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German pharmaceutical major Boehringer Ingelheim (BI) has entered into a partnership with China-based Sinopharm Group Co., Ltd (HKG: 1099), granting the latter the rights to promote Boehringer Ingelheim’s Sifrol (pramipexole) and Pradaxa (dabigatran) in China effective from January 1, 2025. Boehringer Ingelheim will retain ownership and manufacturing responsibilities for both…
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Germany-based Bayer AG (ETR: BAYN) has announced a significant collaboration and license agreement with US-based Cytokinetics, Incorporated (NASDAQ: CYTK), acquiring exclusive development and commercialization rights to aficamten in Japan. The agreement is subject to certain reserved development rights of Cytokinetics. Phase III Study and Global Trial ExpansionUnder the terms of…
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for an expanded polytetrafluoroethylene (ePTFE) implant. This Category III medical device is specifically processed and manufactured for the repair or reconstruction of the pericardium during cardiac surgery.…
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Eli Lilly and Company (NYSE: LLY), a leading US pharmaceutical corporation, has announced positive results from the Phase III SUMMIT study assessing the effects of tirzepatide in heart failure. The study successfully met both primary endpoints, marking a significant advancement in the treatment of heart failure. Study Outcomes and EfficacyTirzepatide,…
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced positive results from a Phase II study for its investigational drug, muvalaplin, a selective lipoprotein(a) [Lp(a)] inhibitor. The study successfully met its primary endpoint, showing a significant reduction in elevated Lp(a) levels in adults, a genetic risk…
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China-based Hasten Biopharmaceutical Co., Ltd, a comprehensive biopharmaceutical company co-established by CBC Group, has announced the first subject dosing in its Phase III clinical study for lerodalcibep, a third-generation PCSK9 inhibitor. The drug was in-licensed from US firm LIB Therapeutics Inc. in September of the previous year. Study Design and…
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Peijia Medical Ltd (HKG: 9996), a leading medical device company, has announced the completion of its first compassionate use case utilizing the Taurus Trio transcatheter aortic valve replacement (TAVR) system in Hong Kong. This milestone marks a significant step in the application of the company’s advanced cardiovascular technology in the…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced that it has received marketing approval in Peru for its HT Supreme drug-eluting stent system. This approval allows the use of the system to improve the diameter of the coronary artery lumen in symptomatic heart…
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Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
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US biotechnology company Windtree Therapeutics, Inc. (NASDAQ: WINT) has announced the receipt of a patent approval in Hong Kong for its drug istaroxime. The patent, titled “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF),” covers formulations comprising istaroxime and methods of use, either alone or in combination with…
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US-based medical device giant Boston Scientific Corporation (NYSE: BSX) has entered into a definitive agreement to acquire Cortex, Inc., a medical technology company under the Ajax Health umbrella. The financial details of the agreement have not been disclosed, and the transaction is expected to close in the first half of…
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced the five-year follow-up results from the Phase III PIONEER study for its first-in-class HT Supreme drug-eluting stent system across the United States, Japan, and Europe. The HT Supreme system represents a significant milestone as the first cardiac stent…
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Sino Medical Sciences Technology Inc., (SHA: 688108) a China-based medical device company, has announced that it has received marketing approval in Morocco for its SC HONKYTONK coronary balloon dilation catheter. This product, designed for balloon catheter dilation of narrowed segments or bridging sites in coronary arteries to enhance myocardial perfusion,…
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China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its adjustable intracranial thrombectomy stent, marking a significant milestone as the first domestically produced device of its kind in China for the treatment of…
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Copenhagen-based healthcare giant Novo Nordisk (NYSE: NVO) has declared the primary outcomes of the SOUL cardiovascular outcomes trial, showcasing that its oral glucagon-like peptide-1 (GLP-1) analogue, semaglutide, successfully reduced major adverse cardiovascular events (MACE) by 14%. The SOUL trial, a global, multi-center, randomized, double-blinded, and parallel-controlled study, enrolled 9,650 individuals…
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MicroPort Scientific Corp., a leading Chinese medical device company (HKG: 0853), through its spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has announced that it has received market approval for its heart valve balloon dilatation catheter, Alwide Plus, from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in…
