JENSCARE (09877) delivered a truly landmark set of interim results on August 31st. During the reporting period, the company achieved revenue of RMB 64.131 million, a substantial year-on-year increase of 377.7%. Concurrently, its adjusted losses (excluding IFRS items) narrowed dramatically by 73.2% to RMB 24.586 million.

These robust figures not only declare that the company has successfully navigated its high-investment R&D cycle and formally entered a new phase of accelerated commercialization, but also signify that its investment value as a comprehensive platform player in China's structural heart disease sector is entering a channel of value re-rating driven by tangible performance delivery.

Global Expansion: From "Innovation in China" to "Expanding Worldwide"

Internationalization is the core strategy for JENSCARE to transcend the limitations of a single market and unlock long-term growth potential. In the first half of 2026, the company's international strategy accelerated into a phase of commercial realization, with overseas revenue contribution surging to 46.0%. This strongly validates the feasibility and effectiveness of its "global clinical data driving global market access" strategic path, with a global commercial landscape covering developed markets in Europe and the US, as well as emerging markets in the Asia-Pacific, rapidly taking shape.

In the United States, LuX-Valve Plus received FDA approval for its Investigational Device Exemption without conditions. The pivotal clinical trial is progressing smoothly and has completed its first patient implants. This study, designed as a prospective, global, multi-center, randomized controlled trial covering the US, Canada, and several European countries, will compare LuX-Valve Plus head-to-head with Edwards Lifesciences' EVOQUE system. This trial design not only reflects the FDA's recognition of the product's differentiated advantages but also underscores JENSCARE's willingness to directly confront the global industry leader under the highest international evidence standards, thereby building a formidable evidence barrier for US market entry. The trial has garnered active participation from multiple global centers, reflecting international academic confidence in LuX-Valve Plus's original design and excellent clinical performance, while also accumulating crucial KOL resources and academic momentum for subsequent commercial promotion. With the Pivotal Trial progressing, the company's registration pathway in the US, the world's largest medical device market, has entered a phase of substantial acceleration, potentially opening up significant medium-to-long-term growth space.

In Europe, LuX-Valve Plus secured EU MDR CE certification, becoming the second globally approved and the first Chinese-origin in-situ transcatheter tricuspid valve replacement product. This represents more than just a regulatory milestone; it signifies that the product's design and clinical data have received deep recognition from one of the world's most stringent medical device regulatory systems, paving an institutional pathway for entry into other CE-mark countries. Concurrently, the CE certification application for JensClip is being actively advanced. If approved as scheduled, it will further enrich the company's product portfolio in Europe, creating a synergistic global force from multiple products.

Dedicated efforts in the Asia-Pacific and other markets further validate the replicability of the internationalization strategy. LuX-Valve Plus and Ken-Valve have obtained registration approval in New Zealand, and Ken-Valve subsequently received approval from the Hong Kong Department of Health, effectively promoting commercial deployment in the Hong Kong market. In mainland China, leveraging the "Hong Kong and Macau Drug and Device Connect" policy, LuX-Valve Plus has achieved early commercial clinical use in the Guangdong-Hong Kong-Macao Greater Bay Area, marking it as one of the first innovative devices for this indication to achieve commercial application domestically. The LuX-Valve product series now covers five continents, having served over a thousand patients with a longest follow-up record exceeding six years. It has also garnered multiple international recognitions, including selection for the European Clinical Expert Committee's scientific advice pilot and FDA Breakthrough Device designation. As the global registration and commercialization network continues to expand, revenue scale is poised for rapid further growth, with the international strategy accelerating its transition from "individual breakthroughs" to a "networked market access" model.

In essence, JENSCARE's strategic value lies not simply in exporting products, but in reconstructing its clinical evidence system and market access pathways according to the world's highest regulatory standards, thereby granting its global growth higher sustainability and competitive moats. Looking at its development trajectory, the company is rapidly advancing along the classic globalization logic of "obtaining approvals – multi-regional commercial scaling – multi-product matrix synergy." As the global registration and commercialization network continues to expand, revenue scale is expected to grow quickly, and the internationalization strategy is transitioning from "individual breakthroughs" to a new phase of "networked market access," with the global growth thesis continuously being validated.

Focusing on Home: Full Product Matrix Enters Harvest Phase with Core Products and Pipeline Synergy

JENSCARE's domestic growth logic has evolved from being driven by a single product to synergistic scaling across its entire product matrix. In the first half of 2026, the company's comprehensive product pipeline covering the tricuspid, aortic, and mitral valves accelerated significantly in both domestic commercialization and registration processes, establishing a tiered growth pattern where "marketed products contribute cash flow, and pipeline products are poised for launch."

