Novlead Biotech files re-application with HKEX; core product iNOwill certified in China and EU, with five approved products spanning cardiopulmonary care scenarios

NewTimeSpace News: On 28 August 2026, Nanjing Novlead Biotechnology Co., Ltd. re-filed its listing application with HKEX. Incorporated in 2018, the Company operates in the gas cardiopulmonary device market, focusing on the R&D and commercialization of inhaled nitric oxide (iNO) therapy. As of the last practicable date, it has five approved products (including its core product iNOwill) and five drug/device candidates in development, covering critical care, ward, outpatient and home-based disease management in the cardiopulmonary diagnosis and treatment field, forming three product lines — iNO therapy, cardiopulmonary circulatory support and exhaled breath diagnostics — with all products developed in-house.

The Company's core product iNOwill received approval from the NMPA in 2022 and EU CE certification in 2025. It delivers iNO as a selective pulmonary vasodilator that, while not curative, primarily provides support in acute critical care settings to patients with severe cardiopulmonary diseases such as pulmonary arterial hypertension requiring ICU and bedside care. Although the core product currently targets a specific patient subgroup with a relatively limited addressable market, the Company is seeking to expand the indications of iNOwill to broaden its potential clinical applications and target patient population, subject to successful clinical development and regulatory approval.

In terms of R&D, the Company's R&D team is led by Chief Executive Officer Dr. Mao and Chief Technology Officer Mr. Zhang Yuyan, comprising 47 employees as of the last practicable date, representing approximately 27.5% of total headcount. R&D expenses amounted to approximately RMB 33.0 million, RMB 34.7 million, RMB 13.7 million and RMB 20.3 million for 2024, 2025, and the six months ended 30 June 2025 and 2026 respectively, of which approximately RMB 12.3 million, RMB 14.5 million, RMB 5.1 million and RMB 8.7 million were attributable to the core product, representing 37.4%, 41.8%, 37.2% and 42.9% of total R&D costs in the respective periods.

In terms of production, during the track record period, the Company's commercialized products mainly include iNOwill, eNOaire, NovaPulse IABP, Reslink and eNOglow. As of 30 June 2026, the Company operated two principal production facilities, located in Yangzhou, Jiangsu Province and Fangchenggang, Guangxi Zhuang Autonomous Region, with total floor areas of approximately 2,200.0 square meters and 1,400.0 square meters respectively.

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