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Ji Xing Pharmaceuticals (Jixing) and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved a significant milestone with the acceptance of their market filing for aficamten by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development for…
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its balloon guided catheter. The device is designed to assist in the insertion of intravascular catheters and guide them into the target vessel within the peripheral…
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National Medical Products Administration (NMPA) for its fiber wool plug spring coil, a device used for the filling treatment of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas. The spring coil is constructed from a platinum…
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced the signing of an exclusive license agreement with China-based CSPC Pharmaceutical Group Ltd (HKEX: 01093). The deal grants AstraZeneca the rights to develop YS2302018, a preclinical stage oral Lp(a) disruptor intended for lipid-lowering therapy to treat various cardiovascular disease (CVD)…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its chemical drug SBK010 for review. SBK010, which is licensed from Chengdu Shibekang Biomedical Technology Co., Ltd, another…
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Shenzhen-based vascular intervention specialist OrbusNeich Medical Group Ltd (HKG: 6929) has announced a significant distribution agreement with Cardiovascular Systems Inc. (CSI), a subsidiary of U.S. giant Abbott Laboratories (NYSE: ABT). Under this agreement, CSI will serve as the exclusive distributor of OrbusNeich’s coronary and peripheral balloon products in the United…
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HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral…
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BEIJING—Baheal Pharmaceutical Group, a leading healthcare services and distribution company in China, is venturing into a new collaborative endeavor with Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS), to establish a joint research and development center focused on myocardial repair and regeneration drugs. This initiative comes in response to the…
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The National Healthcare Security Administration (NHSA) has reported that 12 device manufacturers, both domestic and international, have revised the pricing of their thoracic aortic stent graft products. Among these companies are the US-Irish firm Medtronic (NYSE: MDT), Shanghai-based MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), W. L. Gore & Associates,…
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SINGAPORE—In a strategic move to strengthen its position in the global medical device market, Edwards Lifesciences has announced the acquisition of intellectual property and commercial rights to Genesis MedTech’s J-VALVE transcatheter aortic valve system. This acquisition highlights Edwards Lifesciences’ commitment to advancing cardiovascular care and underscores its ongoing expansion strategy.…
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has secured marketing approval from the National Medical Products Administration for its innovative RECATCHOR device. This anchored balloon dilation catheter is designed to facilitate the anchoring of guidewires and assist in the exchange…
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd. (HKG: 2291) has announced that it has received a medical device license from China’s National Medical Products Administration (NMPA) for its innovative MemoSORB biodegradable atrial septal defect occluder. This cutting-edge device offers significant advantages over traditional nitinol occluders by markedly reducing inflammatory responses,…
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Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in China’s medical device sector, has secured marketing approvals in Morocco for its NC Rockstar non-compliant coronary artery balloon dilation catheter and the HT Supreme drug-eluting stent system. The NC Rockstar catheter is designed for balloon dilation of autologous coronary…
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Shanghai Artech Medical Technology Co., Ltd., a company known for its innovation in the medical device sector, has received marketing approval from China’s National Medical Products Administration (NMPA) for its balloon cryoablation catheter, a groundbreaking product designed for the treatment of paroxysmal atrial fibrillation. This novel device marks a significant…
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, in collaboration with Sanegene Bio USA Inc., has announced the dosing of the first patient in a Phase I First-in-Human (FIH) clinical trial for their siRNA drug candidate, IBI3016. This investigational therapy targets angiotensinogen (AGT) and is being…
