Peijia Medical Limited (Stock Code: 09996) announced its audited annual results for the twelve months ended December 31, 2025, on March 25, 2026. Throughout the 2025 fiscal year, the Group adhered to a development strategy focused on seeking progress while maintaining stability, improving quality, and enhancing efficiency. It proactively navigated a complex and changing industry landscape while continuously strengthening its operational foundation.
During the reporting period, all business segments achieved steady growth, the innovation pipeline saw consecutive breakthroughs, and operational efficiency improved significantly. The Group reported total revenue of RMB 713 million, representing a year-on-year increase of 15.8%. The revenue structure remained stable, with Transcatheter Aortic Valve Replacement (TAVR) related products contributing 40.7% and neurointervention products contributing 59.3%.
Benefiting from expanding economies of scale and cost optimization and efficiency gains driven by lean management initiatives, the Group's overall gross profit margin remained relatively stable, while the expense ratio decreased notably. The neurointervention business segment profit surged 86.6% year-on-year to RMB 97.18 million. Conversely, the loss from the transcatheter valve therapy business segment narrowed by 20.2% year-on-year to RMB 216 million. Excluding the impact of losses from entities associated with frontier technology businesses, the Group's core business net loss was RMB 111 million, a narrowing of 44.1% compared to the previous year.
**Neurointervention Segment Profit Soars 86.6%; Internationalization Reaches Milestone** Revenue from the neurointervention business reached RMB 423 million during the reporting period, an increase of 18.9% year-on-year, primarily driven by the strong performance of core products across various product lines. Sales volumes saw significant increases for products such as the DCwire® microguidewire, Fastunnel® delivery balloon dilatation catheter, and Syphonet® thrombectomy stent, leading to continued market share expansion. Concurrently, the coil series products and the Tethys® intermediate guiding catheter maintained stable sales, holding a certain share in their respective sub-markets. Furthermore, the YonFlow® flow diverter stent, for which the Group holds exclusive distribution rights, commenced commercialization in June 2025, receiving positive market feedback and contributing a substantial incremental revenue during the period.
Internally, the Group continued to advance cost optimization and lean production measures. Despite lower ex-factory prices following the implementation of volume-based procurement (VBP), the overall gross margin was well-maintained at 60.9% (63.7% after adjusting for non-cash effects of purchase price allocation). Simultaneously, efficiencies in sales and distribution, administration, and R&D continued to improve, with the respective expense ratios further optimized, decreasing by 3.5, 3.2, and 4.4 percentage points year-on-year to 23.4%, 4.8%, and 9.8%. As a result, the segment profit surged 86.6% to RMB 97.18 million, with the segment profit margin reaching 23.0%, indicating the effective release of operating leverage.
The Group's neurointervention products have been progressively included in national VBP programs. In the neurointervention VBP projects with results announced in 2025, the Group successfully won bids in all projects for which it was eligible. Notably, in January 2025, through strategic bidding planning, the Group's SacSpeed® balloon dilatation catheter and Fastunnel® delivery balloon dilatation catheter successfully won bids under Rule A, Group 1, in the inter-provincial alliance VBP for vascular interventional consumables led by Hebei province. Following the implementation of this VBP program in relevant provinces in the second half of 2025, the sales volume of the Group's balloon dilatation catheters increased significantly, with the Fastunnel® model seeing nearly 300% year-on-year growth. Several VBP renewal and new projects are currently underway, and the Group is actively participating, aiming to secure bids with competitive pricing and positioning to consolidate or further expand its market share.
In March 2026, the 510(k) registration application for the DCwire® microguidewire was approved by the U.S. Food and Drug Administration (FDA), marking the Group's first regulatory "passport" for its neurointervention products to enter overseas markets. Since its launch in China, DCwire® has gained widespread recognition from physicians for its excellent performance and achieved rapid sales growth. Moving forward, the Group will continue to advance its international strategy, progressively promoting more products for overseas markets, enabling high-quality innovative products to reach the global market. The neurointervention business will continue to enrich its product portfolio, further expand the market share of core products, and gradually develop overseas sales channels. The Group expects the neurointervention business to sustain its expansion in both revenue and profit, continuing to contribute stable cash flow.
**TAVR Business Maintains Leadership; Approval of Regurgitation Valve Expands Indications** During the reporting period, the Group maintained its leading position in the TAVR market and steadily expanded its commercial network. As of December 31, 2025, the Group's TAVR products had cumulatively entered over 780 hospitals, with approximately 130 new additions during the period. For the full year 2025, the terminal implant volume for TAVR products was approximately 3,900 units, a year-on-year increase of 14.4%, significantly outpacing the overall market growth rate. The Taurus series products for treating Aortic Stenosis (AS) continued to gain widespread recognition from clinicians. The Group has established a comprehensive product portfolio, including the mainstream TaurusOne® and TaurusElite®, as well as the premium TaurusMax®. The TaurusMax® 3D steerable TAVR system, with its excellent deliverability and maneuverability, effectively assists physicians in handling complex challenging cases, and its proportion of total implant volume continues to rise.
In December 2025, the Group achieved a significant milestone with the approval from the National Medical Products Administration (NMPA) for the TaurusTrio® TAV system (the localized product of the JenaValve Trilogy™ THV system, for which the Group holds an exclusive license in Greater China) for treating symptomatic severe Aortic Regurgitation (AR). The JenaValve Trilogy™ THV system is the world's first TAVR system specifically designed for AR, having received CE Mark approval in May 2021 and FDA Premarket Approval (PMA) in March 2026. Both the Trilogy™ and TaurusTrio® utilize a globally pioneering integrated locator key design, effectively addressing the anchoring challenges specific to pure AR, and have accumulated solid clinical evidence worldwide. The approval of TaurusTrio® marks a major commercial milestone and further strengthens the Group's transition from a single-indication (AS) product portfolio towards a commercial heart valve platform capable of scale and covering multiple indications, including AS and AR. The Group is actively promoting hospital access and market penetration for this product, planning to leverage its established sales, marketing, and commercial systems to accelerate the adoption of transfemoral AR interventional therapy in China.
