ForQaly
Minimally Invasive Heart Ventricular Assist Device Developer
Pudong Welcomes New Innovation AchievementsOn June 22, the National Medical Products Administration approved via the priority review and approval processKaixing Life Science and Technology (Shanghai) Co., Ltd.Shu Rui Ji Ao Lun Sai Injection (brand name: Kailimei), submitted by (a wholly-owned subsidiary of CARsgen Therapeutics), has been approved for market launch.
On June 18, the National Medical Products Administration approved the registration applications for three innovative medical devices from Shanghai. All three products originate from Pudong—ForQaly Medical (Shanghai) Co., Ltd.(hereinafter referred to as “ForQaly”) interventional left ventricular assist device, interventional left ventricular assist catheter pump kit, andShanghai Siemens Medical Devices Co., Ltd.(hereinafter referred to as “Siemens Healthineers”) X-ray computed tomography equipment.
From Pudong: World’s First CAR-T Therapy for Solid Tumors Approved for Market Launch
Tumors are primarily categorized into two major types: hematologic malignancies and solid tumors. Currently, in the field of CAR-T therapy for solid tumors, most international products are in Phase I or early Phase II clinical trials, with a long path still ahead before filing for new drug approval.
Previously approved CAR-T cell therapies have all targeted hematologic malignancies. With the recent approval of Shu Rui Ji Ao Lun Sai, it has become the world’s first approved CAR-T therapy for solid tumors, marking a significant breakthrough. This also signifies China’s leap from “following” and “keeping pace” to “leading” in the frontier field of cell and gene therapy (CGT), providing a breakthrough therapeutic option for addressing clinical challenges in gastric cancer and offering a novel “Chinese solution.”
CARsgen TherapeuticsAccording to founder Li Zonghai, CARsgen Therapeutics has been a pioneer in advancing investigator-initiated trials (IITs) of Claudin18.2 CAR-T therapy since 2017, cultivating nearly a decade of expertise in the field of CAR-T treatment for solid tumors. In the face of global technical bottlenecks such as immunosuppressive tumor microenvironments and specific target recognition, CARsgen Therapeutics achieved breakthroughs in key technologies through independent innovation, successfully translating original laboratory discoveries into clinical applications that benefit patients. Currently, the clinical efficacy of Survecabtagene Autoleucel has received authoritative recognition from top-tier international medical journals, with the results of its confirmatory randomized controlled trial published in The Lancet.
(Image source: Shanghai Science and Technology)
The market launch of Shu Rui Ji Ao Lun Sai was facilitated by the Pudong New Area.30For years, we have been continuously building a complete ecological closed loop from basic research to industrialization.
As a pioneer zone for the national reform of the drug review and approval system, Pudong has taken the lead in launchingMAH(Marketing Authorization Holder) system pilot, and enjoy the shortened review and approval timeline for clinical trial applications of innovative drugs to30working days and other policy dividends.
Through policies promoting the integration of industry and healthcare, Pudong supports innovative pharmaceutical companies in collaborating with clinical resources in Shanghai, reducing the cost and accelerating the pace of clinical trials, thereby providing a highly cost-effective clinical environment for the research and development of innovative drugs.
Meanwhile, following the establishment of the Yangtze River Delta Branch Center for Drug Evaluation and Inspection under the National Medical Products Administration (NMPA) in Pudong, it has provided key enterprises with services characterized by “early intervention, customized strategies for each enterprise, full-process guidance, and integrated research and review coordination,” thereby accelerating the market approval process for priority product pipelines.
Next, Shu Rui Ji Ao Lun Sai will undergo commercial deployment in China. In addition, the drug has also triggered strong reactions overseas; Li Zonghai revealed that currently there are at least10For example, patients from India, the United States, Nepal, and other countries have inquired about the drug, stating that “they will be able to fly to China for treatment once it is launched domestically.” CARsgen Therapeutics is actively expanding into overseas markets, including Singapore, Saudi Arabia, South Korea, Japan, and the United States.
The World’s Only Approved Motor-Separated pVAD, Significantly Enhancing Clinical Accessibility
ForQalyIndependently DevelopedSynFlow® 3.0 Transvalvular Percutaneous Ventricular Assist SystemComprising a blood-pumping catheter, an extracorporeal control device, perfusion tubing, and a catheter sheath kit. This product adopts a globally pioneering motor-separated design and entered the National Special Examination Procedure for Innovative Medical Devices in January 2023, becoming the first percutaneous interventional ventricular assist pump product in China to enter this green channel.
SynFlow®3.0 Catheter: Imaging After Crossing the Aortic Arch and Reaching the Working Position
(Image source: ForQaly)
The SynFlow® 3.0 Percutaneous Transvalvular Ventricular Assist System is indicated for high-risk percutaneous coronary intervention (PCI), providing left ventricular support to adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and hemodynamic stability.
