康方生物、三生国健等，扎堆申报！

药通社03-05

与PD-1、GLP-1的“热闹”相比，过去自免赛道常被贴上“冷门”标签，如今，该赛道却因IL-4Rα的密集冲刺而热度飙升。近日，康方生物、三生国健等IL-4Rα抗体迎来新进展。根据国家药品监督管理局药品审评中心(CDE)网站近日公示，康方生物自主研发的曼多奇单抗(IL-4Rα单抗，AK120)用于治疗中重度特应性皮炎的新药上市申请(NDA)已获受理。资料显示，曼多奇(AK120)是康方生物自主研发...

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AD)是一种慢性、复发性、炎症性皮肤病。中重度特应性皮炎患者通常全身大部位皮肤红疹，引发强烈持续的瘙痒、皮肤干燥、结痂、渗液等症状，治疗药物非常有限，严重地影响了患者生活质量。过去30年，全球范围内AD患病率逐渐增加，我国成人患病率为6.10%。除了康方生物、三生国健，国内已有多款国产IL-4Rα单抗进入上市冲刺阶段，形成了群雄逐鹿的竞争格局。其中，康诺亚/石药集团的司普奇拜单抗已获批上市；宝船生物/麦济生物的柯美奇拜单抗、康乃德的乐德奇拜单抗、智翔金泰的泰利奇拜单抗等也相继申报上市，各自将凭借差异化优势抢占市场先机。这些产品的密集布局，不仅推动IL-4Rα赛道进入竞争，更加速了自免赛道的国产替代进程。未来，随着国产IL-4Rα抗体的陆续获批，中国近7000万饱受剧烈瘙痒和皮损折磨、生活质量严重受损的中重度特应性皮炎(AD)患者有望迎来国产创新、高效的治疗新选择。参考：制药网↓⭐关注药通社，洞见行业趋势↓投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525）*添加请注明备注及来意","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like 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