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Kang Hong Pharmaceutical's Lifitegrast eye drops (5%) are approved for first-time imitation and launch, providing a new choice for dry eye treatment.

Recently, the official website of the Drug Review Center of the National Medical Products Administration showed that Kang Hong Pharmaceutical's Lifitegrast eye drops (trade name Langyueming) have been launched in China as a Class 3 new drug, providing a new choice for dry eye treatment.

The 'Big Data Report on Dry Eye in Chinese Population' points out that with the widespread use of electronic devices, the acceleration of the aging process, and poor eye habits, the incidence of dry eye in China is showing an increasing trend year by year. The population in China suffering from dry eye or dry eye symptoms exceeds 300 million. According to the research report of the China Economic Research Institute, the market size of dry eye drugs in China 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.

Kang Hong Pharmaceutical's Lifitegrast eye drops (5%) are approved for first-time imitation and launch, providing a new choice for dry eye treatment.

Inflammatory response is a driving factor for ocular surface damage in the pathogenesis of dry eye, which can induce the malignant cycle of dry eye. Lifitegrast (Lifitegrast) is a novel small molecule integrin inhibitor that blocks the interaction between integrin LFA-1 (lymphocyte function-associated antigen-1) by binding to it, thus disrupting various key steps of T cell-mediated inflammation, inhibiting the inflammatory pathway of dry eye throughout the chain, and achieving the purpose of treating dry eye symptoms and signs.

Clinical research data shows that using 5% Lifitegrast eye drops can quickly alleviate dry eye symptoms after about 2 weeks, while the commonly used dry eye treatment drug cyclosporin eye drops (II) usually requires combined treatment with artificial tears and takes 12 weeks or longer to alleviate dry eye symptoms. Lifitegrast can also improve dry eye signs, and after 12 weeks of treatment, the corneal fluorescein staining (ICSS) is significantly lower than that in the placebo group.

The original formulation of Lifitegrast eye drops, Xiidra®, is the first FDA-approved lymphocyte function-associated antigen 1 (LFA-1) antagonist class new drug for the treatment of dry eye. It is the first and only prescription drug for the treatment of dry eye symptoms and signs. It is reported that the patent for the Lifitegrast compound expired in China at the end of 2024, but the difficulty in imitation and clinical trials is not small. Currently, only Kang Hong has been approved, which is of great significance.

Kang Hong Pharmaceutical Co., Ltd. has extensive 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 dry eye conducted in China show that Lifitegrast eye drops are similar to the original in terms of efficacy and safety. As a new generation of dry eye drug launched exclusively, Lifitegrast can quickly improve the signs and symptoms of dry eye patients, provide strong anti-inflammatory effects throughout the chain, and offer a new choice and rapid benefit to Chinese dry eye patients.

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