Zhangjiang's MedTech Surge: 10 Innovative Class III Devices Approved in Just Six Months, Surpassing All of 2025

(Source: Hello Zhangjiang)

In 2026, Zhangjiang Pharma Valley is witnessing an unprecedented surge in innovative achievements.

On June 1, the National Medical Products Administration approvedShanghai Xuanyu Medical Device Co., Ltd.Registration Application for the Innovative Product “Adjustable-Curvature Pulmonary Artery Embolectomy Stent System.” This is another Class III medical device approved for market launch in Zhangjiang Science City this year.Innovative MedicalDevice.

And this is not an isolated case. On April 22,Shenqi MedicalThe independently developed Qilin-M® Transcatheter Mitral Valve Clip System was approved for market launch; just one week later,EndovastecUnder the banner ofBluevascular MedicalThe Fishhawk® disposable thrombectomy device has been approved by the National Medical Products Administration. One targets structural heart disease, while the other enters the field of peripheral venous intervention; behind both products lie clinical areas characterized by high barriers and significant technical challenges.

More noteworthy is another set of data:Since the beginning of this year, a total of 13 Class III innovative medical devices have been approved for market launch in Shanghai, with 10 of them originating from Zhangjiang Science City, accounting for more than three-quarters of the total.To date, the number of innovative medical devices from Zhangjiang that have received approval has already surpassed the total for the entire previous year.

In less than half a year, the figure has surpassed the total for the entire previous year. This pace is making Zhangjiang one of the most concentrated and dynamic hubs for innovative medical devices in China.

Behind the “acceleration” lies not just isolated breakthroughs by individual companies, but an entire innovation ecosystem that is continuously unleashing its potential. R&D resources are converging here, approval processes are being expedited, and clinical translation is being streamlined. As a result, an increasing number of technologies that once remained confined to laboratories are now making their way into hospitals and reaching patients.

From "Untreatable" to "Treatable"

Innovation Begins to Transform Clinical Practice

The approval of Qilin-M® first addresses a long-standing clinical pain point.

The mitral valve is located between the left atrium and left ventricle of the heart, functioning as a "one-way valve." If it fails to close properly, blood will regurgitate, progressively increasing the burden on the heart. Many patients with moderate-to-severe mitral regurgitation experience shortness of breath after exertion and nocturnal dyspnea; in severe cases, this can even progress to heart failure.

The problem is that a significant proportion of these patients are elderly and suffer from multiple comorbidities, making them poorly tolerant of traditional open-chest surgery. "Wanting treatment but having no viable options" was once the harsh reality for many patients.

The significance of Qilin-M® lies inTransformed a treatment that originally required open-chest surgery into a minimally invasive interventional procedure.Without the need for thoracotomy, physicians can precisely deliver the mitral valve clip to the lesion site via a transvascular approach. The product features an independent leaflet capture design, and its delivery system offers multi-directional steerable deflection, allowing for more flexible adaptation to diverse patient-specific valvular anatomies, thereby enhancing clipping success rates and procedural safety. This represents not only a breakthrough for domestically produced high-end medical devices but also new therapeutic opportunities for a broader patient population.

Fishhawk®/Yuying®, approved for market launch a few days later, targets another high-risk disease—Deep Vein Thrombosis. Once a thrombus dislodges, it may trigger a fatal pulmonary embolism; complex thrombectomy has long remained a clinical challenge.

Fishhawk® employs anti-entanglement partition technology to isolate thrombi from transmission components, thereby reducing the risk of occlusion; its integrated, portable design facilitates broader adoption across hospitals at all levels. Underlying this is a transformation currently underway in China’s innovative medical device sector:No longer just “follow-on innovation,” but truly entering the deep waters of clinical practice to address problems that were previously difficult to solve.

And such changes are now occurring intensively in Zhangjiang.

Behind a Product

Standing is the entire industrial ecosystem

Many people view innovative medical devices as a breakthrough for a single company, but in Zhangjiang, behind each product often stands an entire industrial ecosystem.

Shenqi MedicalDuring the research and development process, a large number of high-precision testing instruments are required. From scanning electron microscopes to vascular simulation models, and further to various testing platforms, many of these devices are expensive, making it difficult for a single enterprise to bear the full cost.Zhangjiang Pharma Valleypublic technology platform, which aggregates and shares these resources.

Companies can directly access equipment and technical services, significantly reducing R&D costs and shortening development cycles. Wang Sen, Senior Vice President of Shenqi Medical, previously noted that with the support of relevant authorities in Zhangjiang, the company’s products were included in the key product list for innovative medical devices. Dedicated personnel provided guidance and coordinated throughout the approval process, greatly enhancing efficiency.

Such support is not an isolated case. In recent years, Zhangjiang Pharma Valley has continuously collaborated with the NMPA’s Yangtze River Delta Branch Center for Drug Evaluation and Inspection and the Yangtze River Delta Branch Center for Medical Device Technical Evaluation and Inspection, promoting “early intervention, one-company-one-policy, and end-to-end guidance” for innovative drugs and medical devices.

Many companies have already begun to communicate with regulatory and clinical parties simultaneously during the R&D phase. Issues that previously required companies to repeatedly explore on their own can now receive feedback earlier; processes that originally took longer to advance can now be completed more quickly.

