替雷利珠单抗注射液 | China Drugs ListTislelizumab 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
- 百泽安Baizean
- 企业
- 百济神州BeiGene
- 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. 本品适用于至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤的治疗。 2. 本品适用于PD-L1高表达的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。 3.本品联合紫杉醇和卡铂或注射用紫杉醇(白蛋白结合型)和卡铂用于不可手术切除的局部晚期或转移性鳞状非小细胞肺癌的一线治疗。 4.本品联合培美曲塞和铂类化疗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的一线治疗。 5.本品单药适用于治疗表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK) 阴性、既往接受过含铂方案化疗后疾病进展或不可耐受的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)成人患者,以及EGFR和ALK阴性或未知的,既往接受过含铂方案化疗后疾病进展或不可耐受的局部晚期或转移性鳞状NSCLC成人患者。 6.本品联合含铂化疗新辅助治疗,并在手术后继续本品单药辅助治疗,用于可切除的II期或IIIA期非小细胞肺癌患者的治疗。 7.本品联合依托泊苷和铂类化疗用于广泛期小细胞肺癌(ES-SCLC)的一线治疗。 8.本品单药适用于不可切除或转移性肝细胞癌患者的一线治疗。 9.本品适用于既往接受过索拉非尼或仑伐替尼或含奥沙利铂全身化疗的晚期肝细胞癌患者的治疗。 10.本品适用于不可切除或转移性微卫星高度不稳定型(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者:既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者;既往治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。 11.本品联合紫杉醇和铂类药物或含氟尿嘧啶类和铂类药物用于不可切除的局部晚期、复发或转移性食管鳞状细胞癌的一线治疗。 12.本品适用于既往接受过一线标准化疗后进展或不可耐受的局部晚期或转移性食管鳞状细胞癌的治疗。 13.本品联合吉西他滨和顺铂用于复发或转移性鼻咽癌的一线治疗。 14.本品联合氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除的或转移性的胃或胃食管结合部腺癌的一线治疗。1. For relapsed or refractory classical Hodgkin lymphoma after at least two lines of systemic chemotherapy. 2. For PD-L1-high locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy, including progression within 12 months of neoadjuvant or adjuvant chemotherapy. 3. With paclitaxel and carboplatin, or albumin-bound paclitaxel and carboplatin, as first-line treatment of unresectable locally advanced or metastatic squamous NSCLC. 4. With pemetrexed and platinum-based chemotherapy as first-line treatment of unresectable locally advanced or metastatic nonsquamous NSCLC with negative EGFR mutation and ALK status. 5. Monotherapy for adults with locally advanced or metastatic nonsquamous NSCLC with negative EGFR mutation and ALK status that has progressed after or is intolerant of platinum-based chemotherapy; also for adults with locally advanced or metastatic squamous NSCLC with negative or unknown EGFR and ALK status that has progressed after or is intolerant of platinum-based chemotherapy. 6. With platinum-based chemotherapy as neoadjuvant treatment, followed after surgery by tislelizumab monotherapy as adjuvant treatment, for resectable stage II or IIIA NSCLC. 7. With etoposide and platinum-based chemotherapy as first-line treatment of extensive-stage small cell lung cancer. 8. Monotherapy as first-line treatment of unresectable or metastatic hepatocellular carcinoma. 9. For advanced hepatocellular carcinoma after sorafenib, lenvatinib or oxaliplatin-containing systemic chemotherapy. 10. For adults with unresectable or metastatic MSI-H or dMMR advanced solid tumors: advanced colorectal cancer that has progressed after a fluoropyrimidine, oxaliplatin and irinotecan; or other advanced solid tumors that have progressed after prior treatment and have no satisfactory alternative treatment. 11. With paclitaxel and a platinum agent, or a fluoropyrimidine and a platinum agent, as first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. 12. For locally advanced or metastatic esophageal squamous cell carcinoma that has progressed after or is intolerant of first-line standard chemotherapy. 13. With gemcitabine and cisplatin as first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. 14. With fluoropyrimidine- and platinum-based chemotherapy as first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- 适应症来源与口径
- 来源日期： 2025, 2026. 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。Source date(s): 2025, 2026. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label.
