Neuracle
Developer and Manufacturer of Brain-Computer Interface Systems and Related Equipment
As of mid-2026, Pudong’s innovative drugs and medical devices have delivered impressive results. Since the beginning of this year, a total of two Class 1 innovative drugs and 14 Class III innovative medical devices have been approved for marketing in Pudong. Among them,The number of approved Class III innovative medical devices has doubled compared to last year.。
From the world’s first CAR-T therapy for solid tumors to the world’s first invasive brain-computer interface, “3F” innovative products—First-in-Class, First-in-China, and First-in-Human—are continuously emerging in Pudong, accelerating China’s leap from “following” to “leading” in the frontier fields of biopharmaceuticals.
Two “World Firsts”: Frontier Industries Accelerate Their Rise in Pudong
In the "deep-water zones" of biomedicine, such as cell and gene therapy and brain-computer interfaces, Pudong's frontier biotechnology sector has been reaping abundant achievements.
In recent years, Pudong has repeatedly achieved milestone breakthroughs in the field of cell and gene therapy. Tumors are mainly divided into two categories: hematologic malignancies and solid tumors, with solid tumors accounting for more than 90%. Previously marketed CAR-T products have all targeted hematologic malignancies.
(Image source: Shanghai Science and Technology)
June 22,Kaixing LifeShuruijiaolunsa Injection Approved for Marketing. This is the world’s first CAR-T cell therapy product approved for the treatment of solid tumors, breaking the previous limitation that CAR-T therapies were only applicable to hematologic malignancies.This product is indicated for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2-positive and human epidermal growth factor receptor 2 (HER2)-negative, in patients who have failed at least two prior lines of therapy.
With the approval of Shuruiji Aolun Sai Injection, Pudong now has five CAR-T products on the market, accounting for nearly one-quarter of the global total; furthermore, in the fields of immune cell therapy, stem cell therapy, and gene therapy,PudongMultiple pipelines are also at a leading stage domestically and even internationally, with the industrial cluster effect becoming increasingly prominent.
In the field of brain-computer interfaces, Pudong is also accelerating the commercialization of products, achieving a complete closed loop from technical feasibility to clinical accessibility.
(Image source: Neuracle)
March 13,NeuracleThe implantable brain-computer interface (BCI) system for compensating hand motor function has been approved for market launch, becoming the world’s first invasive BCI medical device to receive marketing authorization. This product is indicated for patients aged 18 to 60 years with quadriplegia and an inability to perform finger grasping movements due to cervical spinal cord injury. By implanting a minimally invasive device the size of a coin, the system can real-time acquire and decode the patient’s electroencephalogram (EEG) signals,Enables patients to control a pneumatic glove via brain意念, allowing them to perform actions such as grasping, picking up objects, and drinking water.
Brain-computer interfaces are at the forefront of global technological competition. The approval and market launch of China’s independently developed product not only demonstrate China’s innovative capabilities in the field of neural engineering but also secure a strategic advantage in capturing the high ground of future industries. Furthermore,Neuracle’s IPO application for the STAR Market has also been accepted by the Shanghai Stock Exchange, with planned fundraising of RMB 2.5 billion for capacity expansion and subsequent research and development.
High-End Medical Devices Successively Approved, Accelerating Leadership in Key Niche Segments
The successive approvals of the world’s first products underscore Pudong’s emergence as a hub and “powerful magnet” for related industries. In the medical device sector, Pudong now covers six key advantageous sub-segments, with passive implantable and interventional devices, active implantable devices, and in vitro diagnostic reagents continuing to lead, while brain-computer interfaces, medical robots, and radiofrequency ablation devices are rapidly solidifying their leading positions.
Since the beginning of this year, 14 Class III innovative medical devices have been approved in Pudong, covering multiple high-barrier fields such as neurointervention, structural heart disease, electrophysiology, and peripheral vascular intervention.
