诺令生物递表港交所 为全球少数能够实现NO全链路技术自主可控的企业之一

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].