中国生物制品上市药品专利信息公示 | China Approved Biologics Patent Information

最近更新 | Last Updated:  2022-05-25

Product Name / Description

药品名称 / 描述

Marketing Authorization Holder

上市许可持有人

Dosage and Administration

剂量和给药

Patent No.

相关专利号

Claim No.

权利要求项编号

Patent Type

专利类型

Expiration

保护期届满日2

Freeze-dried Live Attenuated Hepatitis A Vaccine

冻干甲型肝炎减毒活疫苗


Live attenuated hepatitis A vaccine

甲型肝炎减毒活疫苗

Changsheng Biotechnology

长春生物

0.5 mL

Injection | 注射剂

ZL200810051441.9 1 Medical use

医药用途

2028-11-17
Daratumumab

达雷妥尤单抗


CD38 antibody

CD38抗体

Genmab

根马布

1800 mg

Injection | 注射剂

ZL200680017915.7

 

 

1-4, 6, 8-10, 13, 29, 30, 34-36, 40, 41 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-03-22
ZL201710164800.0 19, 20, 22, 25-27, 29, 30 Medical use

医药用途

2026-03-22
Dupilumab

度普利尤单抗


IL-4 Receptor antibody

IL-4受体抗体

Regeneron Pharmaceuticals

再生元制药

200 mg

Injection | 注射剂

ZL200980143007.6 1-5, 13, 16 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-10-27
ZL201410018529.6 1-8, 16 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-10-27
Semaglutide

司美格鲁肽

(OZEMPIC®, 诺和泰®)


GLP-1

GLP-1化合物

Novo Nordisk

诺和诺德

1.34 mg/mL (3 mL), 1.34 mg/mL (1.5 mL)

Prefilled injection pen | 预填充注射笔

ZL200680006674.6 1, 3, 4 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-03-20
Velaglucerase alfa

维拉苷酶α

(VPRIV®, 维葡瑞 ®)


Velaglucerase alfa

维拉苷酶α

Takeda Pharmaceutical

武田药品

400 U

Injection | 注射剂

ZL201510580649.X 27 Medical use

医药用途

2030-07-27
Ainocoagulant alfa

艾诺凝血素α

(ALPROLIX®,赛玖凝®)


Coagulation factor IX-Fc fusion protein

凝血因子IX-Fc融合蛋白

Bioverativ Therapeutics 250, 500, 1000, 2000 IU

Injection | 注射剂

ZL200480019188.9 1, 4, 6-8, 12, 14, 30, 70-71, 81, 83, 85, 88, 90-95, 97-98, 105, 107, 112, 115, 117, 119, 122-124 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-05-06
ZL201110082150.8 1,4-7, 10, 15, 17, 19-20, 24, 27, 30-31, 36, 38, 41, 44-46, 49, 51, 53, 59 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-05-06
ZL201410443460.1 1, 16-18, 21-26, 32, 41-42, 44, 46 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-05-06
Guselkumab

古塞奇尤单抗


IL-23 antibody

IL-23抗体

Janssen Biotech詹森生物 100 mg

Injection | 注射剂

 

ZL200680053546.7 2, 4-8, 21-25 Sequence of active biological ingredients

生物制品活性成分的序列结构

2026-12-27
ZL201210297501.1 1-5 Sequence of active biological ingredients

生物制品活性成分的序列结构

2026-12-27
Golimumab

戈利木单抗


TNF antibody

TNF抗体

Janssen Biotech詹森生物 50 mg

Injection | 注射剂

ZL01816960.0 1-3, 10-12 Sequence of active biological ingredients

生物制品活性成分的序列结构

2021-08-06
ZL201010156291.5 1-8 Medical use

医药用途

2021-08-06
Evolocumab

依洛尤单抗

(REPATHA®, 瑞百安®)


PCSK9 antibody

PCSK9抗体

Amgen Inc.

