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Two innovative medical devices from Medtronic have been approved for market in China

Recently, the National Medical Products Administration announced the approval of Medtronic’s registration applications for two innovative products, the “Heart Pulse Electric Field Ablation Generator” and the “Disposable Heart Pulse Electric Field Ablation Catheter”. Unique advantages, suitable for two indications It is reported that the two innovative products approved this time are Medtronic’s PFA product – PulseSelect, which is the first PFA product approved by NMPA that can be used for both paroxysmal and persistent atrial fibrillation. PulseSelect is a new technique for treating atrial fibrillation (AF) using pulsed electric fields, which can provide bipolar and biphasic pulsed electric fields through a circular multi electrode array catheter. This technology consists of five parts: a controllable multi electrode annular ablation catheter, a PFA host ECG-Gated、 Tableside control、10Fr bidirectional sheath. It is worth mentioning that PulseSelect’s controllable multi electrode annular ablation catheter features a proprietary biphasic waveform, unique built-in guide wire, and a ...
- Source: drugdu
- 117
- September 13, 2024
Baiaotai and Boheng published TOFIDENCE (a reference to Yamero) in the journal “Arthritis Research and Treatment” ® Phase III clinical data of biosimilars developed with tocilizumab

Baiaotai Biopharmaceutical Co., Ltd. (stock code: 688177) is a global biopharmaceutical enterprise based on science and innovation located in Guangzhou, China, hereinafter referred to as “Baiaotai” or “the Company”. The company announced today that the article “Evaluating the Phase 3 Clinical Study of BAT1806/BIIB800 during the Second Treatment Phase (TP2, Weeks 24-48)” co authored with Bojian has been published in the Arthritis Research&Therapy journal. BAT1806/BIIB800 is a product developed by BioNTech and referenced by Yamero ® The biosimilar drug developed with tocilizumab has been launched in Europe and America under the brand name TOFIDENCE ™. In a phase 3 clinical study, rheumatoid arthritis patients with insufficient response to methotrexate were randomly assigned to three treatment groups in a 1:1:2 ratio: (1) using the original drug for intravenous injection of 8mg/kg every 4 weeks until week 48; (2) Treat with the original drug until week 24, then switch to using BAT1806/BIIB800 ...
- Source: drugdu
- 80
- September 13, 2024
Yingsi Intelligence has discovered an AI driven WRN inhibitor that targets highly microsatellite unstable cancer

WRN has been identified as a synthetic lethal target in highly microsatellite unstable (MSI-H) cancer cells, with therapeutic potential for MSI-H tumor patients who do not respond to existing therapies. The innovative module Alchemisty under Yingsi Intelligent Chemistry42 utilizes non-equilibrium switching method to accurately and quickly estimate the binding free energy of protein ligand complexes, simplifying and accelerating the optimization process of ISM2196. In preclinical studies, ISM2196 has demonstrated strong in vivo anti-tumor efficacy in various MSI-H cancer models, with good selectivity, safety, and ADMET (absorption, distribution, metabolism, excretion, and toxicity) characteristics. Yingsi Intelligent, a clinical stage biopharmaceutical technology company driven by generative artificial intelligence (AI), announced the nomination of preclinical candidate drug ISM2196, a potential “best in class” WRN inhibitor discovered by AI, aimed at treating advanced metastatic microsatellite instability (MSI) cancer through synthetic lethal strategies. The DNA helicase Werner (WRN) is a member of the RecQ helicase family ...
- Source: drugdu
- 77
- September 13, 2024
【EXPERT Q&A】What certification is required for medical device export clearance to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States for customs clearance involves fulfilling a series of certifications and requirements, primarily encompassing the following aspects: Ⅰ. FDA Registration and Certification FDA Registration: Manufacturers or exporters need to register with the Food and Drug Administration (FDA) in the United States to legally sell medical devices in the American market. This process is typically completed through FDA’s Electronic Registration System (FURLS). 510(k) Premarket Notification: For medical devices classified as “Class II” (Premarket Notification), a 510(k) submission is generally required. This application demonstrates that the device is technologically similar to a legally marketed device and meets FDA requirements. The review period typically takes 90 days. PMA Application: For high-risk medical devices classified as “Class III” (Premarket Approval), a PMA (Premarket Approval Application) may be necessary. This is a more rigorous application requiring substantial clinical data and evidence to prove the safety and ...
- Source: drugdu
- 77
- September 13, 2024
Because of the “Lundy calcium” storm Zhendong Pharmaceutical was claimed more than 1.4 billion yuan

Recently, Zhendong Pharmaceutical (300158.SZ) was once a partner in arbitration, the amount of claims reached 1.47 billion yuan, almost close to the company’s operating income in the first half of the year. September 9, Zhendong Pharmaceutical announcement shows that the company received on September 7, China International Economic and Trade Arbitration Commission issued the “DE20242588 commissioned production contract dispute arbitration notice”, Beijing Lundy Pharmaceuticals Co. (hereinafter referred to as “Lundy Pharmaceuticals”) filed an application for arbitration with the China International Economic and Trade Arbitration Commission in respect of the contract dispute between Lundy Pharmaceuticals and Zhendong Pharmaceuticals. After the announcement, September 10 to 11, Zhendong Pharmaceuticals shares fell more than 10%, closing price of 3.40 yuan / share on the 11th. Market on both sides of the arbitration situation is also quite concerned about the two sides of the disagreement related to the situation, the “China Business ...
- Source: https://finance.eastmoney.com/a/202409123181299525.html
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- September 12, 2024
R&D investment in the first half of the year is about 750 billion yuan listed companies become the main force of science and technology innovation

