Sintilimab injection | China Drugs List

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Medicine type: Biologic
Therapeutic area: Oncology
Indications recorded in the public source: Classical Hodgkin lymphoma: for relapsed or refractory disease after at least two lines of systemic chemotherapy. Nonsquamous NSCLC: (1) with pemetrexed and platinum-based chemotherapy as first-line treatment of unresectable locally advanced or metastatic disease with negative EGFR mutation and ALK status; (2) with bevacizumab, pemetrexed and cisplatin for EGFR mutation-positive locally advanced or metastatic disease after failure of an EGFR TKI. Squamous NSCLC: with gemcitabine and platinum-based chemotherapy as first-line treatment of unresectable locally advanced or metastatic disease. Hepatocellular carcinoma: with bevacizumab as first-line treatment of unresectable or metastatic disease without prior systemic treatment. Esophageal squamous cell carcinoma: with paclitaxel and a platinum agent, or a fluoropyrimidine and a platinum agent, as first-line treatment of unresectable locally advanced, recurrent or metastatic disease. Gastric or gastroesophageal junction adenocarcinoma: with fluoropyrimidine- and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent or metastatic disease. Endometrial cancer: with fruquintinib for advanced mismatch repair-proficient (pMMR) disease after failure of systemic anticancer therapy, when curative surgery or radiotherapy is unsuitable. This endometrial indication has conditional approval based on a surrogate endpoint; clinical endpoint data are not yet available, and efficacy and safety require further post-approval confirmation. Full approval depends on an ongoing confirmatory randomized controlled trial establishing clinical benefit with sintilimab plus fruquintinib. Colon cancer: with ipilimumab N01 as neoadjuvant treatment of resectable stage IIB-III MSI-H or dMMR colon cancer. This indication has conditional approval based on a surrogate endpoint; clinical endpoint data are not yet available, and efficacy and safety require further confirmation. Full approval depends on ongoing confirmatory trials establishing a significant clinical benefit over standard treatment. Renal cell carcinoma: with fruquintinib for locally advanced or metastatic disease after failure of a VEGFR TKI, provided that a PD-1 or PD-L1 inhibitor was not used as first-line treatment.
Indication source and scope: 2026-05-25
Prescribing-information limitations: Complete official prescribing information obtained. Mainland China label.
China availability status: Historical Chinese approval verified; current continuous market availability has not been checked for every product.
Overseas status: Market-by-market verification pending.
Insurance classification: Included in national insurance (Category B)
Insurance edition: 2025 edition; effective 1 January 2026
Insurance restrictions: Restricted to: Classical Hodgkin lymphoma: for relapsed or refractory disease after at least two lines of systemic chemotherapy. Nonsquamous NSCLC: (1) with pemetrexed and platinum-based chemotherapy as first-line treatment of unresectable locally advanced or metastatic disease with negative EGFR mutation and ALK status; (2) with bevacizumab, pemetrexed and cisplatin for EGFR mutation-positive locally advanced or metastatic disease after failure of an EGFR TKI. Squamous NSCLC: with gemcitabine and platinum-based chemotherapy as first-line treatment of unresectable locally advanced or metastatic disease. Hepatocellular carcinoma: with bevacizumab as first-line treatment of unresectable or metastatic disease without prior systemic treatment. Esophageal squamous cell carcinoma: with paclitaxel and cisplatin, or fluorouracil and cisplatin, as first-line treatment of unresectable locally advanced, recurrent or metastatic disease. Gastric or gastroesophageal junction adenocarcinoma: with fluoropyrimidine- and platinum-based chemotherapy as first-line treatment of unresectable locally advanced, recurrent or metastatic disease. Endometrial cancer: with fruquintinib for advanced mismatch repair-proficient (pMMR) disease after failure of systemic anticancer therapy, when curative surgery or radiotherapy is unsuitable.
Insurance period: 2026-01-01 to 2027-12-31
Insurance verification notes: Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.

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