安进公司

140 mg

Injection | 注射剂

 

ZL201380035382.5 17-20 Medical use

医药用途

2033-05-02
ZL200880113475.4 1-7, 9-14, 16-17, 25-29 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2028-08-21
ZL201280034417.9 2-23, 27, 33-35, 37, 39, 40, 42, 43, 47-52, 54-58, 60 Medical use

医药用途

2023-05-09
Lanadelumab

拉那利尤单抗

(AKHZYRO®, 达泽优®)


Plasma kallikrein binding protein

血浆前激肽释放酶结合蛋白

Takeda Pharmaceutical

武田药品

300 mg

Injection | 注射剂

ZL201280011286.2 1-3, 5, 6, 9 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2032-01-05
ZL201610164388.8 1-3 Sequence of active biological ingredients

生物制品活性成分的序列结构

2320-01-05
Insulin Glargine

甘精胰岛素

(LANTUS®, 来得时 ®)


Insulin Glargine Injection

甘精胰岛素制剂

Sanofi

赛诺菲

450 U

Injection | 注射剂

 

ZL201480020095.1 1-15, 17-18, 20-32 Medical use

医药用途

2034-04-01
Disitamab

维迪西妥单抗

(AIDIXI®, 爱地希®)


Anti-HER2 ADC

抗HER2抗体及其缀合物

RemeGen

荣昌生物

60 mg

Injection | 注射剂

 

ZL201480006648.8 1, 14 Sequence of active biological ingredients

生物制品活性成分的序列结构

2034-11-18
Telitacicept

泰它西普

(RC18, 泰爱®)


TACI-Fc fusion protein

TACI-Fc融合蛋白

RemeGen

荣昌生物

80 mg

Injection | 注射剂

ZL200710111162.2 1, 9 Sequence of active biological ingredients

生物制品活性成分的序列结构

2027-06-15
Artemisia annua pollen allergen sublingual drops

黄花蒿花粉变应原舌下滴剂

(畅皓®)


Drug group containing Artemisia pollen allergens

含有蒿属花粉变应原的药物组

Wolwo Biopharma

我武生物

50, 256, 1280, 6400,

32000 BU

Drop | 滴剂

200910147470.X 39-41 Medical use

医药用途

2029-06-08
13-valent pneumococcal polysaccharide conjugate vaccine

13价肺炎球菌多糖结合疫苗


13-valent pneumococcal polysaccharide conjugate composition

13价肺炎球菌多糖-蛋白结合物组合物

Walvax Biotechnology

沃森生物

0.5 mL

Injection | 注射剂

ZL201810053602.1 1-3 Medical use

医药用途

2038-01-19
Tislelizumab

替雷利珠单抗

(百泽安®)


PD1 antibody

PD1抗体

 

BeiGene

百济神州

100mg

Injection | 注射剂

ZL201380079581.6 3-7, 8-14 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2033-09-12
ZL201710207300 .0 1, 2 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2033-09-12
ZL201710208535.1 1 Sequence of active biological ingredients

生物制品活性成分的序列结构

2033-09-12
ZL201810552595 .X 1 Sequence of active biological ingredients

生物制品活性成分的序列结构

2033-09-12
Camrelizumab, 卡瑞利珠单抗

(AiRuiKa™, 艾瑞卡®)


PD-1 antibody

PD-1抗体

Jiangsu Hengrui Medicine

恒瑞医药

200 mg

Injection | 注射剂

ZL201480011008.6 1, 6-11, 21-26 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

 

2034-11-14
Sintilimab

信迪利单抗注射液

(TYVYT®, 达伯舒®)


PD-1 antibody

PD-1抗体

Innovent Biologics

信达生物

100 mg

Injection | 注射剂

ZL201680040482.0 1, 3, 5, 7, 9, 11, 16, 18, 23, 24, 27, 29, 30 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2036-08-09
培集成干扰素α-2注射液

(派益生®)


Peginterferon alfacon-2

培集成干扰素α-2

Beijing Kawin Technology

凯因科技

0.15 mg

Injection | 注射剂

ZL201410146151.8 1 Sequence of active biological ingredients

生物制品活性成分的序列结构

2030-10-25
Mecapegfilgrastim

硫培非格司亭注射液

(艾多®)


Pegylated recombinant G-CSF

聚乙二醇化重组人粒细胞刺激因子

 

Jiangsu Hengrui Medicine

恒瑞医药

6 mg

Injection | 注射剂

ZL200610142737.2 1-4, 6, 10, 12 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-10-30
Conbercept

康柏西普眼用注射液

(LUMITIN®, 朗沐®)


VEGF receptor fusion with Fc

VEGF

受体与Fc融合蛋白

Chengdu Kanghong Pharmaceutical Group

康弘药业

10 mg/mL

Injection | 注射剂

ZL200510073595.4 1, 5 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2025-06-06
人干扰素α1b注射液

(运德素®)


Recombinant human IFN-α1b

重组人干扰素α1b

Tri-Prime Gene

三元基因

6, 10, 20, 30, 40, 50μg,

Injection | 注射剂

ZL200410069390.4 1-3 Medical use

医药用途

2024-07-22
德谷门冬双胰岛素注射液

(RYZODEG®, 诺和佳®)


