As its neurointervention business becomes the core profit driver and its valvular business crosses the commercial profitability threshold for the first time, the dual-engine strategy of Peijia-B (09996) focusing on "neurointervention + valve therapy" has transitioned from concept to reality. Meanwhile, its rapidly advancing globalisation efforts and continuous stream of differentiated innovations are granting this innovative medical device leader even greater potential.

In recent years, the expansion of China's volume-based procurement (VBP) system has significantly accelerated the reshuffling of the medical device industry. Despite the rapidly changing external environment, Peijia-B has managed to achieve financial improvements with "increased revenue and reduced losses." While enhancing its profit structure, the company has also established a clear path to profitability. This acceleration in performance is underpinned by its consistent delivery of innovations and breakthroughs in overseas markets.

Valve Portfolio Takes Shape, Poised for Intensive Harvest

With its rapid commercialisation progress in recent years, stable and fast revenue growth, and a well-rounded, highly competitive product pipeline, Peijia-B has solidified its position as a leading brand in China's transcatheter valve intervention therapy sector.

Taking the transcatheter aortic valve replacement (TAVR) segment as an example, Peijia-B's core value as an industry leader is reflected in its higher R&D efficiency and market share. From a market perspective, the number of patients with valvular heart disease in China is projected to reach 40.2 million by 2025, yet annual surgical procedures number less than 100,000. The market size is approximately RMB 3 billion, with TAVR penetration in China at only 1% (far below the over 15% rate in the US), indicating a vast unmet demand. High treatment costs remain a primary constraint. However, influenced in recent years by breakthroughs in local medical insurance policies and the expansion of VBP, TAVR has entered a new pricing cycle.

Even so, Peijia-B's pipeline products have continued to see volume growth after price adjustments in the aortic stenosis (AS) indication. The core reason lies in its higher R&D efficiency, which has enabled the company to establish a tiered product portfolio for AS: "TaurusOne (basic), TaurusElite (retrievable), and TaurusMax (premium)." This means that within the same price segment, the Taurus series can leverage superior performance to create a more significant "generational advantage" over competing products.

Furthermore, this comprehensive tiered product layout allows Peijia-B to flexibly implement reasonable production, sales, and pricing strategies across the lifecycle of its portfolio based on market dynamics. This approach expands market accessibility while solidifying its moat through a "volume-for-price" strategy.

Beyond strengthening its leadership in the AS segment, Peijia-B is also accelerating its expansion into the aortic regurgitation (AR) indication. In December last year, the company's TaurusTrio transcatheter aortic valve system received approval in China, becoming the country's first integrated positioning key transfemoral access device specifically for AR intervention. This marks a pioneering "leadership" leap for China in the field of minimally invasive AR treatment. The product began ramping up in the first half of this year, driven by Peijia-B's efficient commercial execution.

It is understood that TaurusTrio has achieved hospital formulary inclusion in 97% of Chinese provinces and completed physician training, with cumulative implants in over 200 hospitals. Nearly 100 online and offline academic training sessions have been conducted, covering more than 800 experts. As of June this year, TaurusTrio implants accounted for over 30% of Peijia-B's total TAVR implant volume, with expectations for further increases.

Driven by the scaling of both AS and AR products, Peijia-B's TAVR implant volume accelerated, with cumulative implants exceeding 2,800 cases in the first half of the year, representing a significant year-on-year increase of approximately 37%. According to information disclosed by the company at its corporate open day on July 3rd, Peijia-B achieved a 28% market share in the transfemoral TAVI market in the first half of the year, securing the top market position.

Another highlight of Peijia-B's valvular business is that its full-valve portfolio is taking shape, with a clear treatment matrix covering "all-valve" diseases becoming visible. Supported by efficient innovative R&D capabilities, the company has built a comprehensive diagnostic and therapeutic network covering "aortic, mitral, and tricuspid" anatomical positions. In terms of pipeline breadth (coverage of valve disease types) and depth (technology platforms and reserves), it now rivals international giants like Edwards Lifesciences.

In the domestic market, with four commercialised products and nine products at various R&D stages, Peijia-B's valvular business pipeline is among the largest in China, and its pipeline types are more comprehensive than those of other domestic peers. Continuous technological breakthroughs and patent accumulation are bringing the company closer to an intensive harvest period for its valvular business.

According to company disclosures, the registration application for TaurusNXT was accepted by China's National Medical Products Administration (NMPA) in December last year and included in the innovative medical device special review process. The GeminiOne system has submitted its EU MDR CE Mark registration application, with approval expected by year-end, and its US Early Feasibility Study (EFS) is ongoing. The global clinical study for the MonarQ TTVR system is also underway, with over 40 clinical trial cases conducted across nine centres in the US, Canada, and Europe.

Notably, as the only domestic transcatheter edge-to-edge repair (TEER) product to break through the Freedom-to-Operate (FTO) patents of Abbott's MitraClip and Edwards' PASCAL, the GeminiOne system, upon successful approval, is expected to unlock billions in incremental market value for Peijia-B.