- 说明书信息局限
- 尚未取得可核实的完整药品说明书。现有批准记录或国家医保局申报资料支持所示适应症；最新完整范围尚待确认。A verifiable complete prescribing-information document has not yet been obtained. Available approval records or NHSA submissions support the indications shown; the latest full scope needs confirmation.
- 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.PD-L1高表达的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；2.联合紫杉醇和卡铂或注射用紫杉醇(白蛋白结合型)和卡铂用于不可手术切除的局部晚期或转移性鳞状非小细胞肺癌的一线治疗；3.联合培美曲塞和铂类化疗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的一线治疗；4.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、既往接受过含铂方案化疗后疾病进展或不可耐受的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)成人患者，以及EGFR和ALK阴性或未知的，既往接受过含铂方案化疗后疾病进展或不可耐受的局部晚期或转移性鳞状NSCLC成人患者；5.联合含铂化疗新辅助治疗，并在手术后继续单药辅助治疗，用于可切除的II期或IIIA期非小细胞肺癌患者的治疗；6.联合依托泊苷和铂类化疗用于广泛期小细胞肺癌(ES-SCLC)的一线治疗；7.不可切除或转移性肝细胞癌患者的一线治疗；8.既往接受过索拉非尼或仑伐替尼或含奥沙利铂全身化疗的晚期肝细胞癌患者的治疗；9.不可切除或转移性微卫星高度不稳定型(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者：既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者；既往治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者；10.联合紫杉醇和铂类药物或含氟尿嘧啶类和铂类药物用于不可切除的局部晚期、复发或转移性食管鳞状细胞癌的一线治疗；11.既往接受过一线标准化疗后进展或不可耐受的局部晚期或转移性食管鳞状细胞癌的治疗；12.联合吉西他滨和顺铂用于复发或转移性鼻咽癌的一线治疗；13.联合氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除的或转移性的胃或胃食管结合部腺癌的一线治疗。Restricted to: 1. For PD-L1-high locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy, including progression within 12 months of neoadjuvant or adjuvant chemotherapy. 2. With paclitaxel and carboplatin, or albumin-bound paclitaxel and carboplatin, as first-line treatment of unresectable locally advanced or metastatic squamous NSCLC. 3. With pemetrexed and platinum-based chemotherapy as first-line treatment of unresectable locally advanced or metastatic nonsquamous NSCLC with negative EGFR mutation and ALK status. 4. For adults with locally advanced or metastatic nonsquamous NSCLC with negative EGFR mutation and ALK status that has progressed after or is intolerant of platinum-based chemotherapy; also for adults with locally advanced or metastatic squamous NSCLC with negative or unknown EGFR and ALK status that has progressed after or is intolerant of platinum-based chemotherapy. 5. With platinum-based chemotherapy as neoadjuvant treatment, followed after surgery by tislelizumab monotherapy as adjuvant treatment, for resectable stage II or IIIA NSCLC. 6. With etoposide and platinum-based chemotherapy as first-line treatment of extensive-stage small cell lung cancer. 7. First-line treatment of unresectable or metastatic hepatocellular carcinoma. 8. For advanced hepatocellular carcinoma after sorafenib, lenvatinib or oxaliplatin-containing systemic chemotherapy. 9. For adults with unresectable or metastatic MSI-H or dMMR advanced solid tumors: advanced colorectal cancer that has progressed after a fluoropyrimidine, oxaliplatin and irinotecan; or other advanced solid tumors that have progressed after prior treatment and have no satisfactory alternative treatment. 10. With paclitaxel and a platinum agent, or a fluoropyrimidine and a platinum agent, as first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. 11. For locally advanced or metastatic esophageal squamous cell carcinoma that has progressed after or is intolerant of first-line standard chemotherapy. 12. With gemcitabine and cisplatin as first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. 13. With fluoropyrimidine- and platinum-based chemotherapy as first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- 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.