Two Class 1 Innovative Drugs and Six Innovative Medical Devices Approved in China in April 2024: Companies File IPO Prospectuses

　　【Pharmaceutical Network Product InformationAccording to the review, in April 2024, two Class 1 innovative drugs and several innovative medical device products were approved for marketing in China. The two Class 1 innovative drugs are Entisitib tablets and Ipkaplan hydrochloride capsules.
 

According to the news released by the National Medical Products Administration on April 30, Yiteng Pharmaceutical (Thaizhou) Co., Ltd.'s Class 1 innovative drug Entinostat Tablets (trade name: Jingzhuda) and Novartis Pharma Schweiz AG's Class 1 innovative drug Iptacopan Hydrochloride Capsules have been approved for marketing.
 

Data show that Entinostat Tablets from Yiteng Pharmaceutical (Thaizhou) Co., Ltd. is a histone deacetylase (HDAC) inhibitor, which can selectively inhibit Class I and IV HDACs, suppress cell proliferation, promote terminal differentiation and/or induce apoptosis, exerting an anti-tumor effect. This drug, in combination with aromatase inhibitors, is used to treat patients with locally advanced or metastatic breast cancer that is hormone receptor (HR) positive, human epidermal growth factor receptor-2 (HER-2) negative, and has recurred or progressed after endocrine therapy.
 

Iptacopan Hydrochloride Capsules are indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy. Data show that iptacopan hydrochloride binds to factor B (FB) in the alternative complement pathway, modulating C3 cleavage, downstream effector production, and terminal pathway amplification, controlling extravascular hemolysis mediated by C3b and intravascular hemolysis mediated by the terminal complement. The approval of this product provides a new treatment option for adult patients with paroxysmal nocturnal hemoglobinuria.
 

In terms of medical devices, six innovative products have been approved for marketing in China. These include Medtronic's "Disposable Multi-Pole Renal Artery Radiofrequency Ablation Catheter" and "Renal Artery Radiofrequency Ablation Instrument," magAssist's "Extracorporeal Ventricular Assist Device" and "Extracorporeal Ventricular Assist Pump Head and Tubing," Jiangsu XianSiDa Biotechnology Co., Ltd.'s "Oligosaccharide Chain Detection Kit (Fluorescent Capillary Electrophoresis Method)," and Jiangsu JingCe Medical Technology Co., Ltd.'s "Combined Blood Glucose Meter."
 

Data shows that the Medtronic disposable multi-polar renal artery radiofrequency ablation catheter consists of an electrode array, catheter, catheter handle, catheter connection cable, and straightening tool. The renal artery radiofrequency ablation generator is composed of a generator, remote control, power cord, and DVI-D cable. These two products are used together, with the radiofrequency ablation generator transmitting radiofrequency energy through the catheter electrodes to the intima of the renal artery. Using thermal effects generated by electric current, it deactivates the sympathetic nerves surrounding the renal artery, blocking the transmission of sympathetic nerve excitement to achieve the purpose of lowering the patient's blood pressure. This product lowers blood pressure by physically interrupting the transmission of sympathetic nerve excitement, which, compared to traditional drug treatments, effectively avoids issues related to patient compliance and drug half-life, providing a new auxiliary treatment option for patients with resistant hypertension.
 

magAssist Extracorporeal Ventricular Assist Device consists of a magnetically levitated motor, control unit, and accessories. The extracorporeal ventricular assist pump head and tubing are...Centrifugal PumpComposed of pump head, side hole straight connector, Luer cap, tube clamp, and cable tie. The two products are used in conjunction to form a bypass circuit connected to blood vessels. By controlling the main unit and utilizing a magnetic levitation motor to drive the impeller inside the pump head to rotate in a suspended state, it provides kinetic energy for blood pressurization, serving as temporary extracorporeal mechanical circulatory support for patients after heart surgery. This product adopts full magnetic levitation blood pump technology, featuring anti-vibration, anti-torsion, and improved blood flow field design, effectively reducing the average incidence rate of blood compatibility-related complications.
 

The "Oligosaccharide Chain Detection Kit (Fluorescent Capillary Electrophoresis Method)" developed by Sinotech Biomedical is a self-developed product in China. It uses capillary electrophoresis to qualitatively detect nine oligosaccharide chains in human serum samples, serving as an auxiliary diagnostic tool for primary hepatocellular carcinoma in patients with hepatitis B cirrhosis. This product facilitates the prevention and treatment of primary hepatocellular carcinoma through non-invasive testing methods.
 

Jingce Medical's "Combined Blood Glucose Meter" consists of an invasive blood glucose detection module, a non-invasive blood glucose detection module, a metabolic heat probe, an environmental temperature and humidity monitoring module, and a display screen. As a supplement to existing fingertip blood glucose monitoring, it is suitable for daily self-blood glucose monitoring by patients with type 2 diabetes. The product estimates blood glucose concentration through non-invasive detection of metabolic heat levels. Diabetic patients can achieve the purpose of blood glucose measurement by measuring the dynamic characteristics of deep oral temperature, which helps to reduce patient discomfort and lower measurement costs.
 

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