On August 31, Jianshi Technology (09877) handed over a landmark midterm report card. During the reporting period, the company achieved revenue of RMB 64.131 million, a year-on-year increase of 377.7%; after adjustment, losses for the non-IFRS period narrowed sharply by 73.2% to 24.586 million yuan
This strong data not only announces that the company has successfully crossed the high-investment R&D cycle and officially entered a new stage of accelerated commercialization and release, but also marks its investment value as a full-pipeline platform enterprise in the field of structural heart disease in China, and is entering a value revaluation channel driven by the implementation of performance.
Global layout: from “Chinese innovation” to “global expansion”, the acceleration of the internationalization strategy
Globalization is the core strategy of Jianshi Technology to break through the ceiling of the single market and open up room for long-term growth. In the first half of 2026, the company's international layout accelerated into the commercialization period, and the overseas revenue contribution jumped to 46.0%, fully verifying the viability and effectiveness of its strategic path of “driving global market access with global clinical data”. A global business map covering developed markets in Europe and the US and emerging markets in the Asia-Pacific region is taking shape at an accelerated pace.
In the US, LUX-VALVE Plus received FDA's unconditional IDE approval, and key registration clinical trials progressed smoothly and completed the first batch of implantations. The study was a forward-looking, global multi-center, randomized controlled design, covering the US, Canada and many European countries, and will be compared head-to-head with Edward Life Sciences' EVOQUE system. The test design not only reflects FDA's recognition of product differentiation advantages, but also means that Jianshi Technology dares to face global industry leaders with the highest international evidence-based standards and build a solid evidentiary barrier for entry into the US market. The trial received active participation from many centers around the world, reflecting the international academic community's confidence in Lux-Valve Plus's original design and excellent clinical performance, and also accumulated key KOL resources and academic potential for subsequent commercialization. As the Pivotal Trial clinical process continues to advance, the company's registration path in the US, the world's largest medical device market, has entered a substantial acceleration stage, and medium- to long-term growth space is expected to open up further.
In Europe, Lux-Valve Plus has obtained EU MDR CE certification, becoming the world's second in-situ transcatheter tricuspid valve replacement product approved in China. This is not only a regulatory breakthrough, but also means that product design and clinical data have been deeply recognized by the world's strictest medical device supervision system, paving an institutional channel for subsequent entry into other CE covered regions. At the same time, Jensclip's CE certification registration application continues to be promoted. If approved as scheduled, it will further enrich the company's product matrix in the European market and form a global synergy of multiple products.
In-depth cultivation in the Asia-Pacific region and other markets has further verified the replicability of the internationalization strategy. LUX-VALVE Plus and Ken-Valve have obtained registration approval in New Zealand, and Ken-Valve was subsequently approved by the Hong Kong Department of Health, strongly promoting the commercialization of the Hong Kong market. In mainland China, LUX-Valve Plus was the first to achieve commercial clinical application in the Guangdong-Hong Kong-Macao Greater Bay Area based on the “Hong Kong and Macau Pharmaceutical Device Connect” policy, and is an innovative commercialized device for this indication earlier in China. The LUX-Valve series products have covered five continents, served more than 1,000 patients, had a maximum follow-up record of more than 6 years, and were selected by many international authorities, such as the European Clinical Expert Committee's scientific recommendation pilot and FDA breakthrough device certification. As the global registration and commercialization network continues to expand, the revenue scale is expected to expand rapidly, and the internationalization strategy is accelerating from a “single point breakthrough” to a new situation of “networked market access”.
Simply put, the strategic value of Jianshi Technology is not simply exporting products, but rather reconstructing the clinical evidence system and market entry path with the highest global regulatory standards, giving it greater sustainability and competitive barriers to global growth. Judging from the development trajectory, the company is accelerating its evolution along the classic global evolution logic of “certified breakthrough - multi-regional commercialization volume - multi-product matrix collaboration”. As the global registration and commercialization network continues to expand, the revenue scale is expected to expand rapidly. The internationalization strategy is moving from a “single-point breakthrough” to a new situation of “networked market access”, and the logic of global growth continues to be implemented.
Based on the mainland: the entire product matrix has entered the harvest period, and the core single products work together with the pipeline under development
The growth logic of Jianshi Technology's domestic business has been upgraded from a single product driver to a collaborative amplification of the entire product matrix. In the first half of 2026, the company's complete product pipeline covering the tricuspid valve, aortic valve, and mitral valve was fully accelerated in the domestic commercialization and registration process, forming a gradient growth pattern where “marketed products contribute cash flow and are ready to go in the research pipeline”.