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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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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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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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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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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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China-based Peijia Medical Ltd (HKG: 9996) has announced that its US-based partner JenaValve Technology Inc. will be acquired by Edwards Lifesciences Corporation through a merger agreement. This strategic acquisition comes as part of Edwards Lifesciences’ efforts to strengthen its structural heart portfolio. JenaValve had entered into a licensing agreement with…
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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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Rona Therapeutics, a Shanghai-based nucleic acid drug developer, has secured USD 35 million in a Series A+ financing round led by LongRiver Investments. The funding round also saw participation from Zhaode Investment, Zhongqi Capital, BioTrack Capital, and Lilly Asia Ventures. The company plans to utilize the proceeds to accelerate its…
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Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ⁹⁹ᵐTc tetrofosmin, a SPECT myocardial perfusion imaging agent. This radiopharmaceutical drug, which is utilized for myocardial perfusion imaging in…
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading manufacturer of structural heart disease devices headquartered in Ningbo, has announced the six-month follow-up results from the multi-center TRAVEL II study for its transjugular tricuspid valve replacement product, LuX-Valve Plus. The TRAVEL II study, a prospective, multi-center, single-arm clinical trial, was designed…
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading Chinese medical technology company, has declared its intention for its wholly-owned subsidiary, MicroPort Endovastec B.V., to acquire a controlling 72.37% stake in Optimum Medical Device Inc. (OMD) for a transaction valued at USD 65 million. Following the completion of this…
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
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Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary ZYLOX Unicorn vascular stapler, marking the first approval of its kind in China. The…
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its disposable coronary intravascular impact waveguide, SoniCracker CL. This product is designed to be used in conjunction with the company’s proprietary coronary intravascular shock wave therapy…
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Boston Scientific Corporation (NYSE: BSX), a leading medical device manufacturer in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Agent paclitaxel coated PTCA balloon catheter (AGENT DCB). This product is designed for the treatment of coronary in-stent restenosis (ISR)…
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The China National Intellectual Property Administration (CNIPA) has announced a pivotal decision concerning the patent status of Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor co-developed by Bristol-Myers Squibb and AstraZeneca. The patent (ZL202011290859.2) related to heart failure has been completely invalidated, while the chronic kidney disease patent (ZL202210071080.4) remains intact.…
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Lifetech Scientific Corporation (HKG: 1302), a biopharmaceutical company based in China, has announced the completion of the one-year follow-up of its Phase II clinical study for the IBS absorbable drug-eluting coronary stent system. The results were initially published at the EuroPCR 2024. The prospective, multi-center, single-blinded, random-controlled Phase II study,…
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has received Breakthrough Devices status from the US Food and Drug Administration (FDA) for its AltaValve transcatheter mitral valve replacement device. This product, co-developed with…
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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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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its transcatheter tricuspid valve replacement system, LuX-Valve, did not pass the approval review by China’s Center for Medical Device Evaluation (CDME). The LuX-Valve, which was granted innovative medical device status in China in 2019 and…
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Bayer AG (ETR: BAYN, FRA: BAYN, OTCMKTS: BAYRY), a multinational pharmaceutical and life sciences company based in Germany, recently had its CEO, Bill Anderson, accompany German Chancellor Olaf Scholz on a high-profile visit to China. In a brief interview with Xinhua, Anderson emphasized Bayer’s dedication to developing innovative drugs and…
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Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III trial, highlighting the efficacy of its anticoagulant Xarelto (rivaroxaban) in reducing the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) or rehospitalization in adult patients with nonvalvular atrial fibrillation (AF)…
