托莱西单抗注射液 | China Drugs ListTafolecimab 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。
- 企业
- 信达生物制药（苏州）有限公司Innovent Biologics (Suzhou) Co., Ltd.
- 药品类型
- 生物药Biologic
- 治疗领域
- 心血管Cardiovascular
- 公开来源记录的适应症
- 说明书的适应症描述为:在控制饮食的基础上,与他汀类药物、或者与他汀类药物及其他降脂疗法联合用药,用于在接受中等剂量或中等以上剂量他汀类药物治疗后,仍无法达到低密度脂蛋白胆固醇( LDL-C )目标的原发性高胆固醇血症 (包括杂合子型家族性和非家族性高胆固醇血症)和混合型血脂异常的成人患者,以降低低密度脂蛋白胆固醇( LDL- C )、总胆固醇( TC )、载脂蛋白 B ( ApoB )水平。As an adjunct to diet, in combination with a statin, or with a statin and other lipid-lowering therapy, for adults with primary hypercholesterolemia (including heterozygous familial and nonfamilial hypercholesterolemia) or mixed dyslipidemia who have not achieved their LDL-C target despite moderate-dose or higher-dose statin treatment, to lower LDL-C, total cholesterol (TC) and apolipoprotein B (ApoB).
- 适应症来源与口径
- 来源日期： 2024, 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): 2024, 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
- 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
- 限接受中等剂量或中等以上剂量他汀类药物治疗后，仍无法达到低密度脂蛋白胆固醇(LDL-C)目标的原发性高胆固醇血症(包括杂合子型家族性和非家族性高胆固醇血症)和混合型血脂异常的成人患者。Limited to adults with primary hypercholesterolemia (including heterozygous familial and nonfamilial hypercholesterolemia) or mixed dyslipidemia who have not achieved their LDL-C target despite moderate-dose or higher-dose statin treatment.
- 医保期限
- 2025-01-01 至 2026-12-312025-01-01 to 2026-12-31
- 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.