托珠单抗单药方案获批；依若奇单抗报银屑病NDA

关键词

Divarasib 匹伐他汀 尼塞韦单抗 呼吸道合胞病毒 米吉珠单抗 度普利尤单抗 托珠单抗 依若奇单抗 替瑞利尤单抗 阿替利珠单抗

今日行业热点

①The New England Journal of Medicine：Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation

临床试验：选择性KRAS G12C抑制剂Divarasib在KRAS G12C突变实体肿瘤中的作用

DOI: 10.1056/NEJMoa2303810

②The New England Journal of Medicine：Pitavastatin to Prevent Cardiovascular Disease in HIV Infection

临床试验：匹伐他汀（Pitavastatin）预防在人类免疫缺陷病毒(HIV)感染者心血管疾病的Ⅲ期试验

DOI: 10.1056/NEJMoa2304146

③Morbidity and Mortality Weekly Report (MMWR)：Identification of genetic risk loci and causal insights associated with Parkinson's disease in African and African admixed populations: a genome-wide association study

美国CDC免疫实践咨询委员会：使用尼塞韦单抗（Nirsevimab）预防婴幼儿呼吸道合胞病毒疾病

DOI: 10.15585/mmwr.mm7234a4

④Science Translational Medicine：FcγRIIB expressed on CD8+ T cells limits responsiveness to PD-1 checkpoint inhibition in cancer

CD8+ T细胞表达的抑制性受体FcγRIIB限制了肿瘤对PD-1检查点抑制的反应性

DOI: 10.1126/scitranslmed.add1868

⑤Clinical Pharmacokinetics：Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies

临床分析：靶向IL-23亚基的单克隆抗体米吉珠单抗（Mirikizumab）在中度至重度活动性溃疡性结肠炎患者中的药代动力学特征

DOI: 10.1007/s40262-023-01281-z

⑥Drugs and Aging：Efficacy and Safety of Dupilumab in Older Patients (Aged 80 Years and Above) with Atopic Dermatitis: A Prospective Study

临床研究：度普利尤单抗（Dupilumab）用于80岁及以上老年特应性皮炎患者的疗效和安全性:一项前瞻性研究

DOI: 10.1007/s40266-023-01059-9

⑦抗IL-6R重组人源化单抗托珠单抗（Tocilizumab）单药用于成人中度至重度活动性类风湿关节炎（RA）的新适应症获中国国家药监局（NMPA）上市批准

⑧靶向于IL-12/IL-23的全人源单克隆抗体依若奇单抗上市申请已经获CDE受理，用于中度至重度斑块型银屑病Ⅲ

⑨TIGIT抗体替瑞利尤单抗（tiragolumab）联合PD-L1抑制剂阿替利珠单抗（atezolizumab）用于PD-L1高表达的局部晚期或转移性非小细胞肺癌的Ⅲ期试验SKYSCRAPER-01最新结果积极

⑩重组带状疱疹疫苗Shingrix在中国开展的首个保护效力研究取得积极结果

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