专栏名称: 药物一致性评价

这是个因“仿制药一致性评价”而成立的自媒体平台，立足医药研发，服务医药科技工作者。努力打造成干货平台，打造成药物研发资源平台。投稿/合作：[email protected]

阅读 | 2017年上半年FDA批准新药大盘点

药物一致性评价 · 公众号 · 药品 · 2017-08-02 00:00

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5.Telotristat etiprate (Xermelo)

药物名称: Telotristat etiprate (Xermelo)

公司 : Lexicon Pharmaceuticals

靶点: Tryptophan hydroxylase

分子类型: Small Molecule

给药途径 : Oral (PO)

适应症: Neuroendocrine Tumors (NET)；

Crohn's Disease（Suspended）；

Ulcerative Colitis (UC) （Suspended）；

推荐给药剂量: 250 mg three times daily for patients whose diarrhea is inadequately controlled by SSA therapy in adult patients.

Structure of Telotristat etiprate (Xermelo)

6.Avelumab (Bavencio)

药物名称: Avelumab (Bavencio)

公司: Merck KGaA

靶点: Immune system Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2)

分子类型: Monoclonal Antibody

给药途径 : Intravenous (IV)

适应症:

Merkel Cell Carcinoma（Approved）；

Bladder Cancer(Approved)；

Renal Cell Cancer (RCC)（PhIII）；

Diffuse Large B-Cell Lymphoma (DLBCL) – NHL(PhIII)；

Head and Neck Cancer(PhIII)；

Non-Small Cell Lung Cancer (NSCLC)(PhIII)；

Ovarian Cancer(PhIII)；

Gastric Cancer(PhIII)；

Solid Tumors（PhI/II）；

Hodgkin's Lymphoma(PhI).

推荐给药剂量: 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

7. Ocrelizumab (Ocrevus)

药物名称: Ocrelizumab (Ocrevus)

公司: Genentech/Roche

靶点: Cluster of Differentiation 20 (CD20)

分子类型 : Monoclonal Antibody

给药途径 : Intravenous (IV)

适应症 : Relapsing and primary progressive forms of multiple sclerosis

推荐给药剂量：

8. Dupilumab (Dupixent)

药物名称: Dupilumab (Dupixent)

公司 : Regeneron

靶点 : IL-4 Receptor (IL-4R)

分子类型: Monoclonal Antibody

给药途径 : Subcutaneous (SQ)

适应症:

Atopic Dermatitis (Eczema)(Approved);

Asthma(PhIII);

Nasal Polyposis(PhIII);

Esophagitis(PhiI);

Food Allergies（Preclinical）.

推荐给药剂量: an initial dose of 600 mg (two

300 mg injections), followed by 300 mg given every other week for adult patients.

9. Ribociclib (Kisqali)

药物名称: Ribociclib (Kisqali)

公司 : Novartis

靶点 : Cyclin Dependent Kinase (CDK)

分子类型: Small Molecule

给药途径: Oral (PO)

适应症: HR-positive, HER2-negative breast cancer

推 荐给药剂量: 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. KISQALI can be taken with or without food.

Structure of Ribociclib (Kisqali)