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    Home > Active Ingredient News > Drugs Articles > Hebo Pharma FcRn antibody enters the third clinical phase!

    Hebo Pharma FcRn antibody enters the third clinical phase!

    • Last Update: 2021-10-21
    • Source: Internet
    • Author: User
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    Myasthenia gravis (Myasthenia Gravis, MG) is an autoimmune disease that manifests as drooping eyelids, fatigue, difficulty going upstairs, and even breathing difficulties
    .


    Common treatments include plasma exchange, thymectomy, and drug therapy


    Myasthenia Gravis (MG) and Platinum Medicine

    1 Lost the dream of Olympic champion by myasthenia gravis

    Lost the dream of Olympic champion by myasthenia gravis

    With the smooth convening of the Olympic Games and the National Games this year, everyone can feel the charm of sports and the spirit of sports that do not abandon or give up
    .


    Athletes who have won gold medals are easy to remember by increasing their exposure; but the stories behind some athletes who have not won gold medals are also unforgettable


    Wang Yan in the high-speed sprint (Image source: Tencent.
    com 1)

    Chinese cyclist, Wang Yan is such an athlete
    .


    Born in 1974, she was the national youth champion in 1987 and won the World Cup in Tokyo, Japan in 1995


    Myasthenia gravis

    Because myasthenia gravis is a type of disease that affects muscle activity
    .


    It is often manifested as volatility, weakness and fatigue, which are aggravated after activities and can be relieved after rest


    2 FcRn antibody brings new hope to MG patients

    FcRn antibody brings new hope to MG patients

    According to the "Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2020 Edition)", the global prevalence of MG is 150-250 per million, and the estimated annual incidence is 4-10 per million
    .


    In China, the incidence of MG is about 0.


    Myasthenia gravis (MG) is a type of autoimmune disease with neuromuscular junction (NMJ) transmission disorder.
    Acetylcholine receptor (AChR) antibody is the most common pathogenic antibody
    .


    Like other autoimmune diseases, myasthenia gravis is also caused by the body's immune response to self-antigens


    Reduce pathogenic antibodies and suppress immunity

    The most commonly used drug among cholinesterase inhibitors is brompistigmine, which is the first-line drug for the treatment of all types of MG, which can alleviate and improve the clinical symptoms of most MG patients
    .


    However, the side effects of brompistigmine include nausea, salivation, abdominal pain, diarrhea, bradycardia and increased sweating, etc.


    Cholinesterase Inhibitors

    Immunosuppressive drugs are divided into glucocorticoids and non-hormonal immunosuppressants
    .


    Glucocorticoids are still the first-line drugs for MG, which can significantly improve the symptoms of 70-80% of patients


    Immunosuppressive drugs glucocorticoid non-hormonal immunosuppressant

    Based on the adverse reactions of existing drugs, biological targeted drugs have received more and more attention
    .
    Currently, the biological agents used for MG treatment clinically include eculizumab and rituximab
    .
    However, FcRn is a new type of target with great potential and has received widespread attention in the industry in recent years
    .
    Different from the non-specific immunosuppressive effects of traditional immunosuppressants, it treats diseases by blocking FcRn and accelerating the degradation of disease-causing antibodies in the body
    .

    FcRn ,

    The neonatal Fc receptor (FcRn) is a cellular receptor that binds IgG antibodies and guides the transport of these antibodies
    .
    It plays a role in the passive immunity of the pregnant mother to the fetus, and plays a vital role in the half-life of IgG
    .
    IgG antibodies that bind to FcRn can have a half-life of 21 days, while IgG antibodies that do not bind to FcRn will be degraded by lysosomes 3.

    Neonatal Fc receptor (FcRn)

    FcRn and IgG antibody mechanism of action

    Therefore, blocking FcRn can effectively inhibit the recycling of autoantibodies and accelerate the degradation of pathogenic antibodies in the body
    .
    The mechanism is similar to plasma exchange, which plays a therapeutic role by eliminating disease-causing antibodies
    .

    Blocking FcRn can effectively inhibit the recycling of autoantibodies and accelerate the degradation of disease-causing antibodies in the body
    .

    However, compared with more traditional plasma exchange, anti-FcRn antibodies can reduce the pain suffered by patients during treatment and improve the convenience of treatment
    .
    Therefore, it has good application prospects in autoimmune diseases mediated by humoral immunity
    .

    3 China's FcRn antibody goes further

    Chinese FcRn antibody goes further

    Not long ago, Hebo Pharma announced that its fully human anti-FcRn antibody bartolizumab (HBM9161) for systemic myasthenia gravis (MG) clinical trial has completed the first administration of the first subject in the phase III trial
    .
    Brings new hope to patients with myasthenia gravis
    .

    Bartolizumab restricts the binding of IgG antibodies to FcRn by binding to FcRn
    .
    The IgG antibody that does not bind to FcRn is degraded by lysosomes
    .
    This process speeds up the metabolism and degradation of IgG antibodies
    .