For some time now, the A-share market has been under continuous pressure due to complex internal and external market factors, making it difficult to give full play to resource allocation, value discovery, wealth management and investment functions. No matter how the market evolves and develops, it always has its own laws. Seeing history clearly will help us discover the future. At present, broaden the horizons, calm thinking, help to accurately grasp the historical orientation of the A-share market, see the stock market supply and demand relationship of the marginal improvement, waiting for the active market series of initiatives to accumulate thick into the momentum, landing effect. Recently, the Securities Times launched a series of reports, “Discover the value of A-share investment”, through in-depth interviews and data mining, multi-angle presentation of the A-share market is undergoing positive changes, in order to cohesion of consensus, boost confidence, and jointly promote the A-share ...
- Source: https://finance.eastmoney.com/a/202409123181302392.html
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- September 12, 2024
Ten measures are favorable for innovative medical devices

Recently, the Guangzhou Municipal Health Commission of Guangdong Province issued the “Ten Measures of the Guangzhou Municipal Health Commission to Support the High-quality Development of Innovative Drugs and Devices”, covering the entire process of product research and development-hospital use-payment expansion. The notice proposes to urge medical institutions to hold at least one working meeting of the medical device-related committee every quarter, and hold a meeting within one month after the publication of the “Guangzhou Innovative Drug and Device Product Catalog”, and promptly include innovative drugs and devices in the medical institution’s drug or device catalog as needed, so as to achieve “all-out allocation” and give priority to selection. Encourage qualified medical institutions to accelerate the application of innovative medical devices such as active surgical instruments, passive implantable devices, medical software, medical imaging, radiotherapy, surgical robots, etc., and orderly promote the iterative upgrade of medical institutions’ equipment and facilities. ...
- Source: https://mp.weixin.qq.com/
- 57
- September 12, 2024
The highest increase was 103398%! The revenue of these pharmaceutical companies soared

In September, the 2024 semi-annual reports of various companies have basically been disclosed. According to statistics from Cyber Blue, among the 493 A-share listed pharmaceutical companies (according to the industry classification of Tonghuashun, the same below), the number of companies with year-on-year decline and growth is close to “50-50” – 242 pharmaceutical companies have a year-on-year decline in revenue, accounting for 49% of the total; 252 have an increase in revenue, accounting for 51% of the total. Among the 242 pharmaceutical companies whose revenue decreased compared with the same period last year, 40% of them fell by less than 10%; there were 12 companies with a decline of more than 50%, of which the company with the largest decline had a year-on-year revenue decline of more than 97%. Among the 252 pharmaceutical companies with year-on-year revenue growth, 183 had an increase of less than 20%, accounting for ...
- Source: https://mp.weixin.qq.com/
- 75
- September 12, 2024
Nature Journal | Revealing the Cell Membrane Protein Interactions of Endogenous GLP-1 Receptors!

As a drug therapy target for obesity and type 2 diabetes, glucagon like peptide-1 receptor (GLP-1R) is widely distributed in many tissues and has cell type specific physiological functions. For example, GLP-1R mainly regulates insulin secretion and cell proliferation in pancreatic islets, and has functions such as appetite suppression, neuroprotection, and anti-inflammatory in the brain. Considering that the maturation, localization, activation, and endocytosis of receptors are all influenced by protein interactions, exploring the interactions between receptors and other membrane proteins on the cell surface can provide important clues for the study of the regulatory mechanism of GLP-1R. However, due to the low expression levels and transient and weak interactions of most membrane receptors, the study of the interaction between endogenous GLP-1R and cell membrane proteins requires the development of new research methods. On September 3, 2024, the iHuman Institute of ShanghaiTech University and the research group led by Shui Wenqing ...
- Source: drugdu
- 72
- September 12, 2024
Great earthquake! AlphaProteo breaks doubts! Will become a cancer killer! Leading the way in brand new protein design!

Heavy weight! DeepMind is scaling up again! AlphaFold dominates the field of protein prediction, and AlphaFold 3 breaks through its limitations by predicting all living molecules. When it was released, there were voices claiming that AlphaFold 3’s structured prediction and generation would accelerate the development of AI driven drug design. Now, DeepMind has scaled up its strategy by releasing AlphaProteo for the design of new proteins. AlphaProteo is the first AI system designed specifically for designing novel high-intensity protein conjugates, capable of generating conjugates of multiple target proteins. This system significantly improves the success rate, even 3 to 300 times stronger than existing methods. Especially for the VEGF-A protein related to cancer and diabetes complications, AlphaProteo is the first AI tool to design successful conjugates. In addition, it can effectively bind to various proteins related to infection, cancer, inflammation, and autoimmune diseases, such as BHRF1, SARS-CoV-2 spike protein, IL-7R α, ...
- Source: drugdu
- 100
- September 12, 2024

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