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多替拉韦钠片

同成分其他剂型 / 写法:多替拉韦钠分散片(5)
原研 / 参比—已获批仿制企业5 家(其中过评或按新注册分类批准 5 家)在审申请3 件 · 3 家首家仿制获批2023-09-05不予批准2 件

已获批企业取化学药品目录集收录(按持有人归并、取最早批准日),加上 NMPA 已送达批准但目录集尚未收录的; 「过评」= 通过质量和疗效一致性评价,按化学药品新注册分类批准的仿制药视同过评。排序即获批先后(第几家)。 企业按持有人(工商现名)归并;「本企业后续申报」列同一持有人此后的补充申请、再注册,补充申请同时列了原持有人的 (常见于持有人变更)标「↪ 承接」,为本站按申请人推断。

已获批仿制 5 家

#持有人首次批准类别批准文号受理号 / BE 试验本企业后续申报
1齐鲁制药有限公司2023-09-05新注册分类仿制国药准字H20234126CYHS2200638 CTR20213057
2上海迪赛诺医药集团股份有限公司2025-09-30新注册分类仿制国药准字H20255617CYHS2401058 CTR20233292
3Hetero Labs Limited2026-02-10新注册分类仿制国药准字HJ20260023JYHS2400014
4江苏艾迪药业集团股份有限公司2026-03-10新注册分类仿制国药准字H20263536CYHS2404038 CTR20234240 CTR20241665
5奥锐特药业股份有限公司2026-05-07新注册分类仿制国药准字H20264225CYHS2402993 CTR20232561 CTR20234319补充申请 1(最近 CYHB2500817 2025-04-24)

审评中 3 件

受理号申请人类型受理审评状态已受理天数BE 试验
JYHB2500595ViiV Healthcare B.V.、Delpharm Poznan S.A补充申请2025-11-06在审346
CYHS2601019成都倍特药业股份有限公司仿制上市申请2026-04-30排队待审评171CTR20253373 CTR20254613
CYHS2602412东北制药集团沈阳第一制药有限公司仿制上市申请2026-09-24排队待审评24

不予批准

全部历史申报 (44 件,含补充申请、再注册)
受理号申请人类型受理结论
JTH2600169Delpharm Poznan S.A、ViiV Healthcare B.V.、葛兰素史克(中国)投资有限公司其他2026-08-10已批准
JYHB2600392ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2026-07-16已批准
JYHB2600393ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2026-07-16已批准
JYHB2600370ViiV Healthcare B.V.、Delpharm Poznan S.A补充申请2026-07-07已批准
JYHZ2500138ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)、GlaxoSmithKline (China) Investment Company Limited再注册2025-07-10已批准
JYHZ2500139ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)、GlaxoSmithKline (China) Investment Company Limited再注册2025-07-10已批准
CYHS2501764安徽贝克生物制药有限公司仿制上市申请2025-05-15
CYHB2500817奥锐特药业股份有限公司、江苏和晨药业有限公司补充申请2025-04-24已批准
JYHZ2500096ViiV Healthcare B.V.、Delpharm Poznan S.A、GlaxoSmithKline (China) Investment Company Limited再注册2025-04-24已批准
JYHB2500082ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2025-02-20已批准
JYHB2500083ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2025-02-20已批准
JYHB2500016ViiV Healthcare B.V.、Delpharm Poznan S.A补充申请2025-01-10已批准
CYHS2404038江苏艾迪药业集团股份有限公司仿制上市申请2024-11-23已批准
CYHS2402993扬州奥锐特药业有限公司、江苏和晨药业有限公司仿制上市申请2024-09-10已批准
CYHS2401058上海迪赛诺医药集团股份有限公司仿制上市申请2024-04-10已批准
JYHS2400014Hetero Labs Limited、Hetero Pharma (Beijing) Co., Limited仿制上市申请2024-04-02已批准
JYHB2400125ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2024-03-15已批准
JYHB2400126ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2024-03-15已批准
JYHB2300538ViiV Healthcare B.V.、Delpharm Poznan S.A补充申请2023-09-20已批准
JYHB2300044ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2023-01-13已批准
JYHB2300045ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2023-01-13已批准
JYHB2200686ViiV Healthcare B.V.、Delpharm Poznan S.A补充申请2022-12-31已批准
CYHS2200638齐鲁制药有限公司仿制上市申请2022-04-24已批准
JYHB2101115ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2021-05-26已批准
JYHB2101106ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2021-05-20已批准
JYHB2101107ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2021-05-20已批准
JYHB2002627ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2020-12-21
JYHB2002628ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2020-12-21
JYHB2001841ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2020-09-22
JYHZ2000188ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)再注册2020-08-10
JYHZ2000189ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)再注册2020-08-10
JYHZ2000175ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)再注册2020-07-11
JYHB2000691ViiV Healthcare B.V.、GlaxoSmithKline Pharmaceuticals SA补充申请2020-07-06已批准
JYHB2000262ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2020-03-30
JYHB2000101ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2020-03-21
JYHB2000102ViiV Healthcare B.V.、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2020-03-21
JTH1800205Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)、ViiV Healthcare UK Limited、葛兰素史克(中国)投资有限公司其他2018-06-20
JTH1800206Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)、ViiV Healthcare UK Limited、葛兰素史克(中国)投资有限公司其他2018-06-20
JYHB1800246ViiV Healthcare UK Limited、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2018-03-12
JYHB1800247ViiV Healthcare UK Limited、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2018-03-12
JYHB1600799ViiV Healthcare UK Limited、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)补充申请2016-06-22
JXHS1500037ViiV Healthcare UK Limited、Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)新药上市申请2015-04-24
JXHL1400159ViiV Healthcare UK Limited临床申请2014-05-22
JXHL1400107ViiV Healthcare UK Limited临床申请2014-04-17