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Keymed Biosciences’ IL-4Rα mAb Stapokibart Receives NMPA Approval for Atopic Dermatitis Treatment
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone…
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Siemens Healthineers’ 7T MRI System Terra. X Receives NMPA Marketing Approval
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Siemens Healthineers AG has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Magnetom Terra X, a localized next-generation 7T magnetic resonance imaging (MRI) system. This marks a significant advancement in medical imaging technology within the Chinese market. Terra. X, the first domestically produced 7T clinical MRI…
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Medtronic Secures China Market Approval for Pulsed Electric Field Atrial Fibrillation Treatment Devices
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Medtronic (NYSE: MDT), the US-Irish medical technology giant, has announced that it has received approvals from Chinese regulatory authorities for its innovative heart pulse electric field ablation device and disposable heart pulse electric field ablation catheter. These products, when used in tandem, employ the non-thermal effects of pulsed electric fields…
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CIRC’s Subsidiary HTA Co., Ltd. Secures NMPA Approval for Sodium Fluoride [18F] for Bone Imaging
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China Isotope & Radiation Corporation’s (CIRC) subsidiary, HTA Co., Ltd. (HKG: 1763), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its sodium fluoride [18F]. This product is primarily utilized in positron emission tomography (PET) to identify areas of altered osteogenic activity in…
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Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Aesthetic Use in China
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has granted market approval for its product Daxxify (daxibotulinumtoxin, RT002). This type A botulinum toxin is now approved for the temporary improvement of moderate to severe eyebrow wrinkles in adults in…
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Amoy Diagnostics’ AiHuiJie Lung Cancer Companion Diagnostic Receives NMPA Approval
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AiHuiJie, a companion diagnostic (CDx) reagent designed for lung cancer. This PCR-based product is capable of detecting 11 key driver…
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Genesis MedTech Secures NMPA Approval for Innovative Surgical Energy Products
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Genesis MedTech, a leading medical device company headquartered in Singapore, has secured marketing approvals from China’s National Medical Products Administration (NMPA) for two of its high-frequency electrosurgical energy products: the “OP9 ultrasonic high frequency integrated surgical equipment” and the “disposable cutting and closing knife head.” The OP9 device is a…
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True Health’s Advanced Microwave Ablation System Gains NMPA Nod for Liver Tumor Treatment
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True Health (Guangdong Hengqin) Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative navigation positioning microwave ablation system. This advanced medical device utilizes CT images to devise a precise needle insertion plan prior to surgery and provides real-time guidance for the…
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Sansure Biotech Wins NMPA Nod for ALDH2 Gene Polymorphism Detection Kit
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Sansure Biotech Inc., (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its nucleic acid detection kit for the human ALDH2 gene polymorphism, utilizing the PCR fluorescent probe method. The kit is designed…
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Jafron Biomedical’s Blood Purification Devices Gain EU Market Approval Under MDR
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Jafron Biomedical Co., Ltd, a prominent player in the blood purification sector based in China, has announced that its Category III medical devices, the cytokine adsorption column and the disposable blood perfusion device, have secured market approvals within the European Union. This approval is in accordance with the stringent Medical…
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Beijing Balance Medical Secures NMPA Nod for Renatus Transcatheter Aortic Valve System
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BEIJING—Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has received market approval from the National Medical Products Administration (NMPA) for its Renatus transcatheter aortic valve system. This in-house developed product is now approved for use in patients aged 70 years or older who are diagnosed with symptomatic, calcified, and severe…
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Sino Medical Sciences Secures Hong Kong Approval for Coronary Balloon Dilation Catheter
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HONG KONG—Sino Medical Sciences Technology Inc., (SHA: 688108), a leading medical device company based in China, has announced that it has received marketing approval in Hong Kong for its SC HONKYTONK coronary balloon dilation catheter. This approval marks a significant expansion of the product’s reach, as it is already registered…
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Advancing Peripheral Artery Disease Care: Boston Scientific’s JETSTREAM Receives Marketing Nod in China
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NEW YORK—Boston Scientific Corporation (NYSE: BSX), a leading innovator in medical solutions, has secured a significant regulatory milestone with the National Medical Products Administration’s (NMPA) marketing approval for its JETSTREAM vascular plaque rotary cutting system. This development marks a significant step forward in the treatment of peripheral arterial disease (PAD)…
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Jiangxi Jemincare Secures First Generic Approval for GSK’s Requip in China
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Jiangxi Jemincare Group, based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of GSK’s Requip (ropinirole), marking the first generic approval for this medication in China. The drug is indicated for the treatment of Parkinson’s disease (PD) and PD with non-motor…
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JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
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JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
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Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
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Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
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Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
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Jiangsu Hengrui Pharmaceuticals Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic…
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Chongqing Genrix Biopharmaceutical Receives NMPA Approval for Xeligekimab, First Domestic Anti-IL-17 Antibody
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Chongqing Genrix Biopharmaceutical Co., Ltd, a Chinese biopharmaceutical company, has received marketing approval from China’s National Medical Products Administration (NMPA) for its self-developed Category 1 biologic product, xeligekimab. This marks the first domestically developed anti-IL-17 antibody in China approved for the treatment of moderate-to-severe plaque psoriasis. The introduction of xeligekimab…
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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
