On June 24, Gelonghui announced that Smart Cloud Health (09955.HK) has signed a license agreement with the licensor (Clinect Pty Ltd) and seller (Bluefly Consulting Limited) on June 23, 2024. Accordingly, the seller agrees to transfer the exclusive sub-license previously granted by the licensor to the company for use of the licensed IP in the region for development, manufacturing, promotion, advertising, distribution, and sale of products; the licensor has agreed to the transfer and to grant the company an exclusive sub-license to only use the licensed trademark when manufacturing, promoting, advertising, distributing, selling, and using products in the region.
The product refers to the infusion of iloprost solution, including any form, expression, strength, concentration, administration technology, dosage, formulation, packaging configuration, and mode. Iloprost is a prostacyclin analogue. Its injection was launched in 2001 and inhalation was launched in 2003. Iloprost injection is available in countries such as the United States, the United Kingdom, the Netherlands, the Czech Republic, Israel, and New Zealand. The product developed by the licensor is the only generic drug in the world, and there is no injection product with the same content in the Chinese market yet.
Given that the product qualifies as an orphan drug, it will be allowed to accelerate approval and review through the priority review and approval plan, thus shortening the time to market. After the product is approved for marketing, it is expected to meet the clinical needs of patients with severe pulmonary arterial hypertension with New York Heart Association (NYHA) Class IV heart failure for prostacyclin analogue injection therapy; improve blood supply in patients with thromboangiitis obliterans (also known as Buerger's disease); and alleviate symptoms and improve quality of life in patients with peripheral arterial occlusive disease.
The company believes that the license agreement and the development, manufacturing, promotion, advertising, distribution, and sale of products in the region can expand the group's patent product portfolio, strengthen its R&D capabilities, and deepen its strategic cooperation with pharmaceutical companies. This marks another step forward in our P2M (patient to market) strategic implementation. It is expected to bring additional sources of revenue to the group in the future and contribute to the group's long-term growth and success.