(Image source: Shenqi Medical)
(Image source: NMPA official website)
● In the field of structural heart disease,Shenqi Medicaltranscatheter mitral valve clip system andYingmai MedicalThe successive approvals of transcatheter mitral valve clip systems have provided more minimally invasive treatment options for patients with moderate-to-severe mitral regurgitation who are at high surgical risk. The consecutive approvals of two similar products reflect the booming field of interventional therapy for structural heart disease and demonstrate the innovation capabilities of Zhangjiang Pharma Valley in this area.
Piezoelectric Intravascular Ultrasound Therapy System for Coronary Arteries
(Image source: MicroPort)
● In the field of coronary intervention,Minimally Invasive MelodyofIntravascular Ultrasound Therapy Device, Disposable Coronary Intravascular Ultrasound Guidewire, forming a complete intravascular ultrasound (IVUS) diagnostic and therapeutic solution for coronary arteries, marking a critical step forward for China in the development of integrated equipment for precise interventional diagnosis and treatment.
(Image source: Weimi Medical)
(Image source: MicroPort Endovascular, Xuanyu Medical)
● In the fields of neurointerventional and peripheral vascular interventional procedures,Weimi Medicalself-expanding intrasaccular aneurysm embolization device,Blue Vein Medicala single-use thrombectomy device,Xuanyu Medicaladjustable curved pulmonary artery embolectomy stent systems and other products have been successively launched, filling multiple clinical gaps in China.
Furthermore,MicroPort EPa single-use intracardiac echocardiography imaging catheter,FengkailiInterventional Left Ventricular Assist Device, Interventional Left Ventricular Assist Catheter Pump Kit, then inPrecision Electrophysiological Navigation and Interventional Therapy for Heart Failureachieved a major breakthrough in the field.
Institutional Empowerment: Driving the Implementation of Innovative Achievements to Benefit the Public
As products hailed as the “world’s first,” “China’s first,” “latest breakthroughs,” and “authoritatively recommended” have successively emerged in Pudong, the district has established a closed-loop system driven by institutional innovation, supported by clinical resources, and bonded by ecological synergy. This system accelerates the translation of innovative achievements, facilitates the inclusion of innovative drugs and medical devices in reimbursement catalogs and hospital formularies, and enables products to truly move from the laboratory to the market, thereby ensuring that innovative outcomes are implemented to benefit the public.
February 2026,3SBioSelf-developed IL-17A inhibitor Anmuqita monoclonal antibody approved for market launch, providing a novel treatment option for patients with moderate-to-severe psoriasis that combines "potent and durable efficacy, rapid onset of action, low immunogenicity, and convenient administration."
3SBio revealed that, following the approval and market launch of the new drug, relevant functional departments such as the Pudong New Area Health Commission immediately engaged with the company to include the product in the “Pudong New Area Recommended Catalog of Innovative Drugs and Medical Devices,” thereby accelerating its adoption into hospitals and clinical practice.
SynFlow® 3.0 System
(Image source: VBData)
FengkailiSelf-developedInterventional Left Ventricular Assist Device, Interventional Left Ventricular Assist Catheter Pump KitShortly after approval, it was also included in the “Pudong New Area Recommended Catalog of Innovative Drugs and Medical Devices” (2026, Second Batch).
Beyond the Innovation Catalog, Pudong is also actively building the “Pudong New Area Medical-Industrial Integration Innovation Source Platform,” integrating information from medical institutions, enterprises, and researchers to facilitate precise matchmaking between healthcare providers and companies. By regularly organizing medical-enterprise exchange and matchmaking events, as well as innovative drug promotion conferences, it establishes a tripartite linkage platform involving the government, hospitals, and enterprises. This helps pharmaceutical companies showcase the clinical advantages of their innovative drugs, enables hospitals to promptly access new drug information, reduces information asymmetry, and supports products in transitioning from “market approval” to hospital adoption for patient benefit, and from “laboratory breakthroughs” to “market success.”
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