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MicroPort Scientific’s Bioabsorbable Stent System Gains NMPA Nod for Ischemic Heart Disease Treatment
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Shanghai-based medical device conglomerate MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its proprietary bioabsorbable rapamycin eluting coronary stent system. This innovative device is designed for the treatment of patients suffering from ischemic heart disease due to…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
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Gan & Lee Pharmaceuticals Gains Market Foothold in Algeria with Insulin Product Approvals
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company, has announced that it has received registration approval from Algerian authorities for two of its insulin products: the insulin aspart injection pre-filled pen and the insulin aspart 30 injection pre-filled pen. These products are slated to be manufactured locally by…
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MicroPort Scientific’s Fully Biodegradable Cardiac Stent Earns NMPA Nod
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Shanghai-based medical device titan MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its new generation fully biodegradable and absorbable cardiac stent. This innovation marks a significant advancement in the field of interventional cardiology. The stent is the…
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ShuWen Biotech’s Preeclampsia Self-Test Receives NMPA Approval, Marking a Global First
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Zhejiang-based ShuWen Biotech Co., Ltd has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative CercaTest Red, a patented self-test designed for household use by pregnant women to screen for preeclampsia. This marks the first time a self-test of this kind has…
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Shanghai Sanyou Medical Gains NMPA Approval for 3D Printed Cervical Fusion Device
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Shanghai Sanyou Medical Co., Ltd (SHA: 688085), a prominent player in the medical device industry in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its innovative 3D printing metal additive manufacturing cervical fusion device. This breakthrough product…
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Luye Pharma’s Antipsychotic Erzofri Gains FDA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) marketing approval of its in-house developed antipsychotic medication, Erzofri (paliperidone palmitate extended-release injectable suspension). The approval grants Erzofri the clearance for treatment of schizophrenia and…
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3SBio’s Thrombopoietin Meets Primary Endpoint in Phase III Trial for Chronic Liver Disease Patients
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the…
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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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Beijing Balance Medical Secures NMPA Nod for Pioneering Heart Valve Patch
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a leading medical technology firm based in China, has achieved a significant regulatory milestone with the National Medical Products Administration’s (NMPA) approval for its heart valve biological patch. This marks the first market approval for a product specifically designed for the repair…
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MicroPort MedTech’s Aortic Occlusion Catheter Gets Green Light from China’s NMPA
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical technology sector, has secured a significant regulatory milestone with its aortic occlusion balloon catheter receiving marketing approval from China’s National Medical Products Administration (NMPA). This product, designed for temporary blood flow obstruction in the aorta, marks…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Lepu Scientech Secures NMPA Approval for RF Lance, Advancing Atrial Septal Puncture Technology
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd (HKG: 2291), a leading medical technology company based in China, has announced that it has obtained a medical device license from the National Medical Products Administration (NMPA) for its RF Lance, a novel disposable radiofrequency atrial septal puncture needle. This product is designed…
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Amoy Diagnostics’ APACE Receives Japanese Approval as Companion Diagnostic for MET-Inhibiting Therapies
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a Chinese diagnostics company, has announced that it has received two new indication approvals in Japan for its APACE (also known as PCR-11 gene product), a multi-target rapid screening product designed for lung cancer detection. The product is now approved as a companion…
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Novo Nordisk’s Wegovy Approved in the UK to Reduce Cardiovascular Risks in Overweight Adults
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Novo Nordisk (NYSE: NVO)’s anti-obesity drug Wegovy (semaglutide) has received a new indication approval in the United Kingdom, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for its use in reducing the risk of serious heart problems or strokes in overweight or obese adults. This marks…
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Hangzhou Jianjia Medical’s Arthbot Surgical Robot Receives NMPA Approval for Orthopedic Procedures
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Hangzhou Jianjia Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its Arthrobot surgical robot, a significant step for the company as it looks to enhance precision in orthopedic procedures. The Arthbot is a multifunctional device capable of performing joint replacement surgeries, including…
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RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
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RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to…
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NMPA Approves Chengdu Chipscreen’s Bilessglu for Type 2 Diabetes in Combination with Metformin
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The National Medical Products Administration (NMPA) has granted approval for Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321)’s Category 1 drug Bilessglu (chiglitazar sodium) for use in combination with metformin to treat type 2 diabetes. This decision marks another milestone for the Chinese pharmaceutical company, which has developed chiglitazar as a…
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Eli Lilly’s Mounjaro Approved by China’s NMPA for Long-Term Weight Management
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the US, has announced that it has received a new market approval from the National Medical Products Administration (NMPA) in China for its drug Mounjaro (tirzepatide) as a long-term weight management treatment. Administered as a once-weekly injection, Mounjaro is…
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Bain Capital-Backed Tenacia Wins NMPA Approval for Ganaxolone Oral Suspension for CDKL5 Deficiency
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Tenacia, a central nervous system (CNS) specialist company incubated by Bain Capital, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-licensed drug, ganaxolone oral suspension. This medication is indicated for the treatment of epileptic seizures in patients aged 2 years and…