    Image source: Hebo Pharmaceutical official website

    Early studies have shown that bartolizumab is well tolerated and can rapidly reduce total IgG.
    Studies have also shown that bartolizumab is the first to be proven in Chinese and Caucasian populations to continuously reduce IgG after subcutaneous injection (SC) Anti-FcRn target drugs 5.

    According to the official of Hebo Medical, bartolizumab was awarded the "Breakthrough Therapy Drug Qualification" of the State Food and Drug Administration in January 2021
    .
    As a result, the drug has received rapid review treatment, which has accelerated the progress of the drug’s listing.
    6.
    Based on good clinical data and huge market potential, Hebo Pharma has also accelerated the progress of clinical research and development
    .
    From the publication of phase II clinical data to the completion of the first phase III clinical trial, the first subject was given the first dose, and it only took 1 month for Heboplatinum
    .

    In July 2021, Harmonicare announced the Phase II study data of bartolizumab for systemic myasthenia gravis, and it became the first anti-FcRn therapy in China to obtain clinical research evidence
    .
    The clinical results show:

    China's first anti-FcRn therapy to obtain clinical research evidence

    Compared with placebo, bartolizumab treatment took effect quickly .
    On the 43rd day (one week after the last dose of bartolizumab), the scores of the Myasthenia Gravis Daily Life (MG-ADL) scale were higher.
    The baseline decreased, and the bartolizumab treatment group showed clinically and statistically significant improvements (p=0.
    043)
    .

    Treatment takes effect quickly

    Compared with the placebo group, the four values ​​MG-ADL, QMG, MGC and MG-QoL15 of the clinical efficacy of bartolizumab all showed rapid onset, significant and continuous clinical improvement
    .

    Fast onset, significant and continuous clinical improvement
    .

    57% and 76% of the subjects in the treatment group showed continuous clinical improvement (defined as a 6-week continuous reduction in MG-ADL score by ≥2 points, or QMG score reduction by ≥3 points), compared with only 33% in the placebo group And 11% of the subjects achieved improvements in MG-ADL and QMG

    57% and 76%

    At the same time, both the 340mg and 680mg treatment groups of bartolizumab showed faster, more significant and lasting clinical improvement than the placebo group
    .
    IgG related to clinical benefit was significantly reduced, safety and tolerability were good, and no serious adverse events occurred 6.

    Based on previous research and good experimental data, Hebo Platinum Medicine is rapidly advancing phase III clinical trials, and announced on September 27 that the first dose of the first subject has been completed, which means the official start of phase III clinical trials
    .
    This is also another milestone after the positive results of II clinical trials
    .

    4 Convenient medication and broad market

    Convenient medication and broad market

    It is understood that bartolizumab will be made into a fixed-dose pre-filled syringe, which can be convenient for patients to take medicine at home
    .
    Compared with plasma exchange, this treatment method greatly reduces the suffering of patients and improves patient compliance
    .
    Given that it is a fully human antibody (with low immunogenicity), and the phase II clinical data is very positive, we believe that bartolizumab is a product worth looking forward to, which can be used for patients with myasthenia gravis in China Bring a better treatment plan
    .

    According to Frost&Sullivan’s report, China’s myasthenia gravis market was approximately US$43 million in 2019 and will reach US$1.
    08 billion by 2030, with a compound annual growth rate of 39.
    1% from 2024 to 20307.

    Concluding remarks

    With the release of the "Research Report on the Definition of Rare Diseases in China 2021", China has a clear definition of rare diseases
    .
    It is believed that Chinese pharmaceutical companies will pay more and more attention to rare diseases and people with rare diseases
    .

    As a leader in the field of myasthenia gravis in China, Hebo Medicine is working hard to advance the phase III clinical trial of bartolizumab
    .
    I believe that in the near future, Harmonicare will bring more good news to Chinese patients with myasthenia gravis
    .

    Hebo Pharmaceutical

    Reference materials:

    Reference materials:

    [1] Tencent.
    com: Myasthenia gravis: the story behind a world champion!

    [1] Tencent.
    com: Myasthenia gravis: the story behind a world champion!

    [2] Guidelines for the diagnosis and treatment of myasthenia gravis in China (2020 edition)

    [2] Guidelines for the diagnosis and treatment of myasthenia gravis in China (2020 edition)

    [3] The sky of myasthenia gravis: the therapeutic prospects of targeting FcRn antibody in myasthenia gravis

    [3] The sky of myasthenia gravis: the therapeutic prospects of targeting FcRn antibody in myasthenia gravis

    [4] Nat Rev Immunol.
    2007 Sep:7(9):715-25.

    [4] Nat Rev Immunol.
    2007 Sep:7(9):715-25.

    [5] PR Newswire https://med.
    sina.
    com/article_detail_103_1_95595.
    html

    [5] PR Newswire https://med.
    sina.
    com/article_detail_103_1_95595.
    html

    [6] Hebo Medical official website

    [6] Hebo Medical official website

    [7] Frost&Sullivan report

    [7] Frost&Sullivan report

    【8】 Other public information

    【8】 Other public information
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