The holding subsidiary’s cyclosporine eye drops have been approved for clinical trials, accelerating its strategic transformation toward high-end products.

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2026-01-28


Recently, Huonland, a subsidiary of NORTHLAND Holdings, successfully passed the review by the National Medical Products Administration for its 0.05% cyclosporine eye drops (II), which were filed under Category 3 of chemical products. Huonland has been granted the "Notice of Approval for Clinical Trials of Drugs" (Notice No.: 2026LP00228). This milestone marks another significant step in Huonland's strategic upgrade—from a generic drug manufacturer to a high-end ophthalmic formulation R&D enterprise.

Cyclosporine ophthalmic formulations are primarily used for ocular surface inflammatory diseases such as dry eye syndrome and vernal keratoconjunctivitis. Cyclosporine eye drops (Type II), as a targeted immunosuppressive ophthalmic drug, exerts its core therapeutic effect by precisely inhibiting ocular surface inflammatory responses and promoting tear secretion. It is particularly well-suited for patients with tear-deficient dry eye syndrome caused by ocular inflammation associated with keratoconjunctivitis sicca and represents one of the preferred treatment options currently available for clinical management of dry eye syndrome. Data indicate that the global prevalence of dry eye syndrome ranges from 5% to 50%, while in China, the prevalence has reached as high as 21.0% to 52.4%, resulting in an enormous patient population. In 2024, the overall domestic eye drop market had already reached a scale of 13.1 billion yuan, with the sub-market segment related to dry eye syndrome and eye fatigue accounting for as much as 42.22%—a market size exceeding 5.7 billion yuan. With the widespread adoption of electronic devices and the accelerating aging population, the dry eye syndrome market exhibits robust demand and broad growth prospects.

The cyclosporine eye drops (Phase II) recently approved for clinical trials have a product specification of 0.05% (0.4 ml: 0.2 mg). Classified as a Class 3 chemical drug, this is a high-end generic drug submitted under the new-drug approval pathway. Compared to the original branded product, which uses a traditional emulsion formulation, Huonland’s cyclosporine eye drops represent an innovative breakthrough in formulation design. Leveraging its independently developed nano-microemulsion technology platform, the company has innovatively created a transparent microemulsion formulation. By precisely controlling the particle size of the drug, this formulation significantly enhances ocular compatibility—greatly reducing ocular irritation and making the medication more comfortable for patients. Moreover, it better meets the core needs of dry-eye syndrome patients who require long-term use. The key technologies underlying this product have already been successfully patented at the national level, fully demonstrating the company’s innovative capabilities, technological expertise, and core competitiveness in the field of ophthalmic drug formulation development.

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