Central MediaFocusHisicor Innovation Drug “KeLigabarin”Key Research Progress

On April 21, local time, China's formerResearchInnovative drug Kligabalin treats central nervous system pathologypainA phase III registration study on pain, presented at the Annual Meeting of the American Academy of Neurology (AAN)Latest BreakthroughsPublished in the form of an oral reportIt has attracted widespread attention from the media.

Director of the Department of Neurology, Peking University Third HospitalDoctor, ProfessorFan DongshengRecently, during an interview with People's Daily (Health),TableShowKligabalin fills a gap in the treatment of central nervous system pain.IndicationsIt is expected to be approved in China next year.

neuropathologicalpainPain is a type of pain caused by abnormal reorganization of the nervous system due to disease or injury. Clinically, peripheral neuralgia is relatively common, such as post-herpes zoster neuralgia. Even if the underlying disease is cured, the pain may still persist.sampleCentral nervous system diseases can also cause such pain, especially after stroke or spinal cord damage. In terms of symptoms, pathological neuralgia is not just "pain"; it often comes with stinging, numbness, and even itching and other unusual sensations。These all represent different forms of pain.

In terms of treatment, current clinical practice advocates using calciumIonsChannel regulator is used as a first-line medication, throughYesCalcium channeltheRegulation reduces the release of pain-related substances, thereby alleviating pain.

As the third generation calciumIonsChannel regulator, Kligabalin mainly acts on calcium channels Caᵥα₂δ receptor. This receptor contains α₂δ1 and α₂δ2 two subunits. Kligabalin is innovative.andA three-ring cage structure, making it easier to interact with α₂The δ1 subunit binds efficiently, thereby enhancing bioavailability and pain relief. At the same time, it affects α₂The binding time of the δ2 subunit is short, which helps reduce the incidence of adverse reactions.

In terms of research, previouslyDomesticThere is a lack of clinical studies on central neuropathic pain. This timeThe first registered one in ChinaLarge sample sizeClinicsResearchincludeThe two most common groups of central neural pain after stroke and spinal cord damage fill a gap in related fields.

The study results show that Kligabalin has a clear analgesic effect and acts quickly, at the [time] after administration1There are significant differences immediately, and the efficacy can remain stable up to 12 weeks. Unlike previous generations and second-generation drugs, this medication does not require dose titration and can be used directlyUseUp to the therapeutic dose. Data shows that 30% and 50%Response rateAll are at a high level. In addition, the efficacy is consistent and significant in both stroke and spinal cord injury populations.

Of note is that,Research shows that,The patient's accompanying symptoms such as insomnia, anxiety, and depression have also improved significantly, and the quality of life has greatly enhanced. Based on its...α₂The high selectivity of the δ1 subunit allows Kligabalin to be effective at lower doses, with good overall safety, especially for elderly patientssayImpact on liver and kidney functionsalsosmaller.

At the international academic level, this research result has been published in AAReceived attention at the N annual meeting. As a major global academic conference in clinical neurology, this phase III clinical study was selected from numerous submissions as one of the 20 breakthrough oral reports, highlighting its academic value and clinical significance. The study clearly confirms the efficacy based on evidence-based medical evidence, and is expected to change the current situation in the field of central neuropathic pain, where there is insufficient evidence, limited treatment options, and unsatisfactory outcomes.

As an innovative drug, Kligabalin is expected to fill the gap in domestic central nervous system treatments.Pathological painGaps in the field of pain treatment. The results of related clinical trials are expected to be submitted to the National New Drug Review Center in the near future. IfProgressSuccessful, or will beNear futureApproved for clinical treatment of domestic patients.

RegardingKligabaling】

Kligabalin is the world’s first third-generation calcium ion channel regulator that does not require titration. Thanks to its unique tricyclic cage structure, it features no titration required, rapid onset, improved comorbidities, good tolerance, and sustained effectiveness.，It has become the preferred recommended medication in several guidelines for neuropathic pain. In May 2024, Clegarabalin was approved for marketing by the China National Medical Products Administration (NMPA) for peripheral neuropathic pain such as diabetic peripheral neuropathy (DPNP) in adults and post-herpes zoster neuralgia (PHN).

About AAN

The 78th American Academy of Neurology Annual Meeting (AAN) in 2026 will take place from April 18 to 22, 2026USAChicago and online. The AAN conference iscurrentlyOne of the largest professional conferences for neuroscientists in the world brings together medical and neurology experts to advanceSolveEducation and healthcare、Neurology Department、Problems in neuroscience and the nervous system.

About Haisco

Hisicor is a professional pharmaceutical group listed company focused on new drug research and development, integrating production, manufacturing, and sales promotion (stock code: 002653.SZ). Since its establishment in 2000, Hisicor Pharmaceutical Group has always aimed to become the most trusted international pharmaceutical enterprise. It focuses on areas such as anesthesia and analgesia, respiration, chronic diseases, oncology, and autoimmune diseases. Through innovation-driven strategies and a globalized approach, it strives to build a world-class research and development innovation system. Currently, Hisicor Pharmaceutical Group has developed a range of diversified research and development projects with independent intellectual property rights, covering small molecule innovative drugs, biopharmaceuticals, and high-end generic drugs. Many projects are in the clinical development stage, and several innovative drugs have already been commercialized, providing diverse innovative product solutions to the world.

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