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Shanghai Bio-heart Launches SAKURA-SCB Study for Drug-Coated Balloon in Japan
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced the first patient enrollment for the SAKURA-SCB study at the Cardiovascular Institute in Tokyo, Japan. This single-blinded, multiple comparison study aims to evaluate the efficacy and safety of the company’s investigational drug-coated balloon (DCB) with rapamycin. DCB InnovationThe DCB, designed…
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Abbott Laboratories’ Volt PFA System Receives EU CE Mark for Atrial Fibrillation Treatment
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US-based Abbott Laboratories (NYSE: ABT) has announced the receipt of the CE mark in the European Union (EU) for its Volt PFA System, a novel therapy for patients with atrial fibrillation (AFib). This approval marks a significant advancement in treatment options for AFib, particularly for those with complex conditions. Technology…
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Jiangsu Hengrui Pharmaceuticals Inks Global License Deal with Merck for HRS-5346
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced a license agreement with US-based giant Merck & Co., Inc. (NYSE: MRK). Under the terms, Merck gains exclusive global development, manufacturing, and commercialization rights to Hengrui’s HRS-5346, excluding the Greater China region. Financial TermsMerck will provide an upfront payment of USD 200…
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Beijing Sungen Biomedical’s SGC001 Receives FDA Fast Track Designation for AMI Treatment
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China-based Beijing Sungen Biomedical Technology Co., Ltd, an antibody developer incubated by Hotgen Biotech Co., Ltd (SHA: 688068), has announced receiving Fast Track Designation from the United States Food and Drug Administration (FDA) for its SGC001, which is described as the world’s first acute myocardial infarction (AMI) antibody drug. Drug…
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Lifetech Scientific’s LAmbre Plus LAA Closure System Gains US Medical Insurance Coverage
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced obtaining medical insurance coverage in the United States for an FDA-approved pre-clinical study of its proprietary LAmbre Plus Left Atrial Appendage (LAA) Closure System. This marks the first time a home-grown left atrial appendage closure device from China has achieved this milestone.…
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Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction
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German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for its Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The targeted indication is adult patients with heart failure (HF)…
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Lifetech Scientific’s Aortic Stent System Approved by China’s NMPA
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China-based Lifetech Scientific Corporation (HKG: 1302) announced receiving market approval from the National Medical Products Administration (NMPA) for its aortic branch reconstruction covered stent system (chimney), co-developed with Fuwai Hospital. This innovative product offers a novel treatment option for patients with arch lesions. Product InnovationThe aortic branch covered stent system…
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MicroPort Endovascular MedTech’s Cratos System Approved for Aortic Dissection Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd’s (SHA: 688016) Cratos branched aortic stent graft system has received marketing approval from China’s National Medical Products Administration (NMPA). The approval is for the minimally invasive interventional treatment of thoracic aortic dissection involving branches of the aortic arch. Product InnovationThe Cratos system represents an…
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China Medical System’s CMS-D003 Receives NMPA Approval for Clinical Study in oHCM
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China Medical System Holdings (CMS; HKG: 0867) announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacological characteristics of its investigational drug CMS-D003. The study will focus on healthy adults and those with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…
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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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Roche Launches Genentech Innovation Center in Boston to Accelerate Drug Development
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Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced the launch of the Roche Genentech Innovation Center Boston at Harvard’s Enterprise Research Campus in Allston. This new facility aims to strengthen longstanding partnerships in disease biology, engineering, and artificial intelligence/machine learning. CVRM Hub and AI IntegrationThe center will serve as Roche’s…
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Peijia Medical Completes First Two Implants of Trilogy THV System in Taiwan
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China’s Peijia Medical Ltd (HKG: 9996) announced the completion of the first two implant surgeries using its Trilogy transcatheter heart valve (THV) System for the treatment of severe aortic valve regurgitation in Taiwan. Product DetailsThe Trilogy THV System, a proprietary transcatheter aortic valve replacement product with CE mark, is designed…
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Gensaic and Novo Nordisk Team Up to Develop Cardiometabolic Therapies
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US-based AI-powered biotech Gensaic, Inc. announced the signing of a licensing and discovery cooperation agreement with Denmark-based Novo Nordisk A/S (NYSE: NVO). The collaboration, combining Novo’s deep therapeutic knowledge and drug development experience with Gensaic’s novel protein design technology, is designed to discover tissue-targeting ligands and develop new therapeutic candidates…
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Boston Scientific to Acquire SoniVie, Boosting Hypertension Treatment Portfolio
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Boston Scientific Corporation (NYSE: BSX) is set to acquire SoniVie Ltd, an Israel-based medical device company known for its TIVUS intravascular ultrasound system. The TIVUS system is designed to treat hypertensive disorders, including renal artery denervation (RDN) for hypertension, by denervating nerves surrounding blood vessels. The product is expected to…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HDM1005, a long-acting agonist targeting the GLP-1 receptor and GIP receptor. The drug is set for development to treat adult patients with heart failure with preserved…
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Omron Healthcare and China Jo-Jo Drugstores Launch Atrial Fibrillation Screening Zone
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A joint effort between Japan-based Omron Healthcare and China Jo-Jo Drugstores, Inc. (NASDAQ: CJJD), a large open-shelf affordable pharmacy headquartered in Hangzhou, the atrial fibrillation (AF) risk screening zone became operational late last week. The initiative aims to help the public better identify the risk of atrial fibrillation and raise…
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Jiangsu Hengrui’s HRS-1301 Receives NMPA Approval for Hyperlipidemia
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its Category 1 chemical drug HRS-1301 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of hyperlipidemia. Clinical Approval DetailsThe approval marks a significant milestone for HRS-1301, a novel drug designed to address hyperlipidemia.…
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Hepalink Pharmaceutical’s Enoparin Receives Argentina Approval for Thromboembolic Diseases
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow Pharmaceutical Co., Ltd, has received marketing approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) for its Enoparin (enoxaparin) product. The approved specifications include 0.2ml: 20mg, 0.4ml: 40mg, 0.6ml: 60mg, and 0.8ml:…
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Bio-heart’s Iberis System Approved by NMPA for Hypertension Treatment
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced that its subsidiary, Shanghai Angiocare Medical Technology Co., Ltd, has received market approval from the National Medical Products Administration (NMPA) for its multipole renal arterial radiofrequency ablation system, Iberis. The device is approved as an adjuvant therapy for refractory hypertension…
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MicroPort CardioFlow’s AnchorMan LAA Occluder System Earns CE Mark Approval
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Hong Kong-listed MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has received the CE mark for its AnchorMan left atrial appendage (LAA) occluder system and its guidance system, marking a significant milestone for the China-based medical device company. The approval paves the way for the commercialization of the device in Europe.…
