Chinese Biopharmas Boost Pipelines In Inflammation & Immunology

2024-05-19

临床研究临床结果

Dupixent (dupilumab), the Sanofi and Regeneron’s monoclonal antibody (mAb), is one of the most successful Immunomodulators after Humira in the field of inflammation & immunology.The IL-4Ra and IL-13 inhibitor’s initial FDA approval in atopic dermatitis came in 2017, followed by initial nods for asthma, chronic rhinosinusitis with nasal Polyposis, eosinophilic esophagitis and prurigo nodularis.Dupixent generated megablockbuster sales of $11.6 billion in 2023 and is on the verge of a potentially lucrative approval to become the first biologic treatment for chronic obstructive pulmonary disease (COPD). Cantor Fitzgerald analyst Josh Schimmer has projected Dupixent’s sales potential at more than $20 billion by the end of this decade as it looks to match the might of Humira's glory days.The National Medical Products Administration (NMPA) has approved a variety of new drugs developed by Chinese biopharmaceutical companies over the past few years, particularly in the oncology field. However, a few of new domestic biologic Immunomodulators have been approved in the field of inflammation & immunology.Chinese biopharmaceutical companies have made additions to their R&D pipelines in the field of autoimmune diseases in recent years.Hengrui announced that the NMPA has accepted for filing its Biologics License Application (BLA) for SHR-1314 (Vunakizumab) for the treatment of Ankylosing spondylitis (AS) on 18 February. The BLA is supported by the positive data from the pivotal SHR-1314-302 Phase 2/3 trial in which SHR-1314 demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of the percentage of subjects achieving an ASAS20 response after 16 weeks of treatment with SHR-1314 compared to placebo.Hengrui has 14 Innovative Products Marketed in the other fields in China. If it is approved, SHR-1314 will be Hengrui’s first biologic Immunomodulator. The SHR-1314 will not be alone. Both the anti-IL-5 mAb SHR-1703 and anti-IL-4Rα mAb SHR-1819 are ongoing in Phase III studies.Notably, GSK announced that it would acquired Aiolos Bio for $1 billion upfront and potentially another $400 million in regulatory milestones in January. The biotech’s main asset is AIO-001 (SHR-1905), a anti-thymic stromal lymphopoietin (TSLP) mAb. Aiolos Bio acquired exclusive rights for global development and commercialization of the drug outside of greater China from Hengrui in August 2023.AIO-001 has the potential to be administered only twice per year due to its differentiated potency and long half-life. TSLP inhibition has a proven role in addressing symptoms of severe asthma and is currently under investigation for additional immune conditions like Chronic Obstructive Pulmonary Disorder (COPD) and Chronic Spontaneous Urticaria (CSU).Beside Hengrui, the other competitors including 3SBIO GUOJIAN, Qyuns, Akeso, whose biologic Immunomodulators are all in advanced stages.本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！

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