Since January 2026, the Group and other market participants have gradually reduced the listed prices of relevant products in multiple provinces and municipalities to enhance affordability and accessibility. The Group believes that price optimization will help increase procedure penetration rates, thereby driving overall market growth. The Group will continue to optimize its AS product portfolio to consolidate its leading market share while actively seizing new opportunities in the AR market to further strengthen its leadership in China's TAVR market.
**Steady Progress in Valve R&D Pipeline Builds Long-Term Competitive Barriers** During the reporting period, the Group's R&D pipeline, both domestically and internationally, achieved solid progress, with continuous enhancement of innovation capabilities laying a strong foundation for long-term competitiveness. In China, the Group achieved several important regulatory and clinical milestones. In addition to the approved TaurusTrio®, the Group submitted registration applications to the NMPA for its third-generation long-lasting TAVR product, TaurusNXT®, and its Transcatheter Edge-to-Edge Repair (TEER) product, GeminiOne®. Concurrently, patient enrollment accelerated for the registrational clinical trial of the Transcatheter Mitral Valve Replacement (TMVR) product, HighLife®. Furthermore, the Group's self-developed TAVR robotic assistance system, ReachTact®, officially initiated its registrational clinical trial.
In overseas markets, the Group also steadily advanced regulatory submissions and clinical studies. The GeminiOne® TEER system has been submitted for EU MDR CE Mark registration. The intravascular lithotripsy system for treating Mitral Annular Calcification (MAC) showed preliminary positive results in early clinical studies conducted overseas. The MonarQ TTVR® system has initiated a global clinical study, while the Sutra Hemi-Valve TMVR system has entered the First-in-Man (FIM) trial stage. Additionally, both the ReachTact® TAVR assistance system and the intravascular lithotripsy system were included in the NMPA's Innovative Medical Device Special Approval Procedure ("Green Channel") during the reporting period. As of December 31, 2025, the Group had a total of seven products in the transcatheter valve therapy field entering the Green Channel, ranking first in the industry, fully demonstrating the platform's capability for source innovation.
The Group anticipates several key advancements in 2026: the potential approval and launch of the third-generation TAVR product in China, and potential regulatory approvals for the TEER product in both China (NMPA) and Europe (EU MDR). With its continuously expanding innovation pipeline and growing cross-indication commercialization capabilities, the Group is well-positioned to further consolidate its technological leadership and expand its strategic presence in the global market.
**Transcatheter Valve Therapy Business Achieves Commercial Profit; Operational Efficiency Improves** Benefiting from continued market share expansion in China's TAVR market, the Group's revenue from TAVR-related products reached RMB 290 million during the reporting period, an increase of 11.6% year-on-year. The successful launch of the premium TaurusMax® 3D steerable TAVR system effectively contributed to sales growth. Benefiting from the Group's tiered product portfolio strategy and pricing, coupled with effective control over cost of sales, the overall gross margin for the transcatheter valve therapy business remained stable at 78.7% during the period.
Driven by improved sales team efficiency, more rational industry competition, and expense savings from refined operations management, sales and distribution expenses decreased by 4.6% year-on-year to RMB 222 million. The sales and distribution expense ratio decreased by 13.0 percentage points year-on-year to 76.5%. Consequently, the business achieved a commercial profit (gross profit minus sales and distribution expenses) of RMB 6.45 million during the reporting period.
Regarding R&D expenses, with the completion of three registrational clinical trials (partially offset by accelerated enrollment for the HighLife® TSMVR system registrational trial), these expenses decreased by 3.4% year-on-year to RMB 120 million. The R&D expense ratio was 41.4%, down 6.4 percentage points year-on-year. Administrative expenses also decreased, by 15.3% year-on-year to RMB 102 million, through strengthened budget control, continued cost-saving measures across support functions, and the non-recurrence of one-off expenses recognized in 2024. The administrative expense ratio was 35.1%, down 11.1 percentage points year-on-year.
Overall, the three operating expense lines for this segment were effectively controlled and decreased compared to the prior year, indicating that operating leverage is beginning to be released. Driven by this, the segment's loss narrowed further by 20.2% year-on-year to RMB 216 million. As new products successively enter the commercialization phase, they are expected to further leverage synergies with the existing commercial and administrative systems. Simultaneously, as core products advance into later-stage registration or clinical phases, the segment's profitability is anticipated to accelerate its improvement.
Dr. Zhang Yi, Chairman and CEO, commented, "2025 was a year of steady progress and accumulating strength for Peijia. The commercial capabilities of our valve business continued to strengthen. The approval of the regurgitation valve, along with the mitral clip and third-generation valve entering the registration phase, gives us greater confidence in future development and marks Peijia's further expansion of growth space in the field of transcatheter valve therapy. The profit release from the neurointervention business is accelerating, gradually becoming a key pillar of stable growth for the Group. 2026 will be a critical year, presenting both new opportunities and higher requirements. We will continue to go all out to explore the market, solidly strengthen our internal capabilities, and diligently accomplish our tasks one by one. The road may be long, but walking it will bring us to the destination; the task may be difficult, but doing it will lead to success. We will continue to advance steadfastly with our feet on the ground, protecting lives through innovation and rewarding trust with value."