此前几日，智翔金泰在新药研发上取得重大进展。9月11日晚间，公司公告称，其"泰利奇拜单抗注射液 (GR1802注射液)"用于成人中、重度特应性皮炎适应症III期临床试验达到主要终点指标，且已向国家药 品监督管理局(NMPA)药品审评中心(CDE)提交该适应症新药上市申请并获受理。此外，在感染性疾病 治疗领域，智翔金泰自主研发的全球首个狂犬病被动免疫双特异性抗体GR1801(斯乐韦米单抗)注射液 和抗破伤风毒素单克隆抗体GR2001注射液，均已向CDE提交新药上市申请，且已顺利获得受理，有望 为狂犬病和破伤风的治疗带来新突破。 智翔金泰是一家创新驱动型生物制药企业，自2015年成立以来，专注于抗体药物的研发、生产及商业 化，业务涵盖自身免疫性疾病、感染性疾病和肿瘤等重大疾病领域。目前，公司拥有在研产品14个，凭 借自主研发构建起六大核心技术平台，为持续创新提供技术支撑。此次多款新药上市申请获受理，以及 参与行业业绩说明会，彰显了公司在创新药研发领域的实力和积极与投资者沟通的态度。 中证报中证网讯(王珞)9月16日，智翔金泰(688443)参加2025年半年度科创板创新药行业集体业绩说明 会，此次会议通过上海证券 ...

Core Viewpoint - The company Zhixiang Jintai (688443.SH) has achieved the primary endpoint in the Phase III clinical trial of its drug Taliqibai Injection (GR1802) for the treatment of moderate to severe atopic dermatitis in adults, and has submitted a new drug application to the National Medical Products Administration (NMPA) which has been accepted [1] Group 1: Drug Development - Taliqibai Injection (GR1802) is a recombinant fully human anti-IL-4Rα monoclonal antibody developed by the company, targeting IL-4Rα [1] - The drug specifically binds to the human IL-4Rα on cell surfaces, blocking the binding of IL-4 and IL-13, thereby inhibiting downstream STAT6 phosphorylation and CD23 upregulation, which suppresses Th2-type inflammatory responses mediated by IL-4 or IL-13 [1] Group 2: Clinical Trials - Multiple indications for Taliqibai Injection are in clinical trial stages, including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria, both in Phase III trials [1] - Seasonal allergic rhinitis in adults and adolescents is also in Phase III trials, while asthma is in Phase II trials, and atopic dermatitis in children/adolescents is in Ib/IIa trials [1]

泰利奇拜单抗注射液(GR1802注射液)是一款由公司自主研发的重组全人源抗IL-4Rα单克隆抗体，作用 靶点为IL-4Rα。泰利奇拜单抗注射液能特异性结合细胞表面人IL-4Rα，阻断IL-4、IL-13与IL-4Rα的结 合，抑制下游STAT6磷酸化，抑制CD23上调，从而抑制由IL-4或IL-13介导的Th2型炎症反应。泰利奇拜 单抗注射液(GR1802注射液)的多个适应症处于临床试验阶段，慢性鼻窦炎伴鼻息肉、慢性自发性荨麻 疹、成人以及青少年季节性过敏性鼻炎适应症处于III期临床试验阶段，哮喘适应症处于II期临床试验阶 段，儿童/青少年特应性皮炎适应症处于Ib/IIa期临床试验阶段。 智翔金泰(688443.SH)发布公告，近日，公司的泰利奇拜单抗注射液(GR1802注射液)用于成人中、重度 特应性皮炎适应症III期临床试验达到了主要终点指标，公司向国家药品监督管理局(NMPA)药品审评中 心(CDE)提交了该适应症的新药上市申请并获得受理。 ...