How This Domestic Leader in Vascular Interventional Devices Rose to Prominence: The Secret Lies in Zhangjiang's Innovation Ecosystem

Interface News Reporter |Fan Yicheng

6Month30Recently, at the headquarters of Shanghai Shenqi Medical Technology Co., Ltd. (Shenqi Medical) located in the Zhangjiang Medical Device Industrial Base, Wang Sen, the company's Senior Vice President, was preparing the review documents for a new mitral valve repair product. He introduced: "After this product is launched next year, compared with similar imported products, it will have a significant price advantage!"

This breakthrough was no accident — since2014Since its establishment in Zhangjiang years ago, Shenqi Medical has always focused on product development in the fields of vascular intervention, structural heart disease, and heart failure management, and is committed to achieving excellence in these specialized areas.Domestic Substitution, meeting the clinical needs of more patients.

Technological Breakthroughs and Price Revolution

Interventional treatment for structural heart disease is a revolutionary breakthrough in cardiology. Among various types of valvular heart diseases, mitral valve disease has the highest incidence and is the most challenging in terms of interventional treatment. In China, the number of potential patients with mitral valve disease exceeds ten million, representing a significant treatment gap. Meanwhile, the development of interventional devices for mitral valve diagnosis and treatment remains a major focus and challenge in the global field of cardiovascular interventional therapies.

Shenqi Medical's trans-catheter mitral valve clip system represents a significant breakthrough in the field of mitral valve diagnosis and treatment devices in China. According to Wang Sen, the system adopts a multi-layer adjustable bending delivery sheath design, with the dual-layer sheath enabling controllable bending across multiple dimensions. The product is directly comparable to the latest generation of imported Edwards devices. PASCALAnd AbbottMitraClip G4Transcatheter Mitral Valve Repair System.

"The original price of imported products in30Around ten thousand yuan, and after our product hits the market next year, the price is expected to drop to...20"About 10,000 yuan."Wang Sen stated that Shenqi Medical's transcatheter mitral valve clip system has successfully completed product development and finalization, full-performance bench testing, preclinical standardized large-animal studies, and registration clinical trials.

Shenqi Medical has seen continuous breakthroughs recently. Not long ago, a percutaneous peripheral cutting balloon developed independently by the company received official approval from the National Medical Products Administration (NMPA) for marketing. The product is intended for dilating lesions within the iliac artery, femoral artery, popliteal artery, and renal artery, as well as treating obstructive lesions in autologous or artificial arteriovenous dialysis fistulas. Last year9In the same month, its coronary cutting balloon was approved for marketing. Currently, only three companies in China hold the registration certificate for production and sales, and Shenqi Medical is one of the only two local enterprises.

Second Venture, Aiming atDomestic Substitution

As a Chinese domestic medical device innovation company rooted in Zhangjiang, Shanghai, how did Shenqi Medical step by step grow into a leading enterprise in the field of vascular intervention?

2014Year9Month: Dai Zhihao, who has previously worked for Medtronic, Boston Scientific, MicroPort, and other companies, relies on20Years of experience in the cardiovascular field, establishing Shenqi Medical in Zhangjiang, Shanghai.

2006After first venturing into entrepreneurship in the cardiovascular product agency business, he observed a technological gap in "niche" markets such as drug-coated balloons and occluders, prompting him to embark on a second entrepreneurial journey focused on independently developing domestically produced products. At the outset of founding the company, he decided to bypass the fiercely competitive red ocean of cardiac stents monopolized by medical giants, betting instead on the "intervention without implantation" field, with a primary focus on developing drug-coated balloons.

Dai Zhihao previously stated in an interview that after the invention of cardiac interventional products, many heart disease patients had new hope, but the cost of imported products was a significant issue. "Those who can't afford it are like having their hopes raised only to be dashed again." This is precisely an important motivation for Dai Zhihao to start his business once more, wanting to do something he can "be proud of."

