Core Viewpoint - Nanjing Noling Biotechnology Co., Ltd. is set to become the first company in the nitric oxide (NO) therapy sector to go public on the Hong Kong Stock Exchange, focusing on innovative medical devices for critical care [2][3]. Company Overview - Founded in April 2018, Noling Biotech specializes in inhaled nitric oxide (iNO) therapy, with its core product aimed at treating pulmonary hypertension and other critical conditions [2][3]. - The company has developed a comprehensive technology platform for NO, covering generation, transmission, detection, storage, and clinical application, making it one of the few globally to achieve full control over the NO technology chain [3][19]. Product and Market Position - Noling's flagship product, iNOwill, is projected to lead the domestic iNO treatment market in 2024, with expected revenue of 45.547 million yuan [3][29]. - The company has five products approved and four in development, with a presence in nearly 700 hospitals across 31 provinces in China and exports to ten countries [3][24]. Financial Performance - In 2024, the company anticipates revenues of 45.547 million yuan, with a significant portion of its revenue coming from the iNO treatment devices [29][31]. - The company has experienced substantial growth in valuation, increasing from approximately 50 million yuan at the angel round to 1.648 billion yuan in the C round, representing a growth of over 32 times [34]. Investment and Shareholding - Major external shareholders include Lilly Asia Ventures and Northern Light Venture Capital, holding 12.08% and 11.43% of shares, respectively [4]. - The company has completed multiple funding rounds, attracting investments from various venture capital firms and local government funds [34][35]. Industry Context - The global iNO treatment market is projected to grow from 1.02 billion USD in 2024 to 1.64 billion USD by 2030, with a compound annual growth rate of 8.3% [38]. - The shift towards portable, on-demand NO delivery systems is expected to drive market growth, as traditional high-pressure cylinder systems are being replaced [41]. Strategic Direction - Noling aims to expand its indications from pulmonary hypertension to other respiratory diseases such as ARDS and COPD, and to penetrate various healthcare settings from ICUs to home care [42]. - The company is also focused on global market expansion, with plans for FDA submissions for its products in North America and ongoing commercialization efforts in Asia and Europe [42].

Core Viewpoint - Nanjing Noling Biotechnology Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on the research and commercialization of inhaled nitric oxide (iNO) therapy, with a comprehensive technology platform covering the entire chain of nitric oxide (NO) generation, transmission, detection, storage, and clinical application [1][3]. Company Overview - Noling Biotechnology has five approved products and four candidates in development, targeting critical care, ward, outpatient, and home disease management in the cardiopulmonary field [3]. - The core product, iNOwill, received approval from the National Medical Products Administration in 2022 and is expected to gain EU CE certification in 2025, primarily for use in acute critical care for severe cardiopulmonary diseases [3][4]. - Noling is one of the few companies globally capable of achieving autonomous control over the entire NO technology chain and is the only company with a comprehensive product line covering both NO treatment and diagnostic applications [1][3]. Product Pipeline - The iNOwill device is a portable iNO treatment system that generates medical-grade NO on-site and integrates NO generation, delivery, and real-time monitoring into a single system [4]. - NovaPulse IABP, another key product, is designed for cardiovascular and perioperative care, registered as a Class III medical device in China since September 2025 [4][6]. Financial Information - For the fiscal year ending December 31, 2024, the company reported revenues of approximately RMB 45.547 million, with a gross profit margin of 59.3% [7][10]. - The company incurred a loss of approximately RMB 86.246 million for the same period, with a significant portion attributed to research and development expenses [9][10]. Market Overview - The global iNO therapy market is transitioning from cylinder delivery to real-time generation systems, with the latter expected to grow from approximately USD 100 million in 2024 to USD 550 million by 2030, reflecting a compound annual growth rate (CAGR) of 32.8% [11][12]. - The IABP market in China is projected to expand rapidly, from RMB 313.1 million in 2020 to RMB 641.4 million in 2024, with a CAGR of 19.6% [12][13].

Company Overview - Nanjing Noling Biotechnology Co., Ltd. ("Noling Bio") submitted its listing application to the Hong Kong Stock Exchange on February 13, with Jianyin International as the sole sponsor [1] - Noling Bio focuses on the research and commercialization of inhaled nitric oxide (iNO) therapy, having developed a comprehensive technology platform covering the entire chain of nitric oxide (NO) generation, transmission, detection, storage, and clinical application [1][3] - The company has five approved products and four candidates in development, covering critical care, ward, outpatient, and home disease management [3] Product Lines - Noling Bio's product lines include: 1. iNO therapy 2. Cardiopulmonary support 3. Exhaled breath diagnostics [3] - The core product, iNOwill, received approval from the National Medical Products Administration in 2022 and is expected to gain EU CE certification in 2025, primarily for use in acute critical care for severe cardiopulmonary diseases [3][4] - NovaPulse, another key product, is the first domestically approved pneumatic intra-aortic balloon pump (IABP) in China, designed for cardiovascular and perioperative care [4] Financial Performance - For the fiscal year ending December 31, 2024, the company reported revenues of approximately RMB 45.547 million, with a gross profit margin of 59.3% [6][9] - The company incurred a loss of approximately RMB 86.246 million for the same period, with a significant portion attributed to research and development expenses [8][9] - As of September 30, 2025, the company reported revenues of approximately RMB 31.565 million and a gross profit margin of 49.9% [7][9] Market Overview - The global iNO therapy market is transitioning from cylinder delivery to real-time generation systems, with the latter expected to grow from approximately USD 100 million in 2024 to USD 550 million by 2030, reflecting a compound annual growth rate (CAGR) of 32.8% [10][11] - The IABP market in China is projected to grow from RMB 313.1 million in 2020 to RMB 641.4 million in 2024, with a CAGR of 19.6%, and is expected to reach RMB 1.3709 billion by 2030 [11][12] Technology Platform - Noling Bio's precision gas-liquid control technology platform integrates NO generation, real-time gas sensing and monitoring, and software-enabled fluid control to ensure accurate handling of gaseous and liquid media in various clinical scenarios [4] - The iNOwill device is a portable iNO treatment system that generates medical-grade NO on demand, integrating NO generation, delivery, and real-time monitoring into a single system [4]

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