For a long time, the global market for percutaneous ventricular assist devices (pVADs) has been dominated by the intracorporeal motor approach. Although the clinical benefits of this solution have been validated, the integration of precision motors into disposable components results in a single-treatment cost reaching hundreds of thousands of yuan, which has become a significant factor restricting its wider adoption.
“Technology that fails to achieve widespread adoption has limited value. Even the best equipment, if affordable only to a few, betrays its mission of ‘saving lives,’” stated Tang Zhirong, founder of ForQaly. He emphasized that the most direct approach to fundamentally reducing treatment costs is to relocate the motor from within the catheter, transforming it into a reusable device.
The externalized motor not only reduces the cost per treatment but also eliminates the risks of thrombosis and hemolysis caused by potential heat generation within the vasculature by moving the motor from inside to outside the body. Furthermore, the catheter is no longer constrained by a rigid motor segment, offering greater flexibility and improved navigability through complex vascular structures.
(Image source: ForQaly)
In 2015, ForQaly was officially established, focusing on innovative R&D centered around the "motor separation and reusable" technical solution. Prior to this, leading foreign medical device companies had attempted the technical route of extracorporeal motor drive, but numerous failures led to skepticism within the industry: the path of extracorporeal motors was deemed unviable.
But ForQaly’s response was: “Just because others haven’t succeeded doesn’t mean we can’t. Precisely because it is difficult, it is worth our effort. If it were easy, others would have already accomplished it.”
(Image source: VBData)
After more than a decade of arduous research and development, ForQaly has ultimately realized its original aspiration and dream. As the only motor-separated pVAD approved for market launch globally, SynFlow® 3.0 is not only a significant milestone in the development of Chinese-made pVADs, but also a critical step for Chinese high-end medical devices to engage in global competition through a differentiated path of original innovation.
SynFlow® 3.0 not only delivers effective circulatory support but is also poised to significantly reduce the cost per treatment; by ensuring long-term operational safety and markedly improving clinical accessibility, it aligns more closely with China’s current reimbursement system, thereby enabling a broader population of heart failure patients to benefit.
Ecosystem Empowerment: Pudong’s Innovative Medical Devices “Accelerate”
(Image source: Shanghai Municipal Medical Products Administration)
Approved on the Same DaySiemens HealthineersofX-ray Computed Tomography Equipment, representing another technological pinnacle in high-end imaging diagnostics. This product adopts innovative dual photon-counting detector technology, supports large-pitch scanning, features high temporal resolution, and achieves ultra-high-definition imaging, whole-domain spectral imaging, and low-dose imaging, while also providing images for radiotherapy planning. The device is suitable for routine clinical CT examinations and supports coronary CT angiography and spectral imaging.
(Image source: Siemens Healthineers)
Just shortly before this,Siemens Healthineers' First China-Made Dual-Source Photon-Counting CT: NAEOTOM Alpha.ProMarket approval signifies that the world’s leading photon-counting CT technology has taken firm root in China, with this product slated for future production at Siemens Healthineers’ Shanghai R&D and manufacturing base in Pudong. From imports to local production, and from single products to a diversified portfolio, Siemens Healthineers is continuously deepening its presence in Pudong.
The reason why Pudong has become a "strong magnetic field" for the localization of international medical equipment lies in its construction of all-dimensional empowerment advantages.
✅ At the policy level,In October 2025, Pudong released the "Implementation Plan for Promoting the Full-Chain Development of the High-End Medical Device Industry in Pudong New Area (2025–2027)," clearly stating that it would be driven by the dual engines of "technological innovation and institutional innovation" to fully build a high-end medical device cluster with global influence. Furthermore,As the sole pilot zone nationwide, Pudong has taken the lead in launching reform pilots such as imported product labeling and financial leasing, building on its earlier pilot of the Medical Device Registrant System, with institutional dividends accelerating their release.
✅ At the industrial level,Pudong has developed a cluster of enterprises covering niche sectors such as high-end imaging, laser medicine, and implantable and interventional devices, forming a complete industrial chain with upstream and downstream synergy, thereby providing ample supply chain support for the localization of multinational corporations.
✅ Ecological level,Pudong collaborates with universities, research institutes, and medical institutions to build a collaborative innovation platform integrating “industry, academia, research, and medicine,” while providing end-to-end enterprise services to help multinational corporations rapidly integrate into the local market.
The world’s first CAR-T therapy for solid tumors, the world’s only motor-separated pVAD, the world’s first invasive brain-computer interface... As “3F” innovative achievements—“First-in-Class,” “First-in-China,” and “First-in-Human”—continue to emerge, Pudong is accelerating its rise as a global hub for biomedical innovation.
Compiled from: National Medical Products Administration, Shangguan News, ForQaly, VBD Medical, etc.
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