特瑞普利单抗注射液 | China Drugs ListToripalimab injection | 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。

商品名: 拓益 / LoqtorziTuoyi / Loqtorzi
药品类型: 生物药Biologic
治疗领域: 肿瘤科Oncology
公开来源记录的适应症: 1. 本品适用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗; 2. 本品适用于不可切除或转移性黑色素瘤的一线治疗; 3. 本品适用于含铂化疗失败包括新辅助或辅助化疗12个月内进展的局部晚期或转移性尿路上皮癌的治疗; 4. 本品适用于既往接受过二线及以上系统治疗失败的复发/转移性鼻咽癌患者的治疗; 5. 本品联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗; 6. 本品联合紫杉醇和顺铂适用于不可切除局部晚期/复发或转移性食管鳞癌的一线治疗; 7. 本品联合培美曲塞和铂类适用于表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)的一线治疗; 8. 本品联合含铂化疗围手术期治疗,继之本品单药作为辅助治疗,用于可切除IIIA-IIIB期非小细胞肺癌(NSCLC)的成人患者; 9. 本品联合阿昔替尼用于中高危的不可切除或转移性肾细胞癌患者的一线治疗; 10. 本品联合依托泊苷和铂类用于广泛期小细胞肺癌(ES-SCLC)的一线治疗; 11. 本品联合注射用紫杉醇(白蛋白结合型)用于经充分验证的检测评估PD-L1阳性(CPS≥1)的复发或转移性三阴性乳腺癌(TNBC)的一线治疗; 12. 本品联合贝伐珠单抗用于不可切除或转移性肝细胞癌患者的一线治疗。【2026年5月新增】联合维迪西妥单抗用于HER2表达（IHC 1+、2+或3+）的局部晚期或转移性尿路上皮癌一线治疗。1. Unresectable or metastatic melanoma after failure of prior systemic therapy. 2. First-line treatment of unresectable or metastatic melanoma. 3. Locally advanced or metastatic urothelial carcinoma after failure of platinum-containing chemotherapy, including progression within 12 months of neoadjuvant or adjuvant chemotherapy. 4. Recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of systemic therapy. 5. With cisplatin and gemcitabine for first-line treatment of locally recurrent or metastatic nasopharyngeal carcinoma. 6. With paclitaxel and cisplatin for first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma. 7. With pemetrexed and a platinum agent for first-line treatment of unresectable locally advanced or metastatic nonsquamous NSCLC without EGFR mutations or ALK alterations. 8. With platinum-containing chemotherapy as perioperative treatment, followed by toripalimab monotherapy as adjuvant treatment, for adults with resectable stage IIIA-IIIB NSCLC. 9. With axitinib for first-line treatment of intermediate- or high-risk unresectable or metastatic renal cell carcinoma. 10. With etoposide and a platinum agent for first-line treatment of extensive-stage SCLC. 11. With albumin-bound paclitaxel for first-line treatment of recurrent or metastatic triple-negative breast cancer that is PD-L1 positive (CPS >=1) by an adequately validated test. 12. With bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma. Added in China in May 2026: With disitamab vedotin for first-line treatment of HER2-expressing (IHC 1+, 2+ or 3+) locally advanced or metastatic urothelial carcinoma.
适应症来源与口径: 来源日期： 2025, 2026, 2026-05-21. 适应症转录自国家医保局公开的企业申报资料；不代表已核实完整的现行说明书。新增适应症可能由较新的公告或申报资料支持，而非旧版完整说明书；请查看适应症来源。Source date(s): 2025, 2026, 2026-05-21. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
说明书信息局限: 已取得完整官方药品说明书。现有完整说明书来自海外辖区；尚未取得完整的中国现行说明书。中国适应症另由中国来源支持。Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
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: 加拿大: 已取得当地获批／上市公告及官方价格来源。每条价格记录注明适应症与日期；未全面核查其他市场。Canada: local approval / launch announcements and official price sources obtained. Indications and dates are specified in each price record; other markets not exhaustively reviewed.
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.既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗；2.不可切除或转移性黑色素瘤的一线治疗；3.含铂化疗失败包括新辅助或辅助化疗12个月内进展的局部晚期或转移性尿路上皮癌的治疗；4.既往接受过二线及以上系统治疗失败的复发/转移性鼻咽癌患者的治疗；5.联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗；6.联合紫杉醇和顺铂适用于不可切除局部晚期/复发或转移性食管鳞癌的一线治疗；7.联合培美曲塞和铂类适用于表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)的一线治疗；8.联合含铂化疗围手术期治疗，继之本品单药作为辅助治疗，用于可切除IIIA-IIIB期非小细胞肺癌(NSCLC)的成人患者；9.联合阿昔替尼用于中高危的不可切除或转移性肾细胞癌患者的一线治疗；10.联合依托泊苷和铂类用于广泛期小细胞肺癌(ES-SCLC)的一线治疗；11.联合注射用紫杉醇(白蛋白结合型)用于经充分验证的检测评估PD-L1阳性(CPS≥1)的复发或转移性三阴性乳腺癌(TNBC)的一线治疗；12.联合贝伐珠单抗用于不可切除或转移性肝细胞癌患者的一线治疗。Limited to: 1. Unresectable or metastatic melanoma after failure of prior systemic therapy. 2. First-line treatment of unresectable or metastatic melanoma. 3. Locally advanced or metastatic urothelial carcinoma after failure of platinum-containing chemotherapy, including progression within 12 months of neoadjuvant or adjuvant chemotherapy. 4. Recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of systemic therapy. 5. With cisplatin and gemcitabine for first-line treatment of locally recurrent or metastatic nasopharyngeal carcinoma. 6. With paclitaxel and cisplatin for first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma. 7. With pemetrexed and a platinum agent for first-line treatment of unresectable locally advanced or metastatic nonsquamous NSCLC without EGFR mutations or ALK alterations. 8. With platinum-containing chemotherapy as perioperative treatment, followed by toripalimab monotherapy as adjuvant treatment, for adults with resectable stage IIIA-IIIB NSCLC. 9. With axitinib for first-line treatment of intermediate- or high-risk unresectable or metastatic renal cell carcinoma. 10. With etoposide and a platinum agent for first-line treatment of extensive-stage SCLC. 11. With albumin-bound paclitaxel for first-line treatment of recurrent or metastatic triple-negative breast cancer that is PD-L1 positive (CPS >=1) by an adequately validated test. 12. With bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma.
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.

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