Nuo Ling Biotech, formally known as Nanjing Nuo Ling Biotech Co., Ltd., has submitted a fresh application to the Main Board of the Hong Kong Stock Exchange on August 28, with CCB International serving as its sole sponsor. The company, which specializes in gas cardiopulmonary medical devices, has built its commercial strategy in mainland China around a model that blends academic promotion with a network of distributors and agents. As of the latest practicable date, this approach has enabled the firm to establish a presence across all 31 provinces nationwide and gain entry into close to 700 hospitals.

Looking beyond domestic borders, the company has adopted distinct strategies tailored to both emerging and more developed overseas markets. Its products have already achieved commercial rollout in ten foreign countries and territories, including France and Hungary, as of the latest practicable date.

Company Overview

Founded in 2018, the group focuses on the research, development, and commercialization of inhaled nitric oxide (iNO) therapy within the gas cardiopulmonary device sector. The company currently holds approval for five products, with its core offering being iNOwill, alongside a pipeline of five candidate products in development. These span the cardiopulmonary diagnosis and treatment spectrum, covering intensive care, general wards, outpatient settings, and home-based disease management, organized across three main product lines: iNO therapy, cardiopulmonary circulatory support, and exhaled breath diagnostics. All of the company's products are the result of in-house research and development efforts.

Within the iNO therapy segment, the flagship product iNOwill secured approval from China's National Medical Products Administration in 2022 and later obtained CE certification in Europe in 2025. This device is primarily designed for ICU environments, where inhaled nitric oxide is administered to support patients needing acute ventilation and pulmonary vascular management. Leveraging its proprietary real-time nitric oxide generation technology, the company is working to broaden the therapy's indications beyond pulmonary arterial hypertension to include ARDS, COPD, and CAP. The ultimate ambition is to extend iNO therapy from its current ICU-centric applications to a wider array of respiratory disease management scenarios across the entire cardiopulmonary care continuum.

In the cardiopulmonary circulatory support line, the key product NovaPulse IABP gained NMPA approval in 2025. This device is engineered for mechanical circulatory support in ICUs, operating rooms, and catheterization labs, where respiratory and circulatory assistance are frequently delivered in tandem. From a clinical standpoint, iNO therapy offers pulmonary vascular support by reducing pulmonary vascular resistance and right ventricular afterload, whereas IABP provides temporary circulatory support by lowering left ventricular afterload and boosting coronary artery perfusion. NovaPulse and iNOwill are designed to complement one another, allowing the company to address both respiratory and circulatory needs within the same critical care workflow. This synergy is intended to reinforce its clinical strengths in ICU and perioperative care while expanding its presence in cardiopulmonary critical care.

On the exhaled diagnostics front, the company is developing a pulmonary function diagnostic platform called PElink, designed to support disease assessment and long-term monitoring from hospital settings to outpatient clinics and eventually home-based care. PElink, together with VQfit—a portable iNO candidate intended for outpatient and home use—is expected to facilitate at-home diagnosis, treatment, and longitudinal tracking of chronic respiratory conditions. During the track record period, the company's commercialized products primarily included iNOwill, eNOaire, NovaPulse IABP, Reslink, and eNOglow. As of June 30, 2026, the firm operates two main manufacturing facilities, one in Yangzhou, Jiangsu Province, and another in Fangchenggang, Guangxi Zhuang Autonomous Region, with approximate floor areas of 2,200.0 square meters and 1,400.0 square meters, respectively.

Financial Highlights

The company generated revenues of approximately RMB 45.547 million, RMB 63.207 million, and RMB 58.132 million for the fiscal years 2024 and 2025, and the six-month period ended June 30, 2026, respectively. Gross profit for the same periods reached roughly RMB 27.012 million, RMB 35.36 million, and RMB 34.75 million, translating to gross margins of 59.3%, 55.9%, and 59.8%. The company recorded net losses of approximately RMB 86.246 million for 2024, RMB 95.271 million for 2025, and RMB 51.864 million for the first half of 2026.

Market Context

The global iNO treatment market was valued at an estimated US$1,054.1 million in 2025. Projections indicate this figure could climb to roughly US$1,580.4 million by 2030 and US$2,721.0 million by 2035, representing compound annual growth rates of about 8.4% and 11.5%, respectively. Growth patterns vary considerably based on market maturity. The US and EU represent relatively established iNO markets with high current adoption rates and well-integrated neonatal and critical care workflows, where growth is expected to derive primarily from repeat usage, device replacement cycles, and gradual uptake of newer delivery systems. In contrast, China and other parts of the world start from significantly lower penetration levels, offering greater upside in terms of hospital adoption, increased therapeutic utilization, and improved accessibility. Longer-term expansion also hinges on extending the therapy to new indications and care settings, subject to supportive clinical evidence and regulatory approvals.