Behind the accelerated approval process lies the essence of gradually forming synergy among R&D, regulation, and clinical practice. This synergy has also led to a concentrated surge in innovative achievements from Zhangjiang.

Since the beginning of this year, in addition to Shenqi Medical and Bluevascular Medical,NeuroXess, MicroPort Melody, MicroPort EPOther companies have also achieved key breakthroughs in succession. Among them, Neuracle’s invasive brain-computer interface (BCI) system has received marketing approval, becoming the first invasive BCI medical device globally to enter the clinical application stage. For patients with quadriplegia resulting from cervical spinal cord injury, this means they now have the possibility of regaining the ability to perform grasping movements through a brain-computer interface for the first time.

Meanwhile, Zhangjiang-based enterprises continue to break records with their innovative achievements.Approved by the National Medical Products Administration (NMPA)Xuanyu MedicalAdjustable Curved Pulmonary Artery Embolectomy Stent System,Provides a new interventional treatment option for patients with acute pulmonary embolism.This product consists of a thrombectomy stent catheter, an aspiration catheter, and accessories. It is categorized into two types: steerable and coated. It is indicated for catheter-based thrombus removal treatment in patients with acute high-risk pulmonary embolism (PE) and intermediate-risk PE accompanied by clinical deterioration. For patients with a high risk of bleeding, contraindications to thrombolysis, or poor response to conventional thrombolytic therapy, this innovative product offers a new therapeutic option, further enhancing China’s innovative landscape in the field of interventional therapy for pulmonary thromboembolism.

From heart valve repair and thrombus removal to brain-computer interfaces and interventional therapy for pulmonary embolism, breakthroughs in innovative medical devices from Zhangjiang are beginning to cover increasingly complex clinical scenarios.

Zhangjiang’s “Acceleration”: Not Just About Speed in R&D

What truly sets Zhangjiang apart is not merely its R&D capabilities, but more critically, its success in bridging the “last mile” for innovative drugs and medical devices.

In the past, many innovative products, even after successful market launch, continued to face challenges such as difficult hospital access and slow clinical adoption. Today, Pudong is working to change this situation.

For inclusion"Recommended Catalog of Innovative Drugs and Medical Devices in Pudong New Area"For such products, district-level medical institutions can complete the access approval process within one month, achieving “approval and allocation upon authorization.” Meanwhile, policies such as government first-purchase and the “Three Firsts” demonstration applications are also helping innovative products enter real-world clinical settings more rapidly.

This end-to-end support, spanning R&D, regulatory approval, and market adoption, is continuously translating into tangible innovative outcomes. More importantly, this advantage extends beyond merely accelerating regulatory clearance; it enables innovative products to enter clinical practice more rapidly, undergo market validation, and undergo continuous iteration and upgrading in real-world applications.

To this end, Zhangjiang is continuously promoting deep collaboration among the government, industry, and medical sectors. Regularly held hospital-enterprise exchange meetings and promotional events for innovative drugs and medical devices enable hospitals to gain early insights into cutting-edge products, while allowing companies to promptly receive authentic feedback from the clinical frontline. A virtuous cycle covering the entire lifecycle of innovation is taking shape: hospitals identify needs, enterprises conduct R&D, platforms provide support, policies facilitate rapid implementation, and products are continuously optimized based on feedback after entering clinical use.

In such a cycle, innovation is no longer merely a technological breakthrough in the laboratory, but has become an industrial system capable of continuous self-iteration and self-reinforcement. This is precisely the key reason why Zhangjiang’s innovative drugs and medical devices have been able to continuously accelerate their development.

From Domestic Substitution to Global Innovation

Today, what is unfolding in Zhangjiang Pharma Valley is far more than just “domestic substitution.”

An increasing number of enterprises are beginning to charge directly toward the global frontier of innovation.Fosun PharmaFXB0871, a PD-1-targeted IL-2 fusion protein co-developed with Teva, is an innovative therapy targeting a mechanism for which no drugs have yet been approved globally;HenliusThe new generation of recombinant human hyaluronidase is transforming the development of subcutaneous injection for macromolecular drugs.

Nurengjie BiotechNRG-103 injection is the world’s first tumor gene therapy based on in situ transdifferentiation technology. Meanwhile,XtalPiLeveraging AI and automation to advance molecular glue R&D, an increasing number of foundational technological innovations are also converging in Zhangjiang.

The frequent emergence of “First-in-Class,” “First-in-China,” and “First-in-Human” products actually reflects the upgrading of the entire innovation capability system.

In the past, ChinaPharmaceuticals and Medical DevicesMore emphasis was placed on “getting it done”; now, an increasing number of companies are striving to be “the first to get it done.” Zhangjiang is becoming one of the most prominent places where this shift is evident.

From Qilin-M® to Fishhawk®, from brain-computer interfaces to gene therapies, Zhangjiang Pharma Valley is demonstrating with increasingly dense innovative achievements that the so-called “acceleration” is not a sudden burst, but the concentrated release resulting from the long-term accumulation of an entire innovation ecosystem.

In the future, as more innovative drugs and medical devices are developed, launched, and enter clinical trials here, Zhangjiang will continue to be the most dynamic piece in China’s biopharmaceutical innovation landscape.