Shenqi Medical
Cardiovascular Interventional Device Developer
Endovastec
Developer and Manufacturer of Aortic and Peripheral Vascular Interventional Medical Devices
Recently, Zhangjiang Pharm Valley Welcomes "Double Happiness". On April 22,Shenqi MedicalThe self-developed QiLin-M® Transcatheter Mitral Valve Clip System receives NMPA approval for market launch; on April 29,Endovastec™ Subsidiary Bluevascular MedTechThe Fishhawk®/鱼鹰® Disposable Thrombectomy Device developed by Shanghai Bluevascular MedTech Co., Ltd. has been approved for marketing by NMPA.
Behind the accelerating emergence of innovative achievements lies the厚积薄发of Zhangjiang Pharm Valley's over thirty years of deep cultivation, as well as the combined resonance of a "policy-industry-service"三位一体innovation ecosystem.
Cracking Clinical Pain Points, Two Innovative Devices Gain Approval
Shenqi Medical"QiLin-M®" Transcatheter Mitral Valve Clip SystemThe approval marks a key breakthrough for China in the high-barrier field of structural heart disease, providing Chinese patients with mitral regurgitation a domestically produced treatment option, and breaking the absolute monopoly of international giants in this field.
(Image source: Zhangjiang Release)
The mitral valve is the "valve" between the left atrium and left ventricle of the heart. Under normal circumstances, blood can only flow from the atrium to the ventricle; however, mitral regurgitation occurs when the "valve" does not close properly, causing blood to flow backward and increasing the heart's workload. Among these cases, degenerative mitral regurgitation (MR≥3+) represents moderate to severe regurgitation, with patients often experiencing shortness of breath after activity, nocturnal breathing difficulties, and lower limb edema. If left untreated for a prolonged period, it can severely impair cardiac function.
Traditional treatment methods mainly involve surgical repair or replacement of the valve, but many patients, due to older age and multiple underlying health conditions, are assessed as high-risk for surgery and cannot tolerate the trauma of open-heart surgery, leaving them in a dilemma of "wanting treatment but being unable to receive it."
(Image source: Shenqi Medical)
QiLin-M® precisely addresses this clinical pain point. It consists of a mitral valve clip and delivery system, as well as a guidance system. Its core advantages lie in the independent capture of valve leaflets and the multi-directional deflectability of the delivery system, which allows for more flexible adaptation to different patients' valve anatomical structures, improving the success rate and safety of the surgery.
In addition, QiLin-M® adopts a percutaneous minimally invasive approach, without the need for thoracotomy. The device can be delivered to the heart valve area through the blood vessels, achieving precise treatment.
In September 2021, it passed the "Special Review Procedure for Innovative Medical Devices" and entered the National Medical Products Administration's "Green Channel" for innovative products. After nearly five years of technical refinement and clinical trials, QiLin-M® has finally been approved for marketing.
Bluevascular MedTechFishhawk®/Osprey® Disposable Thrombectomy DeviceSimilarly, after years of research and development, it was approved to enter the NMPA Innovative Medical Device Special Review Process in September 2022.
(Image Source: Endovastec)
Deep Venous Thrombosis (DVT) is a venous reflux disorder disease caused by abnormal blood clotting in the deep vein cavity. It commonly occurs in the lower limbs, with main clinical symptoms including distal venous hypertension, limb swelling, pain, and superficial vein dilation. Without effective and timely treatment, acute DVT may lead to fatal pulmonary embolism or post-thrombotic syndrome of the lower extremity deep veins, seriously affecting the patient's life safety and quality of life.
Fishhawk®/鱼鹰® Disposable Thrombectomy Device adopts a safe and effective thrombus removal technology, meeting the clinical need for clearing high-volume venous thrombi. Its unique anti-tangling isolation technology separates the thrombus from the transmission components, preventing catheter blockage and improving surgical success rates. Additionally, its integrated and portable design facilitates the promotion of PMT across hospitals at all levels in China, benefiting more patients with peripheral venous diseases.
Ecological Empowerment: Accelerated Emergence of Innovative Achievements
Class III innovative medical devices must undergo a complex and rigorous approval process before entering the market. As a highland for biopharmaceutical innovation,Zhangjiang MedValley through linkingYangtze River Delta Branch of the National Medical Products Administration's Center for Drug Evaluation and Inspection, Yangtze River Delta Branch of the Center for Medical Device Evaluation and Inspection, helping companies shorten the application cycle, reduce R&D costs, and accelerate the market entry of related products.
