綠葉製藥(02186.HK)：創新長效單抗藥物BA2101注射液在中國獲批進行臨牀試驗
格隆匯10月27日丨綠葉製藥(02186.HK)公吿，公司附屬公司山東博安生物技術股份有限公司("博安生物")自主開發的長效單抗藥物BA2101注射液("BA2101注射液")已獲中華人民共和國國家藥品監督管理局藥品審評中心批准進行臨牀試驗。
BA2101注射液是創新的長效全人源單克隆IgG4型抗體，靶向白細胞介素-4受體亞基α(IL-4Rα)，給藥方式為皮下注射，預期給藥週期為4週一次。BA2101注射液可同時抑制IL-4及IL-13信號通路，調節Th2型炎症，降低嗜酸性粒細胞含量及IgE水平，治療Th2型炎症引起的過敏性疾病，預期用於治療特應性皮炎、哮喘、慢性鼻竇炎伴鼻息肉、結節性癢疹、慢性自發性蕁麻疹等。
已完成的臨牀前研究結果顯示：BA2101在食蟹猴中相比同靶點市售藥物展現出更長的半衰期和更高的藥物暴露量，預期未來在人體上可實現每4週一次的給藥週期，而同靶點藥物通常採用2周給藥週期。在B-hIL4/hIL-4Rα小鼠哮喘模型中，BA2101與市售藥物相比具有相似的藥效，並能顯着抑制小鼠肺組織中嗜酸粒細胞的募集和小鼠體內OVA特異性IgE的產生；在B-hIL4/hIL-4Rα小鼠特應性皮炎模型中，等劑量的BA2101與市售藥物對血清IgE水平的抑制效果相當，能夠明顯抑制小鼠耳腫脹。毒理研究顯示BA2101在B-hIL4/hIL-4Rα小鼠中安全性良好。BA2101注射液未來有望成為重要的Th2型炎症性疾病長效治療藥物。
截止至2022年9月底，首款IL-4Rα單抗Dupilumab(度普利尤單抗，Dupixent®，達必妥®)已獲美國FDA批准用於治療5種由Th2型炎症導致的疾病：結節性癢疹(PN，成人患者)、嗜酸性粒細胞性食管炎(EoE，≥12歲患者)、特應性皮炎(AD，≥6個月患者)、哮喘(Asthma，≥6歲患者)、慢性鼻竇炎伴鼻息肉(CRSwNP，成人患者)。達必妥®是中國唯一獲批可用於治療中重度特應性皮炎(AD，≥6歲患者)的生物靶向製劑。除目前批准的適應症外，Dupixent®治療由Th2型炎症或其他過敏引起的多種疾病的臨牀試驗正在進行中，包括病因不明的慢性瘙癢、神經性皮炎、特應性手足皮炎、慢性自發性蕁麻疹、寒冷性蕁麻疹、大皰性類天皰瘡、變應性真菌性鼻竇炎、慢性鼻竇炎不伴鼻息肉、慢性阻塞性肺病和過敏性支氣管肺麴黴病等。
根據公開信息顯示，達必妥®2021年在全球的銷售額為52.49億歐元，同比增長52.7%。根據弗若斯特沙利文報吿，由於擴大適應症以及未來將有相同靶點藥物獲批上市，全球IL-4Rα靶向療法的市場規模預期於2030年將達287億美元，中國IL-4Rα靶向療法的市場規模預期於2030年將達人民幣282億元。
公司相信，基於Th2型炎症或其他過敏引起的疾病的巨大臨牀需求，長週期給藥的BA2101注射液將具有廣闊的市場前景。
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