Nanjing Novlead Biotechnology HKEX filing lapsed; core product iNOwill is world's first electrochemical catalytic iNO therapy device

NewTimeSpace News: Nanjing Novlead Biotechnology Co., Ltd. filed with HKEX on 13 February 2026 with CCB International as sole sponsor, which lapsed after six months. The Company is the world's only enterprise covering a complete product line across NO therapeutic and diagnostic applications; core product iNOwill is the world's first electrochemical catalytic iNO therapy device (No. 1 by market share in China's iNO therapy market in 2024), with 5 approved products and 4 pipeline candidates.

NewTimeSpace News: Nanjing Novlead Biotechnology Co., Ltd. filed its listing application with HKEX on 13 February 2026, which has lapsed after six months; CCB International acted as sole sponsor at the time of filing. Incorporated in 2018, the Company is a global leader in gas-based cardiopulmonary diagnosis and treatment equipment, focusing on the R&D and commercialisation of inhaled nitric oxide (iNO) therapy. Through its precision gas-liquid control technology platform, the Company has built full-chain capabilities covering NO generation, delivery, detection, storage and clinical application, and is one of the few companies worldwide with self-controllable full-chain NO technology and the only one covering a complete product line across both NO therapeutic and diagnostic applications.

The Company has 5 approved products and 4 pipeline candidates spanning intensive care, ward, outpatient and home-based disease management, organised into three product lines: iNO therapy, cardiopulmonary circulatory support and exhaled breath diagnosis. All products are developed in-house with global exclusive rights. Core product iNOwill, approved by the NMPA in 2022 and CE-certified in the EU in 2025, is mainly used for acute intensive care of severe cardiopulmonary diseases such as pulmonary arterial hypertension; it is the world's first approved electrochemical catalytic iNO therapy device and China's first approved portable iNO device, ranking first by sales revenue in China's iNO therapy market in 2024. Key product NovaPulse intra-aortic balloon pump (IABP) is China's first approved domestically developed pneumatic IABP for cardiovascular and perioperative care.

As of the latest practicable date, the R&D team comprised 50 employees, approximately 31.7% of total headcount, led by Chief Executive Officer Dr. Mao and Chief Technology Officer Mr. Zhang Yuyan. R&D expenses were approximately RMB 33.0 million for the year ended 31 December 2024 and RMB 20.7 million for the nine months ended 30 September 2025, of which RMB 12.3 million and RMB 7.8 million were attributable to the core product, accounting for 37.37% and 37.42% of total R&D costs respectively. Commercialised products include iNOwill, eNOaire, NovaPulse IABP, Reslink and eNOglow, with production facilities in Yangzhou, Jiangsu Province (approximately 2,200 sqm) and Fangchenggang, Guangxi Zhuang Autonomous Region (approximately 1,400 sqm).

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