Ken-Valve, the company's first product to achieve scaled commercialization, continues to generate stable cash flow, validating its commercial capabilities in the aortic valve intervention field. Leveraging a multi-tiered sales network anchored by "core hospital leadership, regional center support, and primary hospital penetration," coupled with the "Jenscare Academy" academic platform and routine scientific meetings, the company is efficiently converting its technological advantages into market share, with implant volumes steadily increasing. From a financial contribution perspective, Ken-Valve's growth has not only significantly improved the company's revenue scale but, through its high gross margin, also provided crucial financial support for the commercial rollout of subsequent pipeline products. This has created a virtuous cycle of "cash flow fueling R&D," establishing a solid financial foundation for the coordinated advancement of its multi-pipeline strategy.

While Ken-Valve steadily contributes cash flow, the registration processes for LuX-Valve Plus and JensClip have both entered critical stages, signaling that imminent commercial breakthroughs are on the horizon for the company's two core franchises: tricuspid and mitral valves. LuX-Valve Plus operates in the transcatheter tricuspid valve intervention field, one of the fastest-growing segments within the global structural heart disease market, characterized by vast market potential and an as-yet unsettled competitive landscape. The company's domestic deployment in this area has entered its final registration sprint: the NMPA registration application has been accepted and is under review, with clinical follow-up data showing excellent results. More importantly, the product has been approved for inclusion in the "Hong Kong and Macau Drug and Device Connect" catalog, permitting commercial clinical use in designated medical institutions within the Greater Bay Area. This makes it one of the first innovative devices to achieve commercial adoption for this indication domestically. This parallel strategy of "registration review + pilot use first" allows the product to accumulate valuable real-world clinical data domestically while pre-heating the market for rapid scaling upon official approval. From a valuation standpoint, if LuX-Valve Plus secures approval, it will become the first approved transcatheter tricuspid valve replacement product in China, likely securing a first-mover advantage in this blue ocean market and opening a second revenue growth curve for the company, following its success in the aortic valve space.

The mitral valve repair market targeted by JensClip boasts an even larger patient population, representing one of the largest sub-segments in structural heart disease. Its unique claw-wedge mechanical locking design creates a significant differentiation advantage. Its NMPA registration application is currently in a critical review phase, with domestic commercialization potentially achievable in the near term. Successful approval of this product will help the company enter this larger market segment, further perfecting its full-disease-spectrum layout in structural heart disease. This will drive the revenue structure's evolution from single-product dependence to multi-product collaborative growth, significantly expanding the company's medium-to-long-term performance growth potential.

The core value of this synergy between core products and pipeline candidates lies in the fact that, with multiple products successively entering commercial or registration sprint phases, the company is gradually shedding its reliance on any single product. Its revenue structure is diversifying, and consequently, the sustainability of its performance and its resilience against risk are being significantly enhanced.

Forward-Looking Layout: Full-Dimension Matrix Builds Platform Advantage and Systematic Planning Fortifies Long-Term Foundation

If commercial scaling determines JENSCARE's short-term growth elasticity, then its platform-based technology foundation and clear product iteration roadmap define the ceiling of its long-term value. From an investment perspective, the value of platform-based technological reserves lies in enabling each pipeline product to build upon existing technological accumulations, significantly reducing marginal R&D costs and clinical risks. The JeniGal anti-calcification technology is already applied across all commercialized and pipeline products, effectively extending the in-vivo lifespan of valves. The bioprosthetic valve drying technology is in the clinical trial preparation stage, promising to lower storage and transportation costs while enhancing gross margins. The polymer leaflet technology targets a material revolution that, if successful, could fundamentally transform product performance boundaries and cost structures. The establishment of this "R&D leverage" effect implies that the incremental investment required for each new product line added in the future will be significantly lower than industry averages, leading to continuously optimized capital efficiency.

Relying on this platform-based technology, JENSCARE has constructed clear iteration pathways across the tricuspid, aortic, and mitral valve domains, ensuring sustained competitiveness in each sub-segment. The tricuspid valve strategy is particularly illustrative: LuX-Valve Plus establishes the commercial base, while two subsequent pipeline generations, LuX-Valve Pro and LuX-Valve Ultra, are already in the pre-clinical stage. This creates a well-defined technological reserve, significantly extending the core product's lifecycle, effectively dispersing market risks associated with patent expiry or technological shifts of a single product, and continuously enhancing the predictability of long-term revenue. The gradual advancement of product iterations across the tricuspid, aortic, and mitral valve lines not only secures the company's sustained competitiveness in each sub-sector but also, through the synergy of its technology platform, allows R&D achievements across different product lines to empower and accelerate each other's development.

As multiple product generations progressively enter clinical and commercial stages, JENSCARE's platform value will gradually transform from R&D investment into sustainable performance growth momentum, offering investors long-term certainty that transcends any single product cycle.

In summary, JENSCARE's robust 2026 interim performance marks the company's official entry into a new phase of accelerated commercial release. Looking ahead, with the comprehensive acceleration of its commercialization process and the continuous expansion of its global footprint, the company is steadily solidifying its market position in the structural heart disease arena, presenting investors with an investment target that combines both growth potential and certainty.