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Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has announced the acquisition of Shockwave Medical (NASDAQ: SWAV), a specialist in cardiovascular diseases, in a deal valued at approximately USD 13.1 billion. The acquisition, which is expected to close by mid-year 2024, will bring Shockwave’s innovative technologies into J&J’s medical technology…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented compelling real-world data for its innovative small interfering RNA (siRNA) therapy, Leqvio (inclisiran), which is used for the treatment of atherosclerotic cardiovascular disease (ASCVD) in patients who have not responded well to statins. The data, unveiled last week, demonstrated that the early…
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for two of its innovative products: the coronary hypertension balloon dilation catheter wing extension and the microcatheter Vericor-RS. The coronary…
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Denmark-based Novo Nordisk (CPH: NOVO-B) has announced a significant agreement to acquire Germany’s Cardior, a leading expert in RNA biology focused on the prevention, repair, and reversal of cardiovascular diseases (CVDs). The deal, valued at EUR 1.025 billion, which includes upfront and milestone payments, is anticipated to finalize in the…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received marketing approvals from South Korean regulatory authorities for three of its cardiovascular products: the HT Supreme drug-eluting stent, the NC ROCKSTAR non-compliant balloon dilation catheter, and the SC HONKYTONK coronary balloon…
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Microenergy Medical Technology Co., Ltd, a Hangzhou-based manufacturer of active intervention medical devices, has reportedly secured “tens of millions” of renminbi in a pre-Series A financing round. The funding was led by TigerYeah Capital, with contributions from TriWise Capital and HUAGAI Capital. Established in 2021, Microenergy Medtech has a presence…
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Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct the Phase III ACACIA-HCM study for its drug aficamten (CK-3773274) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development…
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The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to Novo Nordisk (NYSE: NVO) for its GLP-1 receptor agonist Wegovy (semaglutide), allowing it to be used for the reduction of major adverse cardiovascular events (MACE) in overweight or obese adults with established cardiovascular disease (CVD).…
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has announced a series of licensing and investment agreements with U.S. device manufacturer Avinger. The partnership aims to expand Zylox-Tonbridge’s portfolio of peripheral vascular intervention devices. According to the agreement, Zylox-Tonbridge will secure exclusive rights…
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Sino Medical Sciences Technology Inc., (SHA: 688108) a Chinese medical device company, has announced that it has received marketing approvals in Pakistan for two of its cardiovascular products: the SC HONKYTONK coronary balloon dilation catheter and the NC ROCKSTAR non-compliant balloon dilation catheter. These approvals mark a further expansion into…
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Hangzhou Kang Ming Information Technology Co., Ltd, (HKG: 9955) trading under the moniker “ClouDr”, has entered into a partnership with CR Sanjiu (SHE: 000999), a state-owned pharmaceutical company specializing in treatments for cardiovascular and cerebrovascular diseases and endocrine disorders. Under this strategic alliance, ClouDr will serve as the general agent…
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California-based biotechnology company Bitterroot Bio has announced the signing of a multi-year research collaboration agreement with China’s Biotheus Inc. The partnership aims to explore the development of innovative drugs that modulate the immune system and inflammatory responses, with a specific focus on targeting cardiovascular diseases (CVDs). By combining Bitterroot’s knowledge…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received marketing approval in Hong Kong for its HT Supreme drug-eluting stent system. The system is now approved for use in symptomatic heart disease patients to improve the coronary artery lumen diameter caused…
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HitGen Inc., (SHA: 688222) a China-based pharmaceutical company, has announced that the Investigational New Drug (IND) filing for its Lipisense (A24110He for injection) has received approval from China’s Center for Drug Evaluation (CDE). Lipisense, an innovative antisense oligonucleotide (ASO) drug originally developed by Swiss firm Lipigon Pharmaceuticals AB, is designed…
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, China, has announced the successful completion of the first clinical implantation surgery using its transjugular tricuspid valve replacement product, LuX-Valve Plus, in Brazil. This milestone marks a significant advancement for the company in the…
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US pharmaceutical company Viatris (NASDAQ: VTRS) has entered into a licensing agreement with Swiss drugmaker Idorsia (SWX: IDIA), in-licensing two late-stage programs with the option to add two more innovative assets in the future. Viatris will pay Idorsia an upfront fee of USD 350 million, along with potential milestone payments…