Shenqi Medical experienced at the beginning of its establishment5During the difficult period of zero annual income, Wang Sen had deep feelings about that time.2014Year12 He joined the company in [Month] as one of the earliest employees and initially served as the head of the company's technology research and development. He revealed that after the product was developed through numerous challenges, it coincidentally encountered the pandemic, causing many difficulties in production and sales. However, Shenqi Medical eventually withstood the pressure.

2019Year, Shenqi Medical's independently developed core product - drug-coated balloon was approved for marketing. In the year before the product launch,2018The total number of coronary heart disease interventions in China mainland in year91More than 10,000 cases, the average number of stents implanted in patients with coronary heart disease is1.46As the use of cardiac stents has grown rapidly, drug-coated balloons have also become a new favorite for treating coronary artery stenosis under the influence of the new concept of "intervention without implantation."

It is reported that drug-coated balloons can locally release anti-proliferative drugs to the arterial vessel wall without implanting stents, achieving the effect of inhibiting intimal hyperplasia. This further helps treat coronary artery stenosis and achieve revascularization. It has the advantages of no need for foreign body implantation, short postoperative dual antiplatelet therapy duration, simple surgical procedure, and wide adaptability to patient populations.

At that time, in the field of coronary intervention surgery in China, the overall usage rate of drug-coated balloons accounted for only a small proportion compared to the overall usage rate of stents.4%, with foreign15%The proportion is far apart, and drug-coated balloons have enormous growth potential. Shenqi Medical's products were launched precisely at this point in time. Technologically, by utilizing a special coating process, they achieved "applicable coating, controllable release, and effective retention." The excellent quality and results quickly gained market recognition. Shenqi Medical’s forward-looking strategic layout eventually yielded fruitful results.

Zhangjiang's "Golden Innovation Ecosystem"

In Wang Sen's view, the company successfully overcoming the difficulties of its initial period and getting on track is inseparable from the help and support of Zhangjiang.

In the early stages of technology development, financial pressure was a constant companion for Shenqi Medical, as the purchase of R&D equipment, procurement of experimental consumables, and recruitment of professional talent all required substantial capital investment. Wang Sen revealed that the then Zhangjiang Management Committee (now "Zhangjiang Science and Construction Office") quickly helped the company secure special scientific research funds through relevant policies. "This funding was like 'timely rain,' helping us get through the toughest period and ensuring the continuous progress of our R&D projects." Establishing the business in Zhangjiang brought not only...It is supported by special funds.

As a Class III innovative medical device in China, Shenqi Medical's products must undergo a complex approval process before entering the market, with strict requirements. Wang Sen recalled that Shenqi Medical, as a strategically emerging industry prioritized and supported by the Pudong New Area, relied on the cluster advantages of the Zhangjiang medical device industry. Under the guidance of relevant departments in Zhangjiang, Shenqi Medical’s products were included in...Innovative HealthcareList of Key Products for Devices"A dedicated person was assigned to provide guidance throughout the preparation of the approval materials, coordinating with various relevant departments to expedite the approval process, significantly shortening the approval cycle. This allowed us to bring our product to market in a short period and gain a competitive edge in the fierce market competition," said Wang Sen.

In2025At the Zhangjiang Life Science International Innovation Summit, Xu Lai, member of the Pudong New Area Party Committee and Deputy District Governor, revealed,2024Year, the scale of Pudong's biopharmaceutical industry reached4100100 million yuan, with an annual growth of nearly300100 million yuan.2019Since the year, cumulatively approved1Class Innovative Drug21Individual, Innovative Medical Devices31, respectively accounting for the city's75%And58.5%; It has also been approved for marketing this year.2Payment1Innovative drugs and4Innovative medical device.

The biopharmaceutical industry is one of Shanghai's three leading industries and also one of the key areas of focus in the new round of technological revolution and competition. Pudong New Area has consistently prioritized the biopharmaceutical industry as a key development sector, providing strong support for its "research and development...+Clinical+Manufacturing+Application of the "whole industrial chain system" is being promoted. Zhangjiang, as the core area leading biomedicine innovation in Pudong, has now become one of the regions with the most complete biomedicine industry chain, the best ecosystem, the most concentrated talent pool, and the most active innovation.