Unlocking Global Value, Accelerating Scale Growth

In recent years, accelerating overseas expansion to unlock a second growth curve has become a "must-have" strategy for leading domestic neurointervention companies. However, in choosing its globalisation path, Peijia-B did not follow the trend of domestic peers targeting emerging markets like Latin America and Southeast Asia. Instead, it chose to directly compete with multinational giants by entering high-paying, premium markets in Europe and the US to unlock deeper global value.

In March this year, the DCwire micro-guidewire, independently designed and developed by Peijia-B's subsidiary Jiaqi Biotech, obtained FDA 510(k) clearance. This clearance, a mandatory entry certificate for Class II medical devices in the US, is a key gateway for Chinese medical devices to enter the formal North American healthcare supply chain.

The FDA certification, one of the core barriers to entering the global high-end medical market, serves as a touchstone for a product's true capabilities. Its review system imposes high requirements on clinical data quality, product design, and patient benefits. Therefore, obtaining such certification not only signifies market access for a domestic company but also serves as an independent endorsement of its technological prowess.

This approval marks the first FDA 510(k) clearance for a Chinese neurointervention micro-guidewire since the tightening of US FDA regulations, and it is also the first overseas registration certificate for Peijia-B. The DCwire micro-guidewire has thus officially entered the high-barrier US market, signifying a critical step for domestic innovative micro-guidewires onto the international stage and representing a major milestone in Peijia-B's global expansion.

As the company continues to increase its focus on overseas markets, optimistic estimates suggest that by 2030, overseas revenue could account for 50% of Peijia-B's total. The confidence to compete in premium European and American markets and unlock global value stems from its technology and operational advantages, which have already been validated in the domestic market.

Taking the DCwire micro-guidewire, which recently secured US clearance, as an example, the product saw its domestic market share expand significantly in 2025 due to its excellent performance, with sales revenue surging nearly 140% year-on-year. The company revealed that in the first half of 2026, implant volume for this product increased by over 50% year-on-year again.

Peijia-B's R&D focus in neurointervention has entered a phase of original development targeting unmet global clinical needs. Leveraging its high R&D efficiency, the company has deployed 14 commercialised products and 8 products under development across three major product lines, presenting a pattern of "leading in access, incremental in ischemia, and stable in hemorrhage." This has made the neurointervention business the cornerstone for solidifying the company's profitability and resisting policy fluctuations.

Furthermore, Peijia-B is enhancing economies of scale by optimising its product structure and expanding market coverage. Following exclusive distribution agreements for products like YonFlow flow-diverter stents, the company's subsidiary Jiaqi Biotech entered into an exclusive distribution agreement with B. Braun Melsungen AG on June 1st this year. This grants Peijia-B exclusive distribution rights for B. Braun's SeQuent Please CIS Paclitaxel-Coated Intracranial Balloon Dilation Catheter in mainland China, further enriching its neurointervention product portfolio and consolidating its leading position in the neurovascular intervention market.

Major Shareholder Buying and Profit Outlook Bolster Confidence

Since the second half of 2025 through the first half of this year, the Hong Kong stock market's innovative pharmaceutical and medical device sector shifted from its previous bull market state into a volatile downtrend, experiencing a sustained decline especially after mid-April. The Hang Seng Healthcare Index fell continuously after mid-April, hitting an intraday low of 2938.07 points on June 22nd. Over a longer timeframe, from the second half of 2025 to the present, the index has seen a maximum decline of over 35%.

This prolonged decline in the Hong Kong healthcare sector stems from a confluence of factors including capital flows, market sentiment, and geopolitics. However, the result has been the mispricing of stocks, including Peijia-B, with fundamentally sound innovative medical companies seeing their share prices unduly punished.

Confronted with market uncertainties, Peijia-B's major shareholder chose to continue increasing their stake, sending a positive signal to the market about the urgent need to reassess the company's intrinsic value. Since December last year, the company's Chairman and CEO, Zhang Yi, has made 21 separate purchases, accumulating 4.554 million shares with a total investment exceeding HKD 25 million. This fully demonstrates the management's sincere commitment to shareholder responsibility.

Coupled with the performance guidance provided at the corporate open day, stating the "entire group is expected to reach breakeven in 2026," this also reflects greater management confidence in the company's future development.

Concluding Remarks

Investors can clearly see that as the R&D pipeline and international layout deepen, the comprehensive and deep-seated industrial synergy benefits brought by Peijia-B's "internal and external cultivation" have become evident, helping the company complete its transformation from an industry "follower" to a "leader."

Although Peijia-B currently possesses a clear systematic competitive advantage, the market has yet to assign it a reasonable valuation. The company's current price-to-sales (P/S) ratio is only 3.45x, which is not only below the industry average but also below its own historical valuation centre in recent years, indicating it remains undervalued. This discrepancy has been noted by research institutions.

CICC previously pointed out that looking ahead to 2026, the company is expected to reach a key inflection point for earnings growth, with revenue acceleration and a full-year turnaround to profitability on the bottom line. The firm stated that as products like the TaurusTrio for AR continue commercial scaling, and several major innovative products such as the third-generation TAVR product TaurusNXT and the mitral valve edge-to-edge repair product GeminiOne are expected to receive approval within 2026, the company's product portfolio in structural heart disease will continue to enrich, further consolidating its technological leadership and long-term competitiveness.