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MicroPort Scientific Corp. (HKG: 0853), a leading Shanghai-based medical device company, has announced that its France-based subsidiary MicroPort Cardiac Rhythm Management Limited (MicroPort CRM) has received a market license from the National Medical Products Administration (NMPA) for its next-generation intravenous magnetic resonance conditionally safe implantable cardiac pacing system. The product…
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Mindray (SHE: 300760), a leading China-based medtech firm, has announced plans to acquire a 21.12% stake in APT Medical Inc., a Shenzhen-based specialist in cardiac electrophysiology that went public on Shanghai’s STAR market in 2021. The acquisition will cost Mindray approximately RMB 6.652 billion (USD 926.6 million). Additionally, Mindray will…
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Apeloa Pharmaceutical Co., Ltd (SHE: 000739), a China-based pharmaceutical company, has announced the termination of a Phase III clinical study for its salfaprodil injection, which is being developed as a treatment for acute ischemic stroke. Salfaprodil is a novel NMDA receptor antagonist. According to the public data, Apeloa first filed…
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading Chinese provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its self-developed coronary mastoid balloon dilation catheter. The device, classified as a Category III medical device, is indicated for balloon dilation in…
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Lee’s Pharmaceutical Ltd (HKG: 0950) has entered into a licensing agreement with US-based Windtree Therapeutics Inc., (NASDAQ: WINT) to develop and commercialize multiple cardiovascular disease (CVD) treatments in the Greater China region. The agreement includes the development of istaroxime, a Phase III-ready, first-in-class dual-mechanism SERCA2a activator for acute heart failure…
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Abbott (NYSE: ABT) has announced that the first patients have been treated with its Volt pulsed field ablation (PFA) system as part of a clinical study in Australia. The study is designed to evaluate the safety and effectiveness of the device in treating common cardiac arrhythmias such as atrial fibrillation…
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Tasly Pharmaceuticals (SHA: 600535), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its human umbilical cord mesenchymal stem cell injection, B2278. The study aims to evaluate the efficacy of this therapy…
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced its intention to acquire a 63% stake in Chongqing Duoputai Pharmaceutical Co., Ltd for RMB 442 million (approximately USD 62 million). This acquisition will elevate CGP Pharma’s ownership in Duoputai to 90%, granting the company full control over…
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Cytokinetics (NASDAQ: CYTK), a specialist in cardiovascular diseases, is reportedly attracting interest from multiple Big Pharma companies keen on its promising pipeline in cardiovascular and neuromuscular diseases. Sources indicate that Novartis (NYSE: NVS) was initially leading the charge against competitors AstraZeneca (AZ, NASDAQ: AZN) and Johnson & Johnson (J&J, NYSE:…
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy (oHCM) has been treated using its drug mavacamten at Ruijin Hospital’s Hainan branch. Mavacamten, the world’s first cardiac myosin inhibitor, received approval from the Hainan Medical Products Administration for special entry into the Hainan Bo’ao…
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a China-based provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary disposable coronary intravascular impact waveguide tube. This Category III device is now authorized for use in the pre-treatment and balloon dilation…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical device company, has announced that it has received market approval in Bangladesh for its HT Supreme drug-eluting stent system. The system is designed to improve the diameter of the coronary artery lumen in patients with symptomatic heart disease caused by…
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Bayer AG (ETR: BAYN, OTCMKTS: BAYRY), a leading German pharmaceutical company, has announced a long-term collaboration with Jixing Pharmaceuticals, a China-based firm, following its leadership in a Series D financing round. The investment is being made in conjunction with RTW Investments, the fund that established and supported Jixing. Bayer’s venture…
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Jiangsu Vcare PharmaTech Co., Ltd, a Chinese pharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its vicagrel, a P2Y12 receptor antagonist. The drug is proposed for the treatment of acute coronary syndrome (ACS), ischemic stroke, and thrombotic cardiovascular and diagnosed…
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Daiichi Sankyo (TYO: 4568)’s European subsidiary, a Japanese pharmaceutical company, has entered into a collaboration amendment agreement with US-based Esperion Therapeutics (NASDAQ: ESPR) concerning Esperion’s antilipidemic drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid + ezetimibe). The revised agreement stipulates that Esperion will receive an immediate payment of USD 100…
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced that a conditional agreement has been reached to acquire a 51% stake in fellow Chinese firm La Ronda for a cash consideration of RMB 141 million (USD 20 million). La Ronda, based…