Wang Sen, Senior Vice President of Shenqi Medical, recalled that as a strategically emerging industry prioritized for support by the Pudong New Area, Shenqi Medical leveraged the cluster advantages of the Zhangjiang medical device industry. Under the guidance of relevant departments in Zhangjiang, Shenqi Medical’s products were included in the key product list for innovative medical devices. Dedicated personnel were assigned to provide full-process guidance in preparing approval materials, while coordinating with various relevant departments to expedite the approval process, significantly shortening the approval cycle. "This allowed us to bring our products to market in a short period of time, securing a competitive edge in the fierce market competition."
There are many such innovative services in Zhangjiang Pharm Valley. "In the R&D process, we need to use various equipment such as hardness testers and scanning electron microscopes, most of which are very expensive," revealed the technical head of Shenqi Medical.Zhangjiang has built multiple public technology service platforms, such as the medical device testing center, providing enterprises with low-cost, high-quality equipment and technical services, significantly reducing R&D costs.
To further build a new highland of industrial services, the Zhangjiang Pharm Valley Comprehensive Service Center provides enterprises with full-chain, high value-added comprehensive services by aggregating service resources and optimizing the industrial ecosystem, stimulating enterprises' innovation vitality and helping them achieve steady and long-term development.
Breaking Through the "Last Mile": Innovative Drugs and Medical Devices Accelerate to Benefit the People
Nowadays, Zhangjiang Pharm Valley is fully implementingImplementation Plan for the Full-chain Development of the High-end Medical Device Industry in Pudong New Area (2025-2027), Build"Global Launch Site for Innovative Pharmaceuticals and Medical Devices, Preferred Destination for Scientist Entrepreneurs, and Pioneer in System Reform"。
(Image Source: BrainRobotics)
Since 2026, Zhangjiang Pharm Valley has had9 ProductsClass III innovative medical devices approved for marketing, with the total exceeding last year's annual total. Among them,BrainLinkInvasive Brain-Computer Interface System Approved for Marketing, Becoming the World's First Invasive Brain-Computer Interface Medical Device to Enter Clinical Application.
In recent years,"World's First" "China's First" "Latest Breakthrough"Products have been emerging in Zhangjiang Pharm Valley. However, how to truly打通 high-value innovative pharmaceuticals and medical devices' "last mile" to provide more quality options for clinical medication has also been a key point of discussion in the industry in recent years.
Pudong has built a closed-loop system driven by institutional innovation, supported by clinical resources, and bonded by ecological collaboration, which accelerates the transformation of innovative achievements and facilitates the inclusion of innovative drugs and medical devices into directories and hospitals, enabling products to truly move from laboratories to markets and achieve the "practical implementation for public benefit" of innovations.
For example, in conjunction with national and Shanghai regulatory review agencies, for innovative drug and device products that meet the criteriaImplement "One Product, One Strategy, Early Intervention, and Full-process Guidance", shortening the registration and listing cycle;
Centering on the entire industrial chain of the biopharmaceutical industry,Improving the "Industry, Academia, Research, Medicine" Collaboration Mechanism to Build a Clinical Transformation Functional Platform, accelerating the deep integration of industry and medicine;
For inclusion"Recommended Directory of Innovative Pharmaceutical and Medical Device Products in Pudong New Area"The innovative pharmaceuticals and medical device products will be granted access by regional medical institutions within one month, ensuring "full allocation where needed" and "immediate use upon approval." Through government procurement and ordering, as well as policy support such as the "three firsts" (first sets of equipment, first batches of materials, and first versions of software) application demonstrations, these innovations will be given priority entry into public medical institutions, further accelerating the clinical implementation of innovative results.
Several Regulations on the Management of Medical Device Financial Leasing in Pudong New AreaThe implementation has also injected tangible momentum into the high-quality development of the industry.
In addition, Pudong regularly hosts medical-enterprise exchange meetings and innovative drug promotion events, building a tripartite collaboration platform involving "government-hospital-enterprise" to help pharmaceutical companies showcase the clinical advantages of innovative drugs, enable hospitals to promptly access new drug information, reduce information asymmetry, and accelerate the availability of innovative drug and medical device products that are both valuable and novel for the benefit of the public.
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