda Receives 10th Indication Approval in China for TNBC
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US-based Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 10th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used to treat early high-risk triple negative breast cancer (TNBC) with tumors expressing PD-L1 (CPS ≥ 20) in…
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BeiGene’s Brukinsa Receives EU Marketing Approval for Marginal Zone Lymphoma
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China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from the European Committee (EC) for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved in the EU for the treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who have…
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Sino Medical Sciences’ Non-Compliant Balloon Catheter Approved by NMPA
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the National Medical Products Administration (NMPA) for its non-compliant balloon dilation catheter. This approval marks a significant step forward in the company’s efforts to enhance cardiovascular treatment options. Product ProfileThe non-compliant balloon dilation catheter is now…
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NMPA Approves Luye Pharma’s LY03005 for Depression Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that its Category 1 chemical drug LY03005 has been approved by the National Medical Products Administration (NMPA) for the treatment of depression. This marks a significant milestone in the company’s efforts to address the growing need for effective depression treatments. LY03005 ProfileLY03005…
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BGI Genomics Receives NMPA Approval for Chromosome Aneuploidy Detection Kit
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China-based genomics firm BGI Genomics Co., Ltd (SHE: 300676), the Shenzhen-listed subsidiary of BGI Group, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its chromosome aneuploidy detection kit (combined probe anchoring polymerization sequencing method). This marks a significant milestone in the company’s efforts to advance…
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Novartis’ Cosentyx Gains Approval for New Doses in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval for two new specifications of Cosentyx (secukinumab) in China. The new 300mg and 75mg prefilled syringe forms are approved for pediatric psoriasis in patients aged six years and above with moderate to severe plaque psoriasis eligible for systemic treatment…
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NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
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Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III/IV) mycosis fungoides (MF) who have previously…
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NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
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The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Henlius Biotech (HKG: 2696). The drug is now approved for the treatment of first-line squamous non-small cell lung cancer (sqNSCLC). Previous Approvals and Clinical ProgressSerplulimab was initially…
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Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
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China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY) announced that the PD-1 inhibitor Tyvyt (sintilimab) has been approved by the National Medical Products Administration (NMPA) for a new indication. The drug is now approved to treat first-line unresectable locally advanced, recurrent, or metastatic…
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Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Biogen’s Tecfidera (dimethyl fumarate). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Tecfidera: Drug Profile and Market ContextTecfidera is…
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BeiGene’s Brukinsa Receives Multiple Marketing Approvals in Latin America
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals in Latin America for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for various indications across several Latin American countries. Approvals and IndicationsBrukinsa has received approval to treat…
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AccuMedical’s Blood Flow-Guided Stent Wins NMPA Approval for Brain Aneurysms
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AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its blood flow-guided dense mesh stent, marking it as the 181st novel medical device approved in the country. The stent is indicated for the treatment of unruptured saccular or spindle wide-necked aneurysms in the internal carotid…
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CSPC Receives CDE Approval for Generic Version of Pfizer’s Xeljanz
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received market approval from the Center for Drug Evaluation (CDE) for its generic version of Pfizer’s Xeljanz (tofacitinib). This marks the second sustained-release tablet version of the drug (in 11mg dosage) to pass China’s generic quality consistency…
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Henlius Biotech’s Hanbeitai Approved for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar, Hanbeitai. The drug is now approved for the treatment of hepatocellular carcinoma (HCC), expanding its therapeutic applications in China. Previous Approvals and Therapeutic IndicationsHanbeitai was first…