Insulin degludec and insulin aspart

德谷门冬双胰岛素

Novo Nordisk

诺和诺德

300 U

Injection | 注射剂

ZL200480021733.8 1-4, 8-10 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-07-22
Insulin degludec,

德谷胰岛素注射液

(TRESIBA®, 诺和达®)


Long-acting insulin

长效基础胰岛素类似物

Novo Nordisk诺和诺德 300 U

Injection | 注射剂

ZL200480021733.8 1-4;

8-10

Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-07-22
Satralizumab

萨特利珠单抗注射液

(ENSPRYNG®, 安适平®)


IL-6 receptor antibody

IL-6受体单抗

Roche

罗氏

120 mg

Injection | 注射剂

ZL200980100709.6 1-3 Sequence of active biological ingredients

生物制品活性成分的序列结构

2029-09-25
Obinutuzumab

奥妥珠单抗注射液

(GAZYVA®, 佳罗华®)


CD20 antibody

CD20单抗

Roche

罗氏

1000 mg

Injection | 注射剂

ZL200480039946.3 1-14, 24-26 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-11-05
Denosumab

地舒单抗注射液

(XGEVA®, 安加维®)


RANKL antibody

核因子-κB受体活化因子配体单抗

Amgen

安进

60 mg

Injection | 注射剂

ZL201310052370.5 1-25, 27-28 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2022-06-24
Dupilumab

度普利尤单抗注射液

(DUPIXENT®, 達必妥®)


High affinity IL-4 receptor antibody

IL-4受体的高亲和性抗体

Regeneron

再生元

300 mg

Injection | 注射剂

ZL200980143007.6 1-5, 13, 16 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-10-27
Regeneron

再生元

300 mg

Injection | 注射剂

ZL201410018529.6 1-8, 16 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-10-27
Ustekinumab

乌司奴单抗注射液

(STELARA®, 喜达诺®)


IL-12 antibody

抗IL-12抗体

Janssen-Cilag

詹森

45, 90, 130 mg Injection | 注射剂 ZL200810100025.3 1-6, 8-13 Sequence of active biological ingredients

生物制品活性成分的序列结构

2021-08-06
Atezolizumab

阿替利珠单抗注射液

(TECENTRIQ®, 泰圣奇®)


PD-L1 antibody

抗-PD-L1抗体


PD-L1 antibody

抗-PD-L1抗体


PDL1 antibody formulation

抗PDL1抗体配制剂

Roche

罗氏

1200 mg

Injection | 注射剂

ZL200980149532.9 1-8, 19, 40, 43, 53 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-12-08
Roche

罗氏

1200 mg

Injection | 注射剂

ZL201410743500.4 1-13, 15, 34-40 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-12-08
Roche

罗氏

1200 mg

Injection | 注射剂

ZL201480064099.X 36 Medical use

医药用途

2034-09-26
Guselkumab

古塞奇尤单抗注射液

(TREMFYA®, 特诺雅®)


IL-23 antibody

抗IL-23抗体

Janssen-Cilag

詹森

100 mg

Injection | 注射剂

ZL200680053546.7 2, 4-8, 21-25 Sequence of active biological ingredients

生物制品活性成分的序列结构

2026-12-27
Janssen-Cilag

詹森

100 mg

Injection | 注射剂

ZL201210297501.1 1-5 Sequence of active biological ingredients

生物制品活性成分的序列结构

2026-12-27
Alirocumab

阿利西尤单抗注射液

(PRALUENT®, 波立达®)


High affinity PCSK9 antibody

抗PCSK9的高亲和力抗体


Methods of reducing lipoprotein with PCSK9 inhibitors

用PCSK9抑制剂降低脂蛋白的方法

Regeneron

再生元

75, 150 mg Injection | 注射剂 ZL200980150206.X 1-2, 8-9 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2029-12-15
Regeneron

再生元

75, 150 mg Injection | 注射剂 ZL201280044795.5 1-8, 11-12, 15-23 Medical use

医药用途

2032-09-12
Durvalumab

度伐利尤单抗注射液

(IMFINZI®, 英飞凡®)


B7-H1 binding agent

针对B7-H1的靶向结合剂

AstraZeneca

阿斯利康

120, 500 mg Injection | 注射剂 ZL201080053042.1 1-4, 6-8, 10-12 Sequence of active biological ingredients