The global iNO therapy market is undergoing a shift in delivery methods, transitioning from traditional cylinder-based gas supply toward real-time generation systems. Between 2020 and 2025, the cylinder segment grew from US$830 million to US$940 million, a CAGR of 2.5%, supported by workflow inertia in the US and EU and the availability of low-cost industrial cylinders. Pharmaceutical-grade cylinders remain clinically preferred for their quality assurance, yet they are supplied by only a handful of medical gas providers. Over the same period, real-time generation expanded from US$60 million to US$110 million, posting a CAGR of 13.2%. Looking ahead to 2030, real-time generation is projected to reach US$490 million with a CAGR of 34.2%, driven by its portability and simplified logistics, which have allowed usage to broaden from neonatal applications to adult and non-traditional departments. The technology is also beginning to carve out specific downstream and home-adjacent use cases in managing chronic respiratory conditions such as COPD, thereby widening the treatable patient population. By 2035, real-time generation is expected to grow to US$1.40 billion at a CAGR of 23.3%, narrowing the gap with cylinder workflows and partially replacing them.

This transformation is even more pronounced in China, where high import costs have hindered widespread adoption of traditional cylinder-based iNO therapy. As a result, the delivery mix is shifting rapidly, with domestically produced real-time generation devices becoming the dominant delivery mode shortly after market entry, supported by guideline recognition and market education. The Chinese iNO treatment market was estimated at approximately RMB 90.1 million in 2025, with projections reaching around RMB 478.4 million by 2030 and RMB 2,959.4 million by 2035, corresponding to CAGRs of roughly 39.6% and 44.0%. This anticipated growth primarily reflects rising treatment penetration from a low base, broader hospital and system adoption, increasing utilization of real-time generation systems, and gradual expansion into other indications over time, rather than growth driven solely by the relevant disease population.

Board Composition and Ownership Structure

The board consists of nine directors, including three executive directors, three non-executive directors, and three independent non-executive directors. In accordance with the company's articles of association, directors are elected and appointed by shareholders at general meetings for three-year terms and may serve consecutive terms through re-election and re-appointment.

As of the latest practicable date, Dr. Mao directly held approximately 7.14% of the company's issued shares, Jingning Nuoling directly held about 21.41%, and Lingxing Hainan directly held roughly 0.71%. Jingning Nuoling is owned 21.12% by Dr. Mao as a limited partner, with its general partner being Nanjing Miyu Technology Co., Ltd., a company wholly owned by Dr. Mao. Furthermore, Jingning Nuoling holds a 14.23% interest in Jingning Nuoming, which in turn is 53.33% owned by Nanjing Miyu as general partner. No other limited partner holds a partnership interest of 30% or more in Jingning Nuoling. Consequently, Dr. Mao is entitled to full control over the voting rights that Jingning Nuoling can exercise in the company. Lingxing Hainan is owned 45.14% by Dr. Mao as a limited partner, with executive director Mr. Zhang Yuyan serving as general partner, who has delegated his voting rights as general partner of Lingxing Hainan to Dr. Mao under a proxy dated December 10, 2025. Dr. Mao thus has full control over the voting rights exercisable by Lingxing Hainan. As a result, under the Securities and Futures Ordinance, Dr. Mao is deemed to be interested in the shares held by Jingning Nuoling and Lingxing Hainan.

The company's single largest shareholder group comprises Dr. Mao, Jingning Nuoling, Mr. Cao Guiping, and Lingxing Hainan. As of the latest practicable date, these parties held approximately 7.14%, 21.41%, 5.35%, and 0.71% of the company's issued shares, respectively, for a combined total of around 34.61%. Pursuant to a concert party agreement dated October 10, 2021, among Dr. Mao, Mr. Cao Guiping, Jingning Nuoling, and Lingxing Hainan, the parties have agreed to act in concert with respect to their voting rights as shareholders of the company, with Dr. Mao's opinion prevailing in the event of any divergence.

Advisory Team

Sole sponsor and sponsor-arranger: CCB International Capital Limited. Overall coordinators: CCB International Capital Limited and CMB International Capital Management Limited. Legal advisors to the company: Davis Polk & Wardwell for Hong Kong and US law, and Jingtian & Gongcheng Law Firm for PRC law. Legal advisors to the sole sponsor: Deacon & Co. for Hong Kong and US law, and Commerce & Finance Law Offices for PRC law. Reporting accountants and auditors: Deloitte Touche Tohmatsu. Industry consultant: Frost & Sullivan Consulting Co., Ltd. Compliance advisor: Hupo Capital Limited.