Currently, Zhangjiang Science City has gathered various innovative entities in the field of biopharmaceuticals.2300Yu Family, Relevant Practitioners9.610,000 people. Global pharmaceutical and device companies10Strong respectively have2/3Settling in Zhangjiang, Global Medicine20Strong10Shanghai Zhangjiang Open Innovation Center,China MedicineTop 100 Industrial Enterprises40%Layout Zhangjiang.

It is precisely due to the high degree of industrial agglomeration and the maturity of the innovation ecosystem,2020In the year, the Yangtze River Delta Sub-center of the National Medical Products Administration for Drug Evaluation and Inspection, and the Yangtze River Delta Sub-center for Medical Device Technical Evaluation and Inspection were established in Zhangjiang Science City, Pudong.

The establishment of the sub-center has greatly promoted the "transformation of achievements and innovative development" of pharmaceuticals and medical devices in the Yangtze River Delta. Zhangjiang, located at the core of the Yangtze River Delta, can efficiently radiate the pharmaceutical industry resources of Jiangsu, Zhejiang, and Anhui. Through nearby review, it has significantly shortened the application cycle for enterprises, reduced R&D costs, and accelerated the market entry of related products.

For a company like Shenqi Medical, this is undoubtedly another booster for helping the company grow. Wang Sen stated that the original product reviews required flying to Beijing. Before a new product launch, it often involved repeated issue discussions and multiple rounds of document communication, with each trip to Beijing meaning significant costs for the company.

"And after the establishment of the Zhangjiang branch, we only need to drive15"Minutes away."Wang Sen frankly stated that it is precisely due to the development advantages of Zhangjiang's biopharmaceutical industry cluster that such an important institution could be established, further promoting the development of more enterprises in Zhangjiang.

There are many supporting resources like this in Zhangjiang. "In the R&D process, we need to use various types of equipment such as hardness testers and scanning electron microscopes, most of which are very expensive," revealed the technical lead at Shenqi Medical. Zhangjiang has established multiple public technology service platforms, such as medical device testing centers, providing companies with low-cost, high-quality equipment and technical services, significantly reducing R&D expenses.

In addition, Zhangjiang also actively organizes various industry exchange events, academic seminars, and technical training courses, building a bridge for enterprises to have in-depth exchanges with experts and peers from home and abroad. This helps enterprises keep abreast of the latest industry trends and broaden their technical perspectives.

2024In that year, Shenqi Medical, as one of the first companies to settle in, established its new headquarters in Zhangjiang Science City, China.ZEMPHeadquarters Park, with the concurrent入驻 of Dongfang Hospital's Cardiology Laboratory,ChemDiagnosticAnd other institutions, forming an industrial ecosystem synergy.

ZEMPThe headquarters park, developed by Shanghai Zhangjiang Medical Device Industry Development Co., Ltd., is managed under a self-operated property model, with a total construction area of approximately18Thousands of square meters, it is the gathering area of Zhangjiang's medical device industry and one of Shanghai's characteristic industrial parks.

The establishment of this new headquarters marks the beginning of another new phase of development for Shenqi Medical.2014At the beginning of the year, the Shenqi Medical office on Newton Road in Zhangjiang had only800Square meters, team members less than10People. As the company grew, the office and processing plant area expanded significantly.9000Square meters.2021Year, Exceed2000The R&D center of Pingmi has been officially launched. Now, with the opening of the brand-new headquarters, the company team has exceeded300People, the company's business reach has extended from within China to the entire globe.

Shenqi Medical's strategic plan includes further expansion into overseas markets. The company's products have already obtained certifications from the European Union and several countries in Southeast Asia, and last year successfully entered the markets of Thailand, Indonesia, and other countries, achieving listing and sales.