生物制品活性成分的序列结构

2030-11-24
Ixekizumab

依奇珠单抗注射液

(TALTZ®, 拓咨®)


IL-17 antibody

抗 IL-17 抗体

Eli Lilly

礼来

 

80 mg

Injection | 注射剂

 

ZL200680046605.8 1-7 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-12-05
ZL201380012452.5 1-10 Medical use

医药用途

2033-03-01
Daratumumab

达雷妥尤单抗注射液

(DARZALEX®, 兆珂®)


CD38 antibody

CD38抗体

Janssen-Cilag

詹森

100, 400 mg Injection | 注射剂 ZL200680017915.7 1-4, 6, 8-10, 13, 29-30, 33-36, 40 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-03-22
100, 400 mg Injection | 注射剂 ZL201710164800.0 19-20, 22, 24-27, 29 Medical use

医药用途

2026-03-22
Recombinant Zoster Vaccine (CHO cell)

重组带状疱疹疫苗(CHO细胞)

(SHINGRIX®, 欣安立适®)


Vaccine

疫苗

GSK

葛兰素史克

 

IgE 50 μg

Injection | 注射剂

ZL201210552767.6 1-4 Medical use

医药用途

2026-03-01
Denosumab

地舒单抗注射液


OPGL antibody

抗OPGL抗体

Amgen

安进

120 mg

Injection | 注射剂

ZL201310052370.5 1-25, 27-32 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2022-06-24
Secukinumab

司库奇尤单抗注射液

(COSENTYX®, 可善挺®)


Interleukin (IL)-17A antibody

IL-17A抗体

Novartis

诺华

150 mg

Injection | 注射剂

ZL200580026569.4 1-5 Sequence of active biological ingredients

生物制品活性成分的序列结构

2025-08-04
Dulaglutide

度拉糖肽注射液

(TRULICITY®, 度易达®)


GLP-1 analogue fusion protein

GLP-1 类似物融合蛋白质

Eli Lilly

礼来

 

0.75, 1.5 mg Injection | 注射剂 ZL200480015953.X 1-4, 6-7, 9, 10 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2024-06-10
0.75, 1.5 mg Injection | 注射剂 ZL201010508567.1 1, 2 Sequence of active biological ingredients

生物制品活性成分的序列结构

2024-06-10
0.75, 1.5 mg Injection | 注射剂 ZL200580035597.2 1-4, 8 Medical use

医药用途

2025-12-15
Pertuzumab帕妥珠单抗注射液

(PERJETA®, 帕捷特®)


HER2 antibody

针对HER2的抗体

健泰科生物

 

420 mg

Injection | 注射剂

 

ZL201210006776.5 1-6, 8-11, 13, 15, 19-27 Medical use

医药用途

2025-06-15
ZL200680013738.5 1-2, 5-14 Medical use

医药用途

2026-02-21
ZL200980111007.8 9, 10 Medical use

医药用途

2029-01-28
ZL200580031905.4 12, 13 Medical use

医药用途

2025-07-15
Emicizumab

艾美赛珠单抗注射液

(HEMLIBRA®, 舒友立乐®)


Multispecific antigen-binding molecule (coagulation factor VIII replaceable)

代替凝血因子VIII 的多特异性抗原结合分子

Chugai

中外制药

 

30, 60, 105, 150 mg Injection | 注射剂

 

ZL201180065133.1 1, 13 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2031-11-17
ZL201610299812.X 1, 9-12 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2031-11-17
Evolocumab

依洛尤单抗注射液

(REPATHA®, 瑞百安®)


Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody针对人前蛋白转化酶枯草溶菌素kexin 9型的抗体

Amgen

安进

 

140 mg

Injection | 注射剂

 

ZL201380035382.5 17-20 Medical use

医药用途

2033-05-02
ZL200880113475.4 1-7, 9-14, 16-17, 25-29 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2028-08-21
ZL201280034417.9 2-23, 27, 33-35, 37, 39, 40, 42, 43, 47-52, 54-58, 60 Medical use

医药用途

2032-05-09
Pembrolizumab

帕博利珠单抗注射液

(KEYTRUDA®, 可瑞达®)


PD-1 antibody

针对PD-1的抗体

Merck

默沙东

100 mg

Injection | 注射剂

ZL200880103544.3 1-4, 13 Sequence of active biological ingredients

生物制品活性成分的序列结构

2028-06-13
Nivolumab

纳武利尤单抗注射液

(OPDIVO®, 欧狄沃®)


