盐酸安罗替尼胶囊 | China Drugs ListAnlotinib hydrochloride capsules | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 非小细胞肺癌：①既往至少接受2种系统化疗后进展或复发的局部晚期或转移性患者；EGFR突变或ALK阳性患者还需在相应标准靶向药治疗后进展。②贝莫苏拜联合紫杉醇和卡铂后，序贯本品联合贝莫苏拜，用于局部晚期或转移性鳞状非小细胞肺癌一线治疗。小细胞肺癌：①既往至少接受2种化疗方案后进展或复发；②联合贝莫苏拜、卡铂和依托泊苷，用于广泛期小细胞肺癌一线治疗。软组织肉瘤：①单药用于腺泡状软组织肉瘤、透明细胞肉瘤，以及既往至少接受一种含蒽环类化疗方案后进展或复发的其他晚期软组织肉瘤；②联合表柔比星用于局部晚期或转移性软组织肉瘤一线治疗；③联合贝莫苏拜用于不可切除或转移性腺泡状软组织肉瘤成人患者，为附条件批准。分化型甲状腺癌：进展性、局部晚期或转移性、放射性碘难治性分化型甲状腺癌。子宫内膜癌：联合贝莫苏拜，用于既往系统性抗肿瘤治疗失败且不适合根治性手术或放疗的非MSI-H或非dMMR复发性或转移性子宫内膜癌，为附条件批准。肾细胞癌：联合贝莫苏拜用于晚期肾细胞癌一线治疗。肝细胞癌：联合派安普利单抗，用于既往未接受系统治疗的不可切除或转移性肝细胞癌。Non-small cell lung cancer (NSCLC): (1) Locally advanced or metastatic disease that progressed or relapsed after at least two systemic chemotherapy regimens; patients with EGFR mutations or ALK-positive disease must also have progressed after the corresponding standard targeted therapy. (2) For first-line treatment of locally advanced or metastatic squamous NSCLC, anlotinib plus benmelstobart follows benmelstobart plus paclitaxel and carboplatin. Small cell lung cancer (SCLC): (1) Progression or relapse after at least two chemotherapy regimens. (2) With benmelstobart, carboplatin and etoposide for first-line treatment of extensive-stage SCLC. Soft tissue sarcoma: (1) Monotherapy for alveolar soft part sarcoma, clear cell sarcoma, and other advanced soft tissue sarcomas that progressed or relapsed after at least one anthracycline-containing chemotherapy regimen. (2) With epirubicin for first-line treatment of locally advanced or metastatic soft tissue sarcoma. (3) With benmelstobart for adults with unresectable or metastatic alveolar soft part sarcoma; this indication has conditional approval. Differentiated thyroid cancer: Progressive, locally advanced or metastatic, radioactive iodine-refractory differentiated thyroid cancer. Endometrial cancer: With benmelstobart for recurrent or metastatic disease that is not MSI-H or not dMMR, after failure of systemic anticancer treatment and when curative surgery or radiotherapy is unsuitable; this indication has conditional approval. Renal cell carcinoma: With benmelstobart for first-line treatment of advanced renal cell carcinoma. Hepatocellular carcinoma: With penpulimab for unresectable or metastatic hepatocellular carcinoma without previous systemic therapy.
- 适应症来源与口径
- 来源日期： 2026-08-21, 2026-10-23. 生产商面向中国大陆的药品说明书。 证据核查日期：2026年10月23日。Source date(s): 2026-08-21, 2026-10-23. Manufacturer prescribing information for Mainland China. Evidence review: 23 October 2026.
- 说明书信息局限
- 已取得完整官方药品说明书。 中国大陆说明书。Complete official prescribing information obtained. Mainland China label.
- 中国可获得性状态
- 已核实中国历史批准记录；尚未逐项核查每个产品目前是否持续上市销售。Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- 海外状态
- 待逐一核查各市场。Market-by-market verification pending.
- 医保分类
- 已纳入国家医保（乙类）Included in national insurance (Category B)
- 医保版本
- 2025版；2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保限制
- 限：1.既往至少接受过2种系统化疗后出现进展或复发的局部晚期或转移性非小细胞肺癌患者的治疗。对于存在表皮生长因子受体(EGFR)基因突变或间变性淋巴瘤激酶(ALK)阳性的患者，在开始本品治疗前应接受相应的标准靶向药物治疗后进展、且至少接受过2种系统化疗后出现进展或复发；2.既往至少接受过2种化疗方案治疗后进展或复发的小细胞肺癌患者的治疗；3.腺泡状软组织肉瘤、透明细胞肉瘤以及既往至少接受过含蒽环类化疗方案治疗后进展或复发的其他晚期软组织肉瘤患者的治疗；4.局部晚期或转移性软组织肉瘤患者的一线治疗；5.具有临床症状或明确疾病进展的、不可切除的局部晚期或转移性甲状腺髓样癌患者的治疗；6.进展性、局部晚期或转移性放射性碘难治性分化型甲状腺癌患者。Limited to: 1. Locally advanced or metastatic NSCLC that progressed or relapsed after at least two systemic chemotherapy regimens. Patients with EGFR mutations or ALK-positive disease must have progressed after the corresponding standard targeted treatment and after at least two systemic chemotherapy regimens. 2. SCLC that progressed or relapsed after at least two chemotherapy regimens. 3. Alveolar soft part sarcoma, clear cell sarcoma, and other advanced soft tissue sarcomas that progressed or relapsed after at least one anthracycline-containing chemotherapy regimen. 4. First-line treatment of locally advanced or metastatic soft tissue sarcoma. 5. Unresectable locally advanced or metastatic medullary thyroid cancer with clinical symptoms or documented disease progression. 6. Progressive, locally advanced or metastatic, radioactive iodine-refractory differentiated thyroid cancer.
- 医保期限
- 2026-01-01 至 2027-12-312026-01-01 to 2027-12-31
- 医保核查说明
- 按成分／剂型名称精确或标准化匹配。报销仍取决于剂型及目录所列支付限制。Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.