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical device company, has announced that it has received market approvals in Taiwan, India, and Uzbekistan for its SC HONKYTONK coronary artery balloon dilation catheter, NC Rockstar non-compliant coronary artery balloon dilation catheter, and HT Supreme drug-eluting stent system. The NC…
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China-based Innovent Biologics (HKG: 1801) has entered into a partnership with Sanegene Bio USA Inc. to co-develop the small interfering RNA (siRNA) candidate drug SGB-3908 for the treatment of hypertension. Innovent Biologics has secured the exclusive option to license global development, manufacturing, and commercialization rights for the drug. Upon the…
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Nanjing F&S Pharmatech Co., Ltd has officially launched its generic version of Novartis’s heart failure therapy Entresto (sacubitril, valsartan) in China, with exclusive commercialization rights held by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196). Entresto, a breakthrough treatment for chronic heart failure, was first approved in China in 2017…
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Kossel Medtech (Suzhou) Co., Ltd., a company specializing in coronary and peripheral intervention medical devices, electrophysiology series products, and related accessories, has reportedly secured over RMB 100 million (USD 14 million) in a Series B funding round. The round was led by Fortune Capital, with additional investments from SIDVC, SND,…
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its R-ONE vascular intervention surgical robot. The robot was introduced by Cathbot, a joint venture between MicroPort and French firm Robocath S.A.S in China. R-ONE, a…
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two of its medical devices in Hong Kong, China, and Malaysia. The NC Rockstar non compliant coronary artery balloon dilation catheter has been approved in Hong Kong and China, while the HT Supreme drug eluting stent…
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Cryofocus Biotechnology Co., Ltd (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for all components of its cardiac cryoablation system. The approvals include the cryoablation equipment, balloon type cryoablation catheter (previously known as the atrial…
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Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance. The…
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The National Medical Products Administration (NMPA) has granted market approval to TINGSN Technology, a China-based firm, for its disposable intracardiac ultrasound diagnostic catheter. This approval is the 239th for an official innovative medical device by the NMPA. The product comprises a catheter body, an operating handle, and a connector, and…
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Jenscare Scientific Co., Ltd. (HKG: 9877), a Ningbo-based manufacturer of devices for structural heart disease, has released promising one-year results from a confirmatory study of its transcatheter tricuspid valve replacement system, LuX-Valve. The prospective, multi-center, single-arm study aimed to evaluate the safety and efficacy of the LuX-Valve in patients suffering…
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Germany-headquartered Bayer (ETR: BAYN) announced the termination of a late-stage trial for its antithrombotic candidate asundexian. Asundexian, once considered a potential blockbuster, was outperformed by the standard of care in preventing stroke and systemic embolism in patients with atrial fibrillation, the most lucrative indication for the drug, with an estimated…
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China-based Venus Medtech (Hangzhou) Inc., (HKG: 2500), has entered into a strategic partnership with Valgen Holding Corporation concerning Valgen’s DragonFly transcatheter mitral valve clamp system (DF). The financial terms of the agreement have not been disclosed. Commercial Collaboration and Market ExpansionUpon obtaining market approval for the DragonFly system, the two…
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China’s Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for a transcatheter aortic valve system for review. Product Features and Clinical ApplicationsThe product is designed for patients with severe aortic valve stenosis who are at…
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Sino Medical Sciences Technology Inc., (SHA: 688108) a leading China-based medical device company, has announced that its HT Supreme drug-eluting stent system has received market approval in Brazil. This system is designed to improve the diameter of the coronary artery lumen in patients suffering from symptomatic heart disease caused by…
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The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Vascepa (icosapent ethyl) for review. The drug is targeted for the prevention and reduction of cardiovascular event risks in adult patients with hypertriglyceridemia who are diagnosed with cardiovascular…
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Hansoh Pharmaceutical (HKG: 3692) has announced that its affiliated company’s self-developed Class 1 new drug, HS-10511 tablets, have received approval for clinical trials from the National Drug Administration. The drug is intended for the treatment of hypertrophic cardiomyopathy, a condition that requires significant medical innovation. Clinical Trial Approval and IndicationThe…
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Novo Nordisk (CPH: NOVO-B), a leading pharmaceutical company, last week announced a substantial plan to invest over DKK 42 billion (USD 6.0 billion) into expanding its production capacity for serious chronic diseases in Denmark. This significant investment underscores the company’s commitment to addressing the growing needs of patients with chronic…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for its HT Supreme drug-eluting stent system. This significant milestone marks the company’s expansion into the Taiwan market with a cutting-edge drug-device…
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer based in Ningbo, has announced that its regulatory filing for the transcatheter artificial aortic valve system, Ken Valve, has been accepted into the priority review process by the National Medical Products Administration (NMPA). This marks a significant…
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of seven clinical implantations of its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty. The surgeries were performed in Denmark and Ireland, with all patients recovering well post-operation.…
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Bristol-Myers Squibb (BMS; NYSE: BMY) is set to regain full control of mavacamten, a treatment for hypertrophic cardiomyopathy (HCM), from China’s LianBio (NASDAQ: LIAN) in China and other Asian markets. This strategic move follows LianBio’s previous acquisition of development rights for mavacamten in Greater China, Singapore, and Thailand from MyoKardia…
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading device maker specializing in structural heart disease solutions, has announced the successful completion of a series of paid compassionate use cases for its innovative transjugular tricuspid valve replacement product, LuX-Valve Plus, across multiple hospitals in the Asia-Pacific region. Clinical Success and Industry…
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its in-house developed semi-automatic external defibrillator. This approval marks a significant milestone in expanding Lepu’s portfolio of life-saving medical devices. The…
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) announced a significant deal this week, valued at up to USD 1.3 billion, for the acquisition of the potential best-in-class antihypertensive drug ocedurenone from Singapore’s KBP Biosciences. The transaction, anticipated to close by the end of the year, is subject to meeting customary…
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has decided to discontinue a Phase III global study evaluating the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The decision was recommended by an…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading medical device company based in China, announced that its HT Supreme drug-eluting stent system has been included in the reimbursement drug list (RDL) in France, effective as of October 4, 2023. This inclusion marks a significant milestone for the company’s efforts…
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Global healthcare company Novo Nordisk (NYSE: NVO) and drug discovery alliance Evotec (NASDAQ: EVO) have jointly launched LAB eN², a drug discovery accelerator dedicated to translating academic research into innovative therapeutics for cardiometabolic conditions, rare blood diseases, and rare endocrine disorders. This initiative marks a significant step in bridging the…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received market approval for its HT Supreme drug-eluting stent system from the Ministry of Health in Turkey. This approval marks a significant expansion of the product’s reach and is set to benefit…
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MitrAssist Lifesciences Ltd, a Shanghai-based innovator in cardiovascular device manufacturing, has reportedly raised nearly USD 100 million in a Series C financing round. The funding was led by Centurium Capital and 6 Dimensions Capital, with contributions from Shanghai Jiading Industrial Development Group, Shanghai Jiajia Group, Hefei Haiheng Holdings, Hefei Industrial…
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has announced a strategic partnership with US company Valo Health. The collaboration aims to leverage Valo Health’s patient genetic database, artificial intelligence (AI) capabilities, and tissue modelling platform for the target identification, discovery, and development of novel treatments for cardiometabolic diseases. Additionally, Novo…
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Lepu ScienTech Medical Technology (Shanghai) Co., Ltd, (HKG: 2291) a China-based medical technology company, has released its 2023 interim report, showcasing significant financial growth. The company reported revenues of RMB 165.9 million, marking a 33.0% increase year-on-year (YOY). Net profits also saw a substantial rise, surging by 213.7% YOY to…
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its in-house developed transcatheter tricuspid valve replacement system product has been included in the Total Product Life Cycle Advisory Program (TAP) of the US FDA. The program’s objective is to ensure that US patients have…