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Gaush Meditech Receives NMPA Approval for Femtosecond Laser Corneal Refractive Surgery System
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for its femtosecond laser corneal refractive surgery system and accompanying disposable eye fixation patient interface. Developed in collaboration with German partner SCHWIND eye-tech-solutions GmbH, the system is designed for producing corneal flaps in…
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Johnson & Johnson MedTech Gains FDA Clearance for MONARCH QUEST with AI Algorithms
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US major Johnson & Johnson MedTech announced receiving U.S. 510(k) regulatory clearance for its MONARCH QUEST. This latest advancement in MONARCH navigation technology features AI-powered algorithms and a verified OEC Open interface with the GE HealthCare OEC 3D mobile CBCT Imaging System. MONARCH QUEST TechnologyThe MONARCH QUEST platform represents a…
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Novartis’ Cosentyx Approved by NMPA for Moderate to Severe Hidradenitis Suppurativa
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Swiss giant Novartis’ (NYSE: NVS) Cosentyx (secukinumab) has secured another indication approval from China’s National Medical Products Administration (NMPA), this time for the treatment of moderate to severe hidradenitis suppurativa (HS). This IL-17A-targeted therapy previously gained approval in China for moderate-to-severe plaque psoriasis, ankylosing spondylitis, and active psoriatic arthritis (PsA).…
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AstraZeneca’s Imfinzi Approved by NMPA for Early-Stage NSCLC Treatment
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UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The approval allows Imfinzi to be used in combination with chemotherapy for adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), specifically for patients without…
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Huihe Healthcare’s K-Clip Wins Chinese Approval for Tricuspid Regurgitation Treatment
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Shanghai-based Huihe Healthcare, a developer of structural heart disease intervention medical devices, announced receiving marketing approval in China for its K-Clip transcatheter tricuspid valve repair system. This approval marks a significant milestone in the treatment of tricuspid regurgitation. Innovation and Market ImpactK-Clip is the first of its kind in China…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Wins New NMPA Approval for NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its sacituzumab tirumotecan (SKB264/MK-2870). The approval allows the use of this TROP2-targeted antibody drug conjugate (ADC) in adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell…
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Hansoh Pharmaceutical’s Ameile Wins New NMPA Approval for Advanced NSCLC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Ameile (almonertinib). The epidermal growth factor receptor (EGFR) inhibitor is now approved to treat unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive non-small…
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Jiangsu Cowin Biotech Obtains NMPA License for Gene Methylation Detection Kit
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China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide…
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Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
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US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive…
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AbbVie’s Skyrizi Approved by China’s NMPA for Moderate to Severe Crohn’s Disease
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US giant AbbVie (NYSE: ABBV) announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its Skyrizi (risankizumab). The drug is approved to treat adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response, or intolerance to traditional or biologic treatments. The…
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Pfizer’s Elrexfio Receives Conditional NMPA Approval for Relapsed Multiple Myeloma
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US giant Pfizer (NYSE: PFE) announced receiving conditional approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Elrexfio (elranatamab). The drug is now approved to treat triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). Mechanism of ActionElrexfio works by binding to CD3 on T…
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SonoScape Medical Corp. Wins First AI-Powered Prenatal Ultrasound Approval in China
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Shenzhen-based SonoScape Medical Corp. announced receiving marketing approval in China for its S-Fetus prenatal ultrasound product. This makes it the first domestic firm to gain approval for an artificial intelligence (AI)-empowered prenatal ultrasound device in the country. Technology Integration and AdvantagesThe device deeply integrates ultrasound technology and AI, representing the…
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Cryofocus Medtech’s Malignant Stenosis Cryoablation System Approved by NMPA for Chinese Market
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Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd (HKG: 6922) has announced receiving endorsement from the National Medical Products Administration (NMPA) to market its malignant stenosis cryoablation system in China. This innovative technology represents a significant advancement in the treatment of malignant airway tumors. Innovative Cryoablation TechnologyThe malignant stenosis…
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Antengene’s Xpovio Receives Marketing Approval in Indonesia
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its Xpovio (selinexor). The approval grants the drug three indications in the Southeast Asian country. Indications ApprovedThe drug is approved for: Drug BackgroundXpovio, the world’s first and only FDA-approved oral XPO1 inhibitor, was discovered by US-based…
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Sino Medical Sciences’ HT Supreme Stent System Gains Vietnamese Marketing Approval
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) announced that it has received marketing approval from the Ministry of Health of Vietnam for its HT Supreme drug-eluting stent system. The approval allows the product to be used to improve the diameter of the coronary artery lumen in symptomatic heart disease…
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BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
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BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change its name to BeOne Medicines Ltd, announced that it has received another indication approval from the US Food and Drug Administration (FDA) for its Tevimbra (tislelizumab). The PD – 1 inhibitor is now approved for…
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Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
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Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic agent TNKase (tenecteplase) has been approved by the US Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS) in adults. Drug ProfileTNKase, a tissue plasminogen activator, is administered as a single…
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Waters and Kehua’s LC-MS Systems Gain NMPA Approval for IVD Use
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Two home-grown liquid chromatography with tandem mass spectrometry (LC-MS) systems, the ACQUITY UPLC I-Class PLUS / Xevo TQ-Loong System and the ACQUITY UPLC I-Class PLUS / Xevo TQ-S cronos System, have obtained marketing approvals from the National Medical Products Administration (NMPA). These products, developed jointly by US firm Waters Corporation…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Zeiss Group’s VISUMAX 800 with SMILE pro Software Approved by China’s NMPA
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Germany-based Zeiss Group, a specialist in optical systems and optoelectronic product manufacturing, announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its new-generation femtosecond laser system VISUMAX 800 with the innovative minimally invasive surgery SMILE pro software. Product HighlightsThe addition of SMILE pro software…
