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Chunlizhengda’s Handheld Orthopedic Robot Approved by China’s NMPA
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Beijing Chunlizhengda Medical Instruments Co., Ltd (HKG: 1858, SHA: 688236) has received marketing approval from China’s National Medical Products Administration (NMPA) for its INS 1 handheld orthopedic robot. This development marks a significant step forward in the adoption of domestic medical robotics in China. To date, 17 domestically produced joint…
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ViiV Healthcare’s HIV-PreP Therapy Approved by China’s NMPA, Offers Alternative to Daily Medication
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GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for both cabotegravir tablets and cabotegravir injection. These medications are intended for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents weighing at least 35kg who are at…
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BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
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Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
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Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the Health Sciences Authority of Singapore for its enoxaparin sodium injection in four specifications: 0.2ml:20mg, 0.4ml:40mg, 0.6ml:60mg, and 0.8ml:80mg. The approval is valid for a period…
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Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
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Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above…
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Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine, marking it as the first of its kind in China for the treatment of malignant tumors. Bendamustine, a bifunctional nitrogen mustard derivative, is recognized for its ability to induce cell death through multiple mechanisms, thereby…
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Jiangsu BioPerfectus’ Dengue Detection Kit Gains NMPA Approval for Commercialization
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Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading in vitro diagnostic (IVD) product manufacturer based in China, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its Dengue virus NS1 antigen detection kit, which employs the colloidal gold method. The product…
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China Grants Marketing Nod to Ferring Pharmaceuticals’ Rekovelle for Assisted Reproduction
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Switzerland-based Ferring Pharmaceuticals Ltd announced that its recombinant human follicle stimulating hormone δ injection, Rekovelle, has been granted marketing approval in China. This product, a recombinant follicle stimulating hormone (rFSH) known as follitropin delta derived from human cell lines, has already received approvals across numerous countries and regions. It is…
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MicroPort MedBot’s Toumai Robot Gets EU Green Light for Broad Surgical Applications
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that its Toumai endoscopic surgery robot has received CE qualification from the European Union, allowing the product to be marketed and used for urology, general surgery, thoracic surgery, and gynecological endoscopic surgeries within the EU. The Toumai robot is the…
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Blue Sail Medical’s New Catheter Receives NMPA Approval for Complex Coronary Lesion Treatment
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has received marketing approval from the National Medical Products Administration (NMPA) for its new coronary artery balloon dilation catheter, classified as a Category III medical device. This development marks a significant step forward in the treatment of complex coronary artery lesions, including…
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Everest Medicines’ Velsipity for UC Receives First Asian Approval in Macau
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the regulatory authority in Macau has approved the New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC). This makes Macau the first region in Everest’s licensed territory in Asia to grant approval…
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Andon Health’s Triplex Virus Test Kit Receives US FDA Emergency Use Authorization
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Andon Health Co., Ltd (SHE: 002432), a leading healthcare company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its novel triplex test kit, capable of detecting COVID-19, influenza A virus, and influenza B virus. The product…
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Medtronic’s RDN System Symplicity Spyral Earns First-Ever NMPA Approval
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Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced that its Symplicity Spyral renal denervation (RDN) system has become the first of its kind to receive market approval from China’s National Medical Products Administration (NMPA). The company celebrates this milestone, which positions it at the forefront of the RDN…
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Everest Medicines’ Nefecon Secures Market Approval for IgAN Treatment in Hong Kong
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval from the Hong Kong Department of Health for its drug Nefecon (targeted-release budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This approval marks the…
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Wondfo Biotech’s WELLlife Test Kit Receives FDA Nod for Home Use in the US
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Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a leading biotechnology company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its WELLlife COVID-19/Influenza A&B Home Test. This triplex test kit, available in an over-the-counter (OTC) version, is…
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United Imaging’s uMR Jupiter 5T Becomes First Ultra-High Frequency MRI System to Gain FDA Approval
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Shanghai-based medical equipment manufacturer United Imaging Healthcare (UIH, SHA: 688271) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its uMR Jupiter 5T magnetic resonance imaging (MRI) system. This product is recognized as the world’s first ultra-high frequency (UHF) system approved for…
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BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
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China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
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Shenzhen Chipscreen Biosciences Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
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Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