As the company's first large-scale commercialized product, Ken-Valve's continuous release contributed stable cash flow to the company and verified the company's commercialization capabilities in the field of aortic valve intervention. The company relies on a three-dimensional sales network of “core hospital leadership, regional center support, and basic hospital penetration”, and uses the “Jianshi Academy” academic platform and regular academic conferences to drive clinical promotion through academic exchanges. It is efficiently transforming technical advantages into market share and achieving a steady increase in implantation scale. In terms of financial contributions, Ken-Valve's volume not only significantly improved the company's revenue scale, but also provided valuable financial support for subsequent commercialization of products under development through a high level of gross margin, forming a virtuous cycle of “cash flow feeds back R&D”, laying a solid financial foundation for the company's multi-pipeline collaborative promotion.
While Ken-Valve is steadily contributing to cash flow, the registration process for LUX-Valve Plus and JensClip has both entered a critical stage, marking that the company's two core tracks, tricuspid valve and mitral valve, are about to usher in commercialization breakthroughs.
The field of transcatheter tricuspid valve intervention in which LUX-Valve Plus is located is one of the fastest-growing segments in the global structural heart disease circuit. The market space is broad and the competitive pattern is yet to be defined. The company's domestic layout in this field has entered the registration sprint stage. The NMPA registration application has been accepted and is in the review stage, and the clinical follow-up data is excellent. More importantly, the product has been approved for inclusion in the Hong Kong and Macau Pharmaceutical Device Guide. It can be used commercially in designated medical institutions in the Guangdong-Hong Kong-Macao Greater Bay Area, making it an innovative device that commercialized this indication earlier in China. This parallel strategy of “registration review+trial first” not only accumulates valuable domestic real-world clinical application data for the product, but also warms up the market for rapid release after official approval. From a valuation perspective, if LUX-VALVE Plus is successfully approved, it will become the first transcatheter tricuspid valve replacement product approved for marketing in China. It is expected to occupy a first-mover advantage in this blue ocean market and open up the company's second performance growth curve after the aortic valve.
JensClip has a larger patient base in the mitral valve repair market and is one of the largest segments in the field of structural heart disease. Its unique claw wedge mechanical locking design has built a significant differentiated competitive advantage. Its NMPA registration application is currently at a critical stage of review and is expected to be commercialized domestically as soon as possible. After the product is successfully approved, it will help the company enter this larger market segment, further improve the company's layout of all diseases in the field of structural heart disease, promote the upgrading of the revenue structure from a single product to a collaborative drive for multiple products, and significantly open up space for the company's medium- to long-term performance growth.
The core value of core single products and collaborative efforts in the research and pipeline is that various products have entered the commercialization or registration sprint stage one after another. The company is gradually getting rid of dependence on a single product, the revenue structure is becoming more diversified, and the sustainability of performance and resilience to risks have improved markedly.
Forward-looking layout: full-dimensional matrix construction platform-based advantage system planning consolidates long-term foundation
If commercialization volume determines the short-term growth elasticity of Jianshi Technology, then the platform-based technology base and clear product iteration path define the company's long-term value ceiling. From an investment perspective, the value of platform-based technology reserves is to enable every product under development to stand on top of existing technology accumulation, significantly reducing marginal R&D costs and clinical risks. JeniGal anti-calcification technology has been applied to all commercialized and under development products to effectively extend the useful life in the valve; biological valve drying technology is in preparation for clinical trials and is expected to reduce storage and transportation costs and increase gross margin; polymer valve technology targets the material revolution, and if a breakthrough is achieved, it will fundamentally change the product performance boundary and cost structure. The establishment of this “R&D leverage” effect means that every time the company adds a new product line in the future, the incremental investment required will be significantly lower than the industry average, and the efficiency of capital use will continue to be optimized.
Relying on the above platform-based technology reserves, Jianshi Technology has built a clear iterative path in the three fields of tricuspid valve, aortic valve, and mitral valve to ensure the continued competitiveness of various race segments. The layout of the tricuspid valve field is particularly typical. LUX-VALVE Plus has laid the foundation for commercialization, and both LUX-VALVE PRO and LUX-VALVE Ultra pipelines have entered the pre-clinical stage, forming well-structured technical reserves, which significantly extend the life cycle of core products, market risks caused by the expiration of single product patents or technology iteration are effectively dispersed, and the predictability of long-term revenue continues to increase. The iterative upgrade of all tricuspid valve, aortic valve, and mitral valve products not only ensures the company's continued competitiveness in various race segments, but also enables R&D results between different product lines to mutually empower and accelerate transformation through the synergy of technology platforms. As multiple product generations enter the clinical and commercialization stages, the platform-based value of Jianshi Technology will gradually transform from R&D investment into a sustainable performance growth engine, providing investors with long-term certainty across a single product cycle.
In summary, the strong performance of Jianshi Technology's 2026 interim results marks that the company has officially entered a new stage of accelerated commercialization and release. Looking forward to the future, with the overall acceleration of the commercialization process and the continuous expansion of the global layout, the company is steadily consolidating its market position in the field of structural heart disease, providing investors with an investment target with both growth and certainty.