PD-1 antibody

针对PD-1的抗体

Ono Pharmaceutical

小野薬品

 

40, 100 mg Injection | 注射剂 ZL200680023860.0 1-3, 11-13, 15-16 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-05-02
ZL201210554886.5 1-15, 28-30 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2026-05-02
Idarucizumab

依达赛珠单抗注射液

(PRAXBIND®, 泰毕安®)


Anticoagulant antibody

抗凝血剂抗体

Boehringer Ingelheim

宝灵家殷格翰

2.5 g

Injection | 注射剂

ZL201180006616.4 1, 2-3, 9 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2031-01-20
Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine

九价人乳头瘤病毒疫苗(酿酒酵母)

(GARDASIL 9®, 佳达修9®)


9-valent human papillomavirus (9vHPV) vaccine

九价宫颈癌(HPV)疫苗

Merck

默沙东

 

0.5 mL

Injection | 注射剂

 

ZL200480007725.8 1, 12 Sequence of active biological ingredients

生物制品活性成分的序列结构

2024-03-19
ZL200480028106.7 1 Sequence of active biological ingredients

生物制品活性成分的序列结构

2024-09-24
ZL03806347.6 21, 23 Medical use

医药用途

2023-03-17
ZL200580019515.5 19, 20 Medical use

医药用途

2025-06-14
Tocilizumab

托珠单抗注射液

(ACTEMRA®, 雅美罗®)


Interleukin-6 receptor (IL-6R) antibody

针对白介素6受体的抗体

Chugai

中外制药

 

80, 200,

400 mg

Injection | 注射剂

 

ZL02807784.9 1-4, 6-7, 9-21, 23-24, 26-27, 29 Medical use

医药用途

2022-04-02
ZL200480011401.1 10-18 Medical use

医药用途

2024-04-28
ZL201511004468.9 7-12 Medical use

医药用途

2024-04-28
Golimumab

戈利木单抗注射液

(SIMPONI®, 欣普尼®)


TNF-α antibody

针对TNF-α的抗体

Janssen Biologics

詹森生物

 

50 mg

Injection | 注射剂

ZL01816960.0 1-3, 10-12 Sequence of active biological ingredients

生物制品活性成分的序列结构

2021-08-06
50 mg

Injection | 注射剂

ZL201010156291.5 1-8 Medical use

医药用途

2021-08-06
Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine

四价人乳头瘤病毒疫苗(酿酒酵母)

(GARDASIL®, 佳达修®)


4-valent human papillomavirus (4vHPV) vaccine

四价宫颈癌(HPV)疫苗

 

Merck

默沙

 

0.5 mL

Injection | 注射剂

 

ZL03806347.6 21, 23 Medical use

医药用途

2023-03-17
ZL200580019515.5 19, 20 Medical use

医药用途

2025-06-14
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

13价肺炎球菌多糖结合疫苗

(PREVENAR 13®, 沛儿®)


Multivalent pneumococcal polysaccharide conjugate composition

多价肺炎球菌多糖-蛋白质缀合物组合物

Wyeth

惠氏

0.5 mL

Injection | 注射剂

ZL200680017776.8 6-7 Medical use

医药用途

2026-03-30
Influenza Vaccine (Split Virion)

流感病毒裂解疫苗


Method for virus splitting and inactivation by using influenza vaccine (split virion)

一种人用流感病毒裂解疫苗的病毒裂解灭活方法

Changchun

长春生物

0.5 mL

Injection | 注射剂

ZL201210129270.3 1 Medical use

医药用途

2032-04-27
Cenegermin

塞奈吉明滴眼液

(OXERVATE™)


Recombinant human nerve growth factor (rhNGF)

重组人神经生长因子

Dompé farmaceutici S.p.A. 1 mL:20 μg

Eye drop | 滴眼液

ZL201280062855.6 1-3, 4-27 Sequence of active biological ingredients;

Medical use

生物制品活性成分的序列结构; 医药用途

2032-12-18

 

1    China has implemented a patent linkage system in the fourth amendments to its patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic of China (2020)).  A patent registration platform has been set up for the Marketing Authorization Holder (MAH) to register certain drug product-related patent information.  For biologics, patents may be registered include those directed to the active pharmaceutical ingredient (API) sequence/structure information and medical use.

2    Excluding any patent term adjustment or patent term extension.  The fourth amendment to the Chinese patent law introduces the patent term adjustment (PTA) and patent term extension (PTE).