On June 30, the official website of the National Medical Products Administration showed that Kanghong Pharmaceutical's Lifitegrast Eye Drops (trade name: Langyueming) was launched exclusively in China as a Category 3 new drug, which will provide a new option for the treatment of dry eye.
With the popularization of electronic devices, the acceleration of aging, and bad eye habits, the incidence of dry eye in China has been increasing year by year. The number of people suffering from dry eye or dry eye symptoms in China exceeds 300 million. According to the research report of Huajing Industry Research Institute, the domestic dry eye drug market scale reached 4.79 billion yuan in 2024, with a compound annual growth rate of 16.17% from 2020 to 2024, providing a huge market space for the development of dry eye drugs.
Inflammatory response is a driving factor of ocular surface damage in the pathological process of dry eye and can induce a vicious cycle of dry eye. Lifitegrast is a new type of small-molecule integrin inhibitor. It binds to integrin LFA-1 (lymphocyte function-associated antigen-1) and blocks the interaction between LFA-1 and ICAM-1 (intercellular adhesion molecule-1), thereby disrupting various key steps of T cell-mediated inflammation, inhibiting the inflammatory pathway of dry eye through the entire chain, and achieving the goal of treating the symptoms and signs of dry eye.
Clinical research data show that the use of 5% Lifitegrast Eye Drops can quickly relieve dry eye symptoms in about 2 weeks, while the commonly used dry eye treatment drug Cyclosporine Eye Drops (Ⅱ) usually needs to be combined with artificial tears for treatment, and it takes 12 weeks or longer to relieve dry eye symptoms. Lifitegrast can also improve dry eye signs. After 12 weeks of treatment, the inferior corneal staining score (ICSS) is significantly lower than that of the placebo group.
The original research of Lifitegrast Eye Drops, Xiidra®, is the first LFA-1 antagonist new drug approved by the FDA for the treatment of dry eye, and it is the world's first and only prescription drug for the treatment of dry eye symptoms and signs. It is reported that the compound patent of Lifitegrast expired in China at the end of 2024, but the difficulty of imitation and clinical trials is not small. At present, only Kanghong has obtained approval, so it is of great significance.
Kanghong Pharmaceutical has rich experience and technical accumulation in the field of drug research and development. The results of the Phase III clinical trial of Lifitegrast Eye Drops (5%) for the treatment of dry eye carried out in China show that Lifitegrast Eye Drops is similar to the original research in terms of efficacy and safety. As an exclusively marketed new-generation dry eye drug, Lifitegrast can quickly improve the signs and symptoms of dry eye patients, and has a full-chain strong anti-inflammatory effect, providing Chinese dry eye patients with a